Leading US Expert Anthony Fauci: ‘Cautiously Optimistic’ About COVID-19 Vaccine Approval This Month Or Next 21/10/2020 Raisa Santos Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the World Conference on Lung Health America’s most-respected public health guru, Dr Anthony Fauci, said Wednesday that he is “cautiously optimistic’ that at least one COVID-19 vaccine will prove to be safe and effective later this month or next. While warning that “one can never guarantee a safe and effective vaccine… we are cautiously optimistic that we will have one based on preliminary encouraging data,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, speaking at a session of the weeklong 51st Union World Conference on Lung Health. “We project that by November and December, we’ll have the answer, and then by the end of the year in the beginning of 2021 will be able to distribute doses of vaccines that have been pre ordered and made – prior to even knowing they would work.” Priority for distribution of the first vaccine doses that are approved should go to healthcare workers and those with underlying conditions, he emphasized. Fauci spoke at a World Conference panel on “the Hope for a Vaccine”; the panel also featured speakers from the World Health Organization, the Geneva Graduate Institute and the Barcelona Institute of Global Health. Three key technologies underlying the leading vaccine candidates In his review of both infection and research developments in the United States, Fauci, noted that the US government has been supporting the development and rollout of six vaccine candidates, with the US government investing billions of dollars in clinical trials and production plans. Three separate platforms are being tested including: included vaccine technologies that use messenger RNA (mRNA); viral vectors, such as adenovirus; and protein subunits to provoke immune response. Five of the six vaccine candidates that have been supported by the US government are currently in Phase 3 trials, two since late July, with the number of Phase 3 trial participants ranging from 30,000 to 60,000, depending on the design of the trial. Fauci hailed the “major financial risk” taken by government investments that not only funded vaccine research, but also manufacturing and pre-purchase agreements, in order to “save time without compromising safety or compromising scientific integrity.” United States Infection Rates Far Outpaced Europe’s – Although Right Now They Are Converging In terms of infection trends, Fauci’s review highlighted the stark differences that have been seen between the United States and Europe in terms of their response to the virus and the overall pattern of infections. The United States did not shut down both outdoor and indoor spaces such as workplaces, parks, and grocery stores. And so, the baseline of US infections never really dipped to the low levels seen by the European Union over the summer, he said. Although as rates now resurge in Europe, they are in fact converging with those seen right now in the US. In the US, rapid reopening the country and the economy in the late spring, especially in the south states of Florida, Georgia, Texas, Arizona, and southern California led to a summer-time peak in new cases of up to about 70,000 a day; this has now plateaued to around 40,000 to 50,000 cases a day – but may still rise yet again this winter. “As we’re getting into the cooler weather, we’re getting more and more cases so this looks like we’re going to have a difficult fall and winter,” Fauci said, adding that a potentially new surge in the US would now begin from a much higher overall rate. US Sees Huge Asymptomatic Transmission and Big Racial and Ethnic Disparities “Hope for Vaccine” speakers, including from left clockwise: Kate O’Brien, Malebona Precious Matsoso, Vasee Moorthy, Jeff Lazarus, Suerie Moon A continuing feature of the virus – and challenge to its containment – are the very high-rates of asymptomatic transmission of the virus, he added. “You don’t need to be coughing or sneezing, to transmit the infection. An important component that distinguishes this infection from so many other viral infections is that about 40-55% of people are asymptomatic.” 80% of people infected have mild to moderate manifestations that don’t require immediate hospitalization, while the other 15-20% have severe or critical manifestations of the virus that have a wide variability, where up to 25% of severe cases require mechanical ventilation. Along with that, he said: “One of the characteristics of this disease that is most disturbing is the extraordinary racial and ethnic disparities.” Minorities groups such as African Americans, Latinos, Native Americans, Alaskan Natives and Pacific Islanders have a higher incidence of getting infected, in the US, he noted. This is primarily because of the nature of their jobs as frontline workers in the community, which means they are exposed to many more people in the course of their day. It is also because of the higher incidence and prevalence of many underlying health conditions conditions among the same groups, which often live in more socio-economically deprived communities. And these conditions, in turn, lead to more severe outcomes from COVID-19. “Including old age, which increases the risk of severe COVID-19 illness, obesity is emerging as an important co-morbidity, as well as diabetes, chronic obstructive pulmonary disease, and a variety of heart conditions,” said Fauci. After Approval, Vaccines Still Need to Demonstrate “Worthwhile Efficacy” – Vaccine Hesitancy Needs to be Addressed Vasee Moorthy, Infectious Diseases Physician, Immunologist and Product Developer, Office of the Research and Development at the WHO Even if a vaccine is demonstrated to be safe and effective, many more questions will still need to be answered about how effective the vaccine may really be. There are several ways that vaccines can demonstrate “worthwhile efficacy,” said Vasee Moorthy, an R&D specialist at WHO. “Always bear in mind that we only know the real vaccine efficacy much later, when the vaccine has been given to many more people. We don’t want to inappropriately declare a winner based on one of the early results,” he said. Phase 3 trials, and their follow-up, need to be looking at enough “endpoints” or indicators of disease and severe disease, between the groups randomized to receive the vaccine and those that received placebo. With limited information on safety, she applauded the decision of pharma companies to “pause and reassess the situation whenever there are adverse outcomes during clinical trials.” Adverse effects have so far caused pauses in two trials, run by AstraZeneca and Johnson&Johnson. The importance of combating vaccine hesitancy was also underlined, by Jeff Lazarus, Associate Professor at the University of Barcelona. To combat hesitancy, trust in government needed to be strong, government health communication needed to be consistent and flexible, and leaders need to avoid the politicization of COVID-19 related issues – a pitfall into which many countries have fallen. “Communication should be two way with informing the public and promoting mutual understanding and acceptance. Trust in government and health officials can improve public cooperation with pandemic measures,” Lazarus said. Vaccine Allocation – Rich Countries Should Refrain From Consuming More Than Their ‘Fair Share’ Vaccine deals by country; Suerie Moon, Co-Director at Global Health Centre, Geneva Graduate Institute With socio-economic, racial and ethnic disparities already being exacerbated by Sars-CoV-2 on a global scale, more equitable distribution of vaccine solutions will be all the more critical, said Suerie Moon, Co-Director of Research at The Graduate Institute of International and Development, who called for proper allocation of the vaccine. “In order to [ensure equitable access] you need a number of countries, particularly those who are wealthy and those that have the production capacity to refrain from trying to consume more than their fair share of vaccines,” Moon stated, remarking on reports that the US, Canada, UK, Japan, and the European Union have each secured access to a basket of vaccines that would provide enough volume to cover 100% of their populations, although it remains unclear which vaccines will prove safe and effective. It is likely that China also has adequate volume and manufacturing capacity to meet its domestic needs. She expressed hopes, nonetheless, that the there will be potentially a larger supply of vaccines that initially anticipated to be approved and manufactured in near term. And certain pharma companies have also made commitments to ensuring vaccine supply and technology transfer to other countries with less capacity, she said. The WHO and Gavi, Vaccine Alliance co-sponsored COVAX vaccine facility, is meanwhile a positive expression of multilateralism – drawing firm commitments to make purchase through the pool from over 171 countries representing 90% of the world’s population. That example of “vaccine multilateralism” will hopefully support a division of available vaccine supplies in a way that is more ethical and equitable, while cautioning that: “Vaccine nationalism and multilateralism operate side by side in a complex environment where it remains uncertain which vaccines will be successful, who will be getting access to them, and at what price.” Another “piece of the puzzle”, she added, is the need for “more emphasis on, and funding, for technology transfer on open data sharing platforms. That, she said, would ultimately help “expand the overall size of the pie.” “There’s no point in having everybody fight for a small pie,” she warned. “That’s not going to serve anyone’s needs. So I do think that in addition to money on the table; in addition to fair allocation, frameworks, equitable allocation frameworks, we need to make that pie bigger. We need the biggest eaters at the table to wait – until everyone has had a bite.” Image Credits: R Santos/HP Watch. The Pandemic Will End – But Tuberculosis, Tobacco and Air Pollution Will Continue To Steal Our Global Breath – Unless We Reimagine The Future 20/10/2020 Svĕt Lustig Vijay The COVID-19 pandemic will end at some point. But TB, tobacco use, air pollution and other lung diseases will continue to “steal the breath and life of millions of people every year”, unless we reimagine the future, said WHO’s director-general Dr Tedros Adhanon Ghebreyesus, appearing at the opening of the 51st Union World Conference On Lung Health in an all-start lineup with former US President Bill Clinton and Crown Princess Akishino of Japan . “COVID-19 is reminding us all that life is fragile, and health is the most precious commodity on Earth. Together, we must harness the same urgency and solidarity with which the world is fighting COVID-19 to make sure everyone everyone can breathe freely and cleanly,” he said. Bill Clinton, former US President As COVID-19 shatters livelihoods, cripples economies and claims the lives of over a million people, the conference comes at an “important time” to redefine the future of the planet, said Clinton, another keynote speaker at The Union’s 100th anniversary event. It was exactly a century ago that the Paris-based organization was founded in 1920 to end all suffering from tuberculosis (TB) and other lung diseases. Even today, despite the progress made since, TB remains the world’s largest infectious disease killer, claiming 4,000 lives a day. “This crisis also gives us a chance to totally reimagine what our future will look like, what our societies, our economies and our healthcare systems [will] look like and how we relate to one another,” Clinton said Tuesday, at the weeklong event. Despite being on a virtual platform, this year’s conference features speakers from 82 countries around the world. “The path to an optimal post-COVID world is unlikely to be simple and quick. But we cannot simply revert to the status quo,” Clinton said. The Union’s executive director José Luis Castro` On a positive note, the world still has the capacity to deliver the Sustainable Development Goals (SDGs) by 2030 despite the pandemic, emphasized The Union’s executive director José Luis Castro. Achieving SDG targets in time is especially feasible for TB, which is still the leading cause of death worldwide, even though it is preventable, treatable and curable. According to Castro, the SDGs are not ideas, but commitments world leaders must uphold “no matter what”. “Today, we have more knowledge, more technology, more resources and more connectivity than humanity has had at any other time in history,” said Castro. “We have the power to see that the Sustainable Development Goals are not just good ideas that get put aside when a crisis arises. But that these are commitments that we have made to each other, no matter what. It is up to us.” Now is not the time to slow down, added Shannon Hadder, deputy executive director of UNAIDS, in her call for more aggressive investments in preventive therapy, infection control, health worker safety, scaled and modern contact tracing, and sufficient social and economic support to achieve it. Given that HIV is the leading cause of death in TB patients, testing for TB in HIV patients and maintaining HIV treatment is particularly important, said Hadder. Even before COVID-19, 50% of TB cases in HIV-positive people were under the radar, she said, adding that a mere six month interruption in HIV treatment could trigger half a million additional TB deaths in Sub-Saharan Africa alone. Building Back Better – Governments Must Foster Honesty & Integrity Dr Tedros Adhanom Ghebreyesus, WHO director-general Apart from transforming health care towards a more inclusive, affordable and equitable model, heads of state must restore their citizens’ trust through honesty, integrity and evidence-based decision-making, said Dr. Tedros. Fostering trust in the general public seems quite urgent given that almost 30% of the world is unlikely to accept a coronavirus vaccine – even if it were proven to be safe and effective – concluded a Nature survey just this Tuesday. The survey was based on responses from over 13,000 randomly selected adults across 19 countries that were heavily affected by COVID-19. Governments must also be held accountable for the decisions they make, added Castro, noting that by March 2021, world leaders will only have two years left to deliver their pledge to ensure that 30 million people have access to TB treatment. According to Castro, there is still time to turn these promises into reality. “We cannot allow the pandemic to become an excuse for failing to deliver on the commitments we have made to end tobacco and air pollution,” added Dr Tedros. “Quite the opposite. The pandemic is showing us why we must work with even more determination, collaboration and innovation to meet those commitments.” Image Credits: The Union. Resistance To COVID-19 Vaccine Running So High It Would Twart Efforts To Reach Community Immunity – New Study 20/10/2020 Madeleine Hoecklin Skepticism over COVID-19 vaccines is rising as vaccine candidates continue to advance with Phase 3 clinical trials. Current levels of public reluctance to be immunized with a forthcoming COVID-19 vaccine are so high that the resistance would in fact pre-empt many countries from reaching sufficient levels of “community” immunity, according to a new study of vaccine hesitancy among people in 19 of the most COVID-impacted countries around the world. The study of 13,436 people, published in Nature Medicine on Tuesday, also reveals that “vaccine hesitancy” is growing worldwide, although are also significant variations in vaccine acceptance between countries and regions. On average, only 71.5 percent of respondents would definitely take a safe and effective COVID-19 vaccine. This is well below the bar of near universal acceptance (typically 95% for other diseases) that is usually needed to build so-called ‘herd immunity’, and means that there are tens of millions of potential vaccine avoiders globally. “It will be tragic if we develop safe and effective vaccines and people refuse to take them. We need to develop a robust and sustained effort to address vaccine hesitancy and rebuild public confidence in the personal, family and community benefits of immunizations,” warned Scott C. Ratzan, a study co-author. “We found that the problem of vaccine hesitancy is strongly related with a lack of trust in government. Vaccine confidence was invariably higher in countries where trust was higher,” said Jeffrey V. Lazarus, a study coordinator. Vaccine hesitancy, defined by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization as a “delay in acceptance or refusal of vaccination despite availability of vaccination services,” could inhibit global control of the pandemic. The study included respondents over the age of 18 across 19 of the top 35 countries most impacted by COVID-19 in terms of cases per million population. Some 71.5 percent of respondents reported that they would likely take a vaccine if it was proven safe and effective, whereas some 14 percent of people would hesitate and 14 percent would refuse altogether. Countries with the highest vaccine acceptance rates, over 80 percent, were predominantly in Asia – China and South Korea – with a strong association between trust in government and willingness to accept a COVID-19 vaccine. Mexico and the United States had rates of around 75-76 percent. Meanwhile, middle-income countries, including Brazil, India, and South Africa, also had a moderate to higher tendency towards vaccine acceptance (75 for India and 85 percent for Brazil). The countries with the lowest vaccine acceptance rates were European countries and Canada, with Russia, Poland, and France displaying the least acceptance – where only 54 to 58 percent of respondents reporting that they would take the COVID-19 vaccine. Percentages of respondents in each country that agree to take a COVID-19 vaccine if it is “proven safe, accepted and available.” Variation within national populations were strikingly linked to age, gender, education level, and income. For instance: Older respondents over the age of 65 were more likely to accept a vaccine compared to younger people; Men were less likely than women to agree to get vaccinated; People with higher education levels (bachelor’s or postgraduate degree) were more likely to accept the vaccine; Respondents earning over $32 a day were more likely than those earning less than $2 a day to take the COVID-19 vaccine. In countries with medium and high COVID-19 incidence and mortality, respondents had a higher likelihood of vaccine acceptance. Interestingly enough, respondents across all countries reported that they would be less likely to get the COVID-19 vaccine if it were mandated by employers, as it could be perceived as limiting freedom of choice and forcefully imposing the employers’ interests. Building Public Trust in COVID-19 Vaccines – Complex Endeavour Needing Consistent Messaging “Trust is an intrinsic, and potentially modifiable, component of successful uptake of a COVID-19 vaccine,” states the study’s authors, from the Barcelona Institute for Global Health, the London School of Hygiene and Tropical Medicine and the City University of New York. Building trust and addressing vaccine hesitancy are complex endeavors, requiring clear and consistent communication from governments and public health institutions to improve vaccine literacy and public confidence, they also advise. The COVID-19 pandemic has been accompanied by an infodemic that has flourished in widespread fear and uncertainty. Misinformation has increased rapidly, particularly on potential COVID-19 vaccines. This, along with the politicization of the vaccine development and approval process in many countries, could contribute to intensifying vaccine hesitancy. Since June, when the survey was conducted, populations have become even more skeptical of COVID-19 vaccines, according to more recent polls. A survey conducted by the New York Times and Siena College in mid-October found that 33 percent of US respondents would definitely not or probably not take a vaccine, after approval by the US Food and Drug Administration (FDA). Similarly, a poll conducted by STAT and The Harris Poll found that the percentage of the US public willing to get vaccinated decreased from mid-August to early October, from 69 percent to 58 percent. “Vaccine misinformation can be as contagious and as dangerous as the disease it helps to spread,” said Dr. Tedros Adhanom Ghebreyesus, Director General of the WHO at the Global Vaccination Summit in September. In the context of the current dynamic and changing landscape, continued research on vaccine hesitancy globally is needed to help governments, policymakers, health professionals, and international organizations design vaccination programs and organize communication campaigns. “What is true about the potential public acceptance of a COVID-19 vaccine is equally true for a TB vaccine should we get one that is more effective – there will be considerable work to do by administrators to educate communities about its benefits,” said Grania Brigden, Director of the TB Department at the International Union Against Tuberculosis and Lung Disease (The Union) – where news about the study’s findings were launched during their 51st global conference. Image Credits: Kerry Cullinan , Nature Medicine. ‘We Are Family’ – WHO Launches Collaboration With Kim Sledge To Reproduce Global Version Of Unity Anthem 19/10/2020 Raisa Santos Mock album cover for ‘We Are Family’ campaign, featuring WHO DG Tedros Adhanom Ghebreyesus, Mike Ryan and Maria Van Kerkhove of the Health Emergencies campaign. WHO is launching a collaboration with R&B Vocalist Kim Sledge of “We Are Family” fame to reproduce her signature album in a campaign aimed to promote global solidarity for COVID-19, and raise funds to battle COVID-19. The campaign, which will be coordinated by The World We Want Foundation, is to feature a special edition cover of the classic song “We Are Family” in a worldwide viral video that would include versions of the song by people ranging from celebrities to frontline health heroes, political leaders and members of the public – singing together to support global public health needs, including COVID-19. American singer Kim Sledge “Together we are unity strong, and we can do this as a family because we are one big global family,” Sledge, of the legendary music group Sister Sledge, said, speaking at a WHO press conference on Monday. Sledge said that she embarked on this initiative after being motivated by those around her who are looking for ways to end the crisis, including her husband and daughter, who both work as doctors on the COVID-19 frontlines. The video campaign invites people to star in the music video by recording themselves with their close family and friends singing the song and sharing on their social media channels. In order to submit sing-along videos to the special edition of the We Are Family song, members of the public can: Record yourself singing We Are Family either alone, or with friends and family, whilst observing physical distancing guidelines. Share the video on your favourite social media channel, with the hashtag #WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof. Upload your video to www.unitystrong.com. If you want your video to be considered for inclusion in the global We Are Family video, you will need to share your video by Monday, 30 November 2020. Video clips will be selected based on age, geographical diversity, and appropriate physical distancing if the video includes groups of people beyond immediate family members and correct handwashing if singing along to the song while washing hands. More details including Terms & Conditions can be found here www.unitystrong.com. Part of the proceeds from the new song, to be released on November 9, are to be donated to the WHO Foundation to support the response to COVID-19, as well as to other health promotion initiatives worldwide. Video Release To Coincide With World Health Assembly Autumn Session The release will coincide with the resumption of the 73rd session of the World Health Assembly, November 9-14. The WHA began in a two-day special virtual session in May to discuss the COVID-19 crisis, and then was adjourned until the autumn. Sledge is also scheduled to perform for the WHA alongside singers from New York to Tonga. Sledge is collaborating with Natasha Mudhar, founder of The World We Want Foundation, and another driving force behind the #WeAreFamily campaign. Natasha Mudhar, Founder of The World We Want Said Mudhar: “We Are Family is one of the most instantly recognizable anthems in the world. The song carries such an inspiring message of unity and solidarity. “What is so powerful about music and what we feel will be so powerful about this particular campaign, the song, and the video is that it will not only just entertain, but inspire action. And that’s just really bringing everybody together.” Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, emphasizes in his closing remarks, “This campaign is more than a song. It’s a call to action for collaboration and kindness, and the reminder of the strength of family and the importance of coming together to help others in times of need. “It represents that to heal the world from this pandemic, we must come together like never before in national unity and global solidarity with a family, and as humankind. We have more in common with one another, than we would ever dare to believe.” This comes after his announcement that 184 countries have now joined the COVAX initiative, Ecuador and Paraguay having joined this weekend. Tedros reiterated the importance of sharing vaccines equitably around the world by safeguarding high risk populations and working together to share life-saving health supplies globally. “Let us use this anthem as a family, to help unite us, unite the world, and together, we wouldn’t just beat this pandemic. We will take on, and successfully tackle other global challenges like air pollution and the climate crisis. So join us in the We Are One Family campaign. Because together we can do anything we put our minds to: national unity and global solidarity. We are one family.” Image Credits: R Santos/HP Watch. US Has Experienced Highest COVID-19 Mortality Rates Among 18 OECD Countries 19/10/2020 Madeleine Hoecklin Doctors and hospital staff in Florida put on personal protective equipment in the COVID-19 unit. Along with recording the most deaths from COVID-19 of any country in the world, the US has ranked highest among leading OECD countries in deaths per capita from the infectious disease, according to a recent study published in the Journal of the American Medical Association (JAMA) by researchers from Harvard University and the University of Pennsylvania. The United States also has experienced consistently high COVID-19 mortality rates since the country saw its first surge of cases in May, more so than other countries with high mortality rates. The JAMA study last week suggests that the comparatively higher death rates may be linked to the US’ weak public health infrastructure and a decentralized and inconsistent pandemic response. An additional factor may be the high level of pre-existing conditions among Americans who have comparatively high rates of obesity, hypertension and diabetes as compared to other developed countries. The authors compared US COVID-19 related deaths and excess all-cause mortality across 18 countries in the Organization for Economic Co-operation and Development, from the start of the pandemic until September 2020. The best performing countries in the study were South Korea, Japan and Australia, with fewer than 5 deaths per 100,000 people. Countries with moderate death rates included Norway, Finland, and Austria, with 5-25 deaths per 100,000 people. The worst performing countries with the highest mortality rates were the United States, Belgium, and Spain – with over 25 deaths per 100,000. The study also examined excess all-cause mortality, per capita, during the pandemic period to capture indirect pandemic effects. COVID-19 mortality comparison between countries with low, moderate, and high mortality. US Rates Were Initially Low – But Consistently High Since May The US’ mortality rate in the early spring was lower than other high mortality countries, with 60.3 deaths per 100,000 compared to 86.8/100,000 in Belgium and 65.0/100,000 in Spain. However, by mid-May, the US had exceeded all countries in deaths per 100,000, with 36.9 compared to 12.4 in Belgium and 8.6 in Spain. In September, the US’ death rates (60.3/100,000) were more comparable with other high morality countries, including Italy (59.1/100,000) and Belgium (86.8/100,000). In May and June, the US had death rates more than double most other high mortality countries, despite the implementation of prevention measures. The patterns observed in the study were also found for excess all-cause mortality, with the US leading in excess all-cause mortality since May. Since September, death rates have increased in several countries, with Peru now leading in COVID-19 deaths per 100,000 (105.35), compared to Spain (72.29), and the US (67.14). Number of deaths per 100,000 population in the 20 most affected countries as of October 19. Image Credits: Flickr – National Guard, Journal of American Medical Association, Johns Hopkins. WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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The Pandemic Will End – But Tuberculosis, Tobacco and Air Pollution Will Continue To Steal Our Global Breath – Unless We Reimagine The Future 20/10/2020 Svĕt Lustig Vijay The COVID-19 pandemic will end at some point. But TB, tobacco use, air pollution and other lung diseases will continue to “steal the breath and life of millions of people every year”, unless we reimagine the future, said WHO’s director-general Dr Tedros Adhanon Ghebreyesus, appearing at the opening of the 51st Union World Conference On Lung Health in an all-start lineup with former US President Bill Clinton and Crown Princess Akishino of Japan . “COVID-19 is reminding us all that life is fragile, and health is the most precious commodity on Earth. Together, we must harness the same urgency and solidarity with which the world is fighting COVID-19 to make sure everyone everyone can breathe freely and cleanly,” he said. Bill Clinton, former US President As COVID-19 shatters livelihoods, cripples economies and claims the lives of over a million people, the conference comes at an “important time” to redefine the future of the planet, said Clinton, another keynote speaker at The Union’s 100th anniversary event. It was exactly a century ago that the Paris-based organization was founded in 1920 to end all suffering from tuberculosis (TB) and other lung diseases. Even today, despite the progress made since, TB remains the world’s largest infectious disease killer, claiming 4,000 lives a day. “This crisis also gives us a chance to totally reimagine what our future will look like, what our societies, our economies and our healthcare systems [will] look like and how we relate to one another,” Clinton said Tuesday, at the weeklong event. Despite being on a virtual platform, this year’s conference features speakers from 82 countries around the world. “The path to an optimal post-COVID world is unlikely to be simple and quick. But we cannot simply revert to the status quo,” Clinton said. The Union’s executive director José Luis Castro` On a positive note, the world still has the capacity to deliver the Sustainable Development Goals (SDGs) by 2030 despite the pandemic, emphasized The Union’s executive director José Luis Castro. Achieving SDG targets in time is especially feasible for TB, which is still the leading cause of death worldwide, even though it is preventable, treatable and curable. According to Castro, the SDGs are not ideas, but commitments world leaders must uphold “no matter what”. “Today, we have more knowledge, more technology, more resources and more connectivity than humanity has had at any other time in history,” said Castro. “We have the power to see that the Sustainable Development Goals are not just good ideas that get put aside when a crisis arises. But that these are commitments that we have made to each other, no matter what. It is up to us.” Now is not the time to slow down, added Shannon Hadder, deputy executive director of UNAIDS, in her call for more aggressive investments in preventive therapy, infection control, health worker safety, scaled and modern contact tracing, and sufficient social and economic support to achieve it. Given that HIV is the leading cause of death in TB patients, testing for TB in HIV patients and maintaining HIV treatment is particularly important, said Hadder. Even before COVID-19, 50% of TB cases in HIV-positive people were under the radar, she said, adding that a mere six month interruption in HIV treatment could trigger half a million additional TB deaths in Sub-Saharan Africa alone. Building Back Better – Governments Must Foster Honesty & Integrity Dr Tedros Adhanom Ghebreyesus, WHO director-general Apart from transforming health care towards a more inclusive, affordable and equitable model, heads of state must restore their citizens’ trust through honesty, integrity and evidence-based decision-making, said Dr. Tedros. Fostering trust in the general public seems quite urgent given that almost 30% of the world is unlikely to accept a coronavirus vaccine – even if it were proven to be safe and effective – concluded a Nature survey just this Tuesday. The survey was based on responses from over 13,000 randomly selected adults across 19 countries that were heavily affected by COVID-19. Governments must also be held accountable for the decisions they make, added Castro, noting that by March 2021, world leaders will only have two years left to deliver their pledge to ensure that 30 million people have access to TB treatment. According to Castro, there is still time to turn these promises into reality. “We cannot allow the pandemic to become an excuse for failing to deliver on the commitments we have made to end tobacco and air pollution,” added Dr Tedros. “Quite the opposite. The pandemic is showing us why we must work with even more determination, collaboration and innovation to meet those commitments.” Image Credits: The Union. Resistance To COVID-19 Vaccine Running So High It Would Twart Efforts To Reach Community Immunity – New Study 20/10/2020 Madeleine Hoecklin Skepticism over COVID-19 vaccines is rising as vaccine candidates continue to advance with Phase 3 clinical trials. Current levels of public reluctance to be immunized with a forthcoming COVID-19 vaccine are so high that the resistance would in fact pre-empt many countries from reaching sufficient levels of “community” immunity, according to a new study of vaccine hesitancy among people in 19 of the most COVID-impacted countries around the world. The study of 13,436 people, published in Nature Medicine on Tuesday, also reveals that “vaccine hesitancy” is growing worldwide, although are also significant variations in vaccine acceptance between countries and regions. On average, only 71.5 percent of respondents would definitely take a safe and effective COVID-19 vaccine. This is well below the bar of near universal acceptance (typically 95% for other diseases) that is usually needed to build so-called ‘herd immunity’, and means that there are tens of millions of potential vaccine avoiders globally. “It will be tragic if we develop safe and effective vaccines and people refuse to take them. We need to develop a robust and sustained effort to address vaccine hesitancy and rebuild public confidence in the personal, family and community benefits of immunizations,” warned Scott C. Ratzan, a study co-author. “We found that the problem of vaccine hesitancy is strongly related with a lack of trust in government. Vaccine confidence was invariably higher in countries where trust was higher,” said Jeffrey V. Lazarus, a study coordinator. Vaccine hesitancy, defined by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization as a “delay in acceptance or refusal of vaccination despite availability of vaccination services,” could inhibit global control of the pandemic. The study included respondents over the age of 18 across 19 of the top 35 countries most impacted by COVID-19 in terms of cases per million population. Some 71.5 percent of respondents reported that they would likely take a vaccine if it was proven safe and effective, whereas some 14 percent of people would hesitate and 14 percent would refuse altogether. Countries with the highest vaccine acceptance rates, over 80 percent, were predominantly in Asia – China and South Korea – with a strong association between trust in government and willingness to accept a COVID-19 vaccine. Mexico and the United States had rates of around 75-76 percent. Meanwhile, middle-income countries, including Brazil, India, and South Africa, also had a moderate to higher tendency towards vaccine acceptance (75 for India and 85 percent for Brazil). The countries with the lowest vaccine acceptance rates were European countries and Canada, with Russia, Poland, and France displaying the least acceptance – where only 54 to 58 percent of respondents reporting that they would take the COVID-19 vaccine. Percentages of respondents in each country that agree to take a COVID-19 vaccine if it is “proven safe, accepted and available.” Variation within national populations were strikingly linked to age, gender, education level, and income. For instance: Older respondents over the age of 65 were more likely to accept a vaccine compared to younger people; Men were less likely than women to agree to get vaccinated; People with higher education levels (bachelor’s or postgraduate degree) were more likely to accept the vaccine; Respondents earning over $32 a day were more likely than those earning less than $2 a day to take the COVID-19 vaccine. In countries with medium and high COVID-19 incidence and mortality, respondents had a higher likelihood of vaccine acceptance. Interestingly enough, respondents across all countries reported that they would be less likely to get the COVID-19 vaccine if it were mandated by employers, as it could be perceived as limiting freedom of choice and forcefully imposing the employers’ interests. Building Public Trust in COVID-19 Vaccines – Complex Endeavour Needing Consistent Messaging “Trust is an intrinsic, and potentially modifiable, component of successful uptake of a COVID-19 vaccine,” states the study’s authors, from the Barcelona Institute for Global Health, the London School of Hygiene and Tropical Medicine and the City University of New York. Building trust and addressing vaccine hesitancy are complex endeavors, requiring clear and consistent communication from governments and public health institutions to improve vaccine literacy and public confidence, they also advise. The COVID-19 pandemic has been accompanied by an infodemic that has flourished in widespread fear and uncertainty. Misinformation has increased rapidly, particularly on potential COVID-19 vaccines. This, along with the politicization of the vaccine development and approval process in many countries, could contribute to intensifying vaccine hesitancy. Since June, when the survey was conducted, populations have become even more skeptical of COVID-19 vaccines, according to more recent polls. A survey conducted by the New York Times and Siena College in mid-October found that 33 percent of US respondents would definitely not or probably not take a vaccine, after approval by the US Food and Drug Administration (FDA). Similarly, a poll conducted by STAT and The Harris Poll found that the percentage of the US public willing to get vaccinated decreased from mid-August to early October, from 69 percent to 58 percent. “Vaccine misinformation can be as contagious and as dangerous as the disease it helps to spread,” said Dr. Tedros Adhanom Ghebreyesus, Director General of the WHO at the Global Vaccination Summit in September. In the context of the current dynamic and changing landscape, continued research on vaccine hesitancy globally is needed to help governments, policymakers, health professionals, and international organizations design vaccination programs and organize communication campaigns. “What is true about the potential public acceptance of a COVID-19 vaccine is equally true for a TB vaccine should we get one that is more effective – there will be considerable work to do by administrators to educate communities about its benefits,” said Grania Brigden, Director of the TB Department at the International Union Against Tuberculosis and Lung Disease (The Union) – where news about the study’s findings were launched during their 51st global conference. Image Credits: Kerry Cullinan , Nature Medicine. ‘We Are Family’ – WHO Launches Collaboration With Kim Sledge To Reproduce Global Version Of Unity Anthem 19/10/2020 Raisa Santos Mock album cover for ‘We Are Family’ campaign, featuring WHO DG Tedros Adhanom Ghebreyesus, Mike Ryan and Maria Van Kerkhove of the Health Emergencies campaign. WHO is launching a collaboration with R&B Vocalist Kim Sledge of “We Are Family” fame to reproduce her signature album in a campaign aimed to promote global solidarity for COVID-19, and raise funds to battle COVID-19. The campaign, which will be coordinated by The World We Want Foundation, is to feature a special edition cover of the classic song “We Are Family” in a worldwide viral video that would include versions of the song by people ranging from celebrities to frontline health heroes, political leaders and members of the public – singing together to support global public health needs, including COVID-19. American singer Kim Sledge “Together we are unity strong, and we can do this as a family because we are one big global family,” Sledge, of the legendary music group Sister Sledge, said, speaking at a WHO press conference on Monday. Sledge said that she embarked on this initiative after being motivated by those around her who are looking for ways to end the crisis, including her husband and daughter, who both work as doctors on the COVID-19 frontlines. The video campaign invites people to star in the music video by recording themselves with their close family and friends singing the song and sharing on their social media channels. In order to submit sing-along videos to the special edition of the We Are Family song, members of the public can: Record yourself singing We Are Family either alone, or with friends and family, whilst observing physical distancing guidelines. Share the video on your favourite social media channel, with the hashtag #WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof. Upload your video to www.unitystrong.com. If you want your video to be considered for inclusion in the global We Are Family video, you will need to share your video by Monday, 30 November 2020. Video clips will be selected based on age, geographical diversity, and appropriate physical distancing if the video includes groups of people beyond immediate family members and correct handwashing if singing along to the song while washing hands. More details including Terms & Conditions can be found here www.unitystrong.com. Part of the proceeds from the new song, to be released on November 9, are to be donated to the WHO Foundation to support the response to COVID-19, as well as to other health promotion initiatives worldwide. Video Release To Coincide With World Health Assembly Autumn Session The release will coincide with the resumption of the 73rd session of the World Health Assembly, November 9-14. The WHA began in a two-day special virtual session in May to discuss the COVID-19 crisis, and then was adjourned until the autumn. Sledge is also scheduled to perform for the WHA alongside singers from New York to Tonga. Sledge is collaborating with Natasha Mudhar, founder of The World We Want Foundation, and another driving force behind the #WeAreFamily campaign. Natasha Mudhar, Founder of The World We Want Said Mudhar: “We Are Family is one of the most instantly recognizable anthems in the world. The song carries such an inspiring message of unity and solidarity. “What is so powerful about music and what we feel will be so powerful about this particular campaign, the song, and the video is that it will not only just entertain, but inspire action. And that’s just really bringing everybody together.” Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, emphasizes in his closing remarks, “This campaign is more than a song. It’s a call to action for collaboration and kindness, and the reminder of the strength of family and the importance of coming together to help others in times of need. “It represents that to heal the world from this pandemic, we must come together like never before in national unity and global solidarity with a family, and as humankind. We have more in common with one another, than we would ever dare to believe.” This comes after his announcement that 184 countries have now joined the COVAX initiative, Ecuador and Paraguay having joined this weekend. Tedros reiterated the importance of sharing vaccines equitably around the world by safeguarding high risk populations and working together to share life-saving health supplies globally. “Let us use this anthem as a family, to help unite us, unite the world, and together, we wouldn’t just beat this pandemic. We will take on, and successfully tackle other global challenges like air pollution and the climate crisis. So join us in the We Are One Family campaign. Because together we can do anything we put our minds to: national unity and global solidarity. We are one family.” Image Credits: R Santos/HP Watch. US Has Experienced Highest COVID-19 Mortality Rates Among 18 OECD Countries 19/10/2020 Madeleine Hoecklin Doctors and hospital staff in Florida put on personal protective equipment in the COVID-19 unit. Along with recording the most deaths from COVID-19 of any country in the world, the US has ranked highest among leading OECD countries in deaths per capita from the infectious disease, according to a recent study published in the Journal of the American Medical Association (JAMA) by researchers from Harvard University and the University of Pennsylvania. The United States also has experienced consistently high COVID-19 mortality rates since the country saw its first surge of cases in May, more so than other countries with high mortality rates. The JAMA study last week suggests that the comparatively higher death rates may be linked to the US’ weak public health infrastructure and a decentralized and inconsistent pandemic response. An additional factor may be the high level of pre-existing conditions among Americans who have comparatively high rates of obesity, hypertension and diabetes as compared to other developed countries. The authors compared US COVID-19 related deaths and excess all-cause mortality across 18 countries in the Organization for Economic Co-operation and Development, from the start of the pandemic until September 2020. The best performing countries in the study were South Korea, Japan and Australia, with fewer than 5 deaths per 100,000 people. Countries with moderate death rates included Norway, Finland, and Austria, with 5-25 deaths per 100,000 people. The worst performing countries with the highest mortality rates were the United States, Belgium, and Spain – with over 25 deaths per 100,000. The study also examined excess all-cause mortality, per capita, during the pandemic period to capture indirect pandemic effects. COVID-19 mortality comparison between countries with low, moderate, and high mortality. US Rates Were Initially Low – But Consistently High Since May The US’ mortality rate in the early spring was lower than other high mortality countries, with 60.3 deaths per 100,000 compared to 86.8/100,000 in Belgium and 65.0/100,000 in Spain. However, by mid-May, the US had exceeded all countries in deaths per 100,000, with 36.9 compared to 12.4 in Belgium and 8.6 in Spain. In September, the US’ death rates (60.3/100,000) were more comparable with other high morality countries, including Italy (59.1/100,000) and Belgium (86.8/100,000). In May and June, the US had death rates more than double most other high mortality countries, despite the implementation of prevention measures. The patterns observed in the study were also found for excess all-cause mortality, with the US leading in excess all-cause mortality since May. Since September, death rates have increased in several countries, with Peru now leading in COVID-19 deaths per 100,000 (105.35), compared to Spain (72.29), and the US (67.14). Number of deaths per 100,000 population in the 20 most affected countries as of October 19. Image Credits: Flickr – National Guard, Journal of American Medical Association, Johns Hopkins. WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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Resistance To COVID-19 Vaccine Running So High It Would Twart Efforts To Reach Community Immunity – New Study 20/10/2020 Madeleine Hoecklin Skepticism over COVID-19 vaccines is rising as vaccine candidates continue to advance with Phase 3 clinical trials. Current levels of public reluctance to be immunized with a forthcoming COVID-19 vaccine are so high that the resistance would in fact pre-empt many countries from reaching sufficient levels of “community” immunity, according to a new study of vaccine hesitancy among people in 19 of the most COVID-impacted countries around the world. The study of 13,436 people, published in Nature Medicine on Tuesday, also reveals that “vaccine hesitancy” is growing worldwide, although are also significant variations in vaccine acceptance between countries and regions. On average, only 71.5 percent of respondents would definitely take a safe and effective COVID-19 vaccine. This is well below the bar of near universal acceptance (typically 95% for other diseases) that is usually needed to build so-called ‘herd immunity’, and means that there are tens of millions of potential vaccine avoiders globally. “It will be tragic if we develop safe and effective vaccines and people refuse to take them. We need to develop a robust and sustained effort to address vaccine hesitancy and rebuild public confidence in the personal, family and community benefits of immunizations,” warned Scott C. Ratzan, a study co-author. “We found that the problem of vaccine hesitancy is strongly related with a lack of trust in government. Vaccine confidence was invariably higher in countries where trust was higher,” said Jeffrey V. Lazarus, a study coordinator. Vaccine hesitancy, defined by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization as a “delay in acceptance or refusal of vaccination despite availability of vaccination services,” could inhibit global control of the pandemic. The study included respondents over the age of 18 across 19 of the top 35 countries most impacted by COVID-19 in terms of cases per million population. Some 71.5 percent of respondents reported that they would likely take a vaccine if it was proven safe and effective, whereas some 14 percent of people would hesitate and 14 percent would refuse altogether. Countries with the highest vaccine acceptance rates, over 80 percent, were predominantly in Asia – China and South Korea – with a strong association between trust in government and willingness to accept a COVID-19 vaccine. Mexico and the United States had rates of around 75-76 percent. Meanwhile, middle-income countries, including Brazil, India, and South Africa, also had a moderate to higher tendency towards vaccine acceptance (75 for India and 85 percent for Brazil). The countries with the lowest vaccine acceptance rates were European countries and Canada, with Russia, Poland, and France displaying the least acceptance – where only 54 to 58 percent of respondents reporting that they would take the COVID-19 vaccine. Percentages of respondents in each country that agree to take a COVID-19 vaccine if it is “proven safe, accepted and available.” Variation within national populations were strikingly linked to age, gender, education level, and income. For instance: Older respondents over the age of 65 were more likely to accept a vaccine compared to younger people; Men were less likely than women to agree to get vaccinated; People with higher education levels (bachelor’s or postgraduate degree) were more likely to accept the vaccine; Respondents earning over $32 a day were more likely than those earning less than $2 a day to take the COVID-19 vaccine. In countries with medium and high COVID-19 incidence and mortality, respondents had a higher likelihood of vaccine acceptance. Interestingly enough, respondents across all countries reported that they would be less likely to get the COVID-19 vaccine if it were mandated by employers, as it could be perceived as limiting freedom of choice and forcefully imposing the employers’ interests. Building Public Trust in COVID-19 Vaccines – Complex Endeavour Needing Consistent Messaging “Trust is an intrinsic, and potentially modifiable, component of successful uptake of a COVID-19 vaccine,” states the study’s authors, from the Barcelona Institute for Global Health, the London School of Hygiene and Tropical Medicine and the City University of New York. Building trust and addressing vaccine hesitancy are complex endeavors, requiring clear and consistent communication from governments and public health institutions to improve vaccine literacy and public confidence, they also advise. The COVID-19 pandemic has been accompanied by an infodemic that has flourished in widespread fear and uncertainty. Misinformation has increased rapidly, particularly on potential COVID-19 vaccines. This, along with the politicization of the vaccine development and approval process in many countries, could contribute to intensifying vaccine hesitancy. Since June, when the survey was conducted, populations have become even more skeptical of COVID-19 vaccines, according to more recent polls. A survey conducted by the New York Times and Siena College in mid-October found that 33 percent of US respondents would definitely not or probably not take a vaccine, after approval by the US Food and Drug Administration (FDA). Similarly, a poll conducted by STAT and The Harris Poll found that the percentage of the US public willing to get vaccinated decreased from mid-August to early October, from 69 percent to 58 percent. “Vaccine misinformation can be as contagious and as dangerous as the disease it helps to spread,” said Dr. Tedros Adhanom Ghebreyesus, Director General of the WHO at the Global Vaccination Summit in September. In the context of the current dynamic and changing landscape, continued research on vaccine hesitancy globally is needed to help governments, policymakers, health professionals, and international organizations design vaccination programs and organize communication campaigns. “What is true about the potential public acceptance of a COVID-19 vaccine is equally true for a TB vaccine should we get one that is more effective – there will be considerable work to do by administrators to educate communities about its benefits,” said Grania Brigden, Director of the TB Department at the International Union Against Tuberculosis and Lung Disease (The Union) – where news about the study’s findings were launched during their 51st global conference. Image Credits: Kerry Cullinan , Nature Medicine. ‘We Are Family’ – WHO Launches Collaboration With Kim Sledge To Reproduce Global Version Of Unity Anthem 19/10/2020 Raisa Santos Mock album cover for ‘We Are Family’ campaign, featuring WHO DG Tedros Adhanom Ghebreyesus, Mike Ryan and Maria Van Kerkhove of the Health Emergencies campaign. WHO is launching a collaboration with R&B Vocalist Kim Sledge of “We Are Family” fame to reproduce her signature album in a campaign aimed to promote global solidarity for COVID-19, and raise funds to battle COVID-19. The campaign, which will be coordinated by The World We Want Foundation, is to feature a special edition cover of the classic song “We Are Family” in a worldwide viral video that would include versions of the song by people ranging from celebrities to frontline health heroes, political leaders and members of the public – singing together to support global public health needs, including COVID-19. American singer Kim Sledge “Together we are unity strong, and we can do this as a family because we are one big global family,” Sledge, of the legendary music group Sister Sledge, said, speaking at a WHO press conference on Monday. Sledge said that she embarked on this initiative after being motivated by those around her who are looking for ways to end the crisis, including her husband and daughter, who both work as doctors on the COVID-19 frontlines. The video campaign invites people to star in the music video by recording themselves with their close family and friends singing the song and sharing on their social media channels. In order to submit sing-along videos to the special edition of the We Are Family song, members of the public can: Record yourself singing We Are Family either alone, or with friends and family, whilst observing physical distancing guidelines. Share the video on your favourite social media channel, with the hashtag #WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof. Upload your video to www.unitystrong.com. If you want your video to be considered for inclusion in the global We Are Family video, you will need to share your video by Monday, 30 November 2020. Video clips will be selected based on age, geographical diversity, and appropriate physical distancing if the video includes groups of people beyond immediate family members and correct handwashing if singing along to the song while washing hands. More details including Terms & Conditions can be found here www.unitystrong.com. Part of the proceeds from the new song, to be released on November 9, are to be donated to the WHO Foundation to support the response to COVID-19, as well as to other health promotion initiatives worldwide. Video Release To Coincide With World Health Assembly Autumn Session The release will coincide with the resumption of the 73rd session of the World Health Assembly, November 9-14. The WHA began in a two-day special virtual session in May to discuss the COVID-19 crisis, and then was adjourned until the autumn. Sledge is also scheduled to perform for the WHA alongside singers from New York to Tonga. Sledge is collaborating with Natasha Mudhar, founder of The World We Want Foundation, and another driving force behind the #WeAreFamily campaign. Natasha Mudhar, Founder of The World We Want Said Mudhar: “We Are Family is one of the most instantly recognizable anthems in the world. The song carries such an inspiring message of unity and solidarity. “What is so powerful about music and what we feel will be so powerful about this particular campaign, the song, and the video is that it will not only just entertain, but inspire action. And that’s just really bringing everybody together.” Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, emphasizes in his closing remarks, “This campaign is more than a song. It’s a call to action for collaboration and kindness, and the reminder of the strength of family and the importance of coming together to help others in times of need. “It represents that to heal the world from this pandemic, we must come together like never before in national unity and global solidarity with a family, and as humankind. We have more in common with one another, than we would ever dare to believe.” This comes after his announcement that 184 countries have now joined the COVAX initiative, Ecuador and Paraguay having joined this weekend. Tedros reiterated the importance of sharing vaccines equitably around the world by safeguarding high risk populations and working together to share life-saving health supplies globally. “Let us use this anthem as a family, to help unite us, unite the world, and together, we wouldn’t just beat this pandemic. We will take on, and successfully tackle other global challenges like air pollution and the climate crisis. So join us in the We Are One Family campaign. Because together we can do anything we put our minds to: national unity and global solidarity. We are one family.” Image Credits: R Santos/HP Watch. US Has Experienced Highest COVID-19 Mortality Rates Among 18 OECD Countries 19/10/2020 Madeleine Hoecklin Doctors and hospital staff in Florida put on personal protective equipment in the COVID-19 unit. Along with recording the most deaths from COVID-19 of any country in the world, the US has ranked highest among leading OECD countries in deaths per capita from the infectious disease, according to a recent study published in the Journal of the American Medical Association (JAMA) by researchers from Harvard University and the University of Pennsylvania. The United States also has experienced consistently high COVID-19 mortality rates since the country saw its first surge of cases in May, more so than other countries with high mortality rates. The JAMA study last week suggests that the comparatively higher death rates may be linked to the US’ weak public health infrastructure and a decentralized and inconsistent pandemic response. An additional factor may be the high level of pre-existing conditions among Americans who have comparatively high rates of obesity, hypertension and diabetes as compared to other developed countries. The authors compared US COVID-19 related deaths and excess all-cause mortality across 18 countries in the Organization for Economic Co-operation and Development, from the start of the pandemic until September 2020. The best performing countries in the study were South Korea, Japan and Australia, with fewer than 5 deaths per 100,000 people. Countries with moderate death rates included Norway, Finland, and Austria, with 5-25 deaths per 100,000 people. The worst performing countries with the highest mortality rates were the United States, Belgium, and Spain – with over 25 deaths per 100,000. The study also examined excess all-cause mortality, per capita, during the pandemic period to capture indirect pandemic effects. COVID-19 mortality comparison between countries with low, moderate, and high mortality. US Rates Were Initially Low – But Consistently High Since May The US’ mortality rate in the early spring was lower than other high mortality countries, with 60.3 deaths per 100,000 compared to 86.8/100,000 in Belgium and 65.0/100,000 in Spain. However, by mid-May, the US had exceeded all countries in deaths per 100,000, with 36.9 compared to 12.4 in Belgium and 8.6 in Spain. In September, the US’ death rates (60.3/100,000) were more comparable with other high morality countries, including Italy (59.1/100,000) and Belgium (86.8/100,000). In May and June, the US had death rates more than double most other high mortality countries, despite the implementation of prevention measures. The patterns observed in the study were also found for excess all-cause mortality, with the US leading in excess all-cause mortality since May. Since September, death rates have increased in several countries, with Peru now leading in COVID-19 deaths per 100,000 (105.35), compared to Spain (72.29), and the US (67.14). Number of deaths per 100,000 population in the 20 most affected countries as of October 19. Image Credits: Flickr – National Guard, Journal of American Medical Association, Johns Hopkins. WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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‘We Are Family’ – WHO Launches Collaboration With Kim Sledge To Reproduce Global Version Of Unity Anthem 19/10/2020 Raisa Santos Mock album cover for ‘We Are Family’ campaign, featuring WHO DG Tedros Adhanom Ghebreyesus, Mike Ryan and Maria Van Kerkhove of the Health Emergencies campaign. WHO is launching a collaboration with R&B Vocalist Kim Sledge of “We Are Family” fame to reproduce her signature album in a campaign aimed to promote global solidarity for COVID-19, and raise funds to battle COVID-19. The campaign, which will be coordinated by The World We Want Foundation, is to feature a special edition cover of the classic song “We Are Family” in a worldwide viral video that would include versions of the song by people ranging from celebrities to frontline health heroes, political leaders and members of the public – singing together to support global public health needs, including COVID-19. American singer Kim Sledge “Together we are unity strong, and we can do this as a family because we are one big global family,” Sledge, of the legendary music group Sister Sledge, said, speaking at a WHO press conference on Monday. Sledge said that she embarked on this initiative after being motivated by those around her who are looking for ways to end the crisis, including her husband and daughter, who both work as doctors on the COVID-19 frontlines. The video campaign invites people to star in the music video by recording themselves with their close family and friends singing the song and sharing on their social media channels. In order to submit sing-along videos to the special edition of the We Are Family song, members of the public can: Record yourself singing We Are Family either alone, or with friends and family, whilst observing physical distancing guidelines. Share the video on your favourite social media channel, with the hashtag #WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof. Upload your video to www.unitystrong.com. If you want your video to be considered for inclusion in the global We Are Family video, you will need to share your video by Monday, 30 November 2020. Video clips will be selected based on age, geographical diversity, and appropriate physical distancing if the video includes groups of people beyond immediate family members and correct handwashing if singing along to the song while washing hands. More details including Terms & Conditions can be found here www.unitystrong.com. Part of the proceeds from the new song, to be released on November 9, are to be donated to the WHO Foundation to support the response to COVID-19, as well as to other health promotion initiatives worldwide. Video Release To Coincide With World Health Assembly Autumn Session The release will coincide with the resumption of the 73rd session of the World Health Assembly, November 9-14. The WHA began in a two-day special virtual session in May to discuss the COVID-19 crisis, and then was adjourned until the autumn. Sledge is also scheduled to perform for the WHA alongside singers from New York to Tonga. Sledge is collaborating with Natasha Mudhar, founder of The World We Want Foundation, and another driving force behind the #WeAreFamily campaign. Natasha Mudhar, Founder of The World We Want Said Mudhar: “We Are Family is one of the most instantly recognizable anthems in the world. The song carries such an inspiring message of unity and solidarity. “What is so powerful about music and what we feel will be so powerful about this particular campaign, the song, and the video is that it will not only just entertain, but inspire action. And that’s just really bringing everybody together.” Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, emphasizes in his closing remarks, “This campaign is more than a song. It’s a call to action for collaboration and kindness, and the reminder of the strength of family and the importance of coming together to help others in times of need. “It represents that to heal the world from this pandemic, we must come together like never before in national unity and global solidarity with a family, and as humankind. We have more in common with one another, than we would ever dare to believe.” This comes after his announcement that 184 countries have now joined the COVAX initiative, Ecuador and Paraguay having joined this weekend. Tedros reiterated the importance of sharing vaccines equitably around the world by safeguarding high risk populations and working together to share life-saving health supplies globally. “Let us use this anthem as a family, to help unite us, unite the world, and together, we wouldn’t just beat this pandemic. We will take on, and successfully tackle other global challenges like air pollution and the climate crisis. So join us in the We Are One Family campaign. Because together we can do anything we put our minds to: national unity and global solidarity. We are one family.” Image Credits: R Santos/HP Watch. US Has Experienced Highest COVID-19 Mortality Rates Among 18 OECD Countries 19/10/2020 Madeleine Hoecklin Doctors and hospital staff in Florida put on personal protective equipment in the COVID-19 unit. Along with recording the most deaths from COVID-19 of any country in the world, the US has ranked highest among leading OECD countries in deaths per capita from the infectious disease, according to a recent study published in the Journal of the American Medical Association (JAMA) by researchers from Harvard University and the University of Pennsylvania. The United States also has experienced consistently high COVID-19 mortality rates since the country saw its first surge of cases in May, more so than other countries with high mortality rates. The JAMA study last week suggests that the comparatively higher death rates may be linked to the US’ weak public health infrastructure and a decentralized and inconsistent pandemic response. An additional factor may be the high level of pre-existing conditions among Americans who have comparatively high rates of obesity, hypertension and diabetes as compared to other developed countries. The authors compared US COVID-19 related deaths and excess all-cause mortality across 18 countries in the Organization for Economic Co-operation and Development, from the start of the pandemic until September 2020. The best performing countries in the study were South Korea, Japan and Australia, with fewer than 5 deaths per 100,000 people. Countries with moderate death rates included Norway, Finland, and Austria, with 5-25 deaths per 100,000 people. The worst performing countries with the highest mortality rates were the United States, Belgium, and Spain – with over 25 deaths per 100,000. The study also examined excess all-cause mortality, per capita, during the pandemic period to capture indirect pandemic effects. COVID-19 mortality comparison between countries with low, moderate, and high mortality. US Rates Were Initially Low – But Consistently High Since May The US’ mortality rate in the early spring was lower than other high mortality countries, with 60.3 deaths per 100,000 compared to 86.8/100,000 in Belgium and 65.0/100,000 in Spain. However, by mid-May, the US had exceeded all countries in deaths per 100,000, with 36.9 compared to 12.4 in Belgium and 8.6 in Spain. In September, the US’ death rates (60.3/100,000) were more comparable with other high morality countries, including Italy (59.1/100,000) and Belgium (86.8/100,000). In May and June, the US had death rates more than double most other high mortality countries, despite the implementation of prevention measures. The patterns observed in the study were also found for excess all-cause mortality, with the US leading in excess all-cause mortality since May. Since September, death rates have increased in several countries, with Peru now leading in COVID-19 deaths per 100,000 (105.35), compared to Spain (72.29), and the US (67.14). Number of deaths per 100,000 population in the 20 most affected countries as of October 19. Image Credits: Flickr – National Guard, Journal of American Medical Association, Johns Hopkins. WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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US Has Experienced Highest COVID-19 Mortality Rates Among 18 OECD Countries 19/10/2020 Madeleine Hoecklin Doctors and hospital staff in Florida put on personal protective equipment in the COVID-19 unit. Along with recording the most deaths from COVID-19 of any country in the world, the US has ranked highest among leading OECD countries in deaths per capita from the infectious disease, according to a recent study published in the Journal of the American Medical Association (JAMA) by researchers from Harvard University and the University of Pennsylvania. The United States also has experienced consistently high COVID-19 mortality rates since the country saw its first surge of cases in May, more so than other countries with high mortality rates. The JAMA study last week suggests that the comparatively higher death rates may be linked to the US’ weak public health infrastructure and a decentralized and inconsistent pandemic response. An additional factor may be the high level of pre-existing conditions among Americans who have comparatively high rates of obesity, hypertension and diabetes as compared to other developed countries. The authors compared US COVID-19 related deaths and excess all-cause mortality across 18 countries in the Organization for Economic Co-operation and Development, from the start of the pandemic until September 2020. The best performing countries in the study were South Korea, Japan and Australia, with fewer than 5 deaths per 100,000 people. Countries with moderate death rates included Norway, Finland, and Austria, with 5-25 deaths per 100,000 people. The worst performing countries with the highest mortality rates were the United States, Belgium, and Spain – with over 25 deaths per 100,000. The study also examined excess all-cause mortality, per capita, during the pandemic period to capture indirect pandemic effects. COVID-19 mortality comparison between countries with low, moderate, and high mortality. US Rates Were Initially Low – But Consistently High Since May The US’ mortality rate in the early spring was lower than other high mortality countries, with 60.3 deaths per 100,000 compared to 86.8/100,000 in Belgium and 65.0/100,000 in Spain. However, by mid-May, the US had exceeded all countries in deaths per 100,000, with 36.9 compared to 12.4 in Belgium and 8.6 in Spain. In September, the US’ death rates (60.3/100,000) were more comparable with other high morality countries, including Italy (59.1/100,000) and Belgium (86.8/100,000). In May and June, the US had death rates more than double most other high mortality countries, despite the implementation of prevention measures. The patterns observed in the study were also found for excess all-cause mortality, with the US leading in excess all-cause mortality since May. Since September, death rates have increased in several countries, with Peru now leading in COVID-19 deaths per 100,000 (105.35), compared to Spain (72.29), and the US (67.14). Number of deaths per 100,000 population in the 20 most affected countries as of October 19. Image Credits: Flickr – National Guard, Journal of American Medical Association, Johns Hopkins. WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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WHO: Brace Yourselves For Second Wave – COVID-19 Cases In Northern Hemisphere Accelerating 19/10/2020 Elaine Ruth Fletcher Dr Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization As the northern hemisphere enters winter, “COVID-19 cases are accelerating, particularly in Europe and North America,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus, speaking at a Monday press briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 2:11PM EST 19 October 2020. In words that echoed warnings from European officials last week, Dr Tedros and WHO’s health emergencies team stressed that governments need to double down on testing, contact-tracing and quarantine measures – before surges overwhelm health systems – potentially leading to death rates like those seen in the first wave of the spring. “It’s important that all governments focus on the fundamentals that helped to break the chains of transmission and save both lives and livelihoods,” Tedros said at the press briefing. “This means active case finding, cluster investigations, isolating all cases, quarantining contacts, ensuring good clinical care, supporting and protecting health workers and protecting the vulnerable. We are in this for the long haul. But there is hope, that if we make smart choices together, we can keep cases down. Ensure essential services continue and children can still go to school. We all have a part to play. Dr Tedros said he was “encouraged” by the measures that some governments are taking – most of northern Europe has responded by clamping on night-time curfews, limited lockdowns, closures of restaurants and businesses, and the imposition of stricter limits on public and private gatherings. But the WHO Director General also he warned that public “fatigue” was also a worry – without widespread adherence to rules about masks, social distancing and hand sanitation – trends could continue to escalate out of control. “The virus has shown that when we lead our guard down, it can surge back at breakneck speed,” Dr Tedros said. ‘Europe and Others Will Experience ‘High Numbers of Cases; Many Countries Not Doing Enough For Contact Tracing and Quarantine Worldwide trends remain volatile, said Health Emergencies Executive Director Mike Ryan. But particularlyin regions where infections are now surging, many countries are not following through enough on contact tracing and quarantine measures – even after they set out restrictions, he observed. He warned of “high numbers of cases” ahead. “People are tired, as we move into the next few weeks, Europe and others will experience high numbers of cases,” he said. “We must protect the vulnerable, we must protect the health system, we must try to keep our kids in school, but potentially be willing to give up some of the things we love to do. And we must test, test test, and reinforcing quarantine and isolation.” He said the follow-through on testing and tracing and quarantining has been one thing setting apart countries that succeeded in containing outbreaks from those that have not. “Many Asian countries, not only just China, but others in east Asia and also Australia, have managed to crush transmission and keep it down,” he noted, drawing a contrast between trends in Asia and Europe or North America. “The things they had in common were tracking cases and quarantining contacts. The success that countries had in Asia was in their ability to find those [infected] people and continue doing that. Serious follow through, they ran through the finish line and beyond because they knew the race wasn’t over. Too many countries put an imaginary finish line – and then stopped.”. Countries successful in controlling their outbreaks, also zeroed in on hotspots, said Maria Van Kerkhove, technical lead of the health emergencies team. At the same time, health systems have become better at coping with seriously ill cases, she said. And that is reassuring: . “Everyone, everywhere, is better prepared at dealing with severe patients. Health systems check oxygen levels right away; that saves lives. There is dexamethasone, which is widely available all over the world. We are not in the same position, we know a lot more. Now is the time to be really strategic and smart about these interventions.”” Despite Clinical Trial Setbacks – Some Vaccine Candidates Showing Good Results Impacts on Older People Soumya Swaminathan, WHO Chief Scientist Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that she was not “unduly alarmed” over the delays in some vaccine and medicines trials being seen recently. She was speaking in the wake of an announcement last week by Johnson & Johnson that it was temporarily suspending its one-dose vaccine trial after an unexpected illness in one participant. The pharma firm Eli Lilly also suspended its trial of an antibody cocktail after an adverse event – the potential treatment had received a great deal of hype after US President Donald Trump received a similar preparation. “We should stay hopeful and optimistic,” said Swaminathan, about the trials. “These are things that happen in clinical trials but they are getting more attention now now that they are under the spotlight. “Overall we have 45 candidates now in Phase 3 trials,” said Swaminathan, adding that the good news is that some of the vaccines seem to be provoking immune response in older people who are among the most vulnerable. “Some of the vaccines now are showing very good immunogencity for older people – and that is important because older people are a high risk group and we hope it would be possible to protect them with a vaccine,” she said. 184 Countries Committed to WHO Co-Sponsored COVAX Vaccine Facility On another positive note, Dr Tedros said that some 184 countries have now committed to the WHO co-sponsored COVAX vaccine facility, including Ecuador and Uruguay as among the latest to join. With buy in from high income countries – as well as low-income donor dependent nations, the facility aims to foster a more systematic and equitable system to get the first available vaccine doses to the most needy parts of the world’s population, including health workers, older people and people with pre-existing conditions. The facility has, however, also been criticized by medicine advocates who say that the procurement pool hasn’t stopped rich countries from making huge pre-purchase orders for more than one-half of anticipated vaccine stocks that are likely to become available in 2021 – after the first vaccines in final Phase 3 clinical trials are approved as safe and effective. Critics, who grouped around a proposal for a patent “waiver” on all COVID related therapie, that was debated at the World Trade Organization last Friday, have also noted that the COVAX facility fails to address the other equipment and medicines needs of low and middle-income countries. A parallel WHO effort to create an “intellectual property pool” for needed COVID therapies – C-TAP – aimed at easing access to products that are still under patent, has not really gotten off the ground. Tedros made no reference to the criticism of COVAX or the slow progress on the parallel WHO C-TAP initiative, saying only: “equitably sharing vaccines is the fastest way to safeguard high risk communities. Stabilize health systems and drive a truly global economic recovery. “As winter comes we know that the next few months will be tough, but by working together today and sharing life saving health supplies globally including personal protective equipment, supplies of oxygen dexamethasone and vaccines, when they are proven to be safe and effective. Referring to the new WHO partnership with Kim Sledge and The World We Want, to produce a global version of her hit cover “We Are Family,” which was announced by WHO on Monday, Tedros added, “ ‘We are Family’ is more than a song. It’s a call for collaboration and kindness. To heal the world form this pandemic, we must come together like never before in national unity and global solidarity. We are family as humankind – we have more in common with one another than we would ever dare to believe.” Image Credits: Flickr: Prachatai, Johns Hopkins. WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases 19/10/2020 Elaine Ruth Fletcher Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria. Genetically modified mosquitoes could be an innovative tool to combat vector-borne diseases and eliminate malaria, says a new WHO position statement. Genetically modified mosquitoes are designed to suppress mosquito populations and reduce their susceptibility to infection and their ability to transmit disease-carrying pathogens. WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases. “These diseases are not going away,” said John Reeder, Director of TDR, the Special Program for Research and Training in Tropical Diseases. “We really do need to think about new tools that could make an impact.” Each year 700,000 people die from vector-borne diseases and over 80 percent of the global population live in areas with higher risks of contracting a vector-borne disease, including malaria, dengue, yellow fever, and others. Major vector-borne diseases account for 17 percent of the global burden of communicable diseases. Genetically modified mosquito approaches use recombinant DNA technology to introduce heritable traits to reduce the transmission of mosquito-borne diseases. WHO raised concerns about the ethics, safety, and governance of this new potential vector-borne disease control strategy. The statement advised for the implementation of oversight mechanisms, risk assessment, and community engagement for further research and field trials of genetically modified mosquitoes. Guidance on vector-borne disease prevention and control was released by the WHO to respond to key ethical issues involved. Image Credits: Flickr: Tom. “Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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“Perfect Storm’ Of Rising Chronic Diseases And Public Health Failures Fueling COVID-19 Pandemic, Says Global Burden Of Disease Study 16/10/2020 Raisa Santos GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high blood sugar levels, and high body mass index (BMI). The COVID-19 pandemic, along with the continued global rise in chronic illness and related disease risk factors, such as obesity, high blood sugar, and outdoor air pollution exposures, seen over the past 30 years has created a ‘perfect storm’, fueling COVID-19 deaths, says a new study published Thursday in The Lancet . The global disease estimates provide insights into how rising chronic disease, along with public health failures, is fueling excess deaths from SARS-CoV-2 among people with pre-existing conditions. Led by the Institute of Health Metrics and Evaluation, the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) is a comprehensive global study, analyzing and ranking 286 causes of death, 369 disease and injuries, and 87 risk factors in 204 countries and territories. The GBD study, covering 204 countries, also tracks a population’s social and economic status on the basis of socio-demographic index (SDI). SDI combines information on average income per capita, educational attainment, and total fertility rates. Increased COVID-19 Illness and Death Associated With NCDs & NCD Risk Factors The study found that increased illness and death from COVID-19 is associated with several risk factors and non-communicable diseases, including obesity, diabetes, and cardiovascular disease, as well as outdoor air pollution exposures. But these diseases don’t just interact biologically, they also interact with socioeconomic factors, the study highlights. Underlying social inequities that perpetuate chronic diseases need to be addressed through policy and research in order to prevent the burden of disease from worsening and leaving populations vulnerable to increased risk of COVID-19, the study concludes. Said Dr Richard Horton, Editor-in-Chief of The Lancet: “The syndemic nature of the threat we face demands that we not only treat each affliction, but also urgently address the underlying social inequalities that shape them—poverty, housing, education, and race, which are all powerful determinants of health.” He continues, “COVID-19 is an acute-on-chronic health emergency. And the chronicity of the present crisis is being ignored at our future peril. Non-communicable diseases have played a critical role in driving the more than 1 million deaths caused by COVID-19 to date, and will continue to shape health in every country after the pandemic subsides. As we address how to regenerate our health systems in the wake of COVID-19, this Global Burden of Disease Study offers a means of targeting where the need is greatest, and how it differs between countries” . An accompanying Lancet editorial “Global Health: time for radical change” also states: “The message of GBD is that unless deeply embedded structural inequities in society are tackled and unless a more liberal approach to immigration policies is adopted, communities will not be protected from future infectious outbreaks and population health will not achieve the gains that global health advocates seek. It’s time for the global health community to change direction.” The study also reveals that the rise in exposure to key risk factors (including high blood pressure, high blood sugar, high body-mass index [BMI], and elevated cholesterol), combined with rising deaths from cardiovascular disease in some countries (e.g., the USA and the Caribbean), suggests that the world might be approaching a turning point in life expectancy gains. The authors stress that the promise of disease prevention through government actions or incentives that enable healthier behaviours and access to health-care resources is not being realised around the world. “Most of these risk factors are preventable and treatable, and tackling them will bring huge social and economic benefits. We are failing to change unhealthy behaviours, particularly those related to diet quality, caloric intake, and physical activity, in part due to inadequate policy attention and funding for public health and behavioural research”, says Professor Christopher Murray, Director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, USA, who led the research. “Double Down” on Development Promotes Health – Address NCDs in Low & Middle Income Countries Since the 1990s, the health burden has shifted towards NCDs and away from communicable, maternal, neonatal, and nutritional (CMNN) disease The report also contains some good news. Over the past two decades, since the adoption of the UN Millennium Development Goals, low and low-middle income countries have chalked up faster progress in their socio-demographic index (SDI), in comparison to rich countries, the report finds. Such progress is “highly correlated” with better health outcomes as well. “Given the overwhelming impact of SDI on health progress, doubling down on policies and strategies that stimulate economic growth, expand access to primary and secondary schooling, and improve the status of women should be our collective priority,” adds Murray. However, LMICs are not prepared to handle the growing transition in the disease burden from communicable diseases to non-communicable diseases (NDCs), the report also finds. Indeed, most global health policy discussion, including that of WHO, still focuses on communicable diseases, “even though there is an inevitable shift of disease burden to non-communicable disease.” ‘Functional Disorders’ – A Growing Problem Another challenge low- and middle-income countries may face, in particular, is the loss of so-called “functional health” capacities, which may not be well represented in classic health metrics characterizations of so-called “premature disability (DALY’s)”, the report notes. This can include issues such as: musculoskeletal disorders, mental disorders, substance misuse, vision loss, and hearing loss – issues which also become more acute as people live to older ages. Instead, current policy discussion is primarily focused on cardiovascular diseases and cancers, with low investment in research towards understanding underlying causes and therapeutic solutions for functional health loss. Health of Children Has Seen Steady Improvement; Not So for Older Age Groups Since 2000, lower SDI countries have improved in the index faster when compared to higher SDI countries While global health has still steadily improved over the past 30 years, especially for children under 10 years old, thanks to improvements in prenatal care and efforts to tackle infectious diseases, the same cannot be said for older age groups. Worldwide health loss, measured in disability-adjusted life-years (DALYs), is increasing. Six of the causes primarily affect older adults (ischaemic heart disease, diabetes, stroke, chronic kidney disease, lung cancer, and age-related hearing loss) and the other four are common from teenage years into old age (HIV/AIDS, other musculoskeletal disorders, low back pain, and depressive disorders). Though the number of DALYs hasn’t increased, there are a greater number occurring at old age. There has been a global shift towards non-communicable diseases and injuries, with them being half of the disease burden for 11 countries in 2019. However, global public health has focused more on primary causes of death rather than the systemic disparities of health, such as inequalities in access to preventative and curative services for lower socioeconomic groups. As said in the GBD: “Policy makers should remain aware that the number of DALYs represents the burden of disease that the world’s health systems must manage.” Health relies on more than just health systems. Air Pollution among the Fastest Increasing Health Risks Risk factors that have had the largest increases in exposure are high BMI, ambient particulate matter pollution, and high fasting plasma glucose GBD research has also shown that ambient air pollution (from particulate matter) was one of the fastest growing ‘health risks’, along with drug use, high fasting plasma glucose, and high body mass index (BMI) by more than 0.5% per year. Many health risks are considered preventable and can be slowed down and reversed through public health action and policy. Risks that are strongly linked to social and economic development were the largest declines in risk exposure from 2010 to 2019. These included household air pollution; unsafe water, sanitation, and handwashing; and child growth failure. This correlates to increasing global SDI. Global declines were also reported for tobacco smoking and lead exposure. The decrease in tobacco smoking, down 1-2% per year since 2010, is a partial success due partly to the governmental interventions and policy on tobacco control. In comparison, there has been inadequate policy and attention dedicated to BMI, one of the leading causes to contributable DALYs. Speaking about the findings, Murray says, “Governments should invest more funding in research and action to tackle these stagnating or worsening risk exposures. A core obstacle to accelerating progress on behavioural risks is the notion of individual agency and the need for governments to let individuals make their own choices. “This concept is naïve, given that individual choices are influenced by context, education, and availability of alternatives. Governments can and should take action to facilitate healthier choices by rich and poor individuals alike. When there is a major risk to population health, concerted government action through regulation, taxation, and subsidies, drawing lessons from decades of tobacco control, might be required to protect the public’s health.” Image Credits: Igbarrio, The Lancet/IHME. Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. 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Pfizer Won’t Pursue Emergency Authorization for COVID-19 Vaccine Before Mid-November, Says CEO in Open Letter 16/10/2020 Madeleine Hoecklin Albert Bourla, CEO of Pfizer, at a World Economic Forum meeting in 2018. Pfizer CEO, Albert Bourla, announced Friday in an open letter that the pharmaceutical company developing a COVID-19 vaccine will not request an emergency authorization before mid-November – meaning that the file of the vaccine candidate that is regarded as the front-runner in the global race to get a vaccine to market would only be reviewed after the US presidential elections. Pfizer said that it would continue running the trial through final analyses before seeking an emergency authorization from the US Food and Drug Administration (FDA). Moderna is also expected to submit the file for its vaccine around the same time. “Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla. Bourla emphasized the three key areas Pfizer prioritized for public use of the vaccine: vaccine efficacy, safety, and high quality and consistent manufacturing. These were also highlighted by Mike Ryan, Executive Director of WHO Health Emergencies Program, at a WHO press briefing on Friday. “It’s not just about the safety and efficacy of vaccines. It’s the quality of the vaccine as well,” and good manufacturing practices contribute to developing a high quality vaccine, said Ryan. These practices and steps, along with transparency, are necessary to provide reassurance to populations and improve public trust. Bourla noted Pfizer’s commitment to transparency and the importance of clarity in the context of “critical public health considerations.” “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said. The timeline of COVID-19 vaccines has been highly politicized, particularly by US President Donald Trump in his campaigning for re-election. Bourla previously lambasted the President for his politicization of the independent, scientific process of vaccine development and approval. Earlier in October, Bourla published an open letter saying that the company “would never succumb to political pressure” and is “moving at the speed of science.” Pfizer previously had an accelerated timeline compared to the other leading vaccine candidates in the US, due to the shorter interval between the two-doses of the vaccine. Moderna announced in early October that it would not seek Emergency Authorization until after November 25 and Johnson & Johnson’s Phase 3 vaccine trial was “paused” earlier this week for a participant illness. NIH Begins Clinical Trial on Immune Modulator Treatments for COVID-19 Doctor checking on a COVID-19 patient connected to a ventilator in the ICU in Louisiana. Meanwhile, a new Phase 3 clinical trial was launched by the US National Institutes of Health (NIH) to evaluate the efficacy of three immune-modulating therapies in reducing the need for ventilators and the duration of hospital stays. Immune-modulating therapies are drugs that alter the way the immune system works. The therapies will be examined for their ability to suppress an immune response that sometimes occurs in COVID-19 patients, where the immune system releases excessive amounts of proteins that lead to inflammation and life-threatening complications. The trial will be part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, a public-private partnership established in April to coordinate research strategies to speed up development of treatments and vaccines. “This is the fifth master protocol to be launched under the ACTIV partnership in an unprecedented timeframe, and focuses efforts on therapies that hold the greatest promise for treating COVID-19,” said Francis S. Collins, Director of NIH. “Immune modulators provide another treatment modality in the ACTIV therapeutic toolkit to help manage the complex, multi-system conditions that can be caused by this very serious disease.” The clinical trial will evaluate Remicade, developed by Johnson & Johnson’s Janssen Research unit, Bristol Myers Squibb’s Orencia, and AbbVie’s Cenicriviroc. Approximately 2,100 hospitalized adults with moderate to severe COVID-19 symptoms will be enrolled in the study that will last six months. All trial participants will receive Remdesivir, due to the current standard of care treatment of hospitalized COVID-19 patients. It is unclear if the interim results of the WHO’s Solidarity Trial on Remdesivir will impact the guidelines on standard of care treatment. Image Credits: Flickr – World Economic Forum, Flickr – US Navy. Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
Much-Touted Remdesivir Fails To Reduce COVID-19 Deaths; Results Of WHO-Coordinated Solidarity Trial 16/10/2020 Elaine Ruth Fletcher & Madeleine Hoecklin Remdesivir received emergency use approval for COVID-19, only to fall by wayside in WHO Solidarity trial. Two more experimental COVID-19 drugs, including the much-touted Remdesivir, appear to have fallen by the wayside, failing to show significant reductions in mortality among seriously ill patients. Interim results on Remdesivir and three other drug treatments being studied as part of the WHO Solidarity Therapeutics Trial, the world’s largest randomized controlled trial of COVID-19 drugs, were published Friday on the pre-print journal, medRxiv.org. The WHO-coordinated study, covering some 11,266 participants across 30 countries, found that the antiviral Remdesivir, as well as Interferon, had no effect on 28-day mortality among hospitalized COVID-19 patients and little or no effect in reducing the initiation of ventilation or the duration of hospital stay. While the news on Remdesivir was fresh, the study also reported results of treatments with two other drugs, the anti-malarial Hydroxychloroquine, and the HIV/AID drug combination Lopinavir/Ritonavir, which have already been largely disqualified as good treatment options, in light of findings from studies published over the spring and early summer. “These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” states the study. “The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials.” Dr Tedros Adhanom Ghebreyesus, WHO Director-General announcing negative Remdesivir results The study includes findings from drug trials covering some 11,266 participants across 30 countries, with 2750 participants administered Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 Interferon, and 4088 receiving no treatment drug. In a sober announcement of the results at Friday’s WHO press conference, Director General Dr Tedros Adhanom Ghebreyesu made it even more plainly clear: “Interim results from the trial now show that the other two drugs in the trial, Remdesivir and Interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital. “For the moment, the corticosteroid steroid dexamethasone is still the only therapeutic shown to be effective against COVID-19 for patients with severe disease,” Dr Tedros added. WHO Will Push On To Test Monoclonal Antibodies and Other Antivirals Despite the dead-end reached with the drugs that only a few months ago had seemed to offer potential for improving COVID treatment, Dr Tedros also said that WHO Solidarity Trial would push ahead in coordinating new research to “assess other treatments, including monoclonal antibodies and new antivirals.” The potential of drugs containing controlled portions of anti-SARS-CoV2 monoclonal antibodies have catapulted into the spotlight recently, after US President Donald Trump claimed that such a cocktail by the pharma company Regeneron had virtually “cured’ him of COVID-19. Even so, clinical trials on a similar treatment, under development by Eli Lilly, were halted just this week after an adverse reaction occurred in one trial participant. Despite the lack of evidence about either drug, both Eli Lilly and Regeneron have already filed requests with the United States Food and Drug Administration for Emergency Use Authorizations of their products. Remdesivir had also been approved by the FDA as well as by the European Medicines Agency, under the same EUA process. The WHO Director General said that the global Solidarity Trial also is considering for evaluation other, newer antiviral drugs and immunomodulators – the latter are being studied because of the role they may play in tempering over-reactions by the immune system. Mass Gatherings, Protests, Masks & Travel – WHO Offers Views But Says Decisions Up To Member States With no drugs, or a vaccine, yet in sight, WHO officials are also stressing the importance of using what they call “non-pharma” measures that have been demonstrated to be effective in controlling the virus spread. Key among those strategies are the management of mass gatherings, use of masks, and safety in travel, said WHO Health Emergencies Executive Director Mike Ryan. But he hedged on providing firm advice to countries to mandate masks or ban mass gatherings – saying it is ultimately up to the governments themselves to set out policies based on the local context. Some excerpts: Mike Ryan, Executive Director of WHO Health Emergencies Programme Mass gatherings – Not only the United States, but leading countries around Africa and the Eastern Mediterranean are also entering election season. Ryan repeated comments made earlier this week, saying that the pandemic shouldn’t be used as an excuse to discourage people from coming out to vote – saying rather that mass gatherings can be “managed” to ensure that elections can proceed. Ryan: “In terms of people coming together and gathering, many countries, groups and communities have shown that it is possible for communities to come together to express their views, to vote and to do other things, and that can be done in a safe manner. And therefore we continue to offer advice to countries and to organizations who are planning gatherings, especially important gatherings and elections. They must be associated with good risk management measures.” Protests – Civil disobedience and protests are common occurrences, particularly during the COVID-19 pandemic, which has exacerbated existing inequalities and has strained the relationship between individuals and public authorities and institutions, Ryan acknowledged, adding: “We do call for calm. People are suffering and when people are tired and suffering, there can be a gap in trust that emerges between communities and the people that govern them. But governments don’t govern people, governments are there to serve the people first and foremost…Governments should always encourage the right to protest and express dissatisfaction and we will continue to provide support to countries to ensure that they support their communities in that way.” “Many people in many countries have many issues they want to raise with governments, everything from climate, to social justice, to employment, to COVID-19. It’s an important part of our global approach to democracy to ensure that people always have the right to protest and express their views. But obviously, we hope that can be done safely and in a properly risk managed way and can be done peacefully.” Masks – WHO only belatedly began supporting masks as a public health measure – after considerable evidence showed efficacy. Now that it has become enthusiastic about their use, some countries, such as Sweden, still refrain from mandating masks, even in confined and crowded spaces, like public transport. Ryan: “Each country has had to take a different approach in this response, and each country has had to determine what its social contract is, and what is possible within the context of the relationship that the government has with people.” “We, as WHO, would say that masks are an important part of the strategic, comprehensive approach to stopping the spread of this disease, especially where you have widespread community transmission and where you do not understand fully the chains of transmission…We will continue to work in our European regional office with all countries in the region to optimize their strategies.” Maria Van Kerkhove, WHO Health Emergencies Technical Lead Maria Van Kerkhove, Health Emergencies technical lead adds: “Masks must be used as part of a comprehensive package. It must not be masks alone, because you still need hand hygiene and to use alcohol based rub…When you enter the workplace, avoid crowded settings, enclosed spaces, especially with poor ventilation, open the windows, physical distancing. All of this needs to happen.” Travel precautions – WHO’s Tedros and Mike were adamantly opposed to any travel restrictions in the early months of the COVID-19 epidemic, even as international travel was clearly the vector carrying the infection across the world. After most countries ignored WHO’s advice and unilaterally slapped on their own travel restrictions, sometimes closing their air space altogether and at other times, applying more selective measures, WHO fell silent on the matter and has largely remained so, despite pleas by some member states, such as Austria at last week’s Executive Board meeting, for more targeted and nuanced advice. Says Ryan: “Great strides have been made in ensuring that international travel is safer…De-risking travel is one thing in the sense of ensuring people aren’t exposed to the virus while traveling. “It’s a very different issue when it comes to deciding who can travel from one country to the other. If we’re going to see international travel resume in a meaningful way, we can commend the travel industry for doing all they can to reduce the risk of exposure during travel, but there’s still a way to go to create the confidence and trust between countries, so that travel can be opened between countries.” COVID-19 Soaring, but Restrictions May also Help Reduce Flu in Northern Hemisphere Although COVID cases are rising sharply in 8 out of 10 countries of WHO’s European region after a reprieve over the summer, the spread remains uneven and posing various levels of threat, WHO officials also noted at the briefing. Active cases of COVID-19 around the world and COVID-19 deaths globally (top right) as of 8:00PM CET 16 October 2020. “Within Europe there are about 37 areas in 13 countries that have an increasing incidence and increasing hospitalizations that we’re looking at,” said Van Kerkhove. Meanwhile, Dr Tedros expressed hopes this year’s flu season in the northern hemisphere might at least be lighter as a result of the wave of restrictions and preventive measures that are now being adopted by European countries to combat COVID-19. “Many of the same measures that are effective in preventing COVID-19 are also effective for preventing influenza, including physical distancing, hand hygiene, covering coughs, ventilation, and masks,” said Dr Tedros. “But we cannot assume the same will be true in the Northern Hemisphere flu season,” warned Tedros. Every year there are approximately 3.5 million cases of severe seasonal influenza worldwide, however, during this year’s influenza season in the Southern hemisphere, there were far fewer cases than usual, said Dr Tedros. Influenza coupled with COVID-19 has the potential to overwhelm health systems and facilities. Although vaccines exist for influenza, high demands would stretch supplies, particularly in low-income countries. However, it is hoped that the northern hemisphere countries can replicate the experience in the southern hemisphere, where the flu season was light, presumably because of precautionary COVID-19 measures taken there. Influenza Vaccination May Also Help Protect Against COVID-19 – New Study Finds Meanwhile, several recent epidemiological studies also have suggested that there may be cross-protection between influenza vaccination and COVID-19 during the pandemic. Another preprint study published Friday by a group of Dutch researchers on medriXiv.org even suggested the possibility of using an influenza vaccine against both influenza and COVID-19 for the 2020-2021 influenza season. The study found that the quadrivalent inactivated influenza vaccine used in the 2019-2020 influenza season in the Netherlands induced a trained immune response against SARS-CoV2, in laboratory blood samples, suggesting a possible relative protection against COVID-19. In addition, observational study of 10,000 Dutch health workers found somewhat lower levels of COVID-19 infection among people who had received their flu vaccine for the 2019-20 flu season. In the study group, 1.3% of vaccinated workers came down with test-positive cases of COVID-19, as compared to 2% of those who did not get the vaccine. Image Credits: European Medicines Agency, WHO, Johns Hopkins. Posts navigation Older postsNewer posts