Dr Tedros at the June 10 WHO COVID-19 press briefing

Asymptomatic transmission is possible, but the World Health Organization is still unsure as to what extent asymptomatic COVID-19 infections contribute to the spread of the virus, according to WHO Director-General Dr Tedros Adhanom Ghebreyesus on Wednesday.

“Since early February, we have said that there are asymptomatic people that can transmit COVID-19. But we need more research to establish the extent of asymptomatic transmission, and that research is ongoing,” said Dr Tedros.

The WHO Director-General attempted to clarify seemingly contradicting statements made by WHO COVID-19 Technical Lead Maria Van Kerkhove on Tuesday and Monday regarding asymptomatic transmission, the onwards spread of COVID-19 by an infected person who never develops symptoms.

Van Kerkhove had on Monday said that transmission of COVID-19 by asymptomatic people was “very rare,” according to reports from countries doing detailed contact tracing 

“We have a number of reports from countries who are doing very detailed contact tracing. They’re following asymptomatic cases, they’re following contacts and they’re not finding secondary transmission… It is very rare,” said Van Kherkhove at WHO’s regular press briefing on Monday. “From the data we have it still seems to be rare that an asymptomatic person actually transmits onward to a secondary individual.”

The comment seemed to contradict United States Centers for Disease Control guidelines that advise pandemic preparedness teams to assume that 35% of all COVID-19 infections are asymptomatic, and asymptomatic persons are just as likely to transmit the infection as symptomatic persons. The modeling guidelines are based on COVID-19 estimates from the US CDC, and US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).

WHO COVID-19 Technical Lead Clarifies “Rare” Asymptomatic Transmission Comment After Concerns 

WHO COVID-19 Technical Lead Maria van Kerkhove attempts to clear up confusion around claim that asymptomatic transmission of COVID-19 is ‘rare’

Van Kerkhove walked back on her comments on Tuesday, after receiving backlash from scientists concerned that WHO was writing off the threat of asymptomatic transmission.

She clarified that her comment designating asymptomatic transmission as “rare” was based on a small subset of 2 to 3 studies following asymptomatic people and their contacts, and the true extent of asymptomatic transmission was still unknown.

“”The majority of transmission that we know about is that people who have symptoms transmit the virus to other people through infectious droplets. There are a subset of people who do not develop symptoms,” said Van Kerkhove at a Twitter livestream on the issue on Tuesday. “To truly understand how many people don’t develop symptoms – we don’t have that answer yet.

“I wasn’t stating a policy of WHO or anything like that, I was just trying to articulate what we know. In that, I used the phrase ‘very rare’ – and I think that’s misunderstanding to state that asymptomatic transmission globally is very rare.”

Van Kerkhove highlighted that due to the many unknowns, infectious disease modeling groups have used their own estimates of the contribution of asymptomatic transmission.

“What I didn’t report yesterday, was because this is a major unknown, some modeling groups have tried to estimate what is the proportion of asymptomatic people that may transmit,” she said. “And there is a big range, depending on how the models are done, from which country…They can be [quite high].

“Some estimates are around 40% of transmission may be due to asymptomatic [infections],” said Van Kerkhove, a potential nod to the CDC modeling guidelines.

Photo Credit: Marco Verch

In what he described as a great “public health victory,” the World Trade Organization has ruled that Australia’s plain packaging requirements for tobacco products did not infringe on international trade, said the World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus on Wednesday.

The decision by the WTO on Tuesday comes just as it also opened nominations for the selection of its next Director General, following an earlier announcement by Roberto Azevedo that he would resign from his post on August 31st.

So far, three candidates have been formally nominated, including chair of Gavi, the Vaccine Alliance’s Board Ngozi Okonjo-Iweala; Mexico’s chief negotiator for the ‘New NAFTA’, Jesús Seade Kuri; and former director of the Trade in Services Division of the WTO, Abdel-Hamid Mamdouh.

The decision on the case against Australia, the first country to introduce mandatory ‘plain packaging’ for tobacco products in 2012, was described as the final nail in the coffin of the tobacco industry’s nearly decade-long campaign against plain packaging, which has now completely run out of international avenues to appeal such laws.

“This WTO ruling means the tobacco industry has run out of options to challenge plain packaging internationally,” said Dr Tedros in a press briefing.

The WTO decision upheld a 2018 ruling that Australia’s plain packaging laws did not violate WTO rules. That decision was appealed by Honduras and the Dominican Republic on behalf of a bloc of countries, leading to a final ruling on Tuesday that ended the international litigation against Australia.

“This is a fantastic win not just for Australia, but for governments around the world who want to reduce the terrible toll of sickness and death caused by smoking,” Australian Health Minister Greg Hunt said in a statement released Wednesday.

Appellate Body Rules ‘Plain Packaging’ Laws Do Not Violate International Trade Agreements

Australia’s ‘plain packaging’ laws require the display of graphic public health warnings on tobacco products

An WTO Appellate Body ruled Tuesday that the bloc of countries opposing Australia’s laws “had not succeeded in establishing that Australia’s tobacco plain packaging measures are inconsistent with the provisions of the covered [trade] agreements at issue.” 

Therefore, the committee made no recommendations to change Australia’s plain packaging laws.

“This WTO ruling reaffirms that this legislation is within the international trade rules,” said Australia’s Federal Trade Minister Simon Birmingham.

Australia’s precedent-setting ‘plain packaging’  law for tobacco products, adopted in 2012, bars tobacco packaging from using prominent logos or promotional text, and requires the display of graphic public health warnings.

The WHO has said that there is evidence that such packaging, combined with other interventions recommended by the WHO Framework Convention for Tobacco Control (FCTC), helps reduce demand for tobacco products. Smoking is a leading risk factor of deadly non-communicable diseases like heart disease, lung cancer, and chronic obstructive pulmonary disorder (COPD). 

Other countries that have since adopted similar ‘plain packaging laws,’ include France, Ireland, Northern Ireland, and the United Kingdom. Singapore, New Zealand, and more are now in the process of introducing such laws.

Honduras first submitted a request to the WTO to challenge the Australian laws in April 2012, under the claim that the ‘plain packaging’ requirements put up barriers to international trade as outlined under the WTO Agreement on Trade Related Aspects of Intellectual Property (TRIPS Agreement) and the corresponding Technical Barriers to Trade Agreement. 

Image Credits: Flickr: Marco Verch Professional Photographer and Speaker, Twitter: @FCTCofficial.

Switzerland is now the world’s safest country since the pandemic started, followed by Germany and Israel, according to a Regional Safety Assessment of 200 territories and regions during the COVID-19 pandemic.

Overall, Asia and Europe were the regions most successful in fighting the coronavirus although there were wide variations within Europe in terms of how countries really performed, according to the report by Deep Knowledge Group, an international consortium of commercial and non-profit organizations that applies progressive data-driven solutions to healthcare.

Said the report: “On average, Asia and Europe appear to be maintaining regional safety more efficiently than the rest of the world.” 

The study offers policymakers an opportunity to assess and improve their COVID-19 responses by learning from their neighbours, and reveals why some countries fared better than others in the worldwide scramble to curb the pandemic.

Most Critical Finding – Avoid Reckless Reopenings

The quality of specific governmental policies designed to combat the pandemic were a bigger key to success than the quality of its healthcare system in ‘non-pandemic times’, the study found.

The ‘most critical’ finding of the study is that countries should avoid reckless reopenings in the name of short-term economic recovery, or “all the sacrifices” made will have been meaningless”, the reports authors also warned.   

By compiling some eleven thousand data points from over 500 reputable, publicly available sources of data, researchers created a Regional Safety Index – A composite index that ranked, categorized and analyzed health system preparedness of about 200 regions.

The Regional Safety Index is based on a range of social, economic and health indicators, as well as six categories, including – quarantine efficiency; government efficiency of risk management; monitoring and detection; health readiness; regional resilience; and emergency preparedness. 

Switzerland, Germany and Israel ranked ‘exceptionally high’ in the risk assessment, with scores hovering around 750, in comparison to the USA, the UK and France – which performed “much less favourably” than expected given the sophistication of their health systems, at about 530 on the Regional Safety Index.

Sophisticated Healthcare Systems Not Necessary To Effectively Curb Outbreaks – But Timely Policies Are Crucial 

Strikingly, while the European and Asian countries that scored well on the index all have good healthcare systems, the sophistication of the health system was less a predictor of success than might be expected. What was ‘critical’, the study reported, was  timely adoption of evidence-based policies:

“One of the most critical factors impacting regional safety and stability is not the general level of healthcare sophistication in non-pandemic times, but the specific governmental crisis management strategies and policies used to combat pandemics.”

But countries that successfully curbed the pandemic shared a handful of common features, mainly health systems that operate with high levels of emergency preparedness, which enabled: early and proactive government responses; quick and efficient testing, tracing and isolating efforts to prevent overburdening of healthcare systems; and rapid resource mobilization. Such countries include Switzerland, Germany, Israel, Singapore and Japan.

Another similarity between high-performing countries on the Index was a ‘cautious’, evidence-based unfreezing of lockdowns without sacrificing public health and safety.

In contrast, while technological and economic superpowers like the United Kingdom, the United States and France have very sophisticated healthcare systems, they were ‘surprising outliers’ faring much worse in the ratings “than expected by any basic logic”, the study reported:

“We do see a number of so-called outliers in the [European] region as well, i.e., countries who should score well given their generally high degrees of healthcare robustness, such as France and especially the United Kingdom, but which do not,” said the authors. These countries also were among those that suffered from “the highest infection spread and mortality rates, which is a surprising result.”

Significantly, some lower-middle and middle-income ranked better than others as well.  For instance, South Africa and India, as well as Argentina, Uruguay and Ecuador, in Latin America, ranked higher than other neighbours in their region of similar socio-economic levels.

Countries that scored badly on the Index tended to lack whole-government approaches, leading to considerable delays in physical distancing measures and limited COVID-19 testing.

The “Most Critical Risk” – Hasty Economic Recovery Will Make All Efforts ‘Meaningless’

Countries that were battered by the coronavirus have also started to unfreeze lockdowns too fast, warned last week’s study – The “most critical risk” is reckless prioritization of economic concerns over healthcare priorities without the necessary increases in testing, tracing and isolation:

“Above all else, regions should not put economic recovery above public health and safety…or all the sacrifice and joint work of citizens, governments and organizations will have been meaningless,” states the report.  

While countries such as the United Kingdom have erred more on the side of caution since Prime Minister Boris Johnson himself was briefly hospitalized in an intensive care ward for COVID-19 in early April, US President Donald Trump has been adamant about reopening business across the United States, regardless of infection trends, in an attempt to revive the economy.

Image Credits: Deep Knowledge Group .

Shoppers in Wuhan, China, post-COVID-19 lockdown

A novel study published in preprint form by Harvard University suggests that cases of the novel SARS-COV-2 virus that has caused a global pandemic may have begun appearing in Wuhan hospitals as early as August 2019 – several months before China officially admitted that a new coronavirus was circulating.

The study Tuesday found an unusual uptick in traffic at several Wuhan hospitals in the late summer and early fall 2019, as compared to the year before, as well as a significant increase in online searches in China for diseases related to “cough” as well as “diarrhoea” – the latter symptom a distinctive feature of early COVID-19 onset.

Analysis of hospital traffic in Wuhan China indicates shows high number of visitors, compared to the same time, in the year before

“We observe an upward trend in hospital traffic and search volume beginning in late Summer and early Fall 2019. While queries of the respiratory symptom “cough” show seasonal fluctuations coinciding with yearly influenza seasons, “diarrhea” is a more COVID-19 specific symptom and only shows an association with the current epidemic.

“The increase of both signals precede the documented start of the COVID-19 pandemic in December, highlighting the value of novel digital sources for surveillance of emerging pathogen,” says the preprint study, published on Harvard’s DASH repository, and authored by four experts in computational epidemiology and biomedical informatics at Harvard Medical School, Boston University School of Public Health and Boston Children’s Hospital.

Study Strengthens Theory That Virus Emerged From Source Outside Wuhan Seafood Market

The authors said that their findings strengthen the theory that the novel coronavirus may have already been circulating in Wuhan, a city of 10 million people, prior to the identification of a large cluster of infected people associated with the Hunan Seafood Market.

While it has been suggested that the original source of the virus was a wild animal in the market, where mammals, reptiles and other animals were kept in crowded, contained spaces in close proximity to market workers and shoppers, no direct connection to the market has been found for the first 14 individuals who became infected with the virus.  Nor have virology samples taken from wildlife at the market been linked to SARS-COV2,  the study notes, “leaving open the possibility of alternate points of origin and infection.”

“Here we consider that SARS-CoV-2 may have already been circulating in the community prior to the identification of the Huanan Market cluster. This hypothesis is supported by emerging epidemiologic and phylogenetic evidence indicating that the virus emerged in southern China, and may have already spread internationally, and adapted for efficient human transmission by the time it was detected in late December.”

Hospital traffic and Covid-19 symptoms search queries both rise sharply in autumn, 2019

The study examined satellite images of traffic patterns at six Wuhan hospitals as well as several other control sites, to draw its conclusions.  Along with that it searched terms in the Chinese “Baidu” search engine, noting that the same method has been used to estimate influenza trends in China.

Between September and October 2019, 5 of the 6 hospitals studied show their highest relative daily volume of traffic in the series of images that were analysed, the study found. “coinciding with elevated levels of Baidu search queries for the terms “diarrhea and cough”. While searches for cough alone are typical of the influenza season, diarrhea has been one of the more distinctive symptoms marking onset of Covid-19.

Chinese Officials Reject Findings of Study – Still in Preprint
Hua Chunying, China Foreign Ministry Spokeswoman

Speaking at a press briefing on Tuesday, China’s foreign ministry spokeswoman Hua Chunying rejected the study’s findings, saying, “I think it is absurd, actually extremely absurd, to draw this kind of conclusion based on superficial observations such as traffic volume.”

Other experts also urged caution in interpreting the study’s results: “It’s important to remember that the data are only correlative and (as the authors admit) cannot identify the cause of the uptick,” said Paul Digard, a virologist professor at the University of Edinburgh. “By focusing on hospitals in Wuhan, the acknowledged epicentre of the outbreak, the study forces the correlation. It would have been interesting (and possibly much more convincing) to have seen control analyses of other Chinese cities outside of the Hubei region,” he said.

The study is still in its preprint form, and had not undergone peer review, they also noted.  This seemed apparent from one obvious error in the preprint PDF, which refers to a:  “large decrease in hospital [traffic] voume and search query data, following the public health lockdown of Wuhan on January 23, 2019”  – an apparently erroneous reference to the lockdown of January 23, 2020.

 

Image Credits: José Mauquer , Nsoesie, Elaine Okanyene et al. Harvard University Pre-print Repository, , Analysis of hospital traffic and search engine data in Wuhan China indicates early disease activity in the Fall of 2019.

Shoppers mob malls in Geneva, Switzerland after restaurants and stores reopened on 6 June – following nearly two months of lockdown

Stay-at-home orders and lockdown measures helped greatly limit the spread of coronavirus in 11 European countries from the start of the epidemic to May 4th, according to a new modeling paper published in Nature on Monday. 

Some 3.1 million deaths were averted across the study countries thanks to “non-pharmaceutical measures” such as lockdowns and social distancing policies, according to the study.

Meanwhile, the World Health Organization said that the disease was accelerating in South Asia and Latin America, even as European countries saw declines and began lifting lockdown measures. Switzerland, which reported only 20 new cases on Sunday, reopened restaurants, nightclubs, and red-light district services on June 6, and allowed mass demonstrations of up to 300.

“Yesterday, more than 136,000 cases were reported, the most in a single day so far. Almost 75% of yesterday’s cases come from 10 countries, mostly in the Americas and South Asia,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“We’re seeing acceleration of disease now in Central and South America,” said WHO Health Emergencies Executive Director Mike Ryan. “And we’re seeing a similar acceleration and path for South Asia.”

In his strongest statement to date, the WHO Director-General also expressed support for worldwide demonstrations against police brutality and racism, sparked by the death of a black man, George Floyd, after an officer put him in a knee hold in the United States.

“WHO fully supports equality and the global movement against racism. We reject discrimination of all kinds. We encourage all those protesting around the world to do so safely, as much as possible,” said Dr Tedros, the first African leader of the UN’s health agency.

“As much as possible, keep at least 1 metre from others, clean your hands, cover your cough and wear a mask if you attend a protest. We remind all people to stay home if you are sick and contact a health care provider,” he added.

As the US entered its third week of protests, countries around the world have rallied in support of the movement. Similar demonstrations drew masses of people in Switzerland, the United Kingdom, the Republic of Korea, Spain, and other countries.

US Embassy issues alerts on planned demonstrations on “racial discrimination” in Geneva, Switzerland

Nature Paper Finds Non-Pharmaceutical Interventions Lowered Reproductive Number, R0

Only 3.2-4.0% of the total population, or between 12 to 15 million people, were estimated to be infected in 11 countries from the beginning of the epidemic in Europe until May 4th, according to the Nature study.

“Our results show that major non-pharmaceutical interventions and lockdown in particular have had a large effect on reducing transmission. Continued intervention should be considered to keep transmission of SARS-CoV-2 under control,” the authors, a group of researchers from Imperial College London and Oxford, wrote in the analysis.

Empty streets in Italy during lockdown

Non-pharmaceutical measures were able to successfully lower the reproduction number R0, which estimates the average number of susceptible people that will contract the disease from one infected person. When the R0 drops below 1, the epidemic will decline. 

 “Current interventions have been sufficient to drive the reproduction number R0 below 1, and achieve epidemic control,” according to the authors. 

The analysis found that the average R0 was reduced by 82% across the 11 countries, dropping to 0.66 compared to 3.8 at the beginning of the study period, before any “non-pharmaceutical interventions” were put in place. R0 values in individual countries ranged from 0.44 in Norway to 0.82 in Belgium.

The authors used death data from the European Centers for Disease Control to estimate infections across Austria, Belgium, Denmark, France, Germany, Italy, Norway, Spain, Sweden, Switzerland, and the United Kingdom.

Pandemic Hotspots Shift From Europe + US to Latin America + South Asia

Active cases of COVID-19 world wide as of 8 June 2020 evening. Numbers change rapidly

New infections are growing at an alarming rate in several countries in South America. The trends are real, not just due to increased testing and better surveillance, according to Mike Ryan.

In the past day, about 70% of COVID-19 deaths were in the Americas. Brazil overtook the United States in recording the highest number of new cases late last week, and 60% of the world’s new cases were reported in the Americas.

“I would say right now the epidemic in Central and South America is the most complex of all of the situations we face globally.. We’re seeing from Mexico all the way to Chile is an increasing pattern across the Americas across Latin America, with some notable exceptions,” said Ryan on Monday. “I think it’s a time of great concern.

“It’s not one country, it’s many many countries experiencing very severe epidemics [similar to] what we saw in Europe and North America….There’s been an increase of about 50% of cases in Guatemala over the last week, with a worrying over 100% increase in the number of fatalities [for example].”

“The pandemic epicentre moved from China & East Asia to Europe & North America, now to South Asia & Latin America. [We’re] still in the growth phase in many countries,” tweeted  Devi Sridhar, Professor & Chair of Global Public Health at University of Edinburgh.

Locals gather outside public office in Hyderabad, Pakistan

Pakistan, now reporting the highest number of new cases per day in WHO’s Eastern Mediterranean region, reported 4,960 new cases on Sunday.

Some 70% of new cases in WHO’s Southeast Asian Region were recorded in India, now hosting the 6th highest number of COVID-19 cases. The country reported 11,000 new cases in the past 24 hours, some 500 more than the previous day.

The New Delhi’s Department of Health, Family and Welfare overrode a controversial order restricting hospital services for COVID-19 to residents of Delhi on Monday. The order, published on Sunday, limited hospital services for COVID-19 to “bona fide residents of the National Capital Territory of Delhi” – leaving Indian migrants in the capital. About 40% of New Delhi’s population are migrants, and the capital has the highest concentration of inter-state migrants compared to any other region in India.

In the WHO European region, half of Sunday’s new cases were in the Russian Federation, which reported 9000 cases. New cases in Russia have plateaued around 8,000-9,000 per day since mid-May. 

Still, the Russian Federation plans to lift its months-long lockdown starting Tuesday, said Moscow’s Mayor Sergei Sobyanin on Monday. “Moscow can practically get back to its usual rhythm of life,” said Sobyanin on his personal blog.

On Monday, New Zealand Prime Minister Jacinda Ardern declared the country ‘virus-free’, and announced that virtually all COVID-19 restrictions will be dropped reported Reuters. New Zealand last reported new cases of COVID-19 on 19 May, but the country has still taken a cautious approach to reopening, which has been largely supported by the public. 

Image Credits: S. Lustig Vijay/HP-Watch, Flickr: Nicola, Johns Hopkins CSSE, Tasleem Ul Haq.

Peaceful protestors in front of the Brooklyn Public Library in New York City

In the wake of widespread demonstrations in the United States against police brutality, catalyzed by the death of George Floyd while being pinned under an officer’s knee, the World Health Organization has urged protestors to protect themselves against COVID-19.

“We have certainly seen a lot of passion this week, we’ve seen people who’ve felt the need to be out and express their feelings, but we ask them to remember: still protect yourself and others, the coronavirus is all around, protect yourselves and others while expressing yourselves,” said WHO spokesperson Margaret Harris at a briefing in Geneva. “So, all the things we have been saying (still) apply.

“The best precaution is being able to stay one metre away from each other, being able to wash your hands, being able to ensure that you don’t touch your mouth, nose and eyes.”

Meanwhile, in a separate press briefing, WHO also released updated guidance on June 5 for the use of masks to prevent COVID-19 transmission in the general public and healthcare settings.

April Baller, infection prevention & control expert in WHO’s Health Emergencies team, shows how to properly wear a mask – making sure to cover the nose, mouth, and chin.

Governments in areas with widespread COVID-19 transmission should encourage the use of non-medical masks on public transport, in shops and in other locations where physical distancing is difficult, WHO recommends in updated guidance published on Friday.

Additionally, people over 60, or who have underlying health conditions, should wear medical masks in these settings, while all workers in clinical areas of health facilities should also use them – not just those who deal with COVID-19 patients.

For the first time, WHO also released instructions on how to make fabric masks for use by the general public that would provide adequate protection against onwards transmission of the virus, based on scientific research commissioned by the agency.

“What is really new in the guidance, is the research that we requested to be done on looking at which types of materials can actually be used in making these non-medical fabric masks,” said WHO COVID-19 Technical Lead Maria Van Kerkhove.

Masks should consist of an inner layer of absorbent material like cotton, a middle layer of non-woven materials such as polypropylene – a filtering material, and a non-absorbent outer layer made of a polyester or a polyester blend, said Van Kerkhove.

“WHO has developed this guidance through a careful review of all available evidence and extensive consultation with international experts and civil society groups,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “I wish to be very clear that the guidance we’re publishing today is an update of what we have been saying for months – that masks should only ever be used as part of a comprehensive strategy. Masks on their own will not protect you from COVID-19.”

WHO Director-General introducing new mask guidelines at the 5 June WHO COVID-19 press briefing

The slow move towards issuing specific guidelines for the broader use of facial coverings comes after an independent Strategic Technical Advisory Group for Infectious Hazards (STAG-IH) released a note supporting the broader use of masks in the community. Earlier in the week, the Lancet had also published a WHO-sponsored meta-analysis that found mask use decreased the risk of infection, although this reduced risk applied only to the use of N95s, surgical masks, and 12-16 layer cloth masks.

Still, WHO experts emphasized that masking will be an important tactic as countries begin to lift stay-at-home orders.

“In many urban areas in India, it’s impossible to maintain physical distancing, and therefore it will be very important that people wear appropriate face coverings when they are out and about, in office settings where physical distancing cannot be maintained, in public transport, and in educational institutions as some states are thinking about opening,” said Soumya Swaminathan, WHO chief scientist. Swaminathan was formerly director-general of the Indian Council of Medical Research.

Masks are mainly used as a form of “source control,” said WHO Health Emergencies Executive Director Mike Ryan. Ryan emphasized that the proper use of masks is mainly recommended to help prevent an asymptomatic or presymptomatic persons from transmitting the virus to others.

WHO Updates Guidance For Surgical Mask Use In Healthcare Settings, But No Changes In N95 Use Recommendations

In areas with widespread transmission, WHO recommended that any person working in a clinical, be it healthcare worker, janitor, or administrative staff, should wear a medical mask at all times, even while working in wards with no COVID-19 patients.

However, the use of N95 masks should still be restricted to use by healthcare workers conducting aerosolizing procedures.

“Evidence shows that there might be a greater reduction in risk by respirators, but this is still limited evidence, with many limitations due to the fact that these are only observational and small studies,” said Benedetta Allegranzi, coordinator of WHO’s infection prevention global unit. “Respirators may also have more side effects than surgical masks, such as skin lesions or difficulty breathing, etc. Also, assessing recommendations for the global level, [we have] to consider many different contexts in different countries where it’s important to assess resource availability… and equitable access.

“All together, these elements led our experts to consider that there is no strong reason for changing our recommendations [for N95 use].”

Benedetta Allegranzi speaking at the June 5 WHO COVID-19 press briefing
How To Mask Properly, According to the WHO

WHO had previously released lukewarm recommendations supporting countries’ public masking policies in areas where physical distancing is not possible.

But the new recommendations are much more specific, including guidance for different age groups, settings; instructions on how to DIY a fabric mask using materials around the house; and instructions on how to properly use and maintain a fabric mask.

“People can potentially infect themselves if they use contaminated hands to adjust a mask or to repeatedly take it off and put it on, without cleaning hands in between,” said Dr Tedros.

A properly worn mask should cover the nose, mouth, and chin. Care to only touch the earloops when removing a mask will help prevent contamination of the hands, and hands should always be washed before putting a mask on and after taking one off, according to a new instructional video featuring WHO expert on infection prevention and control, April Baller.

WHO experts also emphasized that wearing fabric masks is not protective in itself against getting infected. Maintaining physical distancing and frequent handwashing is important to protect oneself against the virus, said larger public health measures such as contact tracing, quarantining and treating cases, and isolating suspected cases must not be abandoned, said Ryan.

“Wearing a mask in a community level is more about protecting others if you happen to be infected rather than protecting yourself. So it’s an altruistic act,” said Ryan. “[We need a] well educated, empowered community, caring for their own personal hygiene and protection, caring for the rest of their community in terms of protection.

“[They need to be] supported by a public health service that’s capable of finding the virus, isolating and quarantining cases, and health system that’s capable of treating people successfully.

“And all of that in the context of good coordination, good governance being implemented. Then [add] the appropriate and targeted use of masks at community level, in order to reduce transmission within the community in areas where physical distance cannot be maintained.”

 

Image Credits: GF Ginsberg/HP-Watch.

Electron microscope image of SARS-CoV-2, the virus that causes COVID-19

In a series of flip-flops on Friday, the United Kingdom suspended the enrollment of new patients into the hydroxychloroquine arm of its massive RECOVERY trial, one of the largest randomised COVID-19 clinical trials in the world, after preliminary data showed “no benefit” for COVID-19 patients receiving the drug.

The suspension of the trial came just a day after the academic journal The Lancet retracted a widely disseminated  observational hydroxychloroquine study that found an increased risk of mortality and cardiac problems in COVID-19 patients taking the drug, in a highly unusual move. The paper’s withdrawal was requested by three authors who had concerns about the reliability of the underlying data.

“‘We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY trial with immediate effect,” Peter Horby and Martin Landray, chief investigators of the RECOVERY Trial, said in a press statement released Friday.

Preliminary results from the trial showed no significant difference in the proportion of deaths in COVID-19 patients taking hydroxychloroquine compared to those who received standard care. Among 1542 patients receiving the drug, 25.7% died after 28 days, compared to 23.5% of the 3132 patients who received standard treatment.

“There was also no evidence of beneficial effects on hospital stay duration or other outcomes,” said the principal investigators. “These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with COVID-19.”

The full results of the trial will be released “as soon as possible,” said the researchers.

Soumya Swaminathan explains reasoning for continuing WHO hydroxychloroquine trial.

Despite the pause on the RECOVERY Trial, the World Health Organization is continuing the hydroxychloroquine arm of its multicountry Solidarity Trial, which WHO temporarily suspended last week to review preliminary mortality data. After finding no increased risk of mortality in COVID-19 patients taking hydroxychloroquine, the WHO Solidarity Trial oversight committee decided to resume the trial without altering the protocol on Wednesday, according to WHO Chief Scientist Soumya Swaminathan.

“We will continue for now,” said Swaminathan, when asked whether the new RECOVERY Trial results affected WHO’s decision.  “We will wait to see the final data analysis, and the publication that’s going to come out of it and certainly our committee will be considering these results as we go on.”

Swaminathan did note, however, that “Solidarity and RECOVERY are two of the larger trials and moreover, they have very very similar study designs.”

Addressing the confusion around whether hydroxychloroquine is harmful, beneficial, or has no effect for COVID-19 patients, WHO Health Emergencies Executive Director Mike Ryan said, “With a story of such huge public interest with 24 hour coverage of those issues, the normal process of science can sometimes appear confusing.

“It is quite normal to have slightly different results coming out from different trials, and that is why the scientific world normally wants more than one trial for any particular drug or vaccine to really confirm that what you’re seeing is actually a true effect,” added WHO COVID-19 Technical Lead Maria Van Kerkhove.

Lancet Withdraws Controversial Hydroxychloroquine Study Finding No Benefit & Increased Risk of Mortality in COVID-19 Patients

After causing an uproar in the two weeks since its release, the Lancet study was retracted at the request of three out of four of the paper’s authors, after concerns arose around the accuracy of the underlying data.

The three authors requested an independent, third-party peer review of the data collected by Surgisphere, the company that supplied the data for the original analysis.

Surgisphere, however, refused to release the full dataset for audit by an independent panel of experts, citing confidentiality and agreements with clients prevented data sharing. This occurred despite the other three authors obtaining the consent of Sapan Desai, second author on the paper and CEO of Surgisphere, for the independent review.

“As a result, we can no longer vouch for the veracity of the primary data sources,” the authors Mandeep Mehra, Frank Ruschitzka, and Amit Patel wrote in a statement published in the Lancet.

The independent review aimed to evaluate the origin of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.

The WHO Director-General had referred to the study when WHO suspended its hydroxychloroquine arm of the Solidarity trial for review two weeks ago, and France rolled back recommendations for the broader use of the drug to treat severe COVID-19 patients in the wake of the study’s publication.

But soon after Lancet study was published, it drew criticism from other researchers – many of whom were concerned about the design of the analysis and the underlying data sources.

The independent review of the study was meant to address these criticisms, but could not be completed, said the three study authors who retracted the study.

“That is good science, that is doing the right thing,” Ryan said of the paper’s withdrawal at a WHO press briefing Friday. “Occasionally, when a paper is published inadvertently, and subsequently the data that supports that publication is found to be questionable or called in question, then it is the responsible thing to do for the journal to retract their paper.

“I know it sometimes can give the impression that the science community is confused or give mixed messages and for that we all collectively apologize.

“In the vast, vast majority of cases in peer reviewed journals, those papers are not retracted. It’s an incredible success rate.”

Image Credits: National Institute of Allergy and Infectious Diseases, NIH.

United Kingdom Prime Minister Boris Johnson announcing total pledges to Gavi’s 2021-2025 replenishment cycle

Gavi, the Vaccine Alliance raised a whopping US $8.8 billion at the first ever virtual Global Vaccine Summit co-hosted Thursday by the United Kingdom, surpassing the fundraising goal of US $7.4 billion.

“We have secured a fantastic US $8.8. billion for Gavi’s work over the next five years and I’d like to thank everyone very, very much,” said UK Prime Minister Boris Johnson. 

In a rare show of multilateralism, United States President Donald Trump sent a video message of support after Johnson personally reached out – but did not specify the US pledge in his speech. The United States Agency for International Development (USAID) had announced in February a pledge of US $1.16 billion to Gavi for 2020 to 2023.

US President Donald Trump makes rare show of global health solidarity in a video message at the Global Vaccine Summit

”There are no borders, [the virus] doesn’t discriminate, it’s been it’s nasty but we can all take care of it together. It’s great to be partnering with [Gavi]. We will work hard, we will work strong…good luck, let’s get the answer,” said Trump.

Over 25 Heads of State and 50 leaders of agencies, regional associations, and private industry attended the fundraising event for Gavi, a public-private partnership that finances vaccine programs in over 80 low income countries. Germany’s Chancellor Angela Merkel, UN Secretary General Antonio Guterres, the European Commission President Ursula von der Leyen, and World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus were among those who sent messages of support.

“There is an important lesson we need to understand – the vaccine by itself is not enough. Now is the time for global solidarity…to ensure that every person everywhere gets access to the vaccine,” said Antonio Guterres. “In our global village, our individual health depends on our collective health.”

Since COVID-19 struck the world, Gavi’s role has become more important than ever, as 80 million children are at risk of missing out on routine vaccines for TB, pneumonia and diarrhea, said WHO’s Director-General Dr. Tedros.

With the money pledged, Gavi aims to immunise an additional 300 million children in low- and lower-middle income countries, saving an estimated additional 8 million lives between 2020-2025. 

COVID-19 Vaccine Advanced Market Commitment Fund Created to Secure Supply For Low-Income Countries

Gavi also announced an anticipated COVID-19 Advanced Market Commitment (Covax AMC), which will be used to make volume guarantees to sellers of effective COVID-19 vaccines, and make sure a portion of the global supply will be set aside for low-income countries. 

“Donors commit funds upfront to guarantee the price of vaccines once they’ve been developed. This provides vaccine manufacturers with the incentive to invest in vaccine R&D, and to scale up manufacturing capacity,” explained Gavi CEO Seth Berkley. “GAVI’s role is to address [vaccine] market failures when market forces don’t deliver the best outcome for the public.”

GAVI’s CEO Seth Berkley explains how advanced market commitments function

AstraZeneca became the first pharma manufacturer to sign up for the Covax AMC, guaranteeing a supply of at least 300 million doses once their vaccine candidate, developed in conjunction with Oxford University, receives regulatory approval. AstraZeneca had announced the intention to sell any COVID-19 vaccines ‘not-for-profit.’

However, the price-per-vaccine has not yet been disclosed. Médecins Sans Frontières (MSF) released a call ahead of the launch for the vaccine to be sold ‘at-cost,’ and for a price to be set as soon as possible.

“We won’t know whether a vaccine is indeed sold at “not-for-profit” prices if large manufacturers don’t make their investments and cost of goods as well as the final prices publicly available,” Manuel Martin, innovation & access advisor at MSF Access Campaign told Health Policy Watch.

The Gavi Covax AMC has an initial goal of raising US$ 2 billion; enough for Gavi-supported countries to immunise health care workers and high-risk individuals, as well as create a flexible buffer of doses to be deployed where needed most. 

The AMC model had been previously used to provide volume guarantees for the pneumococcal vaccine, giving producers incentive to scale up production and sell to low-income countries. Some US $177.5 million from the PCV advanced market commitment will be rolled over into COVAX.

The initiative is part of a broader COVID-19 Global Vaccine Access Facility (Covax Facility) that will be available for all countries to access.

Donors & Pharma Show Strong Support For Gavi

The top three historical donors, The United Kingdom, the United States, and Norway, each upped their contributions to Gavi in this funding round. 

Johnson kicked off the replenishment event with a £1.6. billion pledge from the UK. The United States pledge stands at US $1.16 billion, and Norway followed closely with a $1 billion commitment. 

“We know from our own experience that investing in vaccines is one of the best public health investments we can make, ” said Norway Prime Minister Erna Solberg. “Norway was one of the founders of Gavi 20 years ago. We believed, and still believe in innovation and the mission to improve the world one vaccine at a time. We must continue to make sure no one is left behind.”

Norway Prime Minister Erna Solberg

Among other major pledges, Germany committed €600 million; Canada committed CAD $600 million, Australia, and Japan pledged US $300 million, and Italy upped it’s pledge to €287.5 million.

China, meanwhile, contributed US $20 million, in stark comparison to its massive contribution at the World Health Assembly of US$2 billion towards the COVID-19 effort and to accelerate the completion of Africa’s CDC headquarters.

Leaders and executives from the pharmaceutical sector also voiced strong support for GAVI, and announced increased supply commitments for the human papillomavirus (HPV) vaccine.

Merck Sharpe&Dohme, Glaxosmithkline, Innovax, The Serum Institute of India, and Chinese vaccine manufacturer Walvax have pledged to ramp up HPV vaccine production to supply Gavi-supported countries with enough doses to vaccinate 84 million girls, an increase from a original commitment to vaccinate 50 million girls.

Pharma is working at “unprecedented levels of collaboration and speed”, said Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA) Thomas Cueni. “Thankfully, what is not unprecedented is the notion that collaborative efforts and partnerships can deliver and can transform lives. We will succeed by working openly.”

GSK CEO Emma Walmsley emphasized that “global, fair access to COVIDー19 vaccines is an absolute priority.” GSK leadership, along with executives from AstraZeneca and Johnson&Johnson announced their companies’ intentions to sell vaccines at a “no-profit” price last week.

“We do it not-for-profit for the pandemic period, as we want to [ensure] equitable access over the world…and especially to get vaccines to make sure we get a stop to the pandemic,” said CSO of Johnson & Johnson Paul Stoffels last week.

Photo Credit: Gavi/Karel Prinsloo

A day ahead of a major pledging event, Gavi-the Vaccine Alliance has received some US $70 million in pledges from a broad range of corporations, foundations, initiatives and individual philanthropists to modernise, streamline and strengthen its delivery of vaccines to children in the world’s poorest countries over the next 15 years.

Meanwhile, Médecins sans Frontières (MSF) issued a call on Tuesday for governments to ensure that COVID-19 vaccines are sold at the cost of production, particularly so that low-income countries supported by Gavi can access any successful products.

Both developments come on the eve of the UK Government-hosted Global Vaccine Summit, which will aim to culminate in pledges of at least US$ 7.4 billion for Gavi’s efforts between 2021 and 2025 to immunise a further 300 million children.

“Gavi is the consummate example of how public-private partnerships play a substantial role in saving lives and putting whole societies on trajectories of progress and prosperity,” said Seth Berkley, CEO of Gavi. “We understand the innovation that exists and can be unlocked when we work with the private sector. As a result, we’re extraordinarily proud of and grateful to our many private sector partners, with whom we have been able to pioneer some transformational changes in immunisation systems.”

Ireland, Italy, Spain, Greece, New Zealand, and Canada have also announced commitments prior to the official event, following a massive US $1 billion pledge by Norway to the Vaccine Alliance.

Vaccine manufacturers Merck Sharpe&Dohme, Glaxosmithkline, Innovax, Serum Institute of India Pvt. Ltd. (SII) and Walvax have also committed to providing enough human papillomavirus vaccine to protect 84 million girls against cervical cancer.

MSF Calls For ‘At-Cost’ Pricing Ahead of Gavi’s COVID-19 Vaccine Funding Facility Launch

Photo Credit: NIAID

A new ‘COVAX’ funding facility will also be launched by Gavi on the same day in order to generate funding for advance commitments to buy highly anticipated COVID-19 vaccines for low-income countries.

Specifically, the MSF statement specifically calls for the vaccine to be sold  at-cost, and for the price point to be negotiated at the outset.

“Governments must ensure any future COVID-19 vaccines are sold at cost and universally accessible to all across the world,” said Kate Elder, senior vaccines policy advisor at MSF’s Access Campaign in a press statement.

Elder’s statement echoed those of several heads of state, including France’s Emmanuel Macron, Germany’s Angela Merkel, South Africa’s Cyril Ramaphosa, and China’s Xi Jinping, who have called for COVID-19 vaccines to be treated as “global public goods.”

Still, MSF Access Campaign director Sidney Wong is concerned that “nationalist interests could lead to a scramble for who can buy [vaccines] first.”

Sanofi, a French pharma company, had previously walked back on a statement saying they would sell any successful vaccines first to the United States, following widespread backlash from health advocates and Macron himself. A Pfizer executive last week said that no premarket agreements had been signed.

Pharma Leaders Say They’ll Sell “No-Profit” Vaccine

Johnson & Johnson CSO, Jonathan Stoffels speaking at a 28 May press briefing

Some pharma industry leaders last week announced intentions to provide any successful COVID-19 vaccines under “not-for-profit” pricing. The International Association of Pharmaceutical Manufacturers and Associations (IFPMA) later released a softened statement regarding the industry commitment to ensuring an accessible vaccine.

“Johnson & Johnson made a commitment to the pandemic period where we will supply [a successful vaccine] all over the world, at a at a ‘not-for-profit’ price,” said Johnson & Johnson Chief Science Officer Jonathan Stoffels, in a Thursday press briefing on vaccine development, organized by IFPMA.

Glaxosmithkline CEO Emma Walmsley and AstraZeneca CEO Pascal Soriot echoed that successful vaccines developed with their companies’ support would likewise be sold at a ‘no-profit’ price. Pfizer CEO Albert Bourla was also present at the briefing, although he did not make any specific references to selling a vaccine “not-for-profit.”

“It’s encouraging to see that pharma companies are claiming that they won’t conduct business as usual during this devastating pandemic, and say that they’ll charge a ‘not for profit’ price for future COVID-19 vaccines,” Elder said to Health Policy Watch.

“Of course, the devil is in the details: how will pharmaceutical corporations substantiate that? Are they planning to open their books so the public can scrutinize their costs and see if indeed the price they set is truly not-for-profit?” questioned Elder, adding a call for companies to be transparent around the cost of production.

IFPMA later released a statement with softened language, affirming the industry’s commitment “to deliver safe, quality, effective, and affordable COVID-19 vaccines to all” without specific reference to selling at a ‘no-profit’ price.

The industry group did however, affirm its commitment to continue supporting Gavi, joining other private industry sectors to support the public-private partnership. Several foundations, including the UPS Foundation, the ELMA Vaccines & Immunization Foundation, Laerdel Global Health Fund and the Rockerfeller Foundation committed funds to Gavi support supply chain strengthening and frontline healthcare workers.

Airtel and Mastercard committed services and funding for digitising immunization data, and social media brand TikTok and Unilever have committed donations to help generate demand for vaccines. United Bank of Africa (UBA) Foundation, Gamers Without Borders (GWB), and Netflix founder Reed Hastings have also made commitments to Gavi ahead of Thursday’s pledging conference.

Image Credits: Gavi/Karel Prinsloo 2017, NIAID.

(Left-right): Mike Ryan, Dr Tedros Adhanom Ghebreyesus, Maria Van Kerkhove, and Soumya Swaminathan at WHO press briefing Wednesday

The World Health Organization finally appears poised to recommend wider public use of masks as an additional measure to prevent transmission of COVID-19 – after months of hesitation while countries took unilateral action mandating face coverings, particularly for busy shops, transport systems and public settings.

The WHO move, announced at a Wednesday press briefing, follows new recommendations by its Strategic and Technical Advisory Group for Infectious Hazards (STAG-IH),  supporting ” mask use by the general public in the community to decrease the risk of infection.”

In another statement at Wednesday’s briefing, WHO’s Chief Scientist Soumya Swaminathan, said that enrollment would resume in WHO co-sponsored clinical trials of the anti-malarial and lupus drug hydroxychloroquine – after a review of the evidence so far found no significant rise in mortality among people using the treatment.

“The advisory committee of both Solidarity and Recovery have recommended that the trials can continue,” said Swaminathan, referring to the consortiums that are guiding the research with WHO. “We hope that the ongoing trials will continue until we have definite answers. That is what the world needs.” 

WHO suspended the trial last week, in the wake of a Lancet study that seemed to find a higher mortality rates among people taking the drug – although the observational study was later criticized for not adequately taking into account the baseline condition of the patients considered in its analysis of death rates.

Said Swaminathan: “The only way to get definite answers is to do well conducted randomized trials, to see which [treatments] will reduce illness and infection rates in the communities, we should be guided by the science and the evidence.”

STAG Report and Lancet Study Tip the Balance on Mask Recommendations

The STAG advisory group recommendations were released shortly before a WHO-sponsored meta-analysis published by The Lancet, concluded that public use of masks could be an effective infection control measure – although there remains a dearth of robust studies on the topic. 

“Face mask use could result in a large reduction in risk of infection…., with stronger associations with N95 or similar respirators compared with disposable surgical masks or similar (eg, reusable
12–16-layer cotton masks,” the Lancet study concluded.

The STAG advisory group particularly recommended the use of masks in settings where there is “active and widespread community transmission occurring with high attack rates in the population… [for] activities in closed environments without efficient air exchanges, such as commuting on public transportation and over-the-counter consultations in pharmacies.” 

Commuters wear masks to protect against transmission of COVID-19 on a train in Singapore

Public use of facial coverings can also be useful “as part of a transitional package from a ‘confinement’ or ‘stay-at-home’ order to demonstrate solidarity, community empowerment, understanding of the seriousness of the situation,” according to the STAG note.

WHO’s COVID-19 Technical lead Maria Van Kerkove said that updated guidance would be forthcoming in light of the STAG Committee’s recommendations. 

“We are planning to update and release new guidance on use of masks in the coming days,” said Van Kerkhove, in response to a query from Health Policy Watch at a Wednesday press briefing. 

Masks  – As Part of A Continuum of Management

However, Health Emergencies Executive Director Mike Ryan stressed, “We see masks as part of a continuum of risk management, not as an alternative to public health interventions, physical distancing, or surveillance.

“As we move back to work and back to school, everyone is concerned [about] how I can reduce risk. How I can manage the risk to me or my family?

“With regard to the use of masks at the community level, they would mainly be used for the purposes of source control. In other words, [they are recommended] for people who may be infectious, reducing the chances that they will infect someone else,” said Ryan. But mounting evidence of asymptomatic transmission makes it impossible for some people to know if they are indeed infectious or not, and thus the move to wider public mask use may be justified, he acknowledged. 

Wearing masks to protect from COVID-19 in Nigeria Credit: @CRSPHCDA1

The STAG recommendations also underline that the use of masks helps prevent transmission of the virus by asymptomatic or presymptomatic individuals – those who may be infected but not yet showing symptoms. 

“The primary role of masks (of any kind) in the community is to reduce exposure risk for others from infected persons in the pre-symptomatic period,” the STAG-IH group writes. “Infections from such persons are not considered a major driver of the pandemic, but there are concerns that viral loads are highest during the early phase of the disease.”

The WHO move towards wider use of masks has been slow. In the early days of the pandemic, Ryan, Kerkhove and others repeatedly stressed that masks should be limited to health clinics or caring for a sick person at home.  Widespread public use of masks in Asia was described by Ryan as a “cultural” habit – although that habit also clearly originated in the Asian experience with previous pandemics such as the 2003 SARS.

Masked protest in Minneapolis against the death of George Floyd

The WHO message evolved slowly, as  the evidence grew about potential virus transmisison by people with no symptoms, and through simple actions like speaking or singing. The number of countries recommending or requiring facial coverings in public also grew well beyond Asia to Africa, where public health leaders stressed that social distancing is almost impossible, as well as more affluent countries such as Hungary, the Czech Republic, Israel, and some US states.

 

Mask use has become even more significant as countries begin to lift stay-at-home orders. Israel, for instance, which had one of the lowest per capita mortality rates in the height of the pandemic, has seen a rapid rise in cases after lifting its lockdown, and has since strengthened its enforcement of requirements to don masks in schools, stores and other public places. In the US, protestors have been circulating advice via social media to wear masks while attending the massive rallies protesting the death of a Minnesota black man, George Floyd, while in police custody. The mass gatherings have put millions of people into much closer contact with each other in the world’s pandemic epicentre, albeit in outdoors environments. 

 

Image Credits: Jade Lee , Cross River State Primary Health Care, Nigeria , Jenny Salita.