Researchers have reported pausing many or all of their late-stage trials due to the COVID-19 pandemic. This is likely to have a knock-on effect.

The demands of fighting the COVID-19 pandemic are draining resources from global health research and development (R&D) programs and disrupting clinical trials and other work, presenting a potential post-pandemic scenario of a world more vulnerable to a host of infectious threats.

That’s what our organization, the Global Health Technologies Coalition (GHTC), learned after conducting extensive, candid conversations at the end of 2020 with global health researchers around the world from both the public and private sectors. We reached out to them to understand how the fight against COVID-19, an effort that has often relied on their expertise and innovations, may be imperiling science to reduce the burden of many other infectious pathogens. That includes malaria, tuberculosis, HIV/AIDS and a broad spectrum of neglected tropical diseases.

Their reports revealed an urgent need to bring together the global health research community and our allies—in government, industry and international institutions—to avoid lasting damage to hard-fought progress and prevent further delays in delivering new advances.

Everyone understands that right now, COVID-19 must be the focus. We spoke with many researchers who were proud to see their capabilities contributing to developing better diagnostics, vaccines and new treatments. But they also were keenly aware of the toll it was taking on any work not related to the pandemic.

Scientists, speaking confidentially in order to provide a frank assessment, talked about staffing and funding being shifted to focus on pandemic-related work—and with no clear indication on when non-COVID-19 work would resume, or if diverted funding would be restored.

Meanwhile, clinical trials—the most costly and complex aspect of developing new health interventions—have been hit especially hard by pandemic-related shutdowns. Nearly every interviewee involved in clinical trials, many of which are located in low- and middle-income countries, reported significant issues, including trials being delayed indefinitely. The biggest disruptions have involved phase 3 trials. That’s understandable, as these trials are logistically complex and typically require managing thousands of participants. But reaching Phase 3 means a project is tantalizingly close to delivering a new breakthrough, which makes interruptions at this stage particularly devastating.

Researchers reported pausing many or all of their late-stage trials. One clinical trial administrator reported that where a trial was already underway, numerous trial participants were not showing up for essential follow-up visits at the clinic due to fears of contracting COVID-19. Virtual follow-ups were proving challenging in many cases, in part due to infrastructure barriers in low-resource settings—such as the need for many people to regularly purchase new SIM cards for their phones, which changes their phone number. Virtual visits are also not an option for trials that require in-person follow-up to collect samples.

Outside of clinical trial disruptions, scientists noted a number of discrete challenges. For example, there were reports of work stymied because laboratory reagents or personal protective equipment (PPE) were needed for pandemic response. Operational expenses have increased significantly for many projects, due to issues like higher shipping costs and additional resources needed for safety.

The cumulative effect of so many obstacles is presenting staggering challenges for global health researchers. But there is a way to recover from these setbacks—and avoid a situation where we emerge from the battle against one deadly disease less prepared to fight off many others.

First, we must work with our partners in the public and private sector to ensure scientists are given the resources and flexibility to recover from their pandemic-related problems and restart their work. Second, we must emphasize that decades of investments in global health R&D generated new insights and alliances that have played a big role in speeding the development of COVID-19 interventions. The fast pace of that work, especially around vaccines, demonstrates that, with greater funding, the field is poised to produce rapid progress in fighting many other infectious diseases.

In fact, we did hear a measure of optimism among some of the researchers we interviewed that the harsh experience of the pandemic—and the fact that scientists are leading the effort to end it— could create a new era in which investments in global health R&D become an enduring political priority.

But another scenario is one in which disruptions caused by the pandemic are compounded by long-term funding problems. Global health R&D funding always has been a hard sell and the economic impact of the pandemic is likely to constrain spending in both the public and private sector for years to come. It will require a concerted effort by our community to ensure global health R&D quickly regains lost ground and, equally important, that we can capitalize on opportunities revealed by pandemic-related advances to accelerate work on a number of diseases.

Jamie Bay Nishi is director of the Global Health Technologies Coalition (GHTC), a coalition of 30 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people. For more on this topic, read the GHTC’s full synthesis of the interviews: Pain Points and Potential: How COVID-19 is Reshaping Global Health R&D.

Image Credits: Dato Koridze /STUDIO for TB Alliance.

Helen Clark, former Prime Minister of New Zealand and co-chair of the Independent Panel review of the COVID-19 pandemic response

The World Health Organization’s (WHO) response to COVID-19 was too slow, hampered by an antiquated pandemic alert system, lack of resources and a lack of authority with member states, according to an interim report by the Independent Panel on Pandemic Preparedness and Response, presented to the WHO’s Executive Board meeting on Tuesday.

It took the WHO an entire month from the time an alarm was sounded in Wuhan to declare a public health emergency. And it’s alert and response system “seems to come from an earlier analogue era and needs to be brought into the digital age,” panel co-chair Helen Clark, the former Prime Minister of New Zealand told a media briefing. She added: “Modern information systems pick up signals of potential diseases by sifting through hundreds of thousands of data points daily, outpacing formal country reporting and outpacing the procedures and protocols of the International Health Regulations.”

But the human deliberations of WHO also slowed down responses. Although the WHO Emergency Committee was convened on 22 January 2020, WHO only declared a “public health emergency of international concern” on 30 January, and first used the word “pandemic” on 11 March.

“Even when WHO declared a Public Health Emergency of International Concern on 30 January – the loudest alarm possible under the International Health Regulations – many countries took minimal action to prevent the spread internally and internationally,” Clark said in the briefing. 

The brand-new report, mandated by the World Health Assembly in May, when the world was reeling from the initial impacts of the pandemic – was presented at the EB during a second day of the exhaustive EB review of the COVID-19 pandemic. EB members also heard a report from yet another review committee, examining the International Health Regulations framework that governs countries’ obligations to monitor, report and respond to emergencies, which found compliance wanting, due partly to a “lack of teeth” in the IHR’s legal enforcement mechanisms.   

“The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels,” said Professor Lothar Wieler, President of the Robert Koch Institute in Berlin, in a statement.

“The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response,” said Wieler, speaking to WHO member states.

Lessons about the past are more relevant than ever today, Clark stressed. Since 1 January, the world is recording almost 12,500 daily deaths and 682,000 new cases, and countries need to urgently implement “basic measures like testing, contact tracing, isolation, physical distancing, and wearing masks,” which are even more pressing as new and reportedly more infectious variants of SARS-CoV2 are detected.

Not Laying Blame on WHO – But …

Former Liberian President Ellen Johnson Sirleaf, co-chair, of the Independent Panel’s review of the COVID19 pandemic response, at a media briefing.

Co-chair Ellen Johnson Sirleaf, former President of Liberia, stressed that the panel was not trying to blame the WHO: “The world is more reliant on an effective WHO than ever before. But while member states turn to the WHO for leadership, they have kept it underpowered and under-resourced to do the job expected of it.”

She added: “Member states are looking to the WHO for leadership, coordination and guidance, but are not equipping it with the authority or access to the funding needed to provide this. WHO has no powers to enforce anything or investigate anything of its own volition within a country.

“When it comes to a potential new disease threat, all WHO can do is ask and hope to be invited in. The panel is asking whether this is enough.”

At the same time, the report makes a number of damning observations about how member states had failed to act on “numerous evaluations, panels and commissions which have issued many recommendations for strengthening preparedness and response” of WHO.

And the Panel also criticised the sometimes overly technical nature of WHO’s advice to countries, saying that it had issued over 330 reports to states, which may have confused them about what their priorities should be.

Panel Criticism of China – Receive Rocky Reception From Beijing  

China’s representative to the Executive Board at the 148th session on Tuesday.

The panel report also criticises China, stressing that “public health measures could have been applied more forcefully by local and national health authorities in China in January.”

“It is also clear to the Panel that there was evidence of cases in a number of countries by the end of January 2020. Public health containment measures should have been implemented immediately in any country with a likely case. They were not.”

Clark would not comment further on China, saying that the panel would have a more detailed report on the chronology of events at a later stage. The final report is due to be presented to the World Health Assembly in May.

However, in a later EB debate, China protested about the way that its response had been characterised, saying that it was being unfairly “judged” for early days when authorities were still grappling with “understanding the unknown”. 

“On January 23 2020, when only four countries outside China reported seven cases, China pressed the pause button in Wuhan, a city with a population of over 10 million, which was not taken lightly. But we did it. And we made huge sacrifices for global fight against the virus that has gone way beyond the traditional public health measures. 

“We urge the international community to look at China’s anti-epidemic efforts from a rational and scientific perspective. 

“These extraordinary and forceful public health measures are mass contributions that China made to the world. China suggests that the review committee …should further improve the report and make scientific, objective, fair, comprehensive and balanced assessments on both prevention and response.”

Incentives For International Cooperation Are Too Weak 

Well beyond the WHO or China, however, the panel made it clear that responsibility is shared globally, while the incentives fostering international cooperation between states remain too weak. 

“Our panel report does identify a series of critical early failings in global and national responses to COVID-19. There had been a failure to prepare adequately for a pandemic threat despite years of warnings that better preparation was necessary,” said Clark at a subsequent afternoon briefing with the EB members themselves on the report’s findings.

“Preparedness methods which were being used did not appear to predict how well individual countries would be able to control COVID-19. Perhaps because they couldn’t capture what seems to be a critical dimension of pandemic control: the mix of government effectiveness, concern and leadership, capacity to work with communities, and being able to be guided by science,” said Clark.

“The panel notes with deep concern that the failure to enact fundamental change despite the warnings issued has left the world dangerously exposed, as the COVID-19 pandemic proves,” according to the report, which added that there has been “a wholesale failure to take seriously the existential risk posed by the pandemic’s threat to humanity and its place in the future of the planet”.

Adds the report: “the incentives for cooperation are too weak to ensure the effective engagement of states with the international system in a disciplined, transparent, accountable and timely manner” despite the fact that the pandemic offers “a once-in-a-generation opportunity for member states to recognize the common benefit of a suitably reinforced suite of tools to enable robust pandemic alert and outbreak containment functions.”

Major weaknesses in the Global Supply Chain 

Other problems flagged by the panel include “major weaknesses in the global supply chain,” while the critical funding gap hampering the Access to COVID-19 Tools Accelerator (ACT-A) platform might result in a “two-tier world, divided between countries where COVID-19 is relatively controlled, and those where COVID-19 adds to the overall burden of disease as yet another ongoing, endemic disease”.

“The effective flow and access of new diagnostics, therapeutics, and vaccines to the populations most in need, based on equitable public health criteria, must be the central plank of international co-operative efforts,” the report notes.

Vaccine Rollout Also Criticized by Panellists  

Related to that, the unequal pattern of vaccine rollout also came in for sharp criticism by the panel’s leaders at the EB session: “The panel is discouraged and frankly disappointed by the unequal vaccine rollout. Tens of millions of vaccines are already available in some of the wealthiest countries, but based on current plans, vaccines will not be widely available across the African continent until 2022 or even 2023,” said Sirleaf.

“It is unacceptable for wealthy countries to be able to vaccinate 100% of their population, while poorer countries may do with only 20%. It is no exaggeration to say that we are at risk of creating a vaccine distribution system grounded in inequity. We cannot let this happen.

“This is a unique opportunity, born out of the gravity of this crisis, to reset the system. Real change in global and national health systems will benefit every country and every citizen,” Sirleaf added. 

EB Members Frame Reviews As Buildup to WHA Resolution Strengthening Emergency Response  

Garett Grigsby, director of the Office of Global Affairs, US Department of Health and Human Services

Despite resistance from China, member states in Europe, the Americas and elsewhere framed the findings of the three reports as useful inputs to a planned resolution to strengthen WHO’s Emergency Response mechanisms, that will go before the World Health Assembly in May.

“It is our duty to provide the WHO and the broader international system with the tools to do its work effectively, efficiently, independently and transparently,” said Garett Grigsby, director of the Office of Global Affairs at the United States Department of Health and Human Services, speaking at Tuesday’s EB session. 

“We must rise to the occasion, even as we combat the pandemic and resurrect our economies,” said Grigsby. “That is why we need to be sure that the recommendations put forward will be given thoughtful consideration, and any additional funding requests for WHO will be justified and directed at areas where strengthening is necessary, such as pandemic preparedness and response. The United States will work with other member states to strengthen the WHO to make it fit for purpose.”

Grigsby also said that the United States was joining the European Union and a wide range of other member states to advance a resolution for the World Health Assembly strengthening WHO’s Emergency Response. 

The statement represented the first sign of other substantive shifts in policy that can be expected from the White House after President-elect Joe Biden is inaugurated in Washington, DC on Wednesday. 

Biden is expected to work rapidly to restore the previously close relationship between WHO and Washington – which was shattered by the maverick policies of outgoing Donald Trump – who leaves the White House in disgrace after igniting the emotions of rioters who charged the Capitol on 6 January in a failed attempt to violently overturn the election results.  

WHO Reaction – We All Have To Learn Lessons 

“We all have lessons to learn from the pandemic, every member state and the Secretariat….We are committed to accountability and we will continue to learn, to change, and to listen,” said Dr Tedros Adhanom Ghebreyesus, responding to the report at the EB’s afternoon session. 

While the report remains an interim one, countries should act immediately on some of the lessons learned, the Independent Panel Co-chairs underlined:

“We are building the necessary evidence base required for the comprehensive, impartial and independent review of the international health response to COVID-19 with which we were tasked,” Clark told delegates. “While our evidence gathering continues, the progress report before you now does have an unequivocal message that course correction of the handling of the pandemic is needed now.

“The panel does strongly recommend that all countries immediately and consistently adopt and implement those public health measures which will reduce the spread and the impact of COVID-19. Simply put, we must do all we can to stop the pandemic now.” 

Image Credits: WHO.

Health care workers administered the COVID-19 vaccine on 16 January at Chacha Nehru Bal Chikitsalaya (children’s hospital) in Delhi.

The Indian government began the world’s largest COVID-19 vaccination program this weekend aiming to vaccinate more than 300 million people, beginning with 10 million health workers, but in the three days since, it appears there has been low uptake among that key demographic.

Based on Health Policy Watch’s estimate, only slightly more than half of the people registered have received their vaccine in the three days since the launch. 100 people are registered per session, with 7,860 sessions held. Despite this, only 4,54,049 have been vaccinated as of Monday night.

Additionally,  vaccination rates in three states  — Tamil Nadu, Punjab and Puducherry — were 40% lower than expected.

“It is sad that members of our medical fraternity – our doctors and nurses – are declining the vaccine,” said Dr VK Paul, member of Indian government think-tank Niti Ayog, said in a press conference on Tuesday.

“I request them to please take the vaccine. We do not know what shape this pandemic will take.”

The country, which began its rollout on Saturday 16 January, is distributing two vaccines: the Oxford/AstraZeneca candidate, known as Covishield, manufactured by India’s own Serum Institute, and Covaxin, developed by Indian-based Bharat Biotech in collaboration with the Indian Council of Medical Research.

Earlier this month, India’s chief drug regulator granted the Serum Institute vaccine an emergency use license based on Phase 3 data from trials in Brazil and the United Kingdom, where the vaccine has already been approved.

But the decision to authorize Covaxin, a vaccine developed by the local firm Bharat Biotech together with the Indian Council of Medical Research, was made without final Phase 3 data. And the lack of transparency around that approval process may also be fuelling vaccine hesitancy.

Anyone receiving a Covaxin shot will be asked to fill in a consent for which notes that “the clinical efficacy of Covaxin is yet to be established and is still being studied in Phase 3 clinical trial” – although Phase 1 and 2 trials indicated the vaccine produces antibodies.

Two people, aged 43 and 52, have reportedly died following their vaccination. It has been confirmed that these deaths were both due to cardiopulmonary disease, and were unrelated to the vaccine.

Dr Manohar Agnani, additional secretary with Indian Ministry of Health and Family Welfare, said: “So far no case of serious or severe adverse events following immunisation attributable to vaccination till date.”

Confusion over Rollout Of Experimental Covaxin Vaccine Fuels Hesitancy

Many doctors employed in national hospitals have been cautious as to go on record about the mixed sentiments the campaign is thus generating.  As one senior doctor in Safdarjung Hospital told Health Policy Watch: “There is a little bit of confusion over Covaxin. Everybody does not want to become part of a trial (as the vaccine is being administered under clinical trial mode). It would have been better if I was given a choice. I would have taken Covishield.”

He later clarified he would be taking his Covaxin shot when offered, however his colleague also expressed apprehensions due to the lacking Phase 3 data.

Each vaccination site has only been provided with one of the two authorized candidates, meaning that people who are registered in that hospital have no choice but to take the vaccine available at the center.

Of the 37 states and union territories in India, 12 received the Covaxin vaccine.

On Saturday, about 22 million health workers were vaccinated were vaccinated across India.

In the Dr Ram Manohar Lohia Institute of Medical Science in Delhi, resident doctors wrote a letter to their hospital’s authority on Saturday,outlining why they were not comfortable taking Covaxin.

The letter read: “The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers thus defeating the purpose of vaccination.”

Signatories then requested to be vaccinated with the Serum Institute-manufactured vaccines.

But Dr D R Meena, Registrar of Safdarjung Hospital, Delhi, took the Covaxin vaccine on Saturday, saying he “had mild myalgia” – or muscle pain – and that he “did not even need paracetamol”.

There have also been some cases of death following vaccination that were widely reported in the media – although these have so far been attributed to pre-existing conditions.

‘A Proud Moment’: Vaccination As A Lifeline

For some doctors, however, the launch of the vaccine campaign process was still an emotional moment.

Dr Prashant Lohmore, 28, is a resident doctor working in the emergency ward at Max Smart Superspeciality Hospital, a private hospital in Delhi. He received his Astra/Zeneca vaccine on Monday.

“I saw a lot of patients facing respiratory distress after Diwali,” he said. “We did not have enough beds at the time.”

That the country’s vaccination program has now begun “is a proud moment for us”, he added.

Dr Meena – the doctor who said he experienced only mild muscle pain from Covaxin – spent 2020 working as an anaesthetist in the Intensive Care Unit. His wife, also a doctor, works about 80km out of Delhi, and was gone for several months.

Their two children – a nine-year-old daughter and a 17-year-old son – both had little contact with their parents. Dr Meena and his wife both received their vaccine on the same day.

“I used to isolate myself in a room. My daughter would insist on talking to me. She is a small girl,” he said.

“Those were the hardest months of my life. Vaccination provides hope to us.”

Image Credits: Press Information Bureau, India.

The vaccine developed by Oxford University and AstraZeneca is the only one to have both been secured by COVAX and already approved by a national regulatory authority (the United Kingdom) in a transparent review process.  

The World Health Organization’s (WHO) COVID-19 vaccine access platform, COVAX, is geared up to deliver vaccines to “far more” than 20% of member states’ populations beyond 2021, Dr Kate O’Brien, the body’s director of vaccines, told its Executive Board meeting on Tuesday.

She was responding to concerns and criticisms expressed by member states at the EB’s opening session on Monday about the ability of COVAX to deliver vaccines to member states that have not been able to purchase them on their own.

As Austria’s Dr Clemens Martin Auer, told the meeting: “COVAX is slow. It has not closed a crucial number of contracts, and therefore, substantial numbers of vaccines are not being timely delivered to member states.”

Distribution datelines for COVAX delivery of 2 billion vaccine doses in 2021, based on data available on 7 January 2021.

Auer, who is also the co-chair of the EU’s vaccine procurement group’s board, said that the EU group had been meeting up to three times a week since June to put together a broad portfolio of vaccines, but the management of COVAX lacked transparency about its procurement programme.

“We did do our homework within the EU to secure the needs for 450 million EU citizens to have access to urgently needed vaccines. We were sceptical that GAVI had the means and the capabilities to fulfill its tasks to negotiate the necessary contracts and to secure the needs of our citizens. 

“The proposals that GAVI negotiated side-by-side with the EU with the producers was rejected by the management of GAVI COVAX. So I would like to express the clear statement that the EU and its member states are exercising their global solidarity and we are the single largest donor when it comes to supporting GAVI COVAX facility.” 

Auer also asked why the COVAX management had initially decided to exclude the mRNA vaccines being produced by Pfizer and Moderna, which have been the first to receive European and American regulatory approvals; what COVAX’s delivery plans were and how many vaccine doses member states could expect?

Dr Bruce Aylward, Senior Advisor to the Director-General, reported that GAVI has “145 million doses contracted for release during the first quarter of this year.”

Bruce Aylward, WHO Senior Advisor to the Director General, at the Executive Board session on Tuesday.

Timing depended on countries’ regulatory support, continued financing of COVAX and co-operation from countries and entities that have large bilateral vaccine deals “because choices have to be made as to which contracts get served in which order, and the dose sharing that we mentioned yesterday,” added Aylward, who represents the WHO at GAVI. 

“There is no question that we can achieve the Director General’s vision of all countries vaccinating their highest risk populations by World Health Day [7 April], which is only a couple of months away, but to achieve that ambition will require a new level of cooperation and coordination as we go forward,” said Aylward.

“Any suggestion that COVAX is not operational has to be scrutinised, as the facility is operational,” stressed Aylward.

WHO Now Examining Indian, Russian & Chinese Vaccines – While Moderna & Pfizer Hold Back

One key holdup with COVAX, in fact, appears to lie in the mismatch between the vaccines for which COVAX has arranged pre-order deals – and those that have received approval so far by WHO or another strict regulatory authority as safe to use. 

Brand names of doses secured by COVAX that would be available for delivery – however only following WHO approval of AstraZeneca, Serum Institute of India and J&J vaccines.

So far, the AstraZeneca/Oxford University vaccine is the only one to have both been secured by COVAX and already approved by national regulators.  

Another key COVAX product, a vaccine candidate by Johnson & Johnson has not yet received US or European regulatory approval. Yet a third, by Sanofi/GSK lags even further behind. 

Meanwhile, as Auer pointed out, COVAX has either been unable or unwilling to secure deals with the other two leading pharma companies that are rolling out millions of mRNA vaccine doses, Pfizer and Moderna. 

And Moderna has not yet even submitted a full dossier on its product for WHO review – despite the fact that it has been approved in Europe, the United Kingdom, the United States and Switzerland.  

In the interim, WHO is in the process of reviewing vaccine candidate submissions by Indian, Chinese and Russian counterparts – which are eager to get the Organization’s seal of approval – and market them independently to the dozens of countries that have already submitted pre-orders. 

In the case of the Indian vaccine, a generic version of the AstraZeneca/Oxford vaccine technology, WHO manufacturing approval would also clear the way for offering it through COVAX – where it comprises the largest single pre-order by the facility. 

“We have full dossiers from three other drug companies right now, Sinopharm, Sinovac, and the Serum Institute of India and they are under assessment,” said WHO’s Dr Mariangela Simao, Assistant Director-General for Access to Medicines, who said the real time status of WHO review and approval for all vaccines can be tracked on the WHO’s website. 

“We have a mission in China right now, to do the inspections in Sinopharm, in Sinovac,” she added.

Mariângela Simão, WHO Assistant Director General of Access to Medicines and Health Products, at the morning session of the EB meeting on Tuesday.

She added that she expects more information on Russia’s Sputnik vaccine next week following a meeting with the vaccines developers at the Gamaleya Research Institute. 

“For Russia, we are still waiting for additional information from Gamalaya, we have a meeting with the team next week.”

She said that WHO is also awaiting further information from the Republic of Korea, where the firm SK Bio is set to produce the AstraZeneca vaccine under a generic license – using the core vaccine technology approved by the United Kingdom. 

Among all of the vaccines in late stage trials or already being rolled out, only the Pfizer vaccine has actually received the full and final WHO seal of approval – although so far there is no COVAX pre-purchase agreement with Pfizer – and the vaccine requires ultra cold storage conditions.

Mixed Results from Chinese and Russian Phase 3 Trials So Far 

While WHO approvals would also be reassuring for the many countries that have already placed orders for the Chinese and Russian vaccines – there have been diverse reports so far about their efficacy. 

Sinovac’s results have generated the most concern. In the results of a Phase 3 trial in Turkey, released late in December, the company proudly announced an efficacy of 91.3%, but subsequent results in other countries have been much less impressive, showing 78% efficacy in one Brazil trial, 65.3% in Indonesia – and only 50.3% in the most recent Brazilian trial of 12,000 healthcare workers. 

That barely makes the 50% mark for the minimum efficiency standards set by WHO  and the FDA – although Sinovac said that the trial of healthcare workers was biased because they would be more intensively exposed to the virus than the general public. 

The Sinopharm vaccine, co-developed by the Beijing Institute of Biological Products, has reportedly yielded an efficacy result of 79.3% in China and 86% in another Phase 3 trial in the United Arab Emirates – although again these have yet to be reviewed independently. 

Over 60,000 volunteers from 125 countries, including Morocco and Peru, are still taking part in late stage clinical trials, said Sinopharm.

Of the three, the Russian Sputnik vaccine claims the highest overall efficacy rate of more than 90%, just trailing behind Pfizer’s and Moderna’s mRNA vaccines by a few percentage points, according to interim findings from late-stage trials in Russia. 

But once more, while the WHO review is still pending, the data has yet to be published in a peer-reviewed journal or reviewed transparently by a regulatory authority.   

Status of COVID-19 vaccines in the process of receiving WHO “Emergency Use Listing” approval, as of 14 January.

 

–Svet Lustig Vijay contributed to this story

Image Credits: John Cairns, WHO, WHO.

WHO Director General Dr Tedros Adhanom Ghebreyesus Tedros makes opening remarks at EB148

The world is “on the brink of a catastrophe and moral failure – and the price of this failure will be paid with the lives and livelihoods in the world’s poorest countries,” declared WHO Director General Dr Tedros Adhanom Ghebreyesus, in his harshest rebuke to date of both countries and the pharma industry for failing to roll out out life-saving COVID-19 vaccines more equitably across the world. 

Speaking on the opening day of what is set to be a marathon session of WHO’s Executive Board, the WHO Director General noted that “more than 79 million doses of the vaccine have now been administered in at least 49 higher income countries, while just 25 doses have been given in one low income country.” 

While some WHO member states, including India’s Minister of Health Harsh Vardhan, EB Board Chair, framed the vaccine roll-outs now underway as the glass “half full” in his opening remarks – which coincided with the launch of India’s own vaccine’s campaign set to become the largest in the world, the WHO DG was not so upbeat. 

Rather Dr Tedros expressed the deep rumbles of dissatisfaction echoing among senior WHO officials over the way in which the WHO co-sponsored COVAX facility is being sidelined in the rush by countries – and even blocs of countries – to arrange their own vaccine deals. In fact that rush, which began with the United States, the European Union and other rich countries, now includes South Africa, Brazil, India, and most recently the African Union – which announced last week that it had secured pre-orders of some 270 million vaccine doses from manufacturers for its member states, outside of the COVAX framework.   Earlier this month, South Africa also announced that it had arranged for its own vaccine purchases, following on from India and Brazil. 

Countries and Companies Continue to Prioritize Bilateral Deals

“Some countries and companies continue to prioritize bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue,” said Dr Tedros, noting that some 44 such deals were signed last year. 

“The situation is compounded by the fact that most manufacturers have prioritized regulatory approval in rich countries where the profits are highest rather than submitting full dossiers to the WHO,” he added.  

The lack of communication from pharma producers, he warned, could also delay WHO approval of vaccines to be rolled out through COVAX: “This could delay COVAX deliveries and create exactly the scenario COVAX was designed to avoid with hoarding a chaotic market, an uncoordinated response and continued social and economic disruption.”

The WHO Director General called on countries and pharma producers to “change the rules of the game in three ways,” including by countries transparently reporting to COVAX the nature of their bilateral deals – “including on volumes, pricing and delivery dates.” 

He also called on countries with large vaccine orders to “share their own doses with COVAX, especially once they have vaccinated their own health workers and at risk populations, so that other countries can do the same.”

And, he called on pharma vaccine producers to “provide WHO full data for regulatory review in real time to accelerate approval… to prioritize supplying COVAX rather than new bilateral deals” as well as to allow countries to share any extra doses with COVAX. 

“My challenge to all member states is to ensure that by the time World Health Day arrives on the seventh of April. COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming, both the pandemic and the inequalities that lie at the root of so many global health challenges,” said Tedros. 

India’s Health Minister More Upbeat  
Indian Minister of Health and Social Welfare Harsh Vardhan presiding at WHO EB 148

While the WHO Director General’s comments certainly reflect the frustrations being experienced by people in many countries who are watching vaccine distribution campaigns get underway among wealthier neighboring states, India’s Vardhan cast a more positive light on the progress seen so far in his opening remarks at the EB:

“Scientific capabilities raced against time and delivered on the promise of a vaccine in the shortest possible time in history,” declared Vardhan, who is the EB chair. “While 2020 was the year of science, 2021 shall be the year of global solidarity and survival,” he forecast optimistically.

“COVID-19 vaccines are being successfully produced across many countries, a tech investment boom is being witnessed, and digital technologies are being adopted. All of this is combining to raise the hope of a new era of progress. I want to express utmost optimism that this year the crisis caused by the COVID19 pandemic shall be mitigated and successfully reversed through committed political leadership and sustainabled global cooperation and solidarity,” said Vardhan, adding that the “COVID-19 vaccines offer a real hope – but that hope needs to reach everyone… therefore we must ensure fair and equitable distribution of the COVID vaccine.”

IFPMA – Concerns Over Speed of Access “Potentially Misleading”

Meanwhile, concerns over the lack of speedy access to coronavirus vaccines to low- and middle-income countries (LMICs) “are potentially misleading and might hinder rather than help this unprecedented effort of global collaboration and solidarity,” said the head of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni, in a lengthy response to the WHO DG’s remarks. 

“Governments around the world – in industrialized as well as developing countries – have moved overnight from concern about vaccine hesitancy to high anxiety at rolling out the distribution. The political urgency is understandably, it is important recall that the roll-out of approved COVID-19 vaccines is just weeks old. In that time, events have unfolded swiftly, with a couple of other vaccines gaining approval and more to follow. 

“While there is no room for complacency, it is important to note that this is the first global-health emergency in which new vaccines are being rolled out to LMICs at about the same time as in richer ones,” said Cueni – drawing a sharp contrast with other pandemics, where it took years for vital health products to reach poor countries.

Executive Board Packed Agenda Addresses COVID Directly and Indirectly

Much of the ten-day governing board meeting will focus on debates and a flurry of initiatives that are a product of the COVID-19 pandemic’s shockwaves. Beyond the optics and the politics, the quality of debate may be a test case for whether the 34-member EB, in its current alignment representing all six WHO member state regions equally, can regain its past lustre as a technically-focused board – or also requires more serious reform in the wake of shortcomings highlighted by the pandemic – as some critics have suggested.  

Items on the table will include, an exhaustive review of WHO’s emergency response operations in general, and its COVID-19 response more specifically. 

There is also an initiative by some 46 member states for more far-reaching reforms in WHO’s emergency powers and response capacity – looking toward a formal resolution to be submitted for approval at the May World Health Assembly.

The EB will also consider a WHO request for a nearly 20% increase in its operating budget to fill out the many performance gaps that have been uncovered in the course of the pandemic; a new framework to examine how to put WHO’s shaky finances on a more sustainable footing; and foster a more efficient Organization through a series of WHO administrative reforms. 

Along with that, there are a host of other core WHO activities, initiatives and issues, now being re-examined through a COVID “lens.” These range from topics like patient safety and medicines access – to non-communicable diseases and mental health.   

Improving WHO’s Emergency Response
Even as high-tech vaccines are rolled out in some countries, other essential COVID-19 supplies like oxygen remain in short supply in many others, notes the report by the Independent Panel for Pandemic Preparedness, under EB review. this week

Responding to the shortcoming already identified in WHO’s often delayed and wavering responses, the European Union, United States, Canada, Australia and Japan, are among the 46 countries seeking an EB mandate to develop a reform-minded WHA resolution that would sharpen WHO’s emergency response capacity. Behind the scenes, the resolution’s backers want to see much stronger enforcement mechanisms built into the legally-binding International Health Regulations that WHO administers – requiring countries that identify a new disease outbreak or pathogen risk to report on it more transparently and promptly – and enabling stronger action if they fail to do so. The proposal would be anchored in the findings of three independent investigative committees currently underway, the initiatives sponsors, led by Australia and Canada state.

The first gleanings of one such review by the Independent Panel on Pandemic Preparedness and Response will also be under the spotlight at the meeting. The review by an expert team led by the former prime ministers of New Zealand and Liberia concludes that the global pandemic alert system was “not fit for purpose” and the WHO was “underpowered” to do the job expected of it. (See related Health Policy Watch story)

NCDs, Mental Health & Patient Safety – Also Being Examined In the COVID Lens

Other items on the marathon EB agenda include a wide range of items relating to WHO’s pre-pandemic “Triple Billion” programme of work for 2019-2023, which also aims to improve the health of 3 billion people worldwide through wider access to universal health coverage as well as more action on preventive health issues, including social and environmental risks, such as poor diets, physical inactivity, and air pollution. But these items, as well, are being looked at with new eyes in light of the pandemic.   

For instance, a World Health Assembly proposal for a Global Action Plan on Patient Safety 2021-2030  states: 

“Patient safety issues such as personal protection, health worker safety, medication safety and patient engagement have become key areas of the COVID-19 response globally. Patient safety interventions must be urgently implemented in order to respond effectively to this global public health emergency of unprecedented scale. Such interventions are also needed to improve preparedness to respond to such challenges in the future.”  

The EB will also be asked to consider updating WHO’s 2013 Global Action Plan for the prevention and control of noncommunicable diseases, with one eye looking through a “COVID” lens – which saw the virus hit hardest against those with other chronic diseases. The updated action plan, which targets risks such as unhealthy diets, physical inactivity, smoking, alcohol consumption and air pollution, also would now include a stronger emphasis on mental health. It would be extended to the year 2030.

Transparency of Medicines Markets & Local Medicines Production 

The transparency of medicines markets and effective access to treatments for cancer and rare and orphan diseases, is another key topic on the EB agenda – resuming discussions over an earlier South African proposal to expand access to cancer treatments and another proposal on rare and orphan diseases by Peru, which the WHO had deferred until 2021. Linked to that, the EB willl also review the broader topic of medicines and vaccines access, in light of a WHO resolution on transparency in medicines markets, which was approved by the World Health Assembly in 2019. 

In another COVID-inspired move, some EB member states also are reportedly preparing a WHA resolution that aims to strengthen local production of medicines, vaccines and other health products, according to a Zero draft of the proposed resolution, obtained by Health Policy Watch. This has surfaced as an issue in light of the severe supply chain interruptions seen over the past year as a result of the pandemic – which left countries rich and poor facing dire shortages of basic medicines  – from antimalarials in some parts of Africa  to certain common antibiotics in Europe. 

Still other issues being considered involve WHO’s actions to address longstanding problems with fake and substandard medicines and a plan for operationalizing the new “Immunization Agenda 2030” that was approved by the World Health Assembly in August 2030. Both issues are even more important now, in light of the rollout of COVID vaccines underway, and the ongoing quest for reliable treatments. 

WHO Proposes 20% Budget Increase for 2022-2023
WHO proposal to Executive Board for some US $ 447 million in new allocations for 2022-23

A proposal to sharply increase the WHO budget for 2022-23 by nearly 20% or US$447 million is also on the table, raising the two-year budget level to US$4.478 billion.

A big chunk of the added funds would go to strengthening WHO capacity at the country level. WHO also promises to use the funds to integrate the “lessons learned” from COVID into other WHO initiatives; and “mainstream” WHO polio eradication teams – which have often serviced as the “backbone” of WHO vaccine support overall for developing countries – into other functions: 

“In the past, because of limited resources, the human resources and operational infrastructure built through the polio programme has been the backbone of the WHO Secretariat’s technical and public health operational support to countries,” states the budget proposal, “this proved to be critical in WHO’s effective emergency response in immunization campaigns and in surveillance, especially in fragile, conflict-affected and vulnerable settings.”

Under the proposal, rather than staff positions being cancelled in the phase-out of polio activities, polio eradication teams would be reassigned to other functions that, de facto, they already perform anyway, supporting overall immunization goals and general primary health care provision.  

A companion proposal to the budget would establish an intergovernmental working group on Sustainable Financing for WHO. The working group would examine ways to ensure more stable contributions from member states or other sources – easing the reliance on unpredictable  voluntary contributions from member states and other donors for many core programme activities.  The reliance on such contributions is widely acknowledged as a factor leading to gaps in more strategic, long-term Organizational staffing.    

WHO Reform

The EB will also consider advancing a controversial proposal to curtail formal presentations by civil society and other non-State actors at official WHO meetings, including the EB and the World Health Assembly – while facilitating new fora for technical exchanges with WHO technical teams and WHA member states. Civil society groups have objected to the proposals – saying that the new venues for interaction will not be as fruitful since they are outside the formal channels where dialogue with member states takes place. Nonetheless, the EB proposal suggests the approach be tested at the 74th World Health Assembly in May. Other reform proposals would sunset nearly 50 WHO resolutions that are more than six years old – and which WHO argues have since been replaced by other initiatives. The sunsetting would cover resolutions as wide ranging as health responses in nuclear war to the elimination of tropical diseases – which still often entail bulky reporting requirements, WHO says. A more systematic rationale for the declaration of World Health Days is part of yet another reform proposal.

Image Credits: WHO, Independent Panel for Pandemic Preparedness – Second Progress Report. .

Johnson & Johnson vaccine research laboratory. The J&J vaccine is one of the COVID-19 vaccines in the pipeline that WHO’s COVAX facility is planning to procure, but COVAX urgently needs US$ 8 billion to cover its commitments, says WHO special adviser Dr Bruce Aylward.

“Escalating bilateral deals” between pharmaceutical companies and World Health Organization (WHO) member states have complicated the global body’s vaccine delivery platform, the COVAX Facility, a number of top WHO officials told the WHO’s Executive Board yesterday in the opening day of the  EB’s 148th session, which focused largely on the pandemic.

“Countries with bilateral deals are urged to be transparent with COVAX so we know what vaccines are going where and we can be sure the unserved are getting served rather than some countries getting double served,” reported Dr Bruce Aylward, special adviser to WHO’s Director-General, urging wealthier countries to ensure that COVAX gets access to the vaccines.

“The unmet demand now for vaccines, evolving viral mutations and escalating bilateral deals, all require us to adjust our strategy and needs for 2021,” Aylward stressed, flagging that while COVAX is ready to distribute vaccines it urgently needs at least US$8 billion to cover its current commitments.

A brand new report released this week by the Independent Panel for Pandemic Preparedness and Response, however, has made a number of scathing observations about the global handling of the pandemic by countries as well as WHO, including that the response has “deepened inequalities”, the global pandemic alert system “is not fit for purpose”, and that WHO has been “underpowered to do the job expected of it”.

The Independent Panel for Pandemic Preparedness and Response said that it was struck by how WHO was “underpowered to do the job expected of it”, and that “inequalities both within and between nations have worsened” as marginalised communities are locked out of healthcare.
WHO Powers To Validate Disease Outbreaks Gravely Limited – Incentives For Countries’ Cooperation ‘Too Weak’ – Says Independent Panel

“The Panel is struck that the power of WHO to validate reports of disease outbreaks for their pandemic potential and to be able to deploy support and containment resources to local areas is gravely limited,” the panel, which is chaired by ‘two former prime ministers, Liberia’s Ellen Johnson Sirleaf and New Zealand’s Helen Clark, reported.

“The incentives for cooperation are too weak to ensure the effective engagement of states with the international system in a disciplined, transparent, accountable and timely manner,” it added.

The report by the panel of 11 international experts also observed that “inequalities both within and between nations have worsened as vulnerable and marginalized people in a number of countries have been left without access to health care, not only to treat COVID-19 infection, but also because health systems have been overwhelmed, shutting many out of basic care and services”.

To address this, it stated that “fundamental and systemic change in preparedness” is necessary to introduce a new global framework “to support the prevention of and protection from pandemics”.

But this will need the global community to “come together with a shared sense of purpose and to leave no actor outside the circle of commitment to transformative change”, it acknowledged.

Trends in vaccine access by the Independent Panel for Pandemic Preparedness & Response (The Independent Panel) to the 148 Executive Board.

As of 17 January, 50 countries have started administering vaccines. 40 of these were high-income countries, and 95% of the estimated 40 million vaccine doses that have been dispensed so far were done so in only 10 countries.

Numerous member states including Australia, Bangladesh, China and New Zealand expressed their concern about the inequitable access to the vaccine.

Representing the African region, Botswana called for “global solidarity to prioritize investment in affordable and safe COVID-19 vaccines and equitable allocation, based on the principle of fairness”.

Lemogang Kwape, Botswana Minister of International Affairs and Cooperation, described the “great inequality in COVID-19 vaccine availability” as a public health concern. It said that Africa’s response to the pandemic had already been affected shortages in personal protective equipment, ventilators and other essential medical items.

Brazil, currently facing rising COVID-19 infections and deaths as part of its second wave, called for action to ensure equitable access of COVID-19 products and technologies.

“At this critical juncture, this Executive Board should make a strong call for members, WHO, other international entities, and pharmaceutical companies to deliver in full and as a matter of urgency on their pledges and commitments to the fair and equitable distribution of COVID vaccines everywhere,” said Ambassador Maria Nazareth Farani Azevêdo, Permanent Representative of Brazil to the UN Office in Geneva.

Dr Mike Ryan, Executive Director of WHO’s Health Emergencies Programme, warned that “case and cluster investigations, contact tracing and support the quarantine of context remain underpowered in almost every country” and “we haven’t expanded the use of rapid diagnostic tests as much as we would like”.

China Appeals for Origin Research Not to Be Politicized

Meanwhile, China appealed for research into the origin of the virus not to be politicized, stressing that the country had “always been open, transparent and responsible”.

After months of delay, A WHO-led investigative team arrived on 14 January in Wuhan to begin what is supposed to be an independent query into the origins of the virus, which first emerged among clusters of people working around a wildlife market in Wuhan.

Leading up to the team’s arrival, however, China has launched an extensive media campaign to try to shift the narrative about the origins of the virus elsewhere – suggesting most recently that it could have come from Southeast Asia. This is despite pre-pandemic research indicating that the SARS-CoV-2 family of viruses pre-pandemic circulates in bats in the Hunan region of south-central China – an area to which Beijing has recently barred access.

The WHO team investigating the origins of the COVID-19 pandemic arrived in Wuhan on Thursday. The US representative to the board said the team’s investigation would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”.

In light of China’s clear interest in shaping the virus origins narrative, leading European, American and western Pacific governments have expressed concern about whether the investigative team could really do its work. Last week, WHO’s Dr Ryan clarified that the investigation is not a matter of assigning blame, but “is about finding the scientific answers”.

Even so, Garrett Grigsby, Director of the Office of Global Affairs in the Department of Health and Human Services, said today the WHO expert team currently in China to investigate the origin of the virus would only be successful if it had access to a wide range of information “currently in the possession of Chinese authorities”. This includes animal tests from in and around Wuhan, environmental samples from the markets, comparative analysis of animal and human genetic data and samples.

This message was echoed by the representatives from Japan, Canada, Australia, and Austria, on behalf of the EU.

“We wish to reiterate the importance of the international expert team to be able to access all the necessary studies and information to achieve a scientific, objective and transparent investigation,” said the EB representative for Japan.

“We welcome that the international expert team was finally allowed to travel to China to start their investigation in cooperation with Chinese counterparts. We hold great importance to this investigation, which requires transparency, access to locations and data, and full cooperation. We request to be regularly briefed on the progress,” said Ambassador Elisabeth Tichy-Fisslberger, Permanent Representative of Austria to the UN Office in Geneva.

Image Credits: Independent Panel on Pandemic Preparedness, Johnson & Johnson, CGTN.

WHO has said there is no need yet for countries to install a “vaccine passport” system for travellers. Meanwhile, a number of countries like the UK have blocked travel from Brazil following the identification of a new variant in the country.

Many areas of Brazil, particularly Manaus, are experiencing worsening COVID-19 outbreaks and extremely high levels of infections, amidst news of a new variant that is spreading in the country.

Brazil joins countries around the world – including those in Europe, the Americas, and some parts of Africa – that are seeing spikes in cases and the spread of numerous SARS-CoV2 variants – as the world surpassed two million deaths from COVID-19, reported World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus at a press conference on Friday.

“This is because we’re collectively not succeeding at breaking the chains of transmission at the community level or within households. We need to close the gap between intent and implementation at the country and individual level,” Dr Tedros said.

Dr Tedros Adhanom Ghebreyesus, WHO Director General, at the press briefing on Friday.

At the press conference, the WHO officials attempted to assuage concerns over the variants, instead highlighting the greater role played by increased social mixing, a breakdown in compliance with public health measures, and health systems already been weakened by previous infection waves.

“A small proportion of [the rise in infections globally] may be due to the emergence of variants that are fitter, but the large proportion of that transmission has occurred because we are reducing our social physical distancing,” said Michael Ryan, Executive Director of WHO’s Health Emergencies Programme. “The virus is exploiting our lack of tactical commitment, our fatigue, the breaking down of our behaviour.

“It’s too easy to just lay the blame on the variant and say it’s the virus that did it. Unfortunately it’s also what we did. And we have to be able to accept our share [of responsibility] as individually and as communities,” said Ryan.

The variant identified in Brazil, with similarities to the highly infectious variants detected in Britain and South Africa, has led to the UK’s decision to ban the travel of individuals from several Latin American countries and Portugal, with other countries potentially following suit.

Areas in Brazil with high caseloads are suspected to have “the worrisome B.1.1.28/P1 lineage. It has [several] mutations in the all-important spike; and moreover mutations in the spike’s critical binding domains,” said Eric Feigl-Ding, Senior Fellow at the Federation of American Scientists, on Twitter. “And most of all the worrisome E484K mutation that can evade antibodies.”

Although several experts have raised the alarm about this particular variant due to its inclusion of the key mutations of interest – E484K and N501Y – Ryan claimed that attributing the blame for increased transmission fully on the variant is unreasonable.

Mike Ryan, Executive Director of WHO Health Emergencies Programme.

The WHO has recorded the deterioration of conditions in Brazil, especially in Manaus, the capital of the state of Amazonas, where hospitals are running out of PPE, beds, and oxygen. 

Over 4,000 new COVID-19 cases and 50 confirmed deaths have been reported per day in Manaus. The ICU has been operating at 100% capacity for the past two weeks, with 2,000 people hospitalized and 400 people with COVID-19 waiting to be hospitalized. 

“This is a health system under extreme pressure,” said Ryan. 

“If this continues, we’re going to see a wave that was greater than what was a catastrophic wave in April and May in Amazonas and particularly in Manaus, which is a tragedy in itself,” he added. 

“This is an unprecedented calamity,” said Jesem Orellana, a local epidemiologist, in an interview with the Guardian. “In the coming hours, Manaus is going to be the protagonist of one of the saddest chapters of the COVID-19 epidemic in the world.”

The situation in Brazil is also due in part to widespread breakdowns in the health system. Mariângela Simão, WHO’s Assistant Director General of Access to Medicines and Health Products.  She called on countries to learn from Brazil.

“Don’t let a false sense of security bring your guard down. If you have built up infrastructure for ICU beds and oxygen distribution points…don’t shut it down because it’s not over yet. I think we need to learn from what’s happening – the terrible situation that Manaus is facing right now,” she said. 

WHO Setting Up Monitoring Framework To Evaluate SARS-CoV2 Variants of Concern

Meanwhile, WHO is setting up a monitoring framework to evaluate the mutations of interest and the variants of concern to better understand what the mutations and variants mean and how they impact the behaviour of the virus.

“We are in a race between the virus, which is going to continue trying to mutate in order to spread more easily, and humanity, which is trying to stop this spreading,” said Didier Houssin, chair of the WHO International Health Regulations Emergency Committee. 

The virus will continue to mutate and variants will continue to be reported, warned Maria Van Kerkhove, WHO COVID-19 technical lead.

“There is pressure on this virus to change [and] the more it circulates, the more opportunities it has to change,” she said. 

This message has been highlighted by other experts. “The fact that we’ve observed 3 variants of concern emerge since September suggests that there are likely more to come,” warned Trevor Bedford, Associate Professor in Fred Hutch’s vaccine and infectious disease division. 

In addition, the simultaneous and independent evolution of the virus resulting in several common mutations is potentially a dangerous sign, as “converging evolution…[typically] means nature discovered repeatedly it works,” said Feigl-Ding. 

As the virus evolves and becomes better adapted to infecting humans, individuals, communities, and countries need to become more efficient at fighting the virus, stressed members of the press conference.

“We still have tools that can break the chains of transmission. The interventions that have been outlined by WHO…work at breaking chains of transmission. Variants and the detection…and the emergence of variants makes it harder, but we still have some control over this virus,” said Van Kerkhove.

Maria Van Kerkhove, WHO COVID-19 Technical Lead, at the press briefing on Friday.

A study published by the US Centers for Disease Control and Prevention (CDC) on Friday – projecting that a SARS-CoV2 variant will become the dominant source of infection in the United States by March – echoed Van Kerkhove’s message.

“Collectively, enhanced genomic surveillance combined with continued compliance with effective public health measures, including vaccination, physical distancing, use of masks, hand hygiene, and isolation and quarantine, will be essential to limiting the spread of SARS-CoV-2” and lessening the potential impact of the B.1.1.7 variant, said the authors of the study.

Travelers Should Not Have To Provide a ‘Vaccine Passport’ At This Stage – WHO Emergency Committee Recommends

In terms of travel policies, international travellers should not be required to provide proof of COVID-19 vaccinations for international travel at this stage because there are still “critical unknowns” about whether the vaccine can reduce transmission – and because vaccines are not widely available, WHO’s Emergency Committee recommended this week.

However, this does not mean that requiring proof of vaccination from travellers “won’t be a good idea in the future,” said Ryan.

“But at the moment, we are lacking critical evidence regarding whether or not persons who are vaccinated could continue to be infected, or continue to transmit disease, and because nobody in the world beyond health workers and very vulnerable people have access to the vaccine,” said Ryan.

“The scientific evidence is not complete and there isn’t enough vaccine and therefore, we shouldn’t create an unnecessary restriction to travel until such time as we have the evidence and the vaccine is available.” .

At the time, more coherent guidance about how people can safely travel “by air, by road [and] by sea” is needed, acknowledged Emergency Committee chairperson Didier Houssin, in reporting about the Committee’s meeting on Thursday.

Didier Houssin, Chair of the WHO Emergency Committee.

“One of the recommendations of the committee is that WHO takes a strong lead in order to produce a very clear guidance and scientifically-based guidance about how best to facilitate and permit the circulation of people in a safe manner,” said Houssin.

Australian airline Qantas has announced that all international passengers will need to provide proof that they have had a COVID-19 vaccine in order to board its planes.

‘Have Hope’ That Vaccines are On the Way

Meanwhile, Soumya Swaminathan, WHO’s Chief Scientist, appealed to those living in countries that have not yet gained access to vaccines to “have hope” that supplies will soon become available through the WHO-supported COVAX vaccine platform, which over 180 countries have joined.

“We do have a guarantee of at least 2 billion doses at the moment [through COVAX], but perhaps a lot more than that by the end of 2021,” she added.

Soumya Swaminathan, WHO Chief Scientist.

The first vaccine doses to be acquired through the COVAX Facility – co-led by WHO, the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance – will be distributed between 92 of the countries that have signed up at very low or no cost.

“We anticipate that the first tranches of vaccines will start going out in the first quarter of this year, even though they may be in small volume. We also need to recognise that vaccines do need to go through the stages of testing and need to complete trials and have data on efficacy and safety, and they need to be manufactured in a quality assurance facility,” said Swaminathan.

COVAX’s procurement plans include pre-orders of just one vaccine, by AstraZeneca and Oxford University, which has received regulatory approval in the USA and Europe.  But others to which it has committed (Johnson & Johnson and GSK/Sanofi) have not yet submitted the results of Phase 3 trials to either WHO or a national regulatory agency for approval.

“In an ideal world, we would not have the unequal access to the COVID-19 vaccine that we are currently seeing,” Simão conceded.

WHO Director-General Dr Tedros Adhanom Ghebreyesus made an appeal for solidarity from wealthier countries, reminding them that when “AIDS drugs were first rolled out, they were only available in right in rich countries until a historic movement of health advocates and civil society led to the rollout of low-cost, generic versions of antiretroviral drugs.

“We don’t want this to be repeated.”

Image Credits: Wikimedia Commons: Nemo, WHO.

A recent poll indicated that less than a third of Filipinos are willing to be vaccinated, sparking concerns that a less efficacious vaccine would do little to change minds.

The Philippines is expecting to receive its first batch of China’s Sinovac Biotech COVID-19 vaccine next month — but one leading Filipino senator is questioning the government’s preference for the candidate as new data indicates a lower efficacy rate than western competitors.

Earlier this week, developer Sinovac Biotech reported an efficacy rate of only 50.38% in its final stage trials, undertaken in Brazil. The company has claimed, however, that this low rate is due the fact the vaccine was trialled on medical workers, who have a naturally higher risk of catching coronavirus.

Western vaccines like Pfizer/BioNtech’s or Moderna’s were trialled mostly among members of the public, and earned efficacy rates of 95% and 94.5% respectively.

The main concern expressed by the Filipino senators appears to be founded in the public’s limited confidence in vaccines; a poll last week by Pulse Asia indicated that less than a third of Filipinos are willing to be vaccinated.

“The insistence or preference for Sinovac cannot be denied and will not augur well for building up confidence of people in our ability to address the pandemic,” said Senate Minority Leader Franklin Drilon, addressing the country’s COVID task force on Friday.  Drilon is the leader of the opposition parties in the Senate.

The country has one of the highest  number of coronavirus cases in Asia, but its vaccination programme is lacking on the continent.

As of 13 January, China had vaccinated around 10 million people. The Philippines had not approved a single vaccine, but the government hopes to vaccinate 70 million people this year.

Drilon questioned: “There are other vaccines with a much higher efficacy at lower, if not more competitive, cost. Why are we insisting that we buy Sinovac?”

The Sinovac vaccine has not yet been granted emergency use authorization, with the Philippine Food and Drug Administration (FDA) only receiving the request on Wednesday. The FDA approved Pfizer the following day: the country’s first vaccine.

President Rodrigo Duterte had previously said that he would prefer to have his country’s COVID vaccines sourced from China or Russia, which some observers have interpreted as as part of the president’s pursuit of closer relations with Beijing.

Image Credits: Bret Bostock/Flickr.

The Berlaymont Building in Brussels, which houses the European Commission

Deliveries of the Pfizer/BioNTech vaccine to all European Union (EU) states will be reduced for an undisclosed period starting from next week, Norway’s National Institute of Public Health has said.

The sudden change to delivery schedules, Pfizer announced on Friday, is due to a reorganization of the company’s production capacity. It did not say how long this would take.

The  pharmaceutical company also said that after the reorganization it will be able to increase production from 1.3 billion doses a year to 2 billion.

Total number of single vaccination doses administered, since 19 December 2020 as of 15 January 2021.

So far, the EU has secured a total of 300 million doses of the Pfizer candidate, to be distributed across its 27 member states by the end of 2021. On 8 January, the European Commission proposed purchasing an additional 200 million doses, with the option to acquire an additional 100 million beyond that. The vaccine was approved for use in the EU in late December.

It is not clear by how much deliveries to the EU will be reduced, or how this will be reflected in doses received by individual member states.

Norway’s National Institute of Public Health confirmed, however, that the 43,875 doses it expected to receive in the third week of its rollout has been lowered to 36,075: a decrease of 17%.

The public health body confirmed that it will cover the reduction with its emergency stock that it had “kept in readiness for such cases”.

Biden Advisor Predicts Rocky Start To Vaccine Plan

Incoming US President Joe Biden had promised to administer an ambitious 100 million vaccines in the first 100 days of his presidency.

But Michael Osterholm, of Biden’s COVID-19 task force, has clarified that the earlier days of that time frame will see less doses injected than the later days.

“The first days of that 100 days may be substantially slower than it will be towards the end,” he said, adding that “it’s not going to occur quickly.

“You’re going to see the ramp-up occurring only when the resources really begin to flow.”

Currently, the Trump administration has vaccinated just more than 10 million citizens in around 30 days. Biden’s pledge to administer 100 million in 100 days — which likely will not be broken down as 1 million per day, based on Osterholm’s comment — would represent a massive step up in the country’s immunization campaign.

The anticipated slow start to Biden’s vaccine plan is largely down to availability of resources, it seems. As Nicole Lurie, a pandemic advisor to Biden, said prior to the election, ramping up vaccinations after the Trump presidency would not be achieved with the “flip [of] a switch”.

The goal, Osterholm said, is “aspirational” but, importantly, “doable”.

Image Credits: almathias, Our World in Data.

COVID-19 immunity from previous infection does not guarantee people still won't carry and transmit the virus
COVID-19 immunity from previous infection does not guarantee people still won’t carry and transmit the virus

Past COVID-19 infection may provide immunity for several months, but still leaves risk of transmission to others, a Public Health England (PHE) study has found.  

“This means even if you believe you already had the disease and are protected, you can be reassured it is highly unlikely you will develop severe infections but there is still a risk that you could acquire an infection and transmit to others,”  said Professor Susan Hopkins, Senior Medical Advisor at PHE and study lead at SARS-CoV-2 Immunity and Infection EvaluatioN (SIREN). 

Since June, the PHE’s SIREN study has performed regular antibody and PCR testing on 20,787 healthcare workers, including frontline clinical staff and those in non-clinical roles. 6,614 of these participants tested positive for COVID-19 antibodies upon recruitment. 

Between 18 June to 24 November, there were 44 potential reinfections identified by the study, with 2 designated ‘probable’ and 42 ‘possible’ based on available evidence. If all 44 cases were confirmed, this would represent an 83% rate of protection from reinfection, though if only the 2 ‘probable’ reinfections were confirmed, the rate would be 99%. Further research is ongoing to clarify this range. 

The study found that antibody protection after infection lasts for at least 5 months, on average. Scientists are studying whether this protection may last for longer, but this means that many people who contracted the disease in the first wave of the pandemic may now be vulnerable to reinfection. 

Although those with antibodies have some temporary protection against COVID-19, some of these individuals carry high levels of the virus and could continue to transmit the virus to others. 

More Research Needed to Understand Effectiveness of Vaccines in Reducing Transmission

In December, the UK identified a vriation of SARS-CoV-2 now known as VOC 202012/01 (Variant of Concern), but formerly referred to as VUI 202012/01 (Variant Under Investigation).

Further work is underway to understand whether and to what extent antibodies also provide protection from this variant. The study will continue to follow participants for 12 months to explore how long any immunity may last and to what extent people with immunity are able to carry and transmit the virus. 

Peer reviewed Phase 3 clinical trial results for Moderna vaccine, published 30 December 2020 in the New England Journal of Medicine, have suggested that vaccination also reduced asymptomatic transmission by about two-thirds, in the case of Moderna’s mRNA-1273 vaccine, though the numbers examined were small. The duration of immunity and the amount of the virus reduced in those vaccinated still needs to be researched. 

SIREN data from the first report does not provide evidence towards antibody or immune responses from COVID-19 vaccines. Vaccine effectiveness will also be studied later this year by the PHE SIREN study. 

With cases at their highest level to date in the United Kingdom, the PHE advocates that everyone does their part to avoid the risk of transmitting to other people. 

Said Hopkins: “This study has given us the clearest picture to date of the nature of antibody protection against COVID-19 but it is critical people do not misunderstand these early findings.” 

“Now more than ever it is vital we all stay at home to protect our health service and save lives.”

Image Credits: Yuri Samilov/Flickr.