Pfizer is one of the front-runners in development of a COVID-19 vaccine.

Acting on the advice of experts, the United States Food and Drug Administration on Tuesday issued new safety-focused guidelines for approval of new COVID-19 vaccines, that would almost certainly delay their emergency approval until after the November Presidential elections.

Just hours after the rules were issued, United States President Donald Trump accused the FDA of carrying out a “political hit job” against him by releasing new standards that could delay authorization of a coronavirus vaccine until after the November election.

“But in a subsequent video issued Wednesday evening, Washington DC time,  Trump said he’d go along with the FDA vaccine timeline, and was switching his focus to accelerating rapid FDA emergency use approval of the new antibody-rich cocktail, Regeneron, that he himself had used as a treatment, while hospitalized for COVID-19 over the past week.

In his video-taped message, issued on his personal Twitter account, the president described rapid approval of the antibody treatments as “much more important than a vaccine” since it could bring immediate relief to people who are already ill with the virus, in the way that it did for him.

“We have Regeneron, we have a very similar drug from Eli Lilly and we are trying to get them on an emergency basis,” Trump said in the video. “We have to get them to the hospital where people are feeling badly, that is much more important than the vaccine….I want to get you what I got. I want to make it free,” he also said.

“On the vaccines, we have many companies that are in final stages, Johnson & Johnson, Moderna, Pfizer… and we are going to have a great vaccine very very shortly.  I think we should have it before the election. But frankly the politics gets involved, and that’s ok. They want to play their games, it’s going to be right after the election.

“The FDA has acted as quickly as ever they acted in history, and no president has pushed them like I did. And so the FDA is approving things in a matter of weeks, that used to take them years,” Trump added in a 5-minute message that also lambasted the virus as “China’s fault.”

The new FDA guidance on vaccine aprovals, posted on the Agency’s website, would require vaccine manufacturers to follow trial participants for at least two months after they completed their vaccine course, to ensure that major adverse effects did not emerge – at least immediately.

Since the two leading vaccines in the most advanced stages of clinical trials, by Moderna and Pfizer, both require two doses, it appeared increasingly unlikely that either firm would have sufficient trial candidates having cleared that two-month milestone before November.

COVID-19 vaccine research

According to news reports, the White House had earlier tried to block the FDA’s plans to formally publish the new safety guidelines including the two-month data requirement, arguing there was “no clinical or medical reason” for it. President also had openly opposed any delays when he talked about the potential offered by forthcoming COVID vaccines in the Presidential debate with former Vice President Joe Biden, the Democratic Party candidate, last week.

But on Tuesday, the FDA posted the guidance on the agency’s website anyway, pushing back against the president’s pressures.  The requirements include a review by a panel of experts and two months of safety data. The guidelines are intended to reassure the American public any vaccine is safe and effective, amid fears that the President has been trying to accelerate approvals ahead of the elections – no matter what the data shows.

FDA Commissioner Stephen Hahn said in a statement posted on the FDA’s website: “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.” Pharma companies have generally taken a prudent stand.

Pfizer’s CEO Albert Bourla even spoke out publicly last week out about his concerns over the politicization of the vaccine approval timetable, saying that it was caught in the “crucible” of the presidential elections.

Albert Bourla, CEO of Pfizer

In an FDA press release introducing the new guidance, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research added:

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”

The FDA said it will now convene on October 22 an open session of its Vaccines and Related Biological Products Advisory Commitee to discuss any upcoming emergency use authorization requests and processes for handling them:

“The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines,” said the press release. “While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.”

Trump, who is still recovering himself from a coronavirus infection, has been tweeting aggressively on a range of matters since returning from Walter Reed medical facility, where he was undergoing medical treatment, back to the White House earlier in the week.

Meanwhile over a dozen of his staff are reported to be ill with COVID-19, while unconfirmed reports put the number closer to 30.

 

Image Credits: Pfizer, Pfizer, Pfizer .

Dr Tedros Adhanom Ghebreyesus, Tuesday 6 October at Special WHO EB session.

The United States on Tuesday gave conditional praise for the “progress made” by an independent oversight committee examining the response of the WHO’s Health Emergencies Programme to the COVID-19 pandemic – asking for more updates in November and early 2021.

The report by the Independent Oversight and Advisory Committee (IOAC) to WHO’s Health Emergencies operations is was one of three reports heard by the EB at Tuesday’s meeting on various aspects of the WHO organizational and global pandemic response.

One of the key findings of the IOAC interim report, however, was that the “politicization of the pandemic response is a material impediment to defeating the virus.”

And indeed it seemed as though the member states were already taking that piece of advice to heart.

While the last Executive Board meeting in May saw significant geopolitical tensions emerge between the United States and China over who was most at fault for the expansion of the pandemic, this meeting remained sober and substantive – with both sides dialing down their remarks.

And after months of blithering White House criticism of the WHO, the conditional endorsement of the inpendent review, still underway, seemed to indicate that Washington was well along the path to remaining within the Organization, despite US President Donald Trump’s announcement in July that the US was withdrawing.

“We appreciate the progress made,” said US Deputy Secretary of Health and Human Services Brett Giroir, asking that EB members be briefed again in November and early 2021 “so we can engage in substantive discussions about how best to address the challenges and issues identified.”

Key Report Findings

Key findings of the report were that despite WHO’s declaration of a global public health emergency (PHEIC), response among member states was inconsistent and delayed.  Key gaps also emerged in national preparedness strategies, further hampering rapid mobilization. And the overall level of COVID-19 data reporting, “needs furhter improvement in terms of speed, consistency, and completeness.

Interim report of the Independent Oversight Advisory Committee (IOAC)

 

EU Bloc; Strengthen WHO’s ‘Perogative’ in Access to Information

While the committee also found that WHO acted within the legal frameworks that is currently has available, key WHO EB members suggested that those need to be strengthened.

Significantly, Germany speaking on behalf of the European Union bloc said member states need to consider “strengthening WHO’s perogative in terms of access to information” and urged the three panels that are now exploring the pandemic response from various angles: “do not to be afraid to tell uncomfortable truths.

Roles and responsibilities of the three independent committees and panels examining various aspects of the response by WHO and countries to the COVID-19 pandemic

“In your recommendations, do not be afraid to challenge all as member states to question current modes of operation and to show boldness and vision. You can count on the full support of the EU and its member states states,” said Björn Kümmel, Germany’s EB representative, to review panel members.

That EU statement, coming after months of heavy US criticism of Beijing, for allegedly withholding vital information on the emergence of a mysterious virus in Wuhan, China in late 2019, is highly significant – as it represents the diplomatic backing Washington may receive for rules changes that require  greater transparency among member states, when it comes to reporting on emerging infection threats.  Along with EU member states, Japan and Australia as well as the United Kingdom have also voiced criticism of Beijing’s handling of the pandemic in the past.

Germany also suggested that the addition of an “intermediate level” of alert that would be short of a full-fledged global public health emergency.

“We support considering the long standing idea of creating an intermediate level of alert. But we need the expertise of the Secretariat and of the evaluation groups regarding its definition, the consequences that will be attached to its activation, and the possible process for its implementation,”  Kümmel, added, also speaking on behalf of the European Union bloc.

“We look forward to discussing ideas such as increased accountability of member states on preparedness, for example, through the establishment of a periodic review mechanism, as proposed by the African Union, and all strengthening WHO’s prerogatives in terms of access to information.

“Emphasis must also be placed on development of proper and unified health data collection at all levels,” Kümmel added.  

The United Kingdom, meanwhile, said that the team leading a second review, The Independent Panel (IPPR), which is examining both national and WHO response, should add a scientific advisory panel to structure.

“Given the potentially unlimited amount of quantitative and qualitative information available to the panel, we believe a scientific advisory group will be a beneficial addition to your structure,” said the UK’s representative Chris Whitty. “It would ensure that the advice given to the Co-chairs and the panel is fully independent and impartial, capturing the best evidence available.

“It would streamline and speed up the collection and analysis of evidence enabling the development of a comprehensive pace to inform your reviews output, and it will provide the co-chairs and panel with consistent advice over the entire course of review, covering the range of necessary technical expertise, including for example, as mentioned by others, human health, animal health, behavioural science, organisational change and modelling and forecasting.”

Russia Criticizes Makeup of Review Committee – China remarks remain muted

The meeting was not without its flashpoints, however couched they were in diplomatic language.

Russia complained about geographic imbalance in the makeup of a second review committee, the Independent Panel, which was mandated by the last World Health Assembly in May to take a broad look at both the WHO and national response to the pandemic.  The 13 member Panel chaired by former New Zealand Prime Minister Helen Clark and former Liberian Prime Minister Helen Johnson Sirleaf,  includes members from all WHO regions.

However,  Minister of Health Mikhail Albertovič Murashko, Russia’s EB representative, maintained nonetheless that the reprsentation on the panel was lopsided.  “As we see it, it’s important to take a balanced approach, and sadly, within the IPPR at present we do not see a balanced situation because there is one whole geographical region that is not represented at all, and if you consider the fact that this region represents a very significant proportion of the world’s population, that is a serious imbalance.”

Yet a third review committee is examining the functioning of the International Health Regulations, which form the legally binding framework under which countries report about health emergencies and WHO’s shapes its guidance and response.

China reacted in a muted way to the reports. It said it hoped the reviews would enhance the ability of WHO and the international community to “take more targeted measures to further support countries with weak health systems.”

China’s EB representative, Zhang Yang, also called upon the review panels to “inform members states of their work in a timely manner and use their platforms to enhance direction with member states.”

WHO Provides Extensive Review of COVID-19 Pandemic Response To Date

The debate over WHO’s performance followed an extensive review by WHO of the state of the pandemic and its response to date – including everything from the direct distribution of emergency supplies to the massive WHO “Solidarity Trial” for new tests, drugs and other health products involving research in dozens of countries; laboratory capacity-building; and the creation of the COVAX vaccine pool,  which 168 countries have joined so far.

The review illustrated the volatile nature of the pandemic in terms of its geographic impacts – but also included somebright spots including strikingly lower case and death counts in the African region, and the beginnings of decline in South-East Asia.  This, as cases in WHO’s European region were seeing a significant rise.

 

At the same time, one sobering note was the striking disruptions of key health services in countries across the world. Among the services hardest hit, according to a recent WHO survey: some 77% of countries have reported pandemic-related  interruptions of dental services, 66 % of countries reported interruptions in routine immunization services; 65% NCD diagnosis, 64% in family planning and contraception, and 55% of countries reported interruptions in treatment for mental health disorders.

-Pippa Cook contributed reporting to this story

President Donald Trump, still ill with coronavirus, waves to his supporters in a drive-by outside of Walter Reed National Military Medical Center on Oct. 4.

A hail of criticism has followed US President Donald Trump’s drive-by to wave at supporters outside of the Walter Reed National Military Medical Center, including by a doctor at Walter Reed who said the president put the Secret Service at great risk.

President Trump was hospitalized on Friday, after testing positive for SARS-CoV2 hours earlier. Trump was moved to Walter Reed after the White House reported that he was experiencing “mild symptoms”, including a low-grade fever, nasal congestion and a cough. 

On Sunday, the White House physician Sean P. Conley corrected previous reports, announcing that Trump had a high fever on Friday and his blood oxygen levels dropped below 95 percent on two occasions, on Friday and again on Sunday. 

The president received an antibody cocktail from Regeneron, a biotech company that has developed a treatment to lower the level of the virus. Later on Friday Trump began taking the experimental drug Remdesivir, developed by Gilead. And the following day, he was given dexamethasone, a drug reserved for use in “severe and critical COVID-19” cases, according to WHO guidelines. He was also reportedly given oxygen on a couple of occasions. 

The White House has been widely criticized for the incomplete and sometimes contradictory information regarding Trump’s health. Infectious disease experts have begun questioning if Trump’s condition is more serious than implied by his doctors due to the combination of drugs he has been given. 

Trump has attempted to quell concerns by posting a video on Twitter, praising his doctors at Walter Reed and saying, “I learned a lot about COVID…I get it and I understand it.” Moments after releasing the video, Trump left the hospital in a vehicle with his Secret Service detail to wave to his supporters – who he referred to as “the great patriots” – gathered outside. Trump was wearing a mask and the Secret Service agents were wearing respirators and eye protection.

Trump’s actions have been harshly criticized by doctors and experts for putting the Secret Service agents at risk. James Phillips, an attending physician at Walter Reed, said Trump’s drive-by was “political theater” and “insanity.” 

“The risk of COVID-19 transmission inside [the vehicle] is as high as it gets outside of medical procedures. The irresponsibility is astounding,” said Phillips. 

According to the White House spokesperson, Judd Deere, the drive was “cleared by the medical team as safe.” However, Secret Service agents told the Washington Post that Trump’s behavior was reckless. 

“By taking a joy ride outside Walter Reed the president is placing his Secret Service detail at grave risk,” said Jonathan Reiner, professor of medicine and surgery at George Washington School of medicine and health services. 

Trump’s Medical Team Report That He Will Be Discharged
White House Physician, Sean Conley, and President Trump’s medical team hold press conference on Oct. 4.

Meanwhile, Conley announced on Monday that the president will be discharged from the hospital and return to the White House on Monday evening. Trump has received a third dose of remdesivir and continues to take dexamethasone, according to his doctors at Walter Reed. 

Trump affirmed that his health has drastically improved, saying on Twitter, “I feel better than I did 20 years ago!” These feelings, however, could be attributed to the dexamethasone that the president has been taking. The steroid dampens the body’s immune response and can cause some patients to develop “insomnia, mania, agitation and grandiosity,” said Céline Gounder, a clinical assistant professor of medicine and infectious diseases at the NYU Grossman School of Medicine. 

Several medical experts have raised concerns about the decision to discharge Trump. “I think it would be disastrous to be in a situation where he gets really sick at the White House, and you’re having to emergency transfer him,” said Gounder. 

However, in the absence of more detailed, and transparent, reports about the President’s health by his doctors, the speculation remained just that.  

As the US COVID-19 deaths reached 210,000 on Monday, President Trump tweeted ,defiantly, “Don’t be afraid of COVID. Don’t let it dominate your life.”

Image Credits: Flickr – White House, Flickr – White House.

The COVID-19 pandemic has disrupted mental health services in 93% of countries at a time when they are most needed, concludes a new WHO survey, released Monday. The survey is based on data from 130 WHO countries gathered between June and August 2020.

Despite rising awareness of the enormous strain that the pandemic has placed on the mental health of people in rich and poor countries alike – as well as mounting research evidence that the SARS-CoV-2 virus can also cause or exacerbate neurological conditions – most of the world’s countries are facing massive shortfalls in funding for mental, neurological and substance use services.

WHO’s director of the Mental Health and Substance Use department Dévora Kestel

And these are exactly the kinds of services that are most needed now – as people face huge economic losses, disruption in school and social plans, and increased isolation as a result of the measures taken to contain the virus spread.  

“We want to make sure that people in need of attention receive the care they deserve and need,” aid WHO’s director of the Mental Health and Substance Use, Dévora Kestel, at a WHO press briefing. “And so we want to make sure that there is better, [and] more investment on essential services for mental, neurological, and substance use [disorders].” 

While nine out of 10 countries surveyed have included mental health and psychosocial support within their national COVID-19 response plans, less than one-fifth have allocated enough funding to implement those plans, according to the report, published just days before World Mental Health is observed on 10 October, including WHO’s Big Event for Mental Health.

“The problem is that only 17% of countries have the funding for the implementation of [mental health and psychosocial] plans,” added Kestel.

Even though evidence-based interventions in mental health are highly cost-effective, mental health funding has stagnated at less than 2% of national health budgets, according to WHO.

The data were collected by WHO through a web-based survey completed by mental health focal points at ministries of health between June and August 2020. 

Children And Adolescents Most Affected By Mental Health Service Disruption

Children and adolescents are the most severely affected by mental health service disruptions

Children, adolescents and older people were the most severely affected groups, said the report. Disruptions in services for these groups were reported by 70% of countries, especially mental health promotion and prevention services in schools. 

Almost two-thirds of mental health services in schools or workplaces were wholly or partially disrupted, warned the report. Only 30% of mental health services for children and adolescents or for older adults were fully available without disruption.

Community-based and outpatient mental health services were also deeply affected, including the closure of, or restrictions on residential, home and day-care services.

Disruptions in mental health services are often a result of travel restrictions that have prevented patients from reaching clinics, especially in low-income countries, which have had trouble responding to COVID-19 through digital healthcare services like telemedicine, teletherapy or hotlines. 

While over 80% of high-income countries said they used digital healthcare to replace in-person consultations, only 50% of low-income countries have been able to do so, revealed the report.

Lower-income countries have found it harder to adopt digital health solutions during the pandemic

Countries Must Ramp Up Mental Health Surveillance And Research

Countries must ramp up mental health surveillance and research, especially as the coronavirus exacerbates existing mental, neurological and substance use issues and triggers new ones – including delirium, strokes or psychoses, said Kestel.  She added that only half of  130 surveyed countries have collected data on mental, neurological and substance use disorders – and fewer than one-tenth are researching how the COVID-19 virus attacks the brain.

People with pre-existing mental, neurological and substance use disorders are also more vulnerable to COVID-19 disease, according to the latest research.

In one cohort study of almost 1,700 patients with COVID-19, those with psychiatric disorders were about 1.5 times more likely to die from COVID-19, even after adjusting for differences in age, underlying conditions or hospital locations, reported researchers from Yale University’s School of Public Health less than a week ago.

Even if people with mental health disorders are safe from the coronavirus, inadequate access to services can be life-threatening. Together, suicides, alcohol and drug overdoses kill over 4 million people a year – or four times more than the coronavirus has killed thus far.

“The impact of the pandemic on people’s mental health is already extremely concerning,” said Director-General of the World Health Organization Dr Tedros Adhanom Ghebreyesus in mid-May. “Social isolation, fear of contagion, and loss of family members is compounded by the distress caused by loss of income and often employment.”

Image Credits: WHO/NOOR/Sebastian Liste, WHO, WHO.

The 5th Special Session of the WHO Executive Board – hybrid virtual and face-to-face meeting

The United States appears to be walking back on threats to withdraw from the World Health Organization – just as US President Donald Trump is reported to be recovering from a bout with COVID-19 in Washington, DC. 

Speaking at the first formal meeting of WHO’s Executive Board governing body to be convened since May, US Assistant Secretary for Health, Brett Giroir, said that the US had developed a “roadmap for WHO reform” together with other members of the Group of 7 industrialized nations, suggesting that the US would be pushing for uptake of those  measures within the global health organization – rather than pulling out altogether.    

“The United States working closely with G7 partners, developed a roadmap for WHO  reform, which I shared with my fellow executive members in August,” said Giroir in his remarks today at the meeting of the 33- WHO member states that guide key policy directions.

“The roadmap outlines opportunities to strengthen the WHO by increasing its accountability, transparency and overall effectiveness, as well as promoting our shared accountability to one another to address new and emerging threats. Germany and France jointly provided a paper also along these lines, and we understand Chile, also has recommendations.” 

In his remarks, Giroir made one pointed, albeit indirect reference to alleged Chinese “failure” to report earlier on the virus spread – but in a departure from the heated anti-China rhetoric coming from the White House, he did not call out Beijing by name.

US Deputy Secretary of Health, Brett Giroir, speaking at a special session of the WHO Executive Board, 5 October 2020.

“Despite the many advances in technology, international cooperation and instantaneous communication, and the positive steps in response outlined this morning,… we cannot overcome the failure of any member state to provide accurate, complete and timely information on outbreaks and potential health emergencies,” Giroir said. 

The balance of his remarks stressed the common goals shared with other WHO member states going forward in beating back the pandemic.

“We also all share the same goal of reforming the WHO, fighting COVID-19 and defeating future outbreaks,” said Giroir. “The US welcomes all good faith efforts to strengthen public health protections, and we hope we can use this special session. To begin, converting these many good ideas, actions. 

“Consistent with our longstanding policy, the United States will be promoting reforms that strengthen transparency and accountability at every international organization, including the WHO.”  

Austria, Brazil and Others Echo Reform Calls  

An assortment of other high-income countries also joined into the US calls for reform – with a range of statements. 

Austria praised “the good and early reaction of WHO.. whoever says different is far from the facts, and believes in fake conspiracies.” But the Austrian representative, Clemens Martin-Auer, also complained that there had been “no global leadership when it comes to the many aspects of travel regimes and restrictions that is hurting commerce and the travel industry in many respects. We have no proper guidance of this valuable organization.”

And while he praised WHO Director General, Dr Tedros Adhanom Ghebreysus for doing an “extraordinary job when it comes to information” he pointedly added that “information is not a substitute for consultation,” saying that the organization’s “governing bodies” such as the Executive Board, could have been consulted more.  

In an obvious swipe at the United States, Martin-Auer added: “In addition to the health crisis, we are also facing a weakening of the organization. This political weakening is further reinforced by the potential withdrawal of a strong WHO Member State from the organization, which means a serious loss of organizational resources.”

Maria Nazareth Farani Azevêdo, Brazilian representative to the United Nations in Geneva

In their remarks, a number of other leading countries signaled their readiness to cooperate with the US ‘reform’ initiative. Brazil, for its part, said it was ready to “engage with other interested member states in a reform process of the WHO, on the basis of the roadmap circulated by the United States in collaboration with G-7 partners.”

And yet others, sidestepped criticism of WHO altogether, preferring to focus on the importance of maintaining a strong WHO leadeship role.  

“Our duty is to demonstrate that protecting the health of the people, makes good economic sense. We need a strong WHO to lead us forward,” said Dr Päivi Sillanaukee, Finland’s representative to the Executive Board. 

Meanwhile, India and Kenya called for a stronger WHO, with more transparent decision-making and better equity in access to vaccines and medicine. “It must be our collective endeavor to make the WHO accountable, stronger, and a more vibrant organization in the interest of our future generations,” said the Indian representative. “The WHO must also put in place a robust mechanism to ensure fair, affordable, equitable access to vaccines diagnostics, and therapeutics.”

The WHO Says Just Three Countries Hold More Than Half of All COVID-19 Cases
Dr Tedros Adhanom Ghebreyesus, Director General of the WHO.

In WHO’s opening remarks Monday morning before the EB governing body, WHO Director General Tedros pointedly noted that while “all countries have been affected by the virus, this is an uneven pandemic.”

“Just 10 countries account for 70% of all reported cases and deaths, and just three countries account for half,” Dr Tedros said. Although he didn’t call out the countries by name, the United States, India, and Brazil have together have had the largest cumulative totals, racking up nearly 19 million of the 35.3 million COVID-19 cases reported to date.

He outlined what he described as the four situations that countries are facing:

“First, some countries acted decisively and quickly and have avoided large outbreaks. Second, some countries have had large outbreaks but were able to bring them under control, and continue to suppress the virus. Third, while some countries brought the virus under control, as economies and societies have eased restrictions, there has been an increase in cases. And fourth, there are still some countries that are in the intense phase of transmission.”

But the virus is highly dynamic, he emphasized, meaning that “every situation can be turned around. And hard-won gains can be easily lost.”

World map representing COVID-19 deaths per 1 million population globally.
Shock Over Sexual Abuse Allegations in Democratic Republic of Congo

While most of the all-day session, which continues tomorrow, was devoted to reviews of the progress and challenges related to pandemic response, some countries, such as the United Kingdom, also expressed their dismay over the recent allegations of sexual exploitation among members of the WHO Ebola team that had been based in the Democratic Republic of Congo. 

“Like others we were shocked to hear the recent allegations of sexual exploitation and abuse against who and other organizations fighting Ebola in DRC. We welcome to DDS commitment to investigate these allegations and to ensure who safeguarding systems are for the offenses,” said the United Kingdom’s representative, Chris Whitty.  

-Raisa Santos and Madeleine Hoecklin contributed to this story.

Image Credits: WHO.

Albert Bourla, CEO of Pfizer, speaking at the World Economic Forum

The CEO of Pfizer, one of the frontrunners in the race to develop a COVID-19 vaccine, has lambasted US President Donald Trump’s politicization of the vaccine approval timeline, declaring in an open letter that the company is “moving at the speed of science” and will not “succumb to political pressure” to prematurely rush its product to market.

The letter by Albert Bourla to “US colleagues” was issued shortly after President Donald Trump declared Tuesday in a televised US presidential campaign that a COVID-19 vaccine could be ready “a lot sooner” than timelines laid out recently by US Centers for Disease Control Robert Redfield and other scientific experts.  

Responding to a debate question about Redfield’s projection that public release of a vaccine might not be feasible until next summer, Trump said: “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. I’ve spoken to the companies and we can have it a lot sooner.”

Bourla retorted that “the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” 

Referring explicitly to Tuesday’s debate in his letter, Bourla said that “once more I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts.”

He added that the political rhetoric swirling around the vaccine approval timeline undermines public confidence, which is crucial for the acceptance of a vaccine: “People, who are understandably confused, don’t know whom or what to believe. Global health has too much at stake, and the public trust and acceptance of a vaccine is so important to me, that I’m writing to explain the principles we are using at Pfizer today.”  

Among the three pharma front-runners in late-stage trials, Pfizer is the only company that has projected that it could have “an answer by the end of October,” before the 3 November US election. President Trump had, in turn, praised Pfizer for their speed and accelerated timeline. Experts have noted that the timeline  is largely driven by the shorter interval required between Pfizer’s two-dose vaccine and another candidate, being tested by Moderna, Inc.  Trials of a third vaccine candidate, by AstraZeneca, have stalled due to safety concerns.  

While Bourla’s letter did not upend the official Pfizer projections, the CEO said the pace of approvals should be determined separately from politics: 

“In March, I declared a bold ambition: that Pfizer would create a vaccine…I further announced, after consulting with our scientists, that we could have vaccine data ready to submit to the FDA by end of the third quarter, in October, and hopefully a hundred million doses delivered by the end of the year. I knew our goal was ambitious, but it would also be critical to protect against the second wave of cases that could accompany the return of colder weather in the Fall.

“Now, we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election. In this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay. Neither of those options are acceptable to me. Against this backdrop, people need to know three things:

“First, we are moving at the speed of science. With a virus this ferocious, time is our enemy. This week, we will hit the grim marker of 1 million deaths globally and the number continues to climb. This danger supersedes any other timing considerations.

“Second, we would never succumb to political pressure. The only pressure we feel—and it weighs heavy—are the billions of people, millions of businesses and hundreds of government officials that are depending on us. We’ve engaged with many elected leaders around the globe through this health crisis, but Pfizer took no investment money from any government. Our independence is a precious asset.  

“Third, our priority is the development of a safe and effective vaccine to end this pandemic…The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence. I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.”   

Newly Established Global Lab Network Will Compare COVID-19 Vaccines 
The manufacturing process of Pfizer’s COVID-19 mRNA vaccine

Presuming that several vaccines, at the least, will eventually make it to marketing approval, scientists are also grappling for ways to assess what are the most effective vaccine(s) for different population groups and settings. 

As part of that effort, a new global laboratory network is being set up to examine data from major COVID-19 vaccine trials and assist with their selection, said Melanie Saville, director of vaccine R&D at CEPI, the Oslo-based Coalition for Epidemic Preparedness Innovations. Ultimately, the information would help inform the choice of vaccines for mass manufacture and procurement by the WHO co-sponsored COVAX initiative, which has brought 168 countries together in a vaccine purchasing pool. 

The non-profit coalition involving Norway as well other donor countries and health research foundations, has co-funded nine of the leading  COVID-19 vaccines in advanced Phase 3 clinical trials, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

In an interview with Reuters, Saville said the aim is to establish a centralized network of labs across Europe, Asia, and North America. Six labs will analyze samples from trials of COVID-19 candidates, of which there are currently over 320 underway at different stages. The labs will try to improve comparisons by creating a centralized system to analyze them “as though [the] vaccines are all being tested under one roof,” said Saville, removing the inter-laboratory variability. 

Due to the variety of vaccine technologies used in potential COVID-19 vaccines, from viral vectors to messenger RNA, there is a high degree of complexity in the evaluation process. The network will begin by assessing early-stage human trials, later moving to Phase 3 trial data, she said. 

Gilead’s Remdesivir is Under Investigation by the European Medicines Agency 

Meanwhile, in what appeared to be a bad turn for the prospects of one key COVID-19 treatment, the European Medicines Agency announced on Friday that its safety committee was reviewing reports of acute kidney injuries in COVID-19 patients taking Gilead Sciences Inc.’s Remdesivir. 

Remdesivir was one of the first treatments found to shorten recovery time in COVID-19 patients and was approved for emergency use by the US Food and Drug Administration as well as by the European regulatory authority, where it has been given a conditional marketing authorisation as a treatment for COVID-19 for severely ill adults and adolescents.

Emer Cooke, WHO

At the time of the authorization, Remdesivir was flagged for the potential risk of renal toxicity. Subsequent reports of acute kidney injury in patients who were treated with the medication triggered action by an EMA safety committee, which has now enhanced monitoring of the drug. 

The EMA said in a press release that kidney injuries can also be caused by other factors, including diabetes and COVID-19 itself, so as of yet, there is no causal relationship between remdesivir and kidney injury. In response to the reports, WHO’s Emer Cooke, said that it would be examining the reports, but that the EMA investigation was still in the “early stage of development.”

 

Image Credits: Pfizer, World Economic Forum.

Donald Trump at a recent White House meeting – close contact among staff may have fueled COVID-19 infection spread

WHO Director General Dr Tedros Adhanom Ghebreyesus joined the chorus of world leaders wishing United States President Donald Trump and his wife a speedy recovery from COVID-19 – while the US presidential campaign entered uncharted waters, with the cancellation of campaign rallies and fears that other White House Staff and political allies who had accompanied Trump recently on the campaign trail, and to a raucous election debate with Democratic candidate Joe Biden, might also have been exposed to the virus.     

Trump revealed on his Twitter account early Friday morning that he, along with first lady Melania Trump, had tested positive for the SARS-CoV-2 virus. He said they will quarantine in the White House for an indeterminate period. 

“Tonight @FLOTUS and I tested positive for COVID-19,” tweeted President Trump at 1 a.m. EST. “We will begin our quarantine and recovery process immediately. We will get through this TOGETHER!”

“The President and First Lady are both well at this time, and they plan to remain at home within the White House during their convalescence,” said Dr. Sean P. Conley, the White House physician, in a statement.

Speaking at a WHO press briefing later the same day, Dr Tedros and other senior WHO officials avoided any reference to the hailstorm of criticism that Trump had directed for months at WHO’s performance in the pandemic. Instead, they struck a conciliatory note, stressing the leadership role the US President could still play in the battle against the pandemic.

“Overnight we heard that the president of the United States of America Donald Trump, and first Lady Melania Trump tested positive for COVID-19; I want to start today by wishing them both a full and swift recovery. Our prayers are with them,” said Dr Tedros in his opening remarks at the briefing. 

Asked whether Trump had failed to show adequate leadership in controlling infection spread  in the United States, where new infections are averaging some 40,000 cases a day, Mike Ryan, Executive Director of Health Emergencies, refrained from explicit comment.  

But Ryan suggested that the US President, who is 74 and overweight, might draw new insights into the disease from experiencing it himself, adding it was still not too late for the United States to “turn the corner” on it’s own chronically high infection rates.  

“We wish the president well. Like we would wish anyone facing this disease well. This is a nasty virus and this virus can cause severe disease. Particularly in older individuals with underlying conditions,” said Ryan. 

“We’ve all been through things in our life, health events that transform our lives whether we want them to or not. And other things that allow us to learn and absorb lessons in our lives. 

“We want all public leaders, particularly leaders of great countries to lead us and to give us hope, to give us certainty, to give us truth and to give us a chance to fight and win against this disease. So it is never, ever too late for that to be true.” 

Election Campaign In Uncharted Waters Alongside Reports Biden may have been infected   
Crowds flock to recent Trump campaign rally in Virginia

The news of Trump’s infection poses a clear challenge to the pace and tone of his re-election campaign against former Vice President Joseph Biden, the Democratic nominee. The President has already cancelled his campaign rallies scheduled over the weekend and early next week, while uncertainty surrounds plans for the next presidential debate, scheduled for October 15 in Miami. 

Disease experts also suggested that a much wider outbreak among White House staff and political allies may be underway. In the week leading up to Trump’s positive test, he interacted with staff members, donors, and supporters at a variety of events. 

It is presumed that the president and first lady tested positive for the virus following close contact with a senior advisor, Hope Hicks, whose positive test results were reported late on Thursday evening. However, according to White House officials, Hicks began exhibiting symptoms on Wednesday, when she traveled with Trump to a campaign rally in Minnesota. The White House wanted to keep the news of Hicks’ positive test result from leaking, said White House aides. 

Advisors to the president were reported as saying that they expected additional cases among those who are in close and regular contact with Trump. Ronna McDaniel, Chairwoman of the Republic National Committee, already had tested positive for the coronavirus on Wednesday, after having contact with Trump last Friday. However, Vice President Mike Pence and Secretary of State Mike Pompeo, tested negative for the virus on Friday as did Biden who had faced off against Trump on Tuesday in a raucous, nationally televised election debate that lasted more than two hours and included ample shouting from the podium.  

Asked about the potential for a wider COVID outbreak among White House staff, Biden and others, WHO’s Ryan added: “Two cases that are linked to space and time can be considered to be an epidemic or a cluster, and there is clearly a cluster of cases occurring in that scenario. And that needs to be properly investigated. And those individuals who may be at risk need to be advised, the necessary quarantines need to be put in place. This is epidemiology 101. 

“We absolutely trust the US public health authorities to make the appropriate decision and advise those individuals whether there may be a risk,” he said, adding, “There is no reason why the United States of America cannot control this disease, turn the corner. But that requires work. Corners don’t turn by themselves, they need to be turned in the case of biologic processes.  You’ve got to fight the virus, push the virus down. That costs, that costs in effort, in commitment in transparency. It costs in honesty and it costs a sustained support to get that job done. 

New Report Charges Trump With Fueling “Infodemic” On COVID-19

Trump’s positive COVID-19 test results emerge after months in which he consistently downplayed the severity of the pandemic and the threat of the virus, saying at times that it was no worse than the flu. While the pandemic advanced, killing 207,816 people in the US so far, Trump continued his appearances before large crowds of people, both indoors and outside. Those appearances had picked up in pace as he hit the campaign trail even harder, in preparation for the November 3 Presidential election, holding big rallies with little social distancing, and limited mask wearing – often in defiance of state public health guidelines and regulations. 

The news also followed the recent publication of a critical report, charging that Trump is one of the leading contributors to the current ‘infodemic’ of misinformation around COVID-19, including disinformation and conspiracy theories about a virus that he has consistently blamed China for releasing, even malevolently. 

He has also been accused of lighting false hopes of an easy resolution to the pandemic from a vaccine – which experts have said would likely only be about 50% effective, and still take a number of more months to develop and release safely. On Thursday night at a political dinner, several hours before Trump’s diagnosis, the US President remained optimistic, saying, “we are on track to develop and distribute a vaccine before the end of the year, and maybe substantially before… the end of the pandemic is in sight.” 

And at the same time, Trump’s eagerness to accelerate the vaccine clinical trial processes  – even overriding standard scientific safety protocols – has also fueled growing distrust among members of the US public that a vaccine, whenever one is released, will be safe and reliable. 

“We don’t comment on the behaviour of any specific individual,” said WHO’s Ryan, when asked about Trump’s overall attitude towards the pandemic as well as the preventive measures that the President may or may not have observed personally.

“We don’t know what risk management measures were put into place, especially around the president. What we do know is that each and every individual and each and every citizen should be guided by the national guidance in their country, and that there are a combination of different measures that reduce risk … washing your hands, staying at a safe distance, avoiding crowded spaces, wearing a mask, both to protect others and yourselves. We are a community and we need to get through this together.” 

Even so, WHO Health Emergencies technical lead, Maria Van Kerkhove, herself a US citizen, acknowledged that Trump, 74, is in an age category considered most vulnerable to the coronavirus. 

“If you have underlying conditions or are above 60, 70, 80 you have a higher risk of death,” Van Kerkhove said at the WHO briefing. She added that the infection fatality rate “increases by age.. estimates overall are around 0.6 %, … and the more infections we have, the more opportunity there is for those infections to reach people of an older age, who are at a higher risk of dying.” 

According to the US Centers for Disease Control, eight out of 10 COVID-19-related deaths in the US have been among adults aged 65 and older. Trump reportedly also has a Body Mass Index over 30, which places him in a higher risk group of overweight people.

Trump’s age has thus raised concerns about the potential incapacitation of the US president, which would have global repercussions. In the case of medical incapacitation, presidential power could temporarily be transferred to Vice President Mike Pence, according to the 25th Amendment in the US Constitution. 

Such scenarios are not far-fetched, particularly in light of the hospitalization of leaders such as Britain’s Prime Minister, Boris Johnson, 56, after contracting a serious case of COVID-19 in April. 

On the other hand, a range of other world leaders have contracted COVID-19 and recovered relatively quickly,  including Jair Bolsanaro, president of Brazil, Juan Orlando Hernandez, president of Honduras, Alexander Lukashenko, president of Belarus, Alejandro Giammattei, president of Guatemala, and Jeanine Anez, the interim president of Bolivia.  So it remains to be seen if Trump will emerge more defiant than ever from a mild bout of the virus –  or visibly humbled by a more serious case. 

 

Image Credits: WHO, White House, Twitter – Donald Trump.

Every year, tobacco consumption claims 8 million lives and costs economies $1.4 trillion

For the second year in a row, Geneva’s International Chamber of Commerce has hosted a dialogue bringing local tobacco industry leaders together with a major Geneva-based UN Agency – in this case to discuss the ‘role of multinationals in economic recovery following the coronavirus’. 

The ICC’s 6th Business Dialogue, involving Teresa Moreira, Head Competition and Consumer Policies Branch of UNCTAD, the UN’s main body for trade, investment and development issues, and Vice President External Affairs of Philip Morris International Gabriela WURCEL, took place on Wednesday evening at the Four Seasons Hotel in Geneva. 

Face-to-face meetings in such fora are supposed to be taboo in the UN system, according to the model policy for agencies of the United Nations system on preventing tobacco industry interference, which was developed out of the WHO Framework Convention on Tobacco Control (FCTC), a WHO official told Health Policy Watch.

“The policy runs across all UN, ‘to ensure that efforts to protect tobacco control from commercial and other vested interests of the tobacco industry are comprehensive, effective and consistent,’” said the official who asked not to be named. 

Thomas Pletscher, the ICC’s Secretary General, said UNCTAD did not express any reservations about participating in the event with PMI, in the same format as it did last year, to Health Policy Watch.

UNCTAD’s Teresa Moreira did not respond to queries from Health Policy Watch regarding her appearance. The UNCTAD media team also declined to respond. 

UNCTAD headquarters in Geneva

Event is Example of Way Tobacco Industry Exerts Political Influence 

The participation of big tobacco in a dialogue focusing on coronavirus recovery was all the more ironic, in light of the fact that tobacco use increases vulnerability to serious cases of COVID-19:

A WHO review of studies by public health experts published in April found that smokers are more likely to develop severe disease with COVID-19, compared to non-smokers.  

And only last week, WHO, released a major brief detailing how most countries in the world are still failing to enact robust policies to increase tobacco taxation, limit advertising and expand smoke-free public spaces — and that is often due to the industry’s outsize political influence. 

Asked about the meeting, happening in WHO’s own Geneva backyard, a WHO spokesperson declined to comment publicly. 

Anti-tobacco campaigners have  frequently called out the ways in which industry exerts its political influence, interferring in the development of stronger national control measures.   

“Interference by the tobacco industry remains one of the greatest obstacles to implementing the WHO FCTC,” one expert source told Health Policy Watch.

“Tobacco industry interference takes many forms…. exaggerating the economic importance of the industry while ignoring the social, environmental and health costs caused by tobacco and tobacco products; manipulating public opinion to gain the appearance of respectability, this is part of efforts to look “socially responsible”. The corporate social responsibility of the tobacco industry is an inherent contradiction since the tobacco industry’s core functions are in conflict with the goals of public health. “

In Switzerland alone, where the tobacco industry still thrives, tobacco products account for 15% of total deaths every year – or four times as many as the coronavirus. The current coronavirus death toll has almost reached 2100 deaths, compared to some 9,500 yearly deaths from tobacco, reports the Federal Office of Public Health.

ICC Calls PMI’s Invitation “Mere Coincidence”

Thomas Pletscher, ICC Secretary General

When asked why the ICC chose to invite PMI, for the second year in a row to its annual dialogue event, Pletscher told Health Policy Watch the choice was “mere coincidence”.

Asked why the ICC didn’t invite one of the many other Swiss-based multinationals, such as Nestlé or Procter & Gamble, Pletscher acknowledged that locally, the ICC’s contacts with P&G were not as close as those with PMI.

“We choose panelists according to familiarity with the topic, mixture of the panel and notably availability,” Pletscher said. “Nestlé was not available for speaking and we do have less close contacts to P&G in Switzerland. There is no priority for PMI, it is mere coincidence.”

Asked why the ICC could justify an invitation to the world’s largest tobacco company for meeting on economic recovery from COVID, Pletscher argued that PMI’s “challenges and opportunities” are “similar” to other multinationals that may be in the same boat as PMI.

PMI headquarters in Lausanne, Switzerland

“In fact, PMI employs more than 70,000 people at 38 production facilities worldwide and is a typical global manufacturer including close links to primary sector, logistics and distribution,” said Pletscher. “We expect contributions on the panel [to] how PMI reacts to such and other challenges [including] organisation of work, protection of workers, working from home and ensuring the supply chain.”

The ICC, headquartered in Paris with 45 million members in 100 countries worldwide, is a well-known vehicle for big tobacco’s interests for over two decades, civil society critics say.

Even so, the policy of the Geneva ICC branch is particularly regrettable, given the plethora of other multinationals headquartered in Switzerland- some of which can “genuinely” contribute to economic recovery, said Mary Assunta, of the Bangkok-based Global Center for Good Governance in Tobacco Control (GGTC). 

“The tobacco industry cannot be involved in economic recovery,” said Assunta, “Its traditional products kill 8 million people a year and cause poverty and human suffering. Its new products [smokeless tobacco and electronic nicotine delivery systems] result in youth addiction and cause health harms.” 

Tobacco Industry Put Workers at Risk In COVID-19 Pandemic  

Louis Laurence, Researcher for University of Bath’s Tobacco Control Research Group

In its rush to maintain supply chains and sales, PMI also put factory workers at risk during the pandemic – especially in Indonesia, Argentina and Pakistan, charged Louis Laurence, Investigative Researcher for the Tobacco Control Research Group at the University of Bath.

“It is sickening that ICC thinks a tobacco company can contribute to economic recovery post COVID-19,” Anna Gilmore, Professor of Public Health at the University of Bath, and a partner of tobacco industry watchog STOP, told Health Policy Watch. 

Along with violating UN policy, UNCTAD’s repeated exchange with PMI at the ICC means that it is also contributing, at least indirectly, to tobacco interference within international fora, Gilmore added. 

Loss Of “Credibility” For Geneva ICC   

Overtures to PMI also reflect a “loss of credibility” for the ICC as an international face of the business community in Geneva, Gilmore said.  While it is member states, and not businesses, that are signatories to the WHO FCTC, the ICC should set the example by aligning to UN norms.

“Since ICC is ostensibly partnering with UN agencies, it should abide by the UN Norms and values that are reflected in the WHO FCTC [these include] WHO FENSA, UN Model Policy on Tobacco Industry Interference for the UN System, and UN human rights principles,” she said.

Anna Gilmore, Professor of Public Health at the University of Bath

Every year, tobacco consumption claims 8 million lives and costs the economy $1.4 trillion, she pointed out. “Even without the additional burden from COVID, most countries around the world already struggle to cope with the massive health care burden caused by smoking.

“Not only is there is clear evidence that smokers have worse outcomes from COVID-19, but tobacco companies have actively sought to undermine efforts to control the pandemic,” warned Gilmore, noting that recent tobacco advertising has also aimed to cast doubts about proven links between smoking and serious COVID-19 disease.

–Updated 2 October 2020

 

Image Credits: SimonDes, WHO FCTC, Mourad Ben Abdallah, ICC, Louis Laurence, Anna Gilmore.

Moderna’s mRNA research and innovation centre

Moderna intends to seek US Food and Drug Administration emergency authorization for its COVID-19 vaccine candidate for frontline medical workers by November 25th at the earliest, and only in late January for use in the general population. 

That means that the vaccine, if approved on schedule, would only be available for widespread distribution to the general population in spring, 2021, said Stéphane Bancel, CEO of Moderna Therapeutics. 

Speaking at a Financial Times’ sponsored US Pharma and Biotech Conference on Wednesday, Bancel said “I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine.” This matches with what public health experts have predicted.

Bancel’s announcement of the timeline appeared to remove the Moderna vaccine, if not other vaccine candidates, from the political turmoil around the November 3rd US presidential elections.  US President Donald Trump had recently expressed hopes that a vaccine would be approved before he stands for re-election. While FDA officials have set guidelines requiring further safety checks after evidence of the vaccine’s efficacy is demonstrated, Trump had even suggested he might override that.

Stéphane Bancel, CEO of Moderna

In fact, sufficient data on the effectiveness of the Moderna vaccine should be available by November, according to a Bancel interview with CNBC. However, in order to comply with the FDA guidelines requiring at least half of the trial participants to have undergone at least two months of screening after their second injection, the timeline for seeking FDA approval for the vaccine, even on an emergency basis, was set back, he said. 

Among the two other vaccine candidates already in late-stage, Phase 3 testing, including AstraZeneca and Pfizer, Pfizer’s candidate is the one most likely to have enough data of its vaccine by late October. Due to the shorter period of time required between Pfizer’s two shots, the company’s trial has operated on a faster timeline than that of Moderna’s Bancel explained.  

FDA Widens Probe into AstraZeneca COVID Vaccine

AstraZeneca’s timeline has been stalled by reports of severe side effects among at least two trial participants.  And in a related development, the US FDA said it would widen its probe into those events, following its decision in early September to halt the late-stage US trials. Trials were also paused in the United Kingdom, Brazil and South Africa after a participant in the UK became ill, reportedly with a spinal inflammation called transverse myelitis – but they have since resumed. 

According to a recent report, the FDA will examine data from earlier trials of similar viral vector vaccines designed by the Oxford University researchers who are AstraZeneca’s COVID-19 vaccine partner, in order to determine if similar side effects were present in other vaccine trials as well, indicating a common thread. 

Chills, Fever and Body Aches Reported By Moderna, Pfizer Trial Participants 

While most clinical trials are cloaked in privacy and secreacy, some of the participants in the Phase 3 Moderna and Pfizer trials have spoken freely to media about their experiences. In a series of interviews with CNBC, participants reported symptoms of high fever, body aches, headaches and exhaustion after receiving the candidate vaccines.   

The side effects were experienced most intensely and sometimes severely after the second dose, lasting up to a day, described by one participant as “full on COVID-like symptoms.” But they said that they felt that the side effects from the vaccine would be well worth it to protect themselves against the SARS-CoV-2 virus that causes COVID-19.  

Both Moderna and Pfizer have recognized the potential for their vaccines to induce such “mild” side effects similar to mild COVID-19 symptoms. In Pfizer’s Phase 1 study, the majority of recipients of the vaccine were reported to have experienced “short-lived fever, mostly mild to moderate in severity.” This, however, does not impact the safety of the vaccine, according to spokespeople of the companies.

In light of the concern over the safety and efficacy of a potential vaccine, some vaccine researchers fear that a lack of communication of the potential side effects of the vaccine to the public could cause widespread backlash and decisions to not get the COVID-19 vaccine.

Study Finds that Young Adults are Biggest Superspreaders in Coronavirus Pandemic

Meanwhile, in other coronavirus science developments, the largest ever contact tracing study in the world published Wednesday in the journal SCIENCE found that the primary source of COVID-19 spread is young adults. It found that infection probabilities ranged from 4.7-10.7 percent. Approximately 8 percent of patients accounted for 60 percent of new infections.

“The young to middle adult age group is the one that is coming into contact with people…They are the ones taking the disease from one place to the other,” said Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics and Policy. 

The findings also contradicted the belief that children are less likely to catch the coronavirus. The researchers identified a high prevalence of infection among same-age contacts. These results may influence decisions to re-open schools. 

The study emphasized surveillance and contact tracing as critical to effective public health responses to COVID-19. 

Image Credits: Moderna, Moderna.

Prime Minister Justin Trudeau announces US$440 million for the COVAX vaccine pool at today’s highl-level UN General Assembly event.

The World Bank will make available up to $12 billion in “fast-track financing” that low- and middle-income countries can access to procure vaccines against Covid-19 – as soon as one is approved, said the Bank’s president David Malpass, on Wednesday.

The announcement at a United Nations high-level panel on the pandemic that also included commitments from the big pharma firm Johnson&Johnson, Bill Gates and numerous heads of states – marks the first serious flow of finance into an ambitious global vaccine pool.  The “Covax” vaccine pool is part of a World Health Organization co-sponsored Act Accelerator initiative to raise some $35 billion to finance 2 billlion vaccine doses, as well as diagnostic tests and treatments, for low- and middle-income countries across the globe.

A handful of rich countries, including Canada, the United Kingdom, Germany and Sweden, also announced nearly $670 milllion in new pledges to the “Covax” pool, which is co-sponsored by the WHO and Gavi, the Vaccine Alliance. Some 168 rich and poor countries have joined the pool, in an unprecedented show of solidarity. But until today, the vaccine facility had only secured $3 billion in donations, far short of the billions that WHO and its partners have said they would need to roll out vaccines in 92 low- and middle-income countries that can’t afford to pay.

In another precedent for the fund-raising effort, Alex Gorsky, CEO of the pharma giant Johnson&Johnson also pledged to “allocate up to 500 million doses” of its Covid-19 vaccine to lower-income countries – should its candidate now under development pass Phase 3 trials with results showing it is safe and effective. Trials were launched just last week for company’s vaccine candidate, which is the only one that would require just one dose. Other vaccines in advanced R&D stages, by AstraZeneca, Pfizer and Moderna, would require two doses.

Gorsky did not elaborate on whether his offer meant that the company would donate the vaccines outright or offer them at a reduced price.  However he underlined that,  “having access to life saving COVID diagnostics therapeutics or vaccines… shouldn’t depend on where you live, whether you’re rich or poor, and whether you live in an industrialized country or in an emerging economy. The COVID-19 virus does not care about any of those things, and neither do we.

“Decisive collaborative action itnow will help us beat this pandemic and better prepare us for the future virus outbreaks.”

Also at the event, Bill Gates announed that his  Bill & Melinda Gates Foundation had signed an agreement with a coalition of 16 pharmaceutical companies and the to cooperate on vaccine manufacturing and to scale up production.

Funds Mark Step Towards Goals, But More Funding Still Needed
Bill Gates, chair of the Bill and Melinda Gates Foundation, at the UN General Assembly event

Altogether, WHO and Gavi have said that some $15 billion is needed immediately to began making the manufacturing orders and planning distribution networks that would allow for the massive rollout of a vaccine in 2021. The US$ 12 billion in World Bank finance goes a long way towards that, most immediate goal.

Among the individual countries making fresh pledges to the COVAX global pool, Canada made the largest outright commitment of $440 million, including $220 million as a donation to low-income countries. But the United Kingdom upped the ante, with Foreign Secretary Dominic Raab, pledging to donate up to £250 million ($322 million) more to match new pledges from other countries. That benchmark was met and then exceeded as Germany and Sweden also threw new cash into the pool, for €100 million and $10 milliion respectively.

Said World Bank President David Malpass: “I’ve proposed to our board to make available up to $12 billion of fast track financing to countries for the purchase and deployment of COVID-19 vaccines. Once the vaccines have been approved by several highly respected stringent regulatory agencies. This additional financing will be to low and middle income developing countries that don’t have adequate access and will help them alter the course of the pandemic for their people. “Our vaccine financing is additional to the COVID fast track health financing we announced in March, and it’s an important part of bank group’s intention to make available $160 billion in grants and financial support over a 15 month period to help developing countries respond to the health, social and economic impacts of COVID-19.”

The World Bank’s pledge, together with a total of nearly $US 3 billion in commitments secured from national and philanthropic donors, means that most of the funds required to get 92 low-income countries access to the vaccine pool have now been secured. High-income countries, on the other hand, will pay for their vaccines, with flexible pre-purchase agreements that will allow them to get the best vaccine options for their nation as well as to trade in their vaccine “shares”, in some cases, according to national needs. ,

However, according to the WHO’s investment case, another $22 billion more in funding would still be needed for the other two pillars of the so-called ACT Accelerator initiative, including hundreds of millions of units of COVID treatments and protective gear and 500 million rapid COVID tests – 120 milliion of which WHO is already planning to roll out in low- and middle-income countries that lack the equipment for expensive PCR laboratory tests.

The new funding for COVAX, largely closes the finance needs for vaccines. However, billions of dollars still need to be raised for tests and treatments.

Still, that is remarkable progrss for the ACT Initiative, which was launched by the WHO together with the European Commission, France and the Gates Foundation five months ago.

Said Gates, “One thing I’ve learned studying the history of pandemics is that they create a surprising dynamic when it comes to self-interest and altruism. Pandemics are rare cases where a country’s instinct to help itself is tightly aligned with its instinct to help others. The self-interested thing and the altruistic thing–making sure poor nations have access to vaccines–are one and the same.

“A number of countries, most recently the United Kingdom and Canada, are good models for what other wealthy nations should do. They have donated enough money for COVAX, the vaccine pillar of the ACT-Accelerator, to procure, probably, hundreds of millions of vaccine doses for poor countries. But more will be needed and I hope wealthy nations will continue to be generous.”

Image Credits: NIAID, UNGA, WHO .