Mariangela Simao speaks at a UNGA side event on the COVID-19 Technology Access Pool

While the COVAX Facility, a global initiative to pool procurement of a safe and effective COVID-19 vaccine, has been gaining momentum, another global initiative to pool intellectual property rights for tools to combat the pandemic has been moving at a much slower pace.

Only three more countries have signed on to support the COVID-19 Technology Access Pool (CTAP), an initiative to pool COVID-19-related intellectual property IP, including patent rights, since the pool was first launched in 29 May. That makes 40 countries now supporting the initiative, according to WHO Access to Medicines, Biologics, and Vaccines Director Mariangela Simão, speaking at a UNGA side event hosted by Costa Rica’s President Carlos Alvarado Quesada on Friday.

The high-level event also included WHO Director General Dr Tedros Adhanom Ghebreyesus and UN AIDS executive director Winnie Byanyima. Byanyima expressed concern about the lack of support the IP pool had received so far from countries as well as industry.

“A vaccine is our greatest hope of rising up from this crisis. But the only place where a COVID-19 vaccine is a global public good is in rhetoric, not reality,” Byanyima said. “We congratulate the hard work of scientists, and yes, of pharma corporations too. And yet despite that – all the knkowledge and technology to make them remains a secret. It is the private property of companies. They are deciding how many vaccines get made. They are deciding what price is charged. They are deciding who gets them.

“The implications are clear. Oxfam’s research shows that rich countries representing 13% of the world’s population have secured half the vaccine supplies belonging to the major candidates…Do I need to remind us of the 10 million lives needlessly lost to HIV and AIDS? That’s what happened the last time we relied on the good will of pharmaceutical corporations in a crisis….

“Together we believe that there must be safe and effective vaccines for everyone. Vaccines that are fairly and speedily distributed across the world – free of charge – according to need and not ability to pay. We need a people’s vaccine not a profit vaccine. To do this all pharma corporations must openly share their know-how and technology for producing their vaccines free of patent and monopoly. This know-how and technology can then be shared with as many producers as possible. Once we have more producers, we have more doses, and there will be no need for this self-defeating vaccine bidding war in which the most at-risk populations will always loose.

“To achieve this, we must push harder on CTAP. This is the most important multilateral solution we have on the table to unlock supply. The World Health Organization have shown us how access pools work, for example with the Medicines Patent Pool. We welcome COVAX, but we need its spirit of solidarity to extend to sharing technology and intellectual property for the global public good.

Public Subsidies in Vaccine R&D Strengthen Argument for IP Sharing

The case for IP sharing is particularly strong in the case of COVID-19 vaccines, where unprecedented amounts of public and government funds have been poured into  R&D and pre-purchaes agreements, argued  Jamie Love, head of the medicines access advocacy group, Knowledge Ecology International, at the event. He described the investements as “massive, effectively derisking the development of products.”

But public funders have not done enough to push for public ownership of IP rights to the innovations that they helped finance, he said.

“Talk about solidarity has not yet been given concrete action …  The funders of R&D, including primarily governments, but also foundations like the Gates Foundation, have not used their leverage to open source the know-how or rights in patents or data. This reinforces shortages and higher prices, and works against building more distributed capacity for manufacturing, not only today, for years to come and future pandemics.”

While the COVAX pool, to which 64 high-income countries as well as pharma have endorsed, strengthens global systems for vaccine procurement, an IP pool would address potential bottlenecks even more fundamentally:  “CTAP is about access to know-how, cell lines and rights inventions and data We have and will face shortages of supply, and inequality of access to products. But there is no legitimate basis for not sharing knowledge, and in particular, manufacturing know-how, access to cell lines and rights in inventions and data.”

In addition, Love added, “we also need more transparency of R&D costs and subsidies, prices, licenses and advance purchase agreements, and trial outcomes.”

CTAP IP Pool Has Not Received Pharma Support; Simão Says Medicines Patent Pool Could Be Way Forward

Unlike the COVAX pooled vaccine facility, which has received broad industry support, CTAP has been dismissed by the pharmaceutical industry, which holds most of the rights to the vaccine technologies, data, and research that the CTAP IP pool would aim to distribute freely. Director-General of the International Federation of Pharmaceutical Manufacturers and Associations Thomas Cueni has previously said that he did not understand the added benefit of the initiative, echoing comments from heads of large pharma companies.

Still, progress is inching along on the initiative, which was originally proposed by Costa Rica in March. And getting private industry on board is key, according to Simão. She noted that the C-TAP Pool would be built on existing expertise and strategies developed by the Medicines Patent Pool, an initiative founded by UNITAID that has experience negotiating voluntary agreements with industry for the pooling and distribution of generic licenses for the production of medicines for HIV/AIDS as well as other infectious diseases, such as Hepatitis C.

“I think we need our [potential] partners to understand that there is a mutual advantage in sharing prices, in sharing data and know-how. In ways, [it helps] accelerate product development and widespread manufacturing,” said Simão. “We are about to ask for a ‘light’ consultation, a strategy for private sector engagement, because without the private sector as partners we won’t go anywhere.”

-Updated 27.9.2020

 

 

 

“Social support, which is about ensuring that people have the material resources and necessities required to be able to ensure effective care is delivered, is a critical piece that has been under-invested in and focused on Europe in the US and the response to the pandemic.” – Katie Bollbach, director Of US Public Health Accompaniment Unit, PIH USA

New York City, USA – With no approved vaccines and cures on the market for COVID-19, countries everywhere have retreated back to the fundamental public health measures to control the pandemic – test, track, and isolate cases.

And many global health organizations, such as global health NGO, Partners In Health, that have helped manage outbreaks in low resource settings for years, could see the impending signs of an outbreak spiraling out of control in the rich countries that were first hit by the pandemic. It was the first time that these organizations had to set up emergency responses in the countries of their headquarters.

The steady disinvestment in local public health systems in rich countries like the United States, even before the pandemic, had left local authorities woefully underprepared for rapidly responding to an emerging infection.

“For those of us Americans who spend most of our career working outside of the US… it’s been incredibly eye-opening and humbling to see how COVID has absolutely overwhelmed the capacity of our system here in the US,” said Bollbach. “We simply have a deeply fragmented, underfunded, and misaligned health system not really focused on prevention and public health and primary care, but rather on a specific slice of for-profit, secondary and hospital based care.

“And so we’ve seen the result of that in terms of our inability to control the epidemic here in the US.

And from the get-go, it became clear that the same barriers to care that patients faced in low resource settings were replicated in the high income countries. In Massachusetts USA, where PIH first began to engage in the COVID-19 response, it quickly became clear that not everyone had the resources to safely isolate at home.

“We know that it’s simply insufficient to call someone and say, you’ve tested positive for COVID, please stay home for two weeks. Not everybody will be able to do that,” said Bollbach. “People’s ability to stay at home and isolate is linked to their material resources and the broader social determinants of health, such as their household dynamics.”

A panel of experts from PIH discussed local pandemic responses in the United States, Mexico, and Lesotho at a webinar discussing “Why Local Public Health Systems Play A Critical Role in Controlling the Spread of COVID-19” on Wednesday. The webinar is the fourth and final installment in the Global Pandemics in an Unequal World series hosted by the New School, Health Policy Watch, and the Independent Panel on Global Governance for Health. Panelists focused on each individual countries’ struggles, and noted what the various countries could learn from each other.

Implementing Social Support In Massachusetts, USA
Panelists and moderator at the “Why Local Public Health Systems Play A Critical Role in Controlling the Spread of COVID-19” webinar.

The large majority of people who get infected with COVID-19 will not require hospitalization, says Bollbach. Approximately 80% of cases will be moderate, mild, or asymptomatic, and people can stay at home to recover.

“We’ve been really focused on ensuring deeper investment in staffing and resourcing at a local community level to facilitate the coordination of care and safe isolation,”  said Bollbach. 

The Massachusetts contact tracing team, for example, refers patients to care resource coordinators, who work with the patient to help identify needs. 

“This ensures that there is referral and follow-up, to get home delivery of groceries, to get cash to make up for lost wages… We’ve found in our work in Massachusetts that 20% of cases require some form of care, referral, or social support,” said Bollbach. 

The care resource coordinator model has been implemented in contact tracing teams in other major US cities as well, including New York City, the original epicentre of the US’ COVID-19 epidemic.

Big Cities Have Resources, But What About Rural Regions? – A Case From Mexico

Mexico City has also instituted a social support program, in which those who are diagnosed with COVID-19 can receive a care package that contains food, medicine, and extra cash to help ease the burden of lost wages.

But in poorer, rural regions of Mexico, such as Chiapas where PIH’s Mexico team works, the state has little money and resources to help support those that require safe isolation, said Daniel Bernal, sub-regional coordinator for Companeros En Salud Mexico.

“Here, 85% of people live below the poverty line,” said Bernal. “In contrast with Mexico City, we in Chiapas are only doing 0.6 tests per 1000 people per day, less than 3% of the suspect cases and 0% of contacts have been tested, there’s no quarantine for contacts, and there is no money for state social support.

This is why local responses are critical. Communities know and care for themselves, and despite having limited resources, so community engagement is the best option…Communities decide and reinforce social distancing norms.”

In the beginning, Bernal noted that communities did not even want to get tested for COVID-19. But having a strong community engagement strategy, especially in engaging with local leaders, has been important in changing the public perception around testing.

“I think the key piece is the community health workers that have been working with us,” said Bernal. “Some of them have been with us for five years now. And the fact that the information comes from someone in the community that works with [a trusted] organization, that’s been really important.”

But ultimately, more “investment [is needed] to shape the response,” said Bernal. “The thing that they did in China was to set up spaces for isolation. And this is the ideal response, and is something that we are trying to fight to have in Mexico.

“The fact that you don’t have the resources [does not mean] that you can just say, ‘well, it’s not going to happen and we won’t do anything.'”

Building On Existing Local Capacities In The COVID-19 Response in Lesotho

In Lesotho, where PIH has been involved in strengthening the country’s response to HIV/AIDS since 2006, the organization was well positioned to build on the existing HIV/AIDS infrastructure to help augment the COVID-19 response, said Melino Ndayizigiye, acting director of PIH Lesotho.

Over the years, PIH has helped support the training, deployment, and retainment of more staff at rural clinics and health centres, built up patient referral systems, and helped procure medical equipment and supplies for clinics.

But when COVID-19 hit, the country, which has one of the lowest life expectancies in the world had been struggling with multiple heath crises such as tuberculosis and HIV/AIDS, said Ndayizigiye. The COVID-19 response had to also consider patients co-infected with the novel coronavirus and disease like tuberculosis or HIV.

“We have also created a treatment center for multidrug resistant tuberculosis patients who are also co infected with COVID-19. We empowered staff and send them guidelines on managing medical conditions co-existent with COVID-19. And we have integrated medical health care and psychological insights, psychological support services,” said Ndayizigiye.

But ultimately, the system is currently still dependent on outside support.

On average, in PIH supported clinics, some 20 staff are paid by the organization, which receives funding from government grants from high-income countries, large private foundations, and private philanthropy. And the country, which is landlocked within South Africa, is still dependent on South Africa to supply medical oxygen, a key tool required for the treatment of more severe COVID-19 cases.

“We are establishing an oxygen plant that will produce oxygen for COVID-19, and for patients [with other diseases] who might need it across the country,” said Ndayizigiye. “We are thinking beyond COVID-19, because what we have seen what the country lacks.”

Image Credits: Partners in Health.

A lineup of global health leaders called upon high income countries to join the new global COVID-19 pool, saying that worldwide access to a safe and equitable vaccine is essential to beat the COVID-19 pandemic. 

Speaking at the virtual UN General Assembly (UNGA) side event on Wednesday, the leaders also said that maintaining essential vaccine services, during the pandemic, would help lay the groundwork for rollout of a COVID-19 vaccine. 

“The building back of the routine immunization program is the underlying fundamental that creates the infrastructure on which we will deliver [COVID] vaccines,” said Katherine O’Brien, of the World Health Organization. 

“Rebuilding trust in national immunization programs, maintaining essential vaccination services and ensuring safe and effective immunization campaigns will not only prevent countless deaths, but also lay the groundwork necessary for the deployment of a safe and effective COVID vaccine,” said Xavier Castellanos, under-secretary-general of the International Federation of Red Cross and Red Crescent Societies (IFRC).

Xavier Castellanos, Undersecretary General of the IFRC

The  appeals came days after some 64 high-income countries, including the 27 states of the European Union, Switzerland, Norway and Iceland, formally joined the vaccine pool – being rolled out by Gavi, The Vaccine Alliance along with the World Health Organization to bring down prices and ensure broad vaccine access. 

However, significant holdouts to the vaccine pool include countries such as the United States, Russia and China. 

And some $7.5 billion still needs to be recruited by the end of 2020 to finance the 2021 procurement  and distribution of 2 billion vaccine doses for 92 low-income countries that already participate in Gavi’s bulk vaccine procurement system, said Seth Berkley, CEO of Gavi. While that is still a huge sum, the $7.5 billion that Berkley cited as immediately needed, is still only about one-fifth of the $35 billion WHO said was the global “ask” for COVID-19 vaccines, tests and treatments.  

Keys to COVAX Success – Money & Solidarity 
Seth Berkley, CEO of Gavi, the Vaccine Alliance

“COVAX is a global insurance policy,” Berkley said. “We now have an exit plan that can help us avoid the indefensible outcome of only a few benefiting,” he said. “The probability of death from Covid-19 increases with increasing poverty, and we know if wealthy countries buy up the first two billion doses of Covid-19 vaccines instead of making sure they’re distributed in proportion to the global population, then almost twice as many people could ultimately die from Covid-19.”

Xavier Castellanos echoed Berkley’s remarks, saying that the COVAX pool represents an  opportunity “to ensure the Covid-19 vaccine will be allocated fairly and equitably,” not reserved for a privileged few.

“To end the acute phase of the pandemic, the vaccine must be available everywhere it is needed, not only where it can be afforded. None of us will be safe until we are all safe,” said Castellanos. “Ensuring fair allocation and timely delivery to all who need [a vaccine], especially the most vulnerable, is the greatest challenge that we are facing.”

Pharma needs to play role in ensuring wide global distribution 

“We need a commitment from [pharmaceutical companies] to make sure that we are able to supply globally and not just to the highest price payer,” Berkeley stressed. 

He was referring to unilateral plans by some countries, including the United States, to eschew the COVAX Facility initiative and pre-purchase large quantities of vaccines on their own. 

Participation of high- and middle-income countries in the pool is critical to increase the volume of vaccine orders and thus keep prices manageable. However, donor aid will still be required to finance the purchase of vaccines for some 92 low-income countries outright, or at greatly reduced prices.

Health Leaders Warn That Battling Stigmatization and Rebuilding Trust Also Key to Rollout 

Panelists also underlined the need to overcome the stigmatization and fear that arises from misinformation about the pandemic, and building trust in health systems.  

The calls also followed WHO/Europe warnings that the SARS-CoV-2 virus is resurging in the region, following the reopening of borders and several tourism hotspots. Countries have doubled back with even stricter quarantine and restriction measures for this second wave. Elsewhere in the world, many low and middle income countries across South East Asia, Latin America, the Middle East and Africa continue to battle against infection resurgence or steadily increasing rates.  

Questions were also raised about how COVAX would ensure that migrants, displaced persons and other non-citizens could be reached by a COVID vaccine. 

Dr. Asha Mohammed, secretary general of Kenya’s Red Cross Society, predicted that there would be big challenges in providing access to a COVID-19 vaccine to such groups; nomadic populations such as Kenya’s highly mobile pastoralists are also likely to be challenging. Cultural and religious beliefs also could pose a threat to the acceptance and access of immunization within these communities, and more broadly, she said.

Secretary General of Kenya Dr. Asha Mohammed

Berkley said, however, that many migrants and displaced populations are already counted among the vaccine-eligible population in countries that receive subsidized vaccines from Gavi, and would be “taken care of by the advanced market commitment mechanisms.” Plans are being made to ensure delivery to such groups, even if  they are excluded from national plans, he said.  

Joyce L. Kilikpo, Executive Director of the Public Health Initiative, Liberia,  highlighted the parallels between the Ebola response in Liberia and the current COVID-19 pandemic, which has left an enormous impact on the Liberian health system. Widespread misinformation has kept families from taking their children to healthcare facilities in the COVID period. Immunization campaigns such as the one for measles have been suspended, leaving children vulnerable. There has also been a disruption in other essential healthcare services for women and children, which was exactly what she witnessed on the frontlines of the Ebola outbreak.

“We need a robust and continuous investment in the healthcare system,” Kilikpo advised. This would require investment in the health workforce, primary health care infrastructures, planning and monitoring systems.

But strong community engagement is the underlying key, according to Kilikpo.

“After all is said and done, and we have the system working, we need the community to make use of it,” she said.

Image Credits: Flickr: Jernej Furman.

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.

Mike Ryan speaks to reporters at a WHO press briefing on 18 September

Political leaders should find a way to collaborate and “follow the science,” taking a page from researchers, public health practitioners, and healthcare workers who have learned to work together during the COVID-19 pandemic, WHO Health Emergencies Executive Director Mike Ryan said on Friday.

“The people have found a way to cooperate, leaders need to find the same way,” said Ryan. “As much as there may not have been collaboration or leadership at the political level, we have seen unprecedented cooperation between scientists, frontline workers, and people in labs, who have worked tirelessly to gather and share information.”

“One major problem that we see now in the world is the lack of global solidarity,” WHO Director-General Dr Tedros Adhanom Ghebreyesus said. “The major powers are not working together.

“And they should, if they are really going to show the commitment to defeating this pandemic.”

The comments from WHO leadership come just as the 75th United Nations General Assembly opens virtually for the first time, with world leaders broadcasting into the New York City UN headquarters.

Already last Friday, tension was felt when the United States and Israel were the only countries to vote against an all-encompassing resolution authored by the chair of the General Assembly urging global cooperation to overcome COVID-19. Ten countries abstained from voting.

Tension Between US Leaders Emerges On Vaccine Timeline
CDC Director Robert Redfield testifies to a Senate Committee

While the United States has made a break from pursuing multilateral solutions in the COVID-19 crisis, disagreements on key actions in the pandemic response have also emerged within US leadership.

United States Centers for Disease Control Director Robert Redfield on Thursday said that it is unlikely that a COVID-19 vaccine would be available for wider use by October, contradicting the timeline that President Trump and his cabinet had been pushing.

“If you are asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we are probably looking at third — late second quarter, third quarter 2021,” said Redfield, testifying at a Congressional hearing.

Trump immediately fired back at a Wednesday press briefing, saying that that CDC director’s statement was “just incorrect,” and that Redfield must have misunderstood the question.

A vaccine would “go to the general public immediately,” he added.

In an attempt to reconcile the contradicting statements, head of the US National Institute for Allergies and Infectious Diseases Anthony Fauci said that “in many respects, both were right.”

Fauci told WTOP News that he thought that it was possible to get an answer on a vaccine by November or December, and immediately distributing it to high risk groups such as health care workers.

But having a wide enough distribution of the vaccine to “go back to a degree of normality” would likely not happen until the first half to third quarter of 2021, he added.

Global Leaders Must Also Cooperate To Relieve Yemen

Ryan on Friday also made a passionate appeal to global leaders to cooperate in order to ease pressure on the years-long humanitarian crisis in Yemen.

“You’ve all seen the price of geopolitical tension on suffering in the case of COVID-19. The people of Yemen have been paying that price for years, and will continue to pay until the international community come together to end the true cause of their suffering, which is the war,” said Ryan.

The Yemeni health system was in bad shape even before COVID-19 hit – less than 40% of the health system is currently functional, added Dr Tedros.

Yemen has only 2000 confirmed COVID-19 cases, but there have been 496 recorded deaths. The high death rate, coupled with the collapsed health system, has WHO officials worried that many COVID-19 cases are being missed by the testing system.

Image Credits: WHO , The New York Times.

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.