FDA Commissioner Stephen Hahn testifies in front of a Senate Committee on Wednesday.

United States President Donald Trump told a press conference that any moves by the Food and Drug Administration (FDA) to delay emergency authorization of any forthcoming COVID-19 vaccine for an additional two months to ensure safety concerns are met, “sounds like a political move more than everything else” and such a delay “has to be approved by the White House.”

Speaking at a White House press conference late Wednesday, Trump  said, “When you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these vaccines, and they have done testing and everything else, why would they have to be adding great length to the process?

“We want to have people not get sick, the vaccine is very important, it is the final step,” Trump added. “I have tremendous trust in these massive companies that are so brilliantly organized, in terms of what they have been doing with the tests… when they come back and they say that we have something that works, and absolutely works. And they are coming back with great numbers and statistics and tests… I don’t see any reason why it should be delayed further.”

FDA Commissioner Vows To Not Bow To Political Pressure To Speed Vaccine Approval

Trump made his remarks, appearing to upend the tradition of FDA scientific independence, just hours after FDA Commissioner, Stephen Hahn, on Wednesday said that the agency would not bow to any political pressure in its review of potential COVID-19 vaccines for approval.

“FDA will not approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness…Science will guide our decisions. FDA will not permit any pressure, from anyone, to change that,” Hahn told a in a Senate committee on Wednesday.

The exchanges came amidst reports that the FDA was poised to enact new rules that would extend the vaccine approval timeline, almost guaranteeing that a potential COVID-19 vaccine would only be approved after the November 3rd US Presidential election. The new rules could be adopted as early as next week, and are currently under review by the White House Office of Management and Budget. Sources told the Washington Post that the move intended to increase transparency and public trust in any potentially approved vaccine.

“While the FDA is committed to expediting [vaccine development], we will not cut corners in our decisions and are making clear… what data should be submitted to meet our regulatory standards. This is particularly important, as we know that some people are skeptical of efforts to develop a safe and effective COVID-19 vaccine,” said Hahn on Wednesday. “In the end, FDA will not authorize or approve a vaccine we would not feel comfortable giving to our families.

While the Commissioner did not obliquely reference the new guidance, which adds more requirements to data that companies must submit for approval, his comments were meant to appease a growing unease within the public regarding a potential vaccine. Mixed messaging around when a safe and effective vaccine could be available has already eroded trust in a potential vaccine. And many experts have pointed out that even if the current Phase 3 clinical trials now underway show positive results, regulatory agencies would normally wait for a couple more months to ensure that unexpected side effects don’t emerge.

Hahn and President Trump have issued seemingly contradictory timelines regarding when a vaccine could be made available to the general public. Trump has been optimistically touting a timeline of late October or early November, which would fall right around the presidential election. However, Hahn also testified at a previous Congressional hearing that he did not believe a vaccine would widely available enough to bring “life back to normal” until mid- or late-2021.

Hahn has also come under fire by scientists, however, for joining with President Trump and Alex Azar in overstating the benefits of convalescent plasma as a potential COVID-19 treatment, after the FDA quickly issued an emergency use approval for the treatment. He later walked back on his comments.

Decision to Increase Regulation Applauded, But it’s Unclear Whether Health Secretary can Overrule the Proposed Process

Health experts applauded the decision to introduce more stringent criteria for emergency use approval of any COVID-19 vaccine.

“This may be the most important, notable positive move the USFDA has made in the course of the pandemic. Credit to [Stephen Hahn, FDA Commissioner] for taking such initiative,” tweeted Eric Topol, cardiologist and director of the Scripps Research Translational Institute.

“But my chief concern remains about the process in the weeks ahead,” he added in a follow-up tweet.

Topol was referring to how a new directive issued last week from the FDA’s parent department Health and Human Services could affect how quickly the FDA could enact more stringent rules for vaccine approval. Now, Health Secretary Alex Azar must sign all new rules passed within the department, and it’s unclear whether that new requirement will slow the process of adopting rules that may be disputed by Trump’s cabinet.

President Trump and his top advisors, including Azar, have repeatedly touted that a vaccine could be approved and begin wider distribution by late October, just ahead of the presidential election.

The pace of the US FDA approval will also set the pace of COVID-19 vaccine approvals worldwide. Pharmaceutical companies usually pursue US FDA regulation before seeking approval from the European Medicines Agency or prequalification from the World Health Organization, because US benchmark prices are usually set higher than elsewhere in the world.

New Guidance Requires Trials Follow Participants For At Least Two Months After Shot

The new rules would require clinical trials to follow volunteers for an average of at least two months after they receive a shot, even when seeking emergency use approval for the vaccine. It will also require that a vaccine be at least 50% effective than the placebo.

Moderna and Pfizer, the two companies furthest ahead in testing their COVID-19 vaccines in the US, began their trials on 27 July. However, by mid-August only 15,000 of the 30,000 people required in the trial had been enrolled, and the participants must receive two shots spaced 3 to 4 weeks apart.

It is unlikely either company will be able to meet the 2-month follow-up period required to submit their vaccine candidate for the FDA’s emergency use approval before the November US presidential election. And so far, the trials have not enrolled pregnant people or children under 18 years old, meaning that an effective vaccine for these populations will take even longer to get to the market.  AstraZeneca’s global trials, meanwhile, were paused after safety concerns emerged among two trial participants in the United Kingdom who had serious adverse reactions. The trials were later resumed in the UK, but remain on pause in the United States.

On Wednesday, however, Johnson & Johnson threw its hat into the ring, launching a Phase 3 trial for a one-shot vaccine that it said would enroll 60,000 candidates across North America, Latin America and in Europe. If proven effective, a one-shot vaccine would likely be far easier to deliver to billions of people worldwide. The vaccine candidate also can be stored at 2-8° C – somewhat higher temperatures than the other candidates – making it potentially much easier to use in low-resourced settings.

Image Credits: Flickr: Marco Verch Professional Photography, US Senate.

Tobacco products increase the risk of coronary heart disease

Over the past two decades, the number of coronary heart disease deaths resulting from tobacco consumption has risen by 10,000 new deaths every year, warned WHO spokesperson Jaimie Guerra, in an interview with Health Policy Watch. 

Tobacco consumption in all its forms increases the risks of developing coronary heart disease, warns a new brief published by the World Health Organization, World Heart Federation and Australia’s University of Newcastle on Tuesday.

Yet most adults are woefully unaware of the link between heart disease and tobacco use, says the brief. Coronary heart disease is the leading cause of death worldwide, responsible for 9.4 million deaths a year – or almost 17% of the 56 million annual deaths around the globe.

In China, 60-70% of adults are unaware that smoking causes strokes or heart attacks, even though a whopping 20% of coronary heart disease deaths – or 2 million deaths – are due to tobacco and second-hand smoke, says the brief, which was published just a week ahead of World Heart Day.

Just one cigarette a day can increase the risk of heart disease

Consuming just one cigarette a day can increase the risk of coronary heart disease (CHD), warns the report. In one BMJ study, people that smoked one cigarette a day were half as likely to develop CHD, in comparison to those that smoked over 20 cigarettes a day.

The WHO recommends a multi-sectoral approach to address these worrying trends. These range from tobacco taxation, anti-tobacco media campaigns, smoke free public-places, to enhanced primary care as well as smoking cessation interventions. 

Often, people with coronary heart disease (CHD) are unaware of their condition until they suffer a heart attack, which can be fatal or result in serious heart damage. 

The findings come on the heels of recent reports from the WHO that found tobacco smoke, heart disease and high blood pressure heighten the risk of developing severe COVID-19 disease. 

According to several meta-analyses reviewed by the WHO, smoking could even double the risk of severe COVID-19. Meanwhile, in Spain, over two-thirds of those that died from the coronavirus had high blood pressure, which is also a driver of coronary heart disease.

Benefits of Tobacco Abstinence Are Almost Immediate
The benefits of quitting tobacco are almost immediate

The benefits of quitting tobacco are almost immediate, notes the WHO. Within 20 minutes of abstinence, a smoker’s heart rate and blood pressure can drop, and within 12 hours, toxic carbon monoxide in the blood reduces, says the WHO.

And a year of abstinence can halve a person’s risk of developing CHD, although up to 15 years are required for smokers to further reduce their risk of CHD to that of a non-smoker, says the brief. 

“Just a few cigarettes a day, occasional smoking, or exposure to second-hand smoke increase the risk of heart disease,” said the WHO on Tuesday in a press release. “But if tobacco users take immediate action and quit, then their risk of heart disease will decrease by 50% after one year of not smoking.

Second-Hand Smoke “Nearly” As Harmful To The Heart As Smoking Itself
All tobacco products, including electronic cigarettes, increase the risk of heart disease

Exposure to second-hand smoke is ‘nearly’ as damaging to the heart as the effects of smoking itself, where one hour of second-hand smoke is sufficient to increase the risk of heart attack, notes the WHO. 

According to the Global Burden of Disease study in 2017, adults that were exposed to second-hand smoke were almost a third as likely of developing CHD, compared to people unexposed to harmful second-hand smoke.

“The heart-related effects of second-hand smoke exposure are nearly as great as the effects of smoking itself,” said the brief. “Exposure to second-hand smoke for as little as one hour can damage the inner layer of the coronary arteries, which increases the risk of heart attack.”

The brief also warns against smokeless tobacco products and electronic nicotine delivery systems like ‘e-cigarettes’ and ‘e-vapes’ – which also increase the risk of heart disease. Smokeless tobacco, for instance, accounts for 204,000 CHD deaths in 2010, according to data from more than 100 countries. 

And while electronic nicotine delivery systems may be less harmful than smokable products, they still contribute to CHD, warns the report. Electronic nicotine delivery systems contain toxic metals like cadmium and nickel, which damage the heart and contribute to high blood pressure.

Image Credits: Chris Vaughan, WHO AFRO, WHO, WHO.

Stephen Hahn (right) being sworn in as the new FDA Commissioner in December 2019. Alex Azar (left) congratulates him.

The United States Food and Drug Administration on Tuesday proposed a new rule regarding regulation of medical products that would be the first in the agency’s history to also require the signature of United States Health and Human Services (HHS) Secretary, before it can be formally adopted. 

As such it will likely be a test case for how the new HHS sign-off policy, announced last week by Secretary Alex Azar, may really work in what some observers have described as a politically-motivated power grab by the FDA’s parent organization.

Previously, new rules could be adopted by the FDA with just the signature of the FDA Commissioner, who is currently Stephen Hahn. But last week, Azar issued a memo to all 27 departments under HHS that declared no new rules could be passed within the 27 agencies and offices under the Department without his signature. 

The new proposed rule clarifies the type of evidence considered when determining the “intended use” of a medical product, which would also clarify whether the product falls under the FDA’s regulatory jurisdiction. 

The speed at which this rule is formally approved could signal how the new requirement of the Secretary’s signature will impact the rule-making process at the FDA. 

“The authority to sign and issue any rule for which notice and comment would normally be required, irrespective of whether notice and comment is waived, is reserved for the Secretary. Any prior delegation of rulemaking authority, including the authority to sign or issue a rule or a proposed rule, is rescinded,” Azar wrote in the memo.

HHS has asserted that the new protocol serves merely as a “housekeeping” step.

“The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed,”  according to a press statement from HHS.

However, the FDA is one of the agencies within the Department that passes the most rules, and in the pandemic, has been the key regulator of COVID-19 diagnostics and treatments. 

And other experts, including former commissioners of the FDA, have called the move “ill-timed” and a “power grab,”  according to the New York Times. 

Indeed Azar’s actions reflect growing political tension between top officials in Trump’s cabinet and scientific and regulatory agencies within the US government. The US Centers for Disease control recently recalled new coronavirus testing guidance that was posted to the CDC website. The faulty guidance was supposedly revised by HHS officials and posted without review by the Center’s top scientists.

And Trump himself last week called FDA Commissioner Stephen Hahn “confused” and “wrong” when Hahn testified in front of Congress that a vaccine would not be available to the general public until late 2021. Trump and his cabinet have been touting that a safe and effective COVID-19 vaccine could be more available by the end of October, a timeline that is also contradicted by blueprints released by the top three firms at the forefront of the COVID-19 vaccine development race.

Tension Between HHS & FDA Escalated With Testing Deregulation
Nurses preparing a diagnostic test for COVID-19 at a “drive-through” testing center at University of Washington Northwest Hospital & Medical Center

It’s unclear whether requiring the Health Secretary’s signature on new rules will affect the regulatory process for approving a COVID-19 vaccine. However, the FDA has already clashed with Azar over testing regulations in the early days of the pandemic.  

Azar in late August overrode the FDA’s rules for reviewing new COVID-19 tests, despite disagreement from Hahn. According to the HHS rule, “the department… determined that the Food and Drug Administration (“FDA”) will not require premarket review of laboratory developed tests (“LDT”) absent notice-and-comment rulemaking.” 

Instead, the FDA would be limited to “informal issuances,” such as providing non-binding guidance or compliance manuals for new COVID-19 tests.

Some clinical laboratories have long supported this position to bypass the FDA’s potentially lengthy review process, and other supporters have said it could help get new, more innovative tests on the market more quickly. However, critics contended that the FDA already had been granting emergency approval to COVID-19 tests in a timely manner, and Azar’s push of the deregulation created tension within the Department and allows flawed tests to encroach on the market. 

Image Credits: Twitter: FDA Commissioner, University of Washington Northwest Hospital & Medical Center.

Seth Berkley, Gavi CEO, speaks at the Sept 20 WHO press briefing

Some 64 higher income countries have now made binding financial commitments to a precedent-setting COVID-19 global vaccine pool that aims to equitably distribute future vaccines to halt the pandemic raging now.

Another 38 countries are expected to commit over the next week, said CEO Berkley, in a WHO press conference Monday that disclosed the landmark agreement formally establishing the COVAX Advance Market Commitments (AMC) mechanism, the first to involve rich as well as poor countries in vaccine pooling.  The COVAX vaccine pooling initiative is led by Gavi, in partnership with the World Health Organization and the Oslo-based Coalition for Epidemic Preparedness Innovations. 

Another 92 lower income countries that qualify for development assistance will be eligible to benefit from subsidized prices that the COVAX Facility will offer, Berkley said. This could mean that a total of 156 countries may be poised to join the initiative, making it the largest pooled procurement mechanism for a vaccine in history. 

However, some US $35 billion is still urgently needed to finance the manufacture and distribution of vaccines to low-income countries that join the COVAX pool, as well as treatments and tests  needed to combat COVID-19 even more immediately, said WHO Director General Dr Tedros Adhanom Ghebreyesus at the press conference. 

He said that US$15 billion is “immediately needed” to “maintain momentum and stay on track for our ambitious timelines… We are at a critical point, and we need a significant increase in countries’ political and financial commitment. 

Only US $3 billion has been invested so far into financing vaccines for the COVAX faciliaty as well as the other pillars of the broader ACT Accelerator initiative, which aims to scale up development and distribution of COVID-19 treatments and diagnostics, said Dr Tedros.

COVAX Announcement Widely Applauded  – But Major Questions about Equitable Distribution to Most Vulnerable Groups Still Remain

Despite the huge gap in financing, the fact that high income countries have begun to make firm commitments from a brand-new global pool to purchase COVID-19 vaccines that haven’t even yet been approved, was seen in global health circles as a major step forward in the drive to ensure that future COVID vaccines that do make it to market can be quickly scaled up and distributed in volume to people worldwide.

With the Commitment Agreements secured, the COVAX Facility can now start signing formal agreements with vaccine manufacturers and developers, which are partners in the COVAX effort, to secure the 2 billion doses that it aims to distribute in 2021, WHO said in a statement. This is in addition to an ongoing effort to raise funding for both R&D and for the procurement of vaccines for lower-income countries via the Gavi COVAX AMC.

Through the COVAX mechanism, countries can initially secure vaccine doses for up to 3% of their population most at risk rising to 20% in a second phase – in order to rationalize supplies, according to a “Fair Allocation Mechanism“, published by WHO on Monday.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which counts among its members most of the major pharma firms now racing to develop vaccines against the SARS-CoV-2 virus, applauded the COVAX agreement.

“It is very encouraging to see so many countries move from talk to full commitment,” said Thomas Cueni, Director General of the IFPMA. “The Facility can only work, and equitable access can only be achieved, if there is solidarity between rich and poorer countries. Today, marks a significant step forward, and is a historic mark of solidarity which has the power to bring the acute phase of this pandemic to an end; and we are proud to be part of this unique endeavour to leave no one behind.”

The pooling agreement will help accelerate future vaccine manufacture and distribution, said Jeremy Farrar, director of The Wellcome Trust, which has been a major funder of vaccine R&D, and of the Oslo-based CEPI coalition. But Farrar cautioned that major questions still remain about how to quickly get what are sure to be initially limited vaccine supplies to those most at risk:

“It’s great to see a large number of countries signing up to COVAX and agreeing to secure vaccines not just for themselves, but for the world. The speed and scale of vaccine development have been remarkable but we still do not know yet which candidates might be successful or the most effective, and not all vaccines will be suitable for all who are at risk. Shared global investments in a range of vaccines that use diverse technologies and which can then be available for priority populations worldwide is critical. The investments today mean that COVAX can now start doing manufacturing deals, which is vital,” Farrar said.

But he also cautioned against the currents of vaccine nationalism that have also been starkly evident during the pandemic, saying that worldwide distribution to those most vulnerable is essential to put the brakes on the pandemic:

“Questions remain… on the detail of how the first vaccines – which will be in limited supply – will reach those who need them most in every country. Vaccinating high-risk people in every country first is not only the right thing to do, it’s in every country’s best interest. Unless every country has access to COVID-19 vaccines, tests and treatments the whole world is at risk. Countries cannot, and do not at this stage need access for every citizen. Countries should only buy doses for those in greatest need – healthcare and essential workers and those at highest risk. Any oversupply secured through bilateral deals must be donated for global supply. Clear and detailed commitments on this are urgently needed from governments now.”

Notably, the United States has been among those countries taking a go-it-alone approach, refusing to participate in COVAX due to its disapproval of the World Health Organization for allegedly failing to act more decisively against the pandemic and catering to political pressure. China, on the other hand, has expressed interest in engaging with the Facility, but has so far not made any binding commitments, according to Berkley.

WHO Comments On Pharma Blueprints for COVID-19 Vaccine Trials
Soumya Swaminathan describes WHO’s minimum criteria for a COVID-19 vaccine’s safety and efficacy

Meanwhile WHO Chief Scientist said that a vaccine candidate should be at least 30% effective in order to receive regulatory approval for widespread public use.

“A vaccine with less than 30% efficacy is probably not going to have a big public health impact,” said Soumya Swaminathan, speaking at the same Monday press conference. She added that vaccine trials should also continue even beyond initial proof of efficacy to determine that vaccines coming on market are truly safe for widespread use: “On the safety side, we would like to see several months of follow-up to assess the potential adverse reactions, particularly since we have so many platforms that are being tried for the first time, such as the mRNA and even the adenovirus vectors are not being used at scale,” she added. “The benefit-risk ratio has to be very very strong.”

Swaminathan’s comments come after three leading firms developing COVID-19 vaccine candidates, Pfizer, Moderna, and AstraZeneca released detailed blueprints of their vaccine development timelines over the weekend in an unprecedented move. The companies bowed to public pressure to increase transparency.

The AstraZeneca Phase 3 trial had been paused previously to investigate two cases of neurological illnesses in patients, potentially associated with the vaccine. While the trial resumed in the United Kingdom after review by a UK data safety board, the US Food and Drug Administration has not yet allowed AstraZeneca to resume its US arms of the trial. 

Vaccine Efficacy Goals Vary by Pharma Firm – From 50-60%

AstraZeneca’s plan revealed that the company was seeking to make a vaccine that was at least 50% effective. Moderna is aiming for a vaccine with 60% efficacy, and Pfizer is aiming for at least 52.3% efficacy in its final analysis.

The AstraZeneca trial currently has 18,000 people enrolled. Once 150 people enrolled in the trial’s control and intervention arms became sick with COVID-19, protectiveness of the vaccine against COVID-19 infection could then be determined – by comparing infection rates among those who received the vaccine and those who did not.

However, the Astra Zeneca plan allows for researchers to conduct an interim analysis of the effectiveness of the vaccine after 75 people get sick with coronavirus, and possibly pause the trial if results of the interim analysis are positive. Similarly, Moderna and Pfizer’s plans allow for two and four such interim analyses. Moderna has enrolled more than 25,000 people so far in its trial, and Pfizer has enrolled more than 10,000.

But stopping trials early could increase the risk of missing potential rare side effects, and too many interim analyses increases the chances of researchers finding results that may be positively biased, Eric Topol, a clinical trials expert at Scripps College told the New York Times. 

The trials also include mild COVID-19 cases in the analysis criteria for stopping the trials early, which could prevent researchers from determining how effective the vaccine may be against preventing more severe disease, says Topol.

And it’s unclear how closely the protocols really align up with a pledge signed by the CEOs of nine investigational COVID-19 vaccine developers, including AstraZeneca’s CEO, that asserted companies would not seek regulatory approval until the vaccine was proven safe and effective in Phase 3 clinical trials. 

Still, despite those questions, all three of the leaders in the race to develop the first COVID-19 vaccine are following a timeline similar to the one US Centers for Disease Control Director Robert Redfield outlined in his testimony last week before the US Congress.

In that testimony, Redfield predicted that a vaccine would only be approved for wider use in the general public by mid-2021 or even the autumn. And he warned that until that point, measures such as universal use of masks, would continue to be even more important in combatting the pandemic than a vaccine.  Redfield’s timeline was sharply criticized later by US President Donald Trump, who had been telling reporters that a vaccine may become available by the end of October, just ahead of the November 6th US presidential election.

Madeleine Hoecklin contributed to this story.

-Updated 22 September, 2020

Image Credits: NIAID.

Protesters outside parliament in Cape Town, South Africa advocating for better food packaging policies

Most shoppers spend less than 10 seconds debating a food choice in the grocery store aisle – and yet choosing processed and low nutrient foods with high levels of sugar, sodium, and fats can lead to chronic diseases, which are expensive to control and often impossible to cure.

Now, national regulatory authorities and food companies can create healthier food environments and combat worrying chronic disease trends through smart, cost-effective and comprehensive obesity prevention policies, based on new guidance from Vital Strategies, a global health NGO.

 “The guide makes available tools to help countries apply an effective and essentially free-to-government behavioral nudge to promote their population’s health,” said Nandita Murukutla, Vice President of Global Policy and Research at Vital Strategies. 

As the coronavirus makes a worrying come-back in Europe and other parts of the world, improving access to safe and nutritious food is more important than ever, given COVID-19’s disproportionate effect on people with preexisting conditions. In one study, obese individuals were almost 50% more likely to die from COVID-19 than people without obesity or chronic diseases. 

According to the WHO, reducing the consumption of micronutrient-poor foods that are highly processed and energy dense is “essential” to tackling obesity, which affects 650 million people worldwide. Unhealthy diets are a key driver of chronic disease, and claim the lives of 11 million people every year, according to recent estimates by The Lancet.

Food Packaging Labels Reduce The Purchase of Nutrient-Poor Products

Explicit “black stop signs” on food packaging are one of the ”most effective” strategies to prevent obesity and other chronic diseases, helping consumers understand the sugar, salt or fat content in the products they buy. They can also reduce long-term purchasing of nutrient-poor products and curb unhealthy consumption behavior, says Vital Strategies.

In 2016, Chile, the world’s leading consumer of sugar-sweetened beverages, was the first to adopt a mandatory national front-of-package labelling system for foods through a comprehensive set of obesity policies (Law of Food Labeling and Advertising).These also included restrictions on child-directed marketing of unhealthy food products, and a ban of unhealthy beverages in schools.

Just 18 months after Chile adopted its Law of Food Labeling and Advertising, sales of sugar- and fat- laden beverages reduced by nearly 25%, according to study from last February. Chile’s success has sparked policymakers to consider similar policies, especially on front-of-package warning-labels, added researchers.

“The best-available evidence suggests that providing clear and informative front-of-packaging nutrient warning labels is one of the most effective approaches to preventing obesity and nutrition-related NCDs [chronic diseases] like diabetes and hypertension,” said Barry Popkin from the University of North Carolina’s Gillings School of Global Public Health.

Effective front-of-package policies in Chile reduced unhealthy beverage sales by nearly 25%

Image Credits: Vital Strategies, PLOS.

DNDi

Nairobi, Kenya – Africa is trailing the rest of the world in  conducting clinical studies on COVID-19 vaccines and drugs. Less than 70 registered studies for drugs and vaccines are currently taking place in Africa, out of more than 1000 studies being conducted globally.

Only 8 of 102 clinical vaccine trials were being conducted in Africa. And out of 1098 clinical studies on potential drugs underway around the world, a mere 56 of them were being done on the continent, data presented to an African Science journalists forum in Nairobi last week showed.

According to Dr Borna Nyaoke, senior clinical project manager for the Drugs for Neglected Diseases Initiative (DNDi)-Africa, part of the reason for the low number of trials was due to lack of government funding for the studies.

Nyaoke noted that successful treatments or vaccines for COVID-19 largely relied on the breadth of trials conducted, with large experiments being more likely to succeed compared to ones enrolling fewer study participants. Yet enrolling, finding, and monitoring a large number of study volunteers is a costly and time-consuming endeavor.

“We need to see African governments committing additional funding for drugs and vaccine trials, finance more international collaborations and engage pharmas for more research to happen on our continent,” she told a virtual pre-conference event hosted by the Media for Science Health and Agriculture (MESHA).

Vaccine studies were only taking place in seven countries, five of them in South Africa. Trials for drugs were more widely distributed, happening in 13 different countries. Egypt has 36 trials for potential COVID-19 treatments underway, followed by South Africa with eight.

More Research Into Mild & Moderate COVID-19 Treatments Required
Dr Borna Nyaoke, senior clinical project manager

And most of the drug and vaccine experiments currently taking place in developed countries of the global north and parts of Asia are concentrated on severe and advanced cases of the disease, Dr Nyaoke observed. But more research was required to understand how to treat mild and moderate cases to help benefit places like Africa, which has a comparatively higher rate of mild and moderate disease.

“Right now only a few studies are happening in the Global South, and as such, trials may not be as conclusive. We have large populations in these regions of the world with over 1 billion people in Africa for example that can provide an adequate sample size for a trial,” she said.

There was therefore a great need for COVID-19 clinical trials in “Africa led by Africans” given the continent’s unique genetic diversity, and existing capacity for conducting such trials. Many efforts by organisations such as DNDi have helped set up a rich research ecosystem across the continent.

“Africa displays genetic diversity which if not represented, trial findings cannot be generalised to our large populations. Responses to drugs or vaccines can be influenced by, among other things, human genetics,” she said.

Conducting clinical studies in Africa would have many advantages besides benefiting from the most genetically diverse population in the world, as such trials also need to be well designed and “adequately powered to generate evidence” – meaning they must enroll massive numbers of people.

In addition, Dr Nyaoke said large, well-conducted clinical trials are urgently needed to support guidelines on prevention and clinical management of COVID-19 in “resource-constrained settings” such as Africa.

Local Trials Will Help Build Local Trust

Local trials would also help influence policy change since policymakers are more apt to trust local evidence. Trials can help support faster adoption of new tools into policy, access to new tools, and development of potential life-saving innovations.

Besides, Nyaoke opined, locally developed disease remedies easily gained trust of communities as local researchers were more likely to win and maintain trust of their communities.

To increase the number of clinical trials in the poor regions of the world, the DNDi and its partners have formed the COVID-19 Clinical Research Coalition, a global partnership aimed at accelerating clinical research in resource-limited settings.

Founded by a coalition of organizations, which include the DNDi and Infectious Diseases Data Observatory (IDDO) among others, the group aimed to advance research in therapeutics, preventive medicines, vaccines, diagnostics, social science, epidemiology and modeling.

Some 22 African countries have so far joined the group.

The partnership formed in March also hoped to establish a vibrant dialogue within a network of research and allied institutions around the world, to facilitate and accelerate research adapted for resource-limited settings, and facilitate prompt sharing of findings to ensure accelerated learning for speedy review of evidence and its adoption into guidelines.

Members of the partnership include research institutions, universities, Non-Governmental Organisations (NGOs) and governments from all regions of the world.

Image Credits: DNDi.

A volunteer receives an injection of an investigational mRNA COVID-19 vaccine, developed by Moderna Inc, with US government support.

Geneva, Switzerland – Moderna, Inc., one of the leaders in the race to develop a new COVID-19 vaccine, has come home — again.

The biotech startup, which raised a significant chunk of its initial US$ 100 million amongst a group of far-sighted Swiss investors and private bankers a decade ago, announced Wednesday that it would be establishing its first commercial hub outside of North America in Basel. The new Swiss hub, located alongside the company’s European headquarters, will be led by Dan Staner, as vice president and managing director, Switzerland.

“Switzerland has a leading biotech and pharma sector. All the conditions exist for a new leading edge technology, such as the mRNA platform, to attract leading vaccine talents from around the world to join us in Switzerland,” Staner told Geneva Solutions.

“By the end of December, we will have around 20-30 specialists at our Swiss headquarters in Basel, where the hub for the whole of Europe is also located. By the end of 2021, we expect to have between 50 and 60 employees, mainly people who already have experience in regulatory affairs, medical, quality, manufacturing or commercial roles,” said Staner, a former executive for Eli Lilly and a Swiss national with a degree from the University of Lausanne.

Dan Staner, vice president and managing director of Moderna, Switzerland
Paving way to Swiss Medic Approval

One of the key missions of the new office will be to ease the way to Swiss regulatory approval for the company’s novel messenger RNA (mRNA) vaccine candidate, currently undergoing Phase III clinical trials, Staner added. Recently, the Swiss Federal Government concluded an agreement with Moderna for the procurement of 4.5 million vaccine doses of the mRNA-1273 candidate, one of nine worldwide at the advanced Phase III trial stage. However, the national regulatory agency, Swiss Medic, operates independently of the European Medicines Agency.

“My goals are firstly to work closely with the Swiss Regulatory Authorities to deliver a high quality, approved vaccine as soon as possible for the Swiss population, secondly, to build a highly effective and professional Moderna team in Switzerland; and thirdly to work closely with key healthcare stakeholders in the country, to ensure we defeat the pandemic together,” said Staner

In an interview with the Swiss business journal Bilan, Moderna CEO Stéphane Bancel predicted that the company’s vaccine could be ready for market approval as early as October, but “without a doubt” by December or January 2021. He noted that the Moderna Phase III trial had already enrolled some 21,000 participants – nearly reaching the 30,000 target set by the United States Food and Drug Administration (FDA) for participation.

Fears of ‘Vaccine Nationalism’

The United States, where the company is based, also has huge political and financial investments in Moderna’s development, with a pre-order of 100 million vaccine doses, announced by US President Donald Trump in an August deal, said to be worth US$ 1.5 billion. The big pre-orders have fueled fears amongst global health officials that once a safe and effective Covid-19 vaccine does become available, rich countries will have already bought up the lion’s share of available supplies – making it harder to get access to low and middle-income countries.

The US Biomedical Advanced Research and Development Agency (BARDA) also had provided Moderna with nearly US$ 1 billion in public funds for Covid-19 vaccine R&D, with the US Defense Advanced Research Projects Agency (DARPA) investing lesser amounts. Recently, that support became the focus of controversy after a medicines access group charged that Moderna had failed to report the public funding, as required, in its US patent applications – something both BARDA and DARPA said they are now investigating. Evidence of public funding is often key to leveraging lower prices among drug and vaccine manufacturers.

Lonza manufacturing agreement also key to Moderna’s Swiss choice. According to Moderna, another reason for the decision to open a Swiss commercial hub, is the agreement announced in May 2020, with the Swiss manufacturing firm, Lonza, for the large scale global manufacture of the vaccine candidate in Switzerland “and additional Moderna products in the future.”

Deep roots in Switzerland. But the strategic decision to develop a commercial outpost in Switzerland, continues a romance with the Confederation that began long before the Lonza agreement. Almost a decade ago, Bancel, head of what was then an unknown startup, Moderna Therapeutics, began raising capital along the shores of Lac Leman among a small group of private Swiss investors as described in an exclusive Geneva Solutions story.

Bancel, who had previously headed BioMérieux in nearby Lyon, won over the hearts and minds of the Swiss financiers, who were shrewd enough to see the potential in the new technology – which went on to yield a number of infectious disease vaccine candidates even before the SARS-CoV-2 virus came along and dramatically changed the company’s trajectory.

“Switzerland is a leader in life-sciences, with a dynamic pool of industry talent, scientists, research organizations, investors and global health policymakers,” said Bancel. “Since Moderna’s founding, Switzerland has played an important role in Moderna’s development thanks to the long-term support of our Swiss investors and their business advice. Opening our first subsidiary outside North America in Switzerland is a natural step for Moderna.”

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Health Policy Watch is partnering with Geneva Solutions, a new non-profit journalistic platform dedicated to covering International Geneva, for a health news stream. Sign up for the daily brief, and follow Geneva Solutions at @GenevaSolutions on Twitter and Facebook. 

Image Credits: Keystone/ Hans Pennick.

Secretary General Antonio Guterres speaks at a virtual event just ahead of the opening of the 75th UNGA

As the 75th United Nations General Assembly opened in an unprecedented virtual session on 15 September, WHO issued a plea to the world’s leaders for funding to fight the COVID-19 pandemic – saying that US$ 35 billion is needed to fast-track development, procurement and distribution of 2 billion vaccine doses, treatments and tests over the coming year.

The call by WHO came on the heels of a pre-session vote last week by the General Assembly on an “omnibus” bill pledging to advance multilateral cooperation in the quest for solutions to the global health crisis and reaffirming WHO’s leadership role.

However WHO leaders stressed that countries need to put their money on the table to fulfill those commitments.

“Pooling investments globally, the ACT-Accelerator provides a chance for all countries to access a greater number of tools more quickly, sharing the risks and costs together.

The ACT-Accelerator needs US$35 billion to fast-track the development, procurement and distribution of 2 billion vaccine doses, 245 million treatments and 500 million tests over the next year,” said a WHO statement, issued as the UN GA was convening.

The WHO framed the call for funds as part of a three-pronged message to the GA, including a call to world leaders to support the ACT-Accelerator mechanism for pooling and more equitable distribution of COVID-19 medicines, tests and vaccines; maintain the momentum on sustainable development goals, despite COVID threats, and invest more in preparing for the next pandemic now.

“According to a recent WHO survey, 90% of countries are experiencing disruptions to essential health services due to the pandemic. The most frequently disrupted areas reported include routine immunization, non-communicable diseases diagnosis and treatment, family planning and contraception, treatment for mental health disorders, and cancer diagnosis and treatment,” said the WHO statement.  “COVID-19 offers a stark reminder of why we need to invest in stronger health and data systems, rooted in primary healthcare, to achieve universal health coverage and to meet the health-related targets of the SDGs.”

In terms of preparing for the next pandemic, WHO pointed to the findings of a report issued on Monday by the UN-sponsored Global Preparedness Monitoring Board, noted that it would take some 500 years to spend as much on preparedness as the world is losing economically as a result of COVID-19.  The report “World in Disorder” also noted that it had warned last year of the likelihood a pandemic could erupt, killing millions and disrupting economies, but nothing was done.

Said the WHO statement, “The investment needed in a global solution aimed at equitable access pales in comparison to the economic impacts of COVID-19 and the domestic stimulus packages designed to keep economies afloat.”

The first high level meeting of the 75th UN General Assembly will convene next Tuesday, 22 September 2020, during New York City’s 2020 Climate Week.

Image Credits: UN/Loey Felipe.

(left-right) Mike Ryan, Dr Tedros, Maria Van Kerkhove at the September 15 2020 WHO press briefing

Countries may be able to reopen schools safely if adults strictly observe masking and social distancing measures, and show restraint in leisure activities, said World Health Organization Health Emergencies Executive Director Mike Ryan.

“We have to reduce transmission at community level in order to lower the risk to those older and vulnerable people, and to maintain an environment in which children can continue to attend school,” Ryan told reporters on Tuesday. “The only way to do that is that the adults separate themselves enough to drive transmission downwards.

“So what is more important? Are children back in school? Or are the nightclubs and bars open? I think these are the decisions that we have to make coming into the winter months.”

Ryan’s comments came as WHO, UNCESCO, and UNICEF released updated guidelines for policymakers to consider when deciding the safest way to reopen schools during the COVID-19 pandemic.

“Keeping children safe and at school is not a job for schools alone, or governments alone or families alone. It’s a job for all of us, working together,” added WHO Director General Dr. Tedros Adhanom Ghebreyesus.

“With the right combination of measures, we can keep our kids safe and teach them that health and education are two of the most precious commodities in life,” he said.

More Research Into COVID-19 Effects in Children is Required

Since the start of the pandemic, understanding how the virus affects children has been a top priority, said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

But “nine months into the pandemic, many questions remain,” he added.

It’s clear so far that children seem to be spared the worst of the virus, with comparatively fewer children than adults getting infected or experiencing severe illness. Less than 10% of reported cases and less than 0.2% of deaths are in people under the age of 20, according to the WHO. However, there have been reports of specific rare COVID-19-related complications in children, and it’s still unclear what role children play in the virus’ spread.

And WHO COVID-19 Technical Lead Maria Van Kerkhove admitted that they were still learning about the “role that schools are playing” in transmission. It is suspected younger children transmit the virus less than adolescents.

Taking public health measures such as ensuring desks are properly spaced, or all students and staff wear masks may help reduce transmission.

However, the key to ensuring safe school reopenings is to make sure that “transmission is under control in the community,” said Van Kerkhove.

Staying Out Of School Has Devastating Effects On Children

The decision to close schools in the wake of COVID-19 outbreaks was a “last resort,” Dr Tedros said. But as the fall semester begins, many countries are struggling with the decision to reopen schools, or pursue distance learning opportunities.

However, half of the global student population is still not yet back in school, said UNICEF Executive Director Henrietta Fore.

A recent UNICEF survey of 158 countries found that 1 in 4 countries have not put a date in place for allowing children back to the classroom, added Fore. And for at least 463 million children whose schools closed in the spring due to the coronavirus, remote learning was never a feasible option. Some 11 million children are at risk of never being able to return to school, most of them being girls.

Schools represent a safe haven for many students, and students from disadvantaged backgrounds often also rely on schools for healthcare and meals, according to UNESCO Director-General Audrey Azoulay.

“Supporting the safe reopening of schools must be a priority. In particular, supporting the return of the most disadvantaged. And while this return to school is crucial, it must be done in a safe manner,” said Azulay.

Monitoring diabetes in Honduras

A new Lancet Commission reports shows for the first time that the main killers of the poorest billion people in the world aren’t traditional “diseases of poverty” such as tuberculosis or neglected tropical diseases, but are non-communicable disease such as heart diseases and stroke, and injuries.

The Lancet NCDs and Injuries (NCDI) Poverty Commission found that these conditions cause over a third of all annual deaths among the poorest billion, killing 800,000 a year in those under the age of 40. In this group, NCDs and injuries kill more people every year than HIV, TB, and maternal deaths combined.

And care for managing these conditions is out of the reach of the poorest billion, with between 19 to 50 million people every year spending a catastrophic amount of money in out-of-pocket healthcare payments.

“The pandemic has exposed the myth that extreme poverty was disappearing,” said Commission Co-Chair Gene Bukhman of Harvard Medical School, Partners In Health, and Brigham and Women’s Hospital. “We need a cross-border movement with a common sense of humanity to serve people living with NCDs in poor countries, whose economic and health status makes them doubly vulnerable to COVID-19.”

In the midst of the coronavirus pandemic, those struggling with preexisting NCDS such as heart diseases and diabetes are at even higher risk of experiencing severe disease or death if infected by COVID-19.

Richard Horton, editor-in-chief of the Lancet, called the syndemic of NCDs, COVID-19, and inequity a “terrifying intersection of forces.”

“We’re seeing that COVID-19, as do all pandemics, strike the poorest people hardest. Here we have a terrifying intersection of forces, a systemic combination of three concurrent epidemics,” said Horton at the launch of the Commission’s report on Tuesday. “That is COVID-19, the epidemic of non communicable diseases, and an epidemic of inequality disparities within countries and between countries.”

NCDs Need A Massive Infusion of Funding

But despite the high burden of NCDs in the poorest billion, many of whom live in Southeast Asia or Sub-Saharan Africa, only US $100 million in development aid is directed towards NCD programs every year.

“Out of the total development assistance for health; the Commission finds just 0.3% goes to the non communicable diseases and injuries,” said Bukhman on Tuesday.

“No disease should practically be a death sentence in one country but treatable, preventable or curable in another,” said Commission Co-Chair Ana Mocumbi of Universidade Eduardo Mondlane and Instituto Nacional de Saúde in Mozambique.“Universal health coverage is unobtainable unless the global health community broadens the geographies and conditions covered by action on non-communicable diseases.”

The report also found that in a number of countries, national plans for NCDs and for poverty reduction fall along separate tracks. Even in national poverty reduction plans published after the UN High-level meeting on NCDs in 2011, NCDs are usually referred to as an “emerging problem.”

But this new report could help turn the assumption that rich countries are affected most by NCDs on its head.

The release of the Commission’s report also marks the launch of the NCDI Poverty Network, which will be dedicated to mobilizing greater funding and political commitment for tackling NCDS as a problem in the poorest billion.

 

Image Credits: WHO/INADI, The Lancet NCDI Poverty Commission.