People wear face masks to prevent the spread of coronavirus as they commute inside a metro station amid the COVID-19 pandemic.

New York City – Echoing a message issued by WHO’s Geneva office today, WHO officials in the Agency’s Americas Regional Office stressed that stronger public health measures are desperately needed, alongside vaccines, to reduce transmission and the risk of even more variants emerging. 

“The vaccine is not a silver bullet. The vaccine will not stop transmission next week,” said  Jarbas Barbosa, Assistant Director of the Pan American Health Organization (PAHO), in a briefing in Washington, DC.

Dr Carissa F Etienne, PAHO Director

“Vaccines are not going to solve our problems immediately,” said PAHO regional director Carissa Etienne. She pleaded with policymakers and the public to continue observing social distancing, masking and hygiene measures to reduce virus transmission..

“We have to do everything that we can to reduce the circulation of the virus. And to do that we have to use the proven public health measures,” she said, adding, “Please do not let your guard down as we await vaccines, and even when we get the vaccines. We will simultaneously reinforce all public health measures [in doing this].” The WHO appeal coincided with an announcement by the United States Centers for Disease Control of new recommendations for “tight fit” or “double masks” to improve their virus filtration. 

In Geneva, WHO’s Kate O”Brien issued a similar message – during an announcement of a WHO expert recommendation to approve use of the AstraZeneca COVID vaccine. 

“The issue of whether or not a person who has been vaccinated can take their foot off the pedal and stop using a mask, stop all the interventions we’ve been communication for the whole pandemic – those interventions need to continue for individuals who have been vaccinated and for communities of people as the vaccine is rolling out,” she said. 

Reaching Migrants and Other Marginalized Groups With Vaccines Also Critical  
Dr Ciro Ugarte, Director of Health Emergencies, PAHO

The WHO has set the initial goal of providing vaccines for at least 20% of the population for countries that are part of the COVAX agreement. In the PAHO region, 37 countries are participating in COVAX.  But that coverage will fall far short of what is ultimately needed to really make a dent in transmission, officials said. 

Latin America and the Caribbean will need to immunize approximately 500 million people to be able to control the pandemic, said Etienne, PAHO Regional Director. The PAHO region itself has more than 934 million people. 

Dr Ciro Ugarte, Director of Health Emergencies at PAHO, also pointed to issues of inequity that have plagued the COVID-19 pandemic and the subsequent vaccine rollout, especially among migrant groups in the Americas region. 

Migrants need to become “regularized” in regards to their legal status in countries, which would allow them to access health services and the COVID vaccine, Ugarte said. 

Fortunately, many of the migrants working in the health sector are likely to be included in the first phase of the vaccine. However, others work in informal sectors, preventing them from receiving the vaccine or even being incorporated for future vaccine rollout as many of them remain (and would like to remain) unidentified. 

These issues of vaccine exclusivity that may prevent migrants from receiving the vaccines could even act as a barrier to controlling the pandemic in many of these countries. 

Getting Vaccines Approved Through National Regulatory Mechanisms & Stepping Up Variant Surveillance Also Critical
WHO PAHO
Dr Jarbas Barbosa, Assistant Director, PAHO

 PAHO officials emphasised the need for national health authorities to actively monitor the pandemic trends in their countries, including the emergence and spread of variants. The three variants of greatest concern, which were first identified in the United Kingdom, South Africa and Brazil, have already been detected in twenty countries in the Americas. 

The WHO has already called attention to the potential reduction in vaccine efficacy against variants of the SARS-CoV-2 virus, particularly against the South African strain. Real-time data collection as vaccine campaigns get underway will allow researchers to understand the real effect of these new variants on vaccine efficacy. 

Countries in the Americas are already uploading and publishing locally-identified genome variants in GISAID, a global platform for genomic data of influenza viruses and SARS-CoV-2. This information will contribute towards improved genomic surveillance. 

PAHO is providing countries with equipment for genome sequencing and technical guidance in the identification of variants.  But officials also called upon national authorities to also step in with more funding for their own laboratory networks. 

Ensuring that new vaccines receive rapid regulatory approval at national level is another key PAHO concern. PAHO has already asked countries to send their plans for regulatory review to the Agency, in order to identify needs and gaps. Thirty-one countries in the Americas region, which includes North America and Latin America and the Caribbean, have already shared their information, while twenty countries have yet to send in their plans for review. 

“It is not sufficient to have a vaccine, all the countries need to have all the regulatory mechanisms [in place] as well as licenses for importation,” said Barbosa. 

Image Credits: Flickr: IMF Photo/Joaquin Sarmiento, PAHO.

The United States Centers for Disease Control has issued new guidance for “tight fit” or “double masks” that it says can filter out over 90% of SARS-CoV2 viruses – much higher averages than if either mask were worn loosely or on its own.

The guidance, issued as the US along with other countries face an onslaught of more infectious virus variants, including a variant B117, first identified in the United Kingdom, rapidly expanding across the world, and believed to be 40-70% more infectious than the variants that were prevalent in 2020.

The CDC recommendation was based upon a series of studies that examined virus penetration through various types of masks, which are widely available to the general public.

The recommendations are based on a new series of experiments that the CDC conducted to assess ways of improving the fit and protective capacity of simple surgical masks (also called medical procedure) masks on their own, or in combination with cloth masks.  According to the new recommendation, the two modifications that “substantially improved’ exposure were:

  • Fitting a cloth mask over a medical procedure mask;
  • Knotting the ear loops of a medical procedure mask and then tucking in and flattening the extra material close to the face.

The two innovations help improve the fit of the mask around the face – preventing air leakage that also allows virus particles in and out, CDC said.

The “double masking” approach involves the use of a three-ply medical procedure mask (surgical masks) covered by a three-ply cloth cotton mask.

While the unknotted medical procedure mask alone blocked 42.0% of the particles from a simulated cough and use of the cloth mask alone blocked 44.3%, the combination of the cloth mask covering the medical procedure mask (double mask) blocked 92.5% of the cough particles, the CDC said in its brief.

Knotting the surgical mask, on the other hand, to give it a “tighter fit” would block about 63% of potentially pathogenic particles emitted someone wearing such a mask, and about 65% of particles to which someone else wearing the tighter-fitting mask might otherwise be exposed.

Nose Wires and Mask Fitters – Other Improvements
Mask fitter or brace
Mask with nose wire

Improvements could also involve using a mask that has a “nose wire”, said the CDC guidance on masking “Dos” and “Don’ts” that was issued just after the release of the study,  Nose wires are a feature of N95 or KN95 masks.  A mask “fitter or brace”  that keeps air from leaking in and out around the face, is another effective modification.

CDC Director Issues Recommednation At White House Briefing

CDC’s director, Rochelle P. Walensky, announced the findings at a White House coronavirus task force briefing Wednesday. She appealed to Americans to wear “a well-fitting mask” that has two or more layers – a measure that is especially critical in light of the fast-expanding array of virus variants in the United States and elsewhere.

Despite the boost provided by vaccine campaigns, Walensky warned the public against relaxing their guard on other “non-pharmaceutical” measures that prevent disease spread.

“With cases hospitalizations and deaths still very high, now is not the time to roll back mask requirements,” she said, adding, “The bottom line is this: masks work and they work when they have a good fit and are worn correctly.”

The “double mask” approach, however, was sported by Chief Medical Advisor Anthony Fauci at the January inauguration of new US President Joe Biden.

Upon his inauguration, President Joe Biden also challenged Americans to wear masks for the first 100 days of his presidency.

The study has limitations: The researchers only tested one brand of surgical mask and one kind of cloth mask in simulations using dummies. But it follows logically that tighter masks, or masks with added layers, would also provide added protection.

However, it is clear that US public health officials feel a sense of urgency with the more contagious B117 variant, first found in Britain, doubling roughly every 10 days in the United States. According to the CDC, it may become the dominant variant in the nation by March.

In Europe, several countries have also issued recommendations to the public to wear N95 masks (also known in Europe as FFP), in order to ensure better protection. WHO, however, has so far resisted such global advice in light of the global shortages of PPE for health workers.  It remains to be seen if in the wake of the CDC recommendations, however, the global health agency might issue updated advice on tighter-fitting or double masking measures.   For the moment, WHO was sticking to general messages:

“Please remember – fit, filtration and breathability are all critical for optimal performance.  Wear them well, wear them appropriately, wear them safely,” said WHO’s Maria Van Kerhkove in a Tweet Wednesday responding to the CDC recommendations.

 

 

Image Credits: US Centers for Disease Control , US CDC .

WHO Chief Scientist Soumya Swaminathan

A World Health Organization expert group has recommended the use of the AstraZeneca two-dose COVID-19 vaccine for use in countries worldwide – and among groups including people over the age of 65. 

The sweeping recommendation by WHO “Strategic Advisory Group of Experts” (SAGE) marks what WHO Chief Scientist Soumya Swaminathan described as an “important milestone” in the plan for the global “COVAX” facility to rollout vaccines more equitably around the world. It is expected to pave the way for a formal WHO “Emergency Use Listing” of the vaccine, followed by the immediate launch of an ambitious plan to distribute over 2 billion vaccine doses in 2021.

“This is one of the the main vaccines in the COVAX facility – so this is an important milestone,” said Swaminathan, speaking at a WHO press briefing on Wednesday.

The COVAX facility recently announced a timetable for the initial rollout of some 336 million AstraZeneca vaccines along with 1.2 million doses of the mRNA Pfizer vaccine, beginning this month.  Since the overwhelming volume of those first-phase vaccines are AstraZeneca products – actual launch of the initiative was dependent on the WHO scientific greenlight. 

WHO Experts Also Recommend For Use in Older People & In Countries With South African Variant 

The recommendation also was good news for AstraZeneca, which co-produced its vaccine with Oxford University – after a number of significant setbacks. 

On Sunday, South Africa had said it was pausing a public rollout of the AstraZeneca vaccine – procured directly from the Serum Institute of India – because the vaccine had failed to show efficacy in protecting against mild and moderate disease from the prevailing variant, B.1351, in a small study of 1750 volunteers. Health officials said that they may, however, continue rolling out the vaccine in a highly controlled way to about 100,000 people, including health workers – to better determine its efficacy in preventing serious disease.  

WHO Recommendations Break With Some European Countries On OIder People 

Joachim Hombach, SAGE Executive Secretary

In addition, a number of European countries, including Germany, have recommended against the use of the vaccine among people over the age of 65, saying that the Phase 3 trials conducted so far lacked sufficient evidence.  Switzerland has refused to approve the vaccine altogether, saying more evidence still is needed about efficacy. 

In speaking at a press briefing on Wednesday, SAGE Chairman Alejandro Cravioto and Joachim Hombach, executive secretary, said that the Phase 3 trial results showed an antibody response in older people that was almost equal to that of younger groups. 

And thus the experts have  “high confidence” in the findings of efficacy among the +65 age group – even though the numbers involved in AstraZeneca’s Phase 3 studies had been small. 

“The immune response in people over age 65 was almost the same as in younger people and this makes us very confident that this is a vaccine that is actually protective, and well protective, in people above 65 years of age” Hombach told the press briefing, echoing a similar statement by AstraZeneca’s Pascal Soriot last week.  

Hombach and Craviato also stressed that a longer gap between first and second vaccine doses, of 8-12 weeks, should improve its efficacy in older people as well as younger groups. as compared to the results from the Phase 3 trials.

Efficacy among older people in AstraZeneca’s Phase 3 trials was 52-56% – as compared to 66.7% among people aged 18-55.  But more recent findings from Great Britain have found that overall vaccine efficacy may be increased to 82% if the time interval between doses is greater.

“With a longer interval between the two doses, you get a better efficacy,” said Katherine O’Brien, WHO head of vaccines and biologicals.” 

Katherine O’Brien, WHO

While some European countries that have limited the vaccine’s use among older people can choose among multiple vaccines – many other countries don’t have that luxury, she added. 

And insofar as people over 65 are at significant risk of severe illness and death, there is “no reason to constrain use of the AstraZeneca product,” she said.

Guidelines Recommend Longer Interval Between Vaccine Doses  – Don’t Rule Out Use in Pregnancy

Notably, the interim WHO recommendations call for an 8-12 week interval between the vaccine’s first and second dose. That is beyond the interval initially recommended by AstraZeneca – but in line with a new policy adopted by the United Kingdom, after new evidence has also suggested that the longer wait may in fact make the vaccine more effective. 

While not explicitly recommending use by pregnant women, the WHO/SAGE recommendations also don’t rule it out in the case of women who may be otherwise at risk. 

Said Cravioto, SAGE had “insufficient information” to make a general recommendation for use in pregnant women, but the group “sees no reason why pregnant women who are otherwise at risk should not be vaccinated” – upon a recommendation of their practitioner.

Southern Africa Hasn’t Halted All AstraZeneca Vaccinations  

As for the vaccine’s efficacy against variants, in the case of the variant that became dominant in the UK, the vaccine has “only slightly reduced efficacy”, Homback said. 

As for the B1351 virus variant, first identified in South Africa, and now comprising some 80-90% of cases there, the experts said that there was still “indirect evidence” that it could reduce disease.  That is despite the recent results of a small South African trial that showed it was not efficacious in preventing mild to moderate cases. .  

Said Cravioto, there is “no reason not to recommend the use of the vaccine even in countries that have the variant, to reduce severe disease.”

Added Swaminathan, even South Africa is not halting use of the AstraZeneca vaccine altogether –  but it will roll out in a more controlled manner to further study its efficacy: “The decision in South Africa is to roll it out, but in a way that you’re collecting evidence & data so that we can inform the future rollout.”

However, she and other WHO officials at the briefing conceded that South Africa might still potentially negotiate with COVAX for a trade back of some of its promised AstraZeneca doses, against those of other vaccines, which have demonstrated more definite efficacy against the locally prevalent virus variant – notably the one-dose Johnson&Johnson shot.

Global Health Leaders Welcome WHO’s Approval – Will Jumpstart COVAX Rollout 

Despite the still evolving picture about  AstraZeneca’s efficacy in fighting the B1351 variant, the overall news of WHO’s approval was lauded by other global health leaders who have been anxiously awaiting WHO approval to ensure that the COVAX vaccine initiative can hit the ground running immediately. 

“COVAX has significant volumes of AZ vaccine supply available starting this month,… it will be a vital tool in our arsenal against this pandemic,” said Seth Berkley, CEO of GAVI, The Vaccine Alliance in a tweet shortly after the announcement was made. 

Oxford University’s Professor Sarah Gilbert, one of the vaccine’s designers, was quoted as saying: “It is excellent news that the WHO has recommended use of the SARS CoV-2 vaccine first produced in Oxford.

“This decision paves the way to more widespread use of the vaccine to protect people against Covid-19 and gain control of the pandemic.”

Added Andrew Pollard, director of the Oxford Vaccine Group, said: “The new guidance from WHO is an important milestone in extending access to the Oxford-AZ vaccine to all corners of the world.  He said that the endorsement, “after rigorous scrutiny by the WHO Strategic Advisory Group of Experts” shows that the vaccine can be used to help protect populations from the coronavirus pandemic.”

Wellcome Trust Renews Call For Rich Nations To Fully Fund COVAX –

Said Jeremy Farrar, Director of The Wellcome Trust: “It is excellent news that the WHO’s Strategic Advisory Group of Experts on Immunization has recommended the AstraZeneca/Oxford vaccine for use in all adults including those over 65 years old.

“This is an important step forward…. which will help ensure vaccines are used in all countries, including low- and middle-income countries, and will be hugely beneficial in our fight against the virus.

Despite the questions around the vaccine’s efficacy against the B1351 variant, which “South Africa is carefully considering” he stressed that overall, “this vaccine will still make an enormous difference to almost all countries and must be rapidly rolled out globally to save lives and get this pandemic under control.”

However, echoing the sense of urgency conveyed by WHO officials, he also stressed that rich countries still need to step up to the bat to fill a US $27 billion funding gap facing the COVAX facility and other elements of the broader Access to COVID Tools (ACT Accelerator) initiative that aims to get vaccines, tests and treatments to people worldwide. The WHO co-sponosred ACT Accelerator initiative includes the Bill & Melinda Gates Foundation, GAVI, Unitaid, The Global Fund and The Wellcome Trust – as well as a Facilitation Council of WHO member states, which the United States formally joined yesterday.

“These new variants are a powerful reminder that we’re now in a new and very unpredictable phase of this pandemic. It is vital healthcare workers and vulnerable populations in all countries are vaccinated as fast as possible,” said Farrar.

“That means it is vital wealthy nations act now to begin sharing doses secured through bilateral deals and follow through on commitments to fair access. This should be done through COVAX and in parallel to national campaigns. Vaccinating a lot of people in a few countries, leaving the virus unchecked in large parts of the world will lead to more variants emerging and inevitably spreading between countries.

“At the same time we need to be rapidly developing second and third generation vaccines, developing a wider range of treatments and increasing testing and sequencing capacity and urgently increase manufacturing capacity. These are all key to long-term control and management of this disease.

“If we’re to get ahead of this pandemic and gain control, we must remain adaptive. That will not be achieved without significant step-up in international resourcing and co-operation. The US officially joining ACT-Accelerator today is a great and crucial step forward. But there is still, unbelievably, a staggering $27bn funding gap.”

 

Ngozi Okonjo-Iweala – poised for election next week as Director General of WTO.

In her first major public statement since the United States signaled that it would approve her candidacy for Director-General of the World Trade Organization (WTO), Ngozi Okonjo-Iweala highlighted the need for rich countries to step up their financial contributions to ensure equitable access to COVID-19 tools.

Okonjo-Iweala was the keynote speaker on Tuesday at the fourth meeting of the Access to COVID-19 Tools (ACT) Accelerator Facilitation Council, where a new burden sharing agreement to recruit more funds from donor countries to fill a $27 billion funding gap was announced. The Council needs the money to rollout key components of the ACT’s flagship project, COVAX, the global vaccine distribution facility, as well as parallel initiatives to ensure global access to COVID-19 tests and treatments.  

Okonjo-Iweala’s appointment as the first woman and first African DG of the WTO is likely to be confirmed next week; WTO members are now set to reconvene Monday – following the shift in the US position, which had been the sole outstanding obstacle to her election last December. 

As she takes over the helm of the WTO, Okonjo-Iweala will have to negotiate a thorny course in a heated COVID-related debate among trade delegates. Low- and middle-income countries, led by South Africa and India, are seeking WTO approval for an “IP waiver” on all COVID-related health products, for the duration of the pandemic – while rich countries that have opposed the move. 

In her comments before the council, Okonjo-Iweala, steered a middle course during the meeting, calling for greater equity in vaccine distribution and more donor funding to support the global COVAX facility and other ACT Accelerator initiatives co-sponsored by WHO and a range of other UN agencies and public-private partnerships. Okonjo-Iweala is currently the WHO Special Envoy for the ACT Accelerator, which was established in April 2020.

Echoing the message conveyed by Dr Tedros Adhanom Ghebreyesus, WHO Director General, in his opening remarks, Okonjo-Iweala emphasised the current inequity in the global vaccine rollout, with people in over 60% of high-income countries being vaccinated, while only a handful of low-income countries have received doses so far. 

The COVID-19 vaccination doses administered globally per 100 people, as of 8 February 2021.

“If we want to stop this pandemic from spreading and mutating, we need to change the way this map looks as fast as we can,” Okonjo-Iweala said, referring to the map of the administered COVID-19 vaccines per 100 people in the population.

We Cannot Delay The Rollout Of Tools

“We cannot delay the rollout of tools around the world. Equitable access to COVID-19 tools is not just a moral imperative, as Dr. Tedros said, it is a strategic and economic one as well. Global solidarity is the fastest, most effective way to defeat the pandemic,” declared Okonjo-Iweala. 

She praised the the ambitious ACT Accelerator initiative as the “fastest, most coordinated and successful global effort in history to develop these tools to fight the disease.”

However, the initiative is plagued by “persistent underinvestment in global solutions and increasing bilateral action,” which undermines the ability of the COVAX facility to procure vaccines for participating countries, including the world’s poorest countries, at an affordable price, she noted. 

“Governments everywhere are under immense pressure to secure doses for all of their citizens. Many cannot afford the bilateral deals, others are still seeking them, and some have secured more doses than their populations require. Solving these problems requires all of us to come together to find solutions,” Okonjo-Iweala said.

“Given the contraction in available official development assistance, many more countries will have to bite the bullet and find sustainable ways to finance and co-finance COVID-19 tools, including through multilateral development banks,” she added.

Countries participating in COVAX are prepared to begin receiving doses and COVAX is prepared to start distributing the vaccines, having already released an interim distribution forecast for the first and second quarter of 2021, however, adequate supplies of the vaccines may not be available to meet the needs of countries. 

“The ACT Accelerator’s COVAX vaccines facility is poised for the fast track distribution of two plus billion doses of internationally recognised safe, effective, and quality assured vaccines across 109 participating countries and economies. And countries are ready…However, there are challenges,” said Okonjo-Iweala. 

“Countries, manufacturers, regulators, civil society, and actors in the multilateral system all have a role to play to ensure that vaccines reach people in all countries, prevent infection and end this pandemic everywhere….This is why we’re here today,” Okonjo-Iweala added. 

Pharmaceutical Companies Dedicated to Ensuring Equitable Access to Vaccines

Meanwhile, the CEO of AstraZeneca, Pascal Soriot, also appearing at the meeting, said he believed the company’s vaccine can remain a critical anchor of the global COVAX effort to roll out vaccines in low- and middle-income countries – despite the poor initial showing the AstraZeneca vaccine has made in stopping mild and moderate disease from a SARS-CoV2 virus variant that first emerged in South Africa.

“Our commitment as a company to supply COVAX, together with our collaboration with the Serum Institute of India, who are developing the vaccine together with us, means that over 300 million doses of the vaccine could be made available to 145 countries in the first half of this year, subject to regulatory approval,” said Soriot. The AstraZeneca vaccine is one of the backbones of the global initiative, with the largest commitment of vaccine volumes to COVAX so far. 

Pascal Soriot, CEO of AstraZeneca, at the ACT Accelerator Facilitation Council meeting on Tuesday.

“Our supply to COVAX means that on average 3% of people in these countries will receive the vaccine. And I’m really proud to say that 61% of our projected supply for COVAX during this period of time is due to go to low and middle income countries,” said Soriot.

On Sunday, however, the vaccine’s image in Africa suffered a major blow as South Africa announced that it was putting the rollout of the Oxford/AstraZeneca vaccine on hold due to data showing low efficacy against the B.1.351 variant that has been spreading in the country.

Soriot stressed, however, that the vaccine still should be able to protect against severe disease. A recent study in Great Britain has also been encouraging, suggesting that the AstraZeneca vaccine may not only prevent disease in those who are immunised, but also reduce virus transmission to others by as much as two-thirds. 

“Right now it is essential that vaccines continue to be administered to as many people as possible,” as the benefits of vaccines far outweigh the risks of their potential lower efficacy against the new variants, said Soriot. 

“We will never fully stop COVID-19 until everyone everywhere has access to an effective vaccine. The need to bring COVID-19 vaccines to the world equitably has become even more pressing in recent weeks as we see more infectious strains of the virus emerge in multiple countries and spread rapidly across the world,” said Paul Stoffels, Chief Scientific Officer at Johnson & Johnson, who also appeared at the meeting.  

While pausing the rollout of AstraZeneca, South Africa is accelerating its plan to vaccinate people with the J&J vaccine, which showed reasonable efficacy against the B.1.351 variant in recently reported Phase 3 trial results.

“Since day one of our program we have been committed to bringing an affordable COVID-19 vaccine on not-for-profit basis for emergency pandemic use,” said Stoffels. 

Paul Stoffels, Chief Scientific Officer at Johnson & Johnson.

As part of the Johnson and Johnson commitment, the company has pledged to provide up to 500 million doses of its single-dose vaccine to low income countries through COVAX in an agreement signed with GAVI, The Vaccine Alliance, in December of last year. 

“Beating COVID-19 will require constant surveillance, continued innovation, including potential boosters development, and all the new vaccine strategies and close partnerships between government and vaccine makers. Only through innovative collaboration fueling new ideas, well planned implementation of equitable approaches, as well as constant vigilance and a sense of urgency will the world beat COVID-19,” said Stoffels. 

Council Discusses New “Burden Sharing” Arrangement To Prod Donors To Fund Budget Gap 

Meanwhile, the Council discussed the refined financing framework, which included a burden sharing mechanism, and the updated priorities and strategies for the ACT Accelerator for 2021. 

In light of the successes in the development of vaccines, diagnostics, and therapeutics, as well as the evolving knowledge about the necessary measures to combat COVID-19 globally – informed by the spread of virus variants and the increasing fragmentation of international collaboration – the ACT Accelerator launched its ‘refreshed’ strategy on Tuesday.

The four new strategic priorities for the ACT Accelerator in 2021.

For 2021, the four core priorities of the ACT Accelerator are: rapidly scaling up the doses available for vaccinations, particularly for the COVAX facility; bolstering R&D to address the virus variants; stimulating the uptake of tests and therapeutics in low- and middle-income countries; and ensuring a robust supply pipeline is established to deliver essential tools to low- and middle-income countries. 

In addition, new and existing financing sources were evaluated through the Council’s finance working group to develop a robust financing framework to ensure the promise of ACT Accelerator is realised. 

The funding commitments to the ACT Accelerator currently total US$6 billion, with the United Kingdom, Canada, Germany, and the Diagnostics Consortium for COVID-19 contributing the most. An additional US$4 billion is projected in funding.

The ACT Accelerator is facing a US$27.2 billion funding gap, of which US$19.2 billion is needed from high-income and upper middle-income countries to fully finance the initiative, according to John-Arne Røttingen, Ambassador for Global Health for the Norwegian Ministry of Foreign Affairs and a member of the Council’s finance working group.

“We are gravely concerned that the current ACT Accelerator’s funding gaps will impede global equitable access to these products and ultimately delay the end to the crisis everywhere,” said the Council co-chairs, Zweli Mkhize, South Africa’s Minister of Health, and Dag-Inge Ulstein, Norway’s Minister of International Development, in a statement released in December. 

The new financing goals and needs to close the funding gap for the ACT Accelerator, presented at the Council meeting on Tuesday.

To recruit funding to fill this gap, a burden sharing framework was developed to determine contribution based on GDP and the level of openness of the economy, with a greater proportion of income paid by richer countries. Countries are then categorised into different ranges of contributions.

A preliminary illustration of what this grouping of countries may look like was introduced at the meeting. While the burden sharing mechanism is not yet fully developed, officials hope it could lead to a rise in contributions.

The grouping of countries under the new burden sharing mechanism proposed by the financial working group of the ACT Acceleration Facilitation Council.

“This is a joint responsibility. We really need to have a framework for splitting the bill responsibly…not based on an old model of donations from a few, but on a new model of collective contribution from a much larger group of countries,” said Røttingen. “This is solidarity in action.”

“We really hope that now countries, hopefully, will increase the contributions in the weeks and months to come [and] they will actually link this to a framework of fair financial contributions from everyone,” he added. 

Member states were largely supportive of the financing framework launched on Tuesday.

“We are currently considering additional contributions and urge all partners, especially other G20 countries to step up their support for ACT A,” said Germany’s delegate. “In addition, we would welcome stronger involvement of the private sector…We have to work together to close this acute funding need.”

“From the UK, we welcome the new and prioritised strategy and the budget for 2021 and we must continue to optimise international and domestic resources,” said the UK’s representative. “For the UK’s G7 presidency, we are going to work with fellow G7 nations to drive an ambitious health agenda that exactly reflects these principles…on equitable and affordable access.” 

Similarly, Italy, which will hold the G20 presidency in 2021, “stands ready to mobilise the political support needed for the ACT Accelerator and the COVAX facility to deliver concretely on the commitments undertaken within the G20 almost a year ago,” said Italy’s delegate. 

Bruce Aylward, Senior Advisor to the WHO Director General and lead for the ACT Accelerator, thanked member states for their “strong endorsement for the vision…in the strategic plan and budget for 2021. It sounds like that plan is right, the priorities are right and the budget is necessary,” he said.

Bruce Aylward, Senior Advisor to the WHO Director General and lead for the ACT Accelerator.

Aylward also expressed gratitude to Japan for its announcement of additional contributions, and to the “UK and Italy, who committed their presidencies of the G7 and the G20 respectively to take forward the ACT A agenda.”

Success of ACT Accelerator and COVAX Threatened

Meanwhile, Dr Tedros warned of the significant challenges and threats to both the ACT Accelerator and the COVAX facility. 

“We have created a dose-sharing mechanism, set up rapid processes for the emergency use listing, set up indemnification and no-fault compensation mechanisms and completed readiness assessments in almost all AMC countries,” said Dr Tedros at the Council meeting.

However, while progress was made, the success of COVAX and the ACT Accelerator is threatened by the $27 billion financing gap, countries signing bilateral vaccine deals that compete with COVAX contracts, and current disruptions in vaccine manufacturing processes. 

Tedros called on countries to donate vaccines and share doses instead of vaccinating lower-risk groups and called for pharmaceutical companies to establish partnerships to develop manufacturing capacities and deal with production obstructions. 

“We need an urgent scale-up in manufacturing to increase the volume of vaccines. That means innovative partnerships including tech transfer, licensing and other mechanisms to address production bottlenecks,” said Dr Tedros.

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

Brazil’s delegate followed up on Tedros’ point and called for the Council to “move beyond principles and…talk about how to make vaccines available to everyone everywhere,” by expanding local vaccine production using licensing and coalition building.

Norway also expressed its support for using technology transfers and voluntary licensing to increase the global production capacity and stressed the importance of the equitable pricing of products.

“We call on pharma companies to implement pricing strategies that take countries’ different levels of ability to pay into account. Companies should agree cost plus prices with the COVAX facility for the countries eligible for the advanced market commitment,” said Norway’s delegate.

Additionally, taking a step to address the funding gap, Tedros “call[ed] on OECD and DAC countries to commit a proportion of stimulus financing to close the funding gap, and to take measures to unlock capital in multilateral development banks.” 

Shift in US Role On Council

The United States announced at the Council meeting that it would shift its role from observer to participant in the Council, making a commitment to multilateralism that follows its decision to rejoin the WHO and take part in COVAX. This move was widely acknowledged and well-received by member states.

“As President Biden expressed on his first day in office, the United States will partner with the WHO and the entire UN system to respond to COVID-19, improve global health and health security, and build a better future for all people,” said the US’ delegate.

“I would like to begin by welcoming the United States of America to the ACT Accelerator,” said Dr Tedros in his opening remarks. “We’re glad to have your support and involvement, and we look forward to your partnership in ensuring that all countries enjoy equitable access to vaccines, diagnostics and therapeutics against COVID-19.”

Image Credits: World Bank Photo Collection, WHO, Our World in Data.

The international team working to understand the origins of the COVID-19 virus at a press conference in Wuhan, China on Tuesday.

The most likely way that the SARS-CoV2 virus spread in Wuhan was from an animal intermediary that transmitted the virus from bats to humans, while the least likely was that it resulted from a laboratory “incident”, according to the World Health Organization (WHO) team on the origin of the virus, which completed a month-long investigation in China on Tuesday. 

Despite reviewing thousands of tests on wild and farm animals in the country, it has not been possible to identify any animals infected with SARS-CoV2 and team leader Dr Peter Ben Embarek, told a press conference in China on Tuesday that more research needed to be done on the cold chain supply of frozen wild animals.

China has been pushing the theory that the virus was imported into the country via frozen foods for some time now. Dr Liang Wannian, head of the Chinese expert panel on COVID-19, told the press conference on Tuesday that “studies have shown that the virus can survive for a long time not only at low temperatures, but also at refrigerator temperature, indicating that it can be carried long distances on culturing products.” 

Liang Wannian, head of the expert COVID-19 panel at China’s National Health Commission, at the WHO press conference on Tuesday.

Differences in WHO & China Narratives About Possibility That Virus Emerged Abroad 

There were, however, subtle but significant differences in the narrative related by the official Chinese representatives at the media briefing and the members of the WHO team. 

While China’s Wannian spoke about the frozen food chain, suggesting products carrying the virus that triggered the Wuhan clusters may have been imported, the WHO’s Embarek made it clear that more research needed to be done on whether the virus could have reached Wuhan from a domestic food source – or an imported one. 

The Wuhan market, one of the places where the virus first appeared, sold “mostly” seafood products, including frozen foods, “but also vendors selling products from domesticated wildlife, farmed wild animals and their products,” said Embarek.

“So the joint team in their studies have identified the vendors who were trading these type of products, identified the suppliers of these vendors, identified the farms, from where these products were coming from – and they were coming from different parts of the country, and some of the products were also imported products, of course,” said Embarek, who is also WHO’s head of food safety and zoonoses.

“So, there is the potential to continue to follow this lead, and further – look at the supply chain, and animals that were supplied to the market in frozen and other processed and semi-processed forms, or raw form.”

Peter Daszak, one of the scientists on the mission echoed Embarek’s remarks in a Tweet directly from the press conference: “KEY COMMENT: Recommendations include sampling potential intermediate hosts & bats both inside & outside China. Possible role of cold chain – incl. “Frozen wild animal that could have been infected by [progenitor] of SARS-CoV-2.”    

Wuhan Laboratory & Direct Bat-Human Contact Ruled Out As Infection Routes

Bats are a reservoir for cornaviruses that circulate in nature

What the Chinese and international scientists did seem to agree upon was that there was little possibility that the virus had somehow escaped from the Wuhan Virology laboratory – as some voices in the administration of former US President Donald Trump had tried to suggest. They also agreed that there was little evidence that people were directly infected from bats harboring the coronavirus themselves.  

Studies have shown that coronaviruses most closely related to SARS-CoV2 are found in bats, which suggests that these animals may be the original reservoir of the virus that causes COVID-19.

Embarek said that the team had investigated whether there had been direct zoonotic spillover from bats to humans but the genome sequencing of the virus in bats was too different from the SARS-CoV2 that emerged in humans to indicate direct transmission, and there was also no obvious connection between Wuhan residents and bats.

“All the work that has been done on the virus and trying to identify its origin continue to point towards a natural reservoir of this virus and similar viruses in bat population,” said Embarek.

“But infection directly from a bat to the city of Wuhan is not very likely. And therefore, we have tried to find what other animal species were introduced and were moving in and out of the city that could have potentially introduced the virus.”

Pangolins, which are widely sold in Chinese markets as wild foods, are another key animal source that was mentioned by both Chinese and international teams at the press briefings as a possible original reservoir – or an “intermediate host”.  

At the press briefing, China’s Wannian also suggested cats and minks could have become the “intermediate source” for the initial coronavirus infections that reached humans. 

China has pointed a finger at minks in the past, after SARS-CoV2 infections in mink farms in Europe had become a widespread issue, leading to the culling of tens of thousands of mink over the past year. 

However, it is widely assumed that the minks were infected by humans after Europe became the epicenter for COVID-19 last spring. WHO’s officials said in December that there is so far no evidence that coronaviruses similar to SARS-CoV2 circulated in the wild in Europe – before the pandemic.  

No Evidence of Virus Circulation in Wuhan Before December 2019 

Marion Koopmans, virologist and WHO advisor on foodborne diseases and emerging disease outbreaks, at the WHO press conference on Tuesday.

The Chinese and WHO/International expert team, also did not find any concrete evidence of the virus circulating in Wuhan before December 2019, said Embarek. 

However, when the first Wuhan virus clusters were identified in December, these were not confined only to the city’s seafood market – that was initially perceived as the original source of the outbreak  – but popped up elsewhere around the same time.

“We agree that we have found evidence of wider circulation of the virus in December 2019,” said Embarek. “It was not just only a cluster outbreak in the Huanan market, but the virus was also circulating outside of the markets in a very classical picture of the start of an emerging outbreak.”

While the virus, which circulates mainly in wild bats and some pangolins, is believed to have jumped at some point to an “intermediate animal host”, which in turn infected the first humans, the team has not gotten close to how, where or when that animal-human leap really occurred.

During the visit, the team reviewed sampling from extensive PCR tests of livestock and poultry from 31 Chinese provinces and 50,000 samples of the wild animals covering 300 different species, but not a single one was found to be infected with SARS-CoV2.

This was why the team flagged that more research needed to be done on the cold chain supply to see whether infected frozen and semi-procssed animal products, including wild animal products, could have been the virus conduit, said Embarek.

Dutch virologist Professor Marion Koopmans also told the press conference that further animal studies needed to see what other animals could have played a role as intermediate hosts.  Rabbits had been confirmed as susceptible to SARS-CoVD, while ferrets, badgers and bamboo rats are also suspected of being susceptible.

“The way that is interpreted is to really say, well, if they were there then, then maybe there could have been similar animals earlier. It is an entry point for a traceback investigation, “ said Koopmans.

Reports of Virus Circulating in Italy earlier than December Also Need to be Investigated

However, Koopmans told the press conference that reports of the virus circulating in Italy earlier than December also need to be investigated.

She was referring to several recent Italian publications suggesting that SARS-CoV2 antibodies were found in blood samples of Italians who had undergone screening for other reasons during the autumn of 2019. Another study found traces in sewage in Milan and Turin.  Those findings suggest that the virus was already circulating under the radar in the country earlier than had been believed. 

“A couple of publications suggest that for instance, in Italy the virus had been already in circulation in December, maybe late November 2019, but it is difficult to know because the methods for that are not were not confirmatory,” said Koopmands. “So, in the next step, what we say is, we should really go and search for evidence for earlier circulation, wherever that is indicated.”

The international, multidisciplinary team was established by a World Health Assembly mandate to design and conduct a series of studies to trace the origins of SARS-CoV2 and the route of its introduction into the human population. The team is comprised of 17 Chinese experts and 17 international experts. Their long-awaited visit to China was delayed for months as Chinese officials, who have been keen to cast the blame for the virus elsewhere, stonewalled over the terms and conditions. 

Image Credits: WHO, CGTN, Shutterstock .

Ebola vaccination campaign in Mbandaka, Équateur Province (DRC) during an outbreak over the summer.

The Democratic Republic of the Congo (DRC) recorded its first case of Ebola on Sunday in Butembo – a city that was one of the epicenters of the last Ebola outbreak – since its last outbreak ended in June 2020. 

A woman with Ebola-like symptoms was detected in Butembo, a city in North Kivu Province, after seeking treatment at a health center on 1 February. She died in the hospital two days later, reported the Ministry of Health of the DRC. 

The patient was married to a man who had contracted Ebola during the previous outbreak. 

“The provincial response team is already hard at work. It will be supported by the national response team which will visit Butembo shortly,” the Ministry of Health said in a statement.

This new case comes nearly eight months after the country’s 10th Ebola outbreak, which ended after two years with a total of 3481 cases, 2299 deaths and 1162 survivors reported. Local and national authorities, along with the WHO, are investigating the case, contact tracing, and disinfecting sites visited by the patient.

During the previous outbreak, WHO trained laboratory technicians, contact tracers, and vaccination teams, leaving behind a strong local and provincial health system with the capacity to mobilize and lead the current response.

“The expertise and capacity of local health teams has been critical in detecting this new Ebola case and paving the way for a timely response,” said Matshidiso Moeti, WHO Regional Director for Africa, in a press release. “WHO is providing support to local and national health authorities to quickly trace, identify and treat the contacts to curtail the further spread of the virus.”

Samples from the patient have been sent to the National Institute of Biomedical Research to sequence the genome, identify the strain of the Ebola virus and establish its link to the previous outbreak. 

“It is not unusual for sporadic cases to occur following a major outbreak,” said WHO in a statement, however it is unclear if this is evidence of a flare up or a new outbreak.

“While there is hope that this early identification of an infection may help with quickly containing this outbreak, back-to-back Ebola outbreaks and Covid-19 has stretched Congo’s health systems to the limit and this could put far greater strain on an already exasperated system,” Jason Kindrachuk, assistant professor at the department of medical microbiology and infectious diseases at Canada’s University of Manitoba, told the Guardian. 

More than 70 contacts have been traced by local health authorities, the Ministry of Health, and WHO epidemiologists on the ground in an effort to detect, contain and treat any other cases.

“So far, no other cases have been identified, but it is possible there will be further cases because the woman had contact with many people after she became symptomatic,” said Dr Tedros Adhanom Ghebreyesus, at a press briefing on Monday. 

Ebola vaccines are being sent to the area and a vaccination program will begin shortly, supported by a rapid response team sent by WHO. 

Image Credits: WHO/Junior D. Kannah.

AstraZeneca’s multi-stage manufacturing and quality testing process for its COVID-19 vaccine, which was developed with Oxford researchers.

The World Health Organization (WHO)’s expert group on immunisations remains confident in the Oxford/AstraZeneca vaccine’s efficacy against severe SARS-CoV2 disease – despite the enormous worldwide concerns triggered by a small South African study that showed it had little effect in stemming mild disease from the B.1.351 variant first identified in that country.

“It is very clear that the vaccine has efficacy against severe disease, hospitalizations and deaths,” Dr Katherine O’Brien, WHO director of Immunization, told the body’s bi-weekly media briefing on Monday after WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) meeting to decide on whether to grant the vaccine an emergency use license earlier in the day. 

“There is also evidence that the likelihood of meaningful impact against severe disease is a very plausible scenario against the B.1.351 [South African identified] variant,” O’Brien added, explaining that SAGE had met earlier in the day with investigators from Oxford/ AstraZeneca trials in the UK, Brazil and South Africa.

Dr Katherine O’Brien, WHO Director of the Department of Immunization, Vaccines and Biologicals.

Stressing that the situation was dynamic, O’Brien said that evidence unfolding from the trial of people with mild disease, might seem to contradict expert opinions that the vaccine could still prevent  severe illness – but that was because “we’re painting the picture in parts and pieces and bits”.  So  far the ongoing trials have not yielded clear evidence of the AstraZeneca’s efficacy on the South African variant. 

Last Friday, WHO officials said that they would be set to make a decision on approving the AstraZeneca vaccine for widespread rollout by the Global COVAX facility sometime this week.

WHO Director General Dr Tedros Adhanom Ghebreyesus described as “concerning” the news that the AstraZeneca vaccine was “minimally effective at preventing mild to moderate disease caused by a variant first identified in South Africa”.

COVAX Suppliers Need To Be Prepared to Adjust Products To Viral Evolution

Meanwhile, Dr Seth Berkley, CEO of the vaccine alliance, GAVI, stressed that pharma manufacturers supplying vaccines to the global COVAX facility “must be prepared to adjust to COVID-19’s viral evolution, including potentially providing future booster shots and or adaptive vaccines, if found to be scientifically necessary”.

Seth Berkley, CEO of Gavi, the Vaccine Alliance

“COVAX has signed advanced purchase agreements with AstraZeneca and the Serum Institute of India, and we’ve published plans to distribute near nearly 350 million doses in the first half of the year, hopefully starting later this month, should the emergency use listing be forthcoming,” said Berkley, who added that while COVAX was currently dependent on AstraZeneca and Pfizer vaccines, other vaccines would be added to its portfolio later in the year.

Richard Hatchett, CEO of  the Coalition for Epidemic Preparedness Innovations (CEPI) stressed that a diversity of vaccine candidates “provides us with a large number of tools which we need to explore to see which works best against the variants.”

“We can also look potentially at combinations of the vaccines and of course we must accelerate the development of new strain-specific vaccines. A large number of companies have already begun to undertake that work,” said Hatchett.

Image Credits: AstraZeneca, WHO.

Civil society organizations, pharmaceutical industries, and other stakeholders support the ratification of the AMA Treaty.

On the two-year anniversary of the establishment of the African Medicines Agency (AMA) Treaty, over 40 patient and civil society organizations, health and pharmaceutical industries, and product development partnerships called upon African Union member states to ratify the Treaty. 

Rapidly ratifying the Treaty, which was created to provide a unified approach to the approval of new medicines and vaccines, is a “matter of priority” and the failure to do so undermines patients’ access to effective therapies and vaccines, according to the numerous stakeholders representing patients, researchers and industry leaders. 

The Treaty was adopted at the 32nd African Union Assembly to enhance regulatory oversight across the continent’s 54 countries. It has been signed by 19 countries but only ratified by eight out of the required 15. 

“The African Medicines Agency is important for universal health coverage [UHC] in Africa. The 148th World Health Organization’s Executive Board has resolved to ask the 74th World Health Assembly to adopt the WHO Flagship Global Patient Safety Action Plan 2021-2030,” Kawaldip Sehmi, CEO of the International Alliance of Patients Organisations (IAPO), told Health Policy Watch. 

“A cornerstone of this plan is that each Member State must have a competent institutional, legislative, policy, practice and standards framework in place for the regulation of safe and quality innovative medicines, health devices and other health products. The African Union, like the European Union and its European Medicines Agency, can ensure that all 54 African countries can place this cornerstone of their UHC together at the same time,” he added.

The AMA has a critical role to play, particularly in the midst of the COVID-19 pandemic, when a competent and efficient regulatory authority – similar to the European Medicines Agency or the US Food and Drug Administration – is needed to review, approve and monitor vaccines, therapeutics, diagnostics and health technologies. 

“If we had the AMA, it would be working very closely with the WHO and other bodies to facilitate regulatory issues on drugs to help control the COVID-19 pandemic” and to ensure their rapid and streamlined introduction to markets, said John Nkengasong, Director of the Africa Centres for Disease Control and Prevention, at press briefing in October.

As COVAX, the global initiative to procure and equitably distribute COVID-19 vaccines, prepares to start shipping 90 million doses to Africa in February, the continent is almost two months behind vaccine rollouts that began in Europe and the US in December. 

“That is precisely what the AMA’s mission will be: to help African countries fight disease outbreaks by ensuring that only high-quality drugs, vaccines, and other health-related supplies reach the market and health systems from Cape to Cairo,” said Sehmi in a press release. 

Similarly, disruptions in the approval or rollout of vaccines could be investigated and solved by a regional regulatory agency. South Africa’s decision on Sunday to halt its use of the Oxford/AstraZeneca vaccine will have serious implications for massive African vaccine rollouts planned by both the WHO co-sponsored COVAX facility as well as the African Union’s dedicated African Vaccine Acquisition Task Team (AVATT).

“The events this weekend, with South Africa suspending the AstraZeneca vaccinations and seeking new information and advice from the manufacturer and European medicines regulatory agencies, is exactly what we wanted to avoid in our call to action,” Ellos Lodzeni, Treasurer of the IAPO Governing Board and founder of the Patient and Community Welfare Foundation of Malawi, told Health Policy Watch.

“This has left vaccination programmes in the rest of Africa in a limbo. The African Medicines Agency could have been that competent pan-African medicines regulatory agency that could have resolved this matter very early. The African Union must have a competent regional medicines regulatory agency that can help us build back better faster and safer,” Lodzeni said.

Additionally, establishing the AMA could improve country participation in clinical research and scientific innovation, boost manufacturing capacities, and allow for greater collaboration and knowledge sharing.

While progress has been made over the past couple of months on increasing the ratification of the Treaty, less than half of countries that have signed it have ratified it and established it as part of their national law. Only eight countries have ratified the agreement – Rwanda, Mali, Burkina Faso, Ghana, Seychelles, Guinea, Morocco, and Namibia.

Leading southern and eastern African nations, such as South Africa, Kenya, Uganda, and Tanzania, along with Cameroon, Nigeria, and Egypt have yet to sign onto the Treaty. 

Regional Challenges and Aims of the AMA

Over a quarter of the continent’s medicines are substandard or falsified, while only 2% are produced in Africa, according to the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD).

Weak regulatory systems have led to the circulation of falsified or substandard products, which pose a risk to public health and undermine confidence in health systems. The current network of separate national regulatory authorities has resulted in slow processes for new medicines to be approved by each country – time that is severely lacking during a public health emergency.

“No single country has enough resources and capability to efficiently and effectively regulate the whole supply chain system alone in this globalised world,” said Karim Bendhaou, who heads Africa Affairs for Merck and is chair of the IFPMA’s Africa Engagement Committee.

The main aims of the AMA are to:

  • Strengthen and harmonize efforts of regional health organizations and member states;
  • Provide evidence-based scientific regulatory decisions and guidance;
  • Improve patients’ access to effective, safe and quality medicines; 
  • Minimize administrative hurdles; and
  • Manage the prevalence of substandard and falsified medical products. 

A strong, unified regulatory system could coordinate market surveillance for falsified and substandard medical products, centralize information collection and sharing, strengthen national efforts to improve access to safe and innovative products, and optimize healthcare systems. 

“The establishment of the African Medicines Agency is a critical next step to enable all patients in Africa to have timely access to quality medicines that are safe and effective,” said Adam Aspinall, chair of the Fight the Fakes Alliance. 

-Updated on 9 February

Image Credits: Interpol, IFPMA.

CAPE TOWN – The failure of the Oxford/ AstraZeneca SARS-COV2 vaccine to protect against the COVID-19 variant identified in South Africa has serious implications for massive African vaccine rollouts planned by both the WHO co-sponsored COVAX vaccine facility as well as the African Union’s dedicated African Vaccine Acquisition Task Team (AVATT).

The bulk of Africa’s COVAX allocations and a significant proportion of the AVATT acquisitions are for the AstraZeneca vaccine produced by the Serum Institute of India (SII).  Yet most southern African countries neighboring South Africa are almost certain to be dominated by the B.1.351 variant  (also called 501Y-V2) which was first identified in South Africa. The variant has already appeared in Malawi, eSwatini, Lesotho, Mozambique, Zambia and Zimbabwe, experts say, and it could have already spread to East Africa.

South Africa’s health minister, Dr Zweli Mkhize told a media briefing on Sunday night that the country had suspended its planned rollout of the AstraZeneca vaccine – due to the failure of a recent South African trial to show that the vaccine was effective against preventing mild to moderate disease from the B.1.351 variant. The decision came just one week after one million AstraZeneca doses had arrived in the country as a result of a bilateral deal with SII.

SA health minister Dr Zweli Mkhize
South Africa’s Health Minister, Dr Zweli Mkhize

The country now plans to vaccinate its health workers with the Pfizer vaccine, which it will get via COVAX. It is also in negotiations with Johnson & Johnson to purchase its vaccine, which has shown reduced efficacy against the 501Y-V2 variant but was 85% effective in reducing serious illness, although it is not yet approved by the country’s regulator.

Officials also are considering rolling out the AstraZeneca vaccine to 100,000 people and monitoring hospitalisations – to see if the vaccine may still be more effective in reducing serious disease.

“If we are confident that the vaccine is effective in preventing hospitalisation, then we can roll it out,” said South Africa’s co-chair of the Ministerial Advisory Committee on COVID-19, Professor Salim Abdool Karim. “Alternatively, if it’s above that threshold, then we need to look at alternatives.

“So put very simply. We don’t want to end up with a situation where we vaccinated, a million people, or too many people with a vaccine, that may not be effective in preventing hospitalisation and severe disease.”

Vaccine Study Inadvertently Tested Efficacy on Variant

At a media briefing on Monday, Professor Shabir Madhi, principal investigator on the South African arm of a Phase 2 trial on the two-dose AstraZeneca vaccine, the progress of the trial and its findings, which included 1750 largely young and healthy participants. 

Initially, the vaccine showed 75% efficacy at 14 days, but as the trial progressed – and the majority of participants who became infected by the variant – this protective plummeted until it was “not statistically significant”, said Madhi.

“Inadvertently, because of the timing of when we enrolled participants into the study, 95% of all of the individuals infected after two doses, were infected as a result of the variant, so this study was able to show the vaccine’s efficacy on the variant” said Madhi.

Of the 42 people who contracted the virus, 23 were in the placebo arm and 19 in the vaccine arm. 

“What data doesn’t tell us is whether or not this vaccine might still protect against severe COVID-19, as two thirds of those infected had mild symptoms and a third had moderate symptoms,”, said Madhi. 

It remains possible that the AstraZeneca vaccine may offer protection against severe illness, insofar as it uses the same viral vector technology as the Johnson & Johnson vaccine, which was found to be 85% effective at reducing severe illness and death in a recent Phase 3 trial.

The J&J study involved over 44,000 people, a third of whom were over the age of 60. Overall, it showed 72% efficacy against the virus in the US but only 57% efficacy rate in South Africa because of the B.1.351 variant, reported Dr Glenda Gray, head of the SA Medical Research Council who ran the South African arm of the study.

Gray said that, given J&J’s proven efficacy in protecting against severe illness and death, she would be expanding her study to health workers within the next few days while waiting for it to be approved in the country.

Meanwhile, AstraZeneca and Oxford University are already developing a booster shot based on the locally-identified variant. 

“Efforts are underway to develop a new generation of vaccines that will allow protection to be redirected to emerging variants as booster jabs, if it turns out that it is necessary to do so,” said Sarah Gilbert, Professor of Vaccinology at the University of Oxford in a press release.

“We are working with AstraZeneca to optimise the pipeline required for a strain change should one become necessary. This is the same issue that is faced by all of the vaccine developers, and we will continue to monitor the emergence of new variants that arise in readiness for a future strain change.”

Professor Barry Schoub, co-chair of the South African Ministerial Advisory Committee on COVID-19 vaccines, described the AstraZeneca results as “rather disappointing”, but said there may be a way to salvage the vaccine.

“For example, we need to look at the cell mediated immune responses; we may need to look at a combination of AZ vaccine with other vaccines which may in fact give a synergistically good response. So I just think we need to maybe suspend use of AstraZeneca, but investigate more fully [if we] can utilise it more effectively,” Schoub told the Sunday media briefing.

South Africa’s Professor Salim Abdool Karim summarised what the country knows about the variant for a recent press breiefing.

 

Meanwhile, Mkhize said that the country needed to figure out its next step in regard to the vaccine, which it paid more than twice the price that the European Union did, with the guidance of scientists.

Novavax and Moderna have also shown decreased efficacy against the 501Y-V2 variant. 

Australia’s Minister for Health, Greg Hunt, said on Monday that “there is currently no evidence to indicate a reduction in the effectiveness of either the AstraZeneca or Pfizer vaccines in preventing severe disease and death.”

Australia is on the brink of approving the AstraZeneca vaccine and has ordered 53 million doses, largely relying on the Oxford/AstraZeneca vaccine to inoculate the whole population. But the 501Y-V2 variant has already spread to at least 32 countries, including Australia. 

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) was meeting on Monday to review AstraZeneca’s clinical trial results and propose recommendations to WHO on the provision of Emergency Use Listing to the vaccine. 

This setback for AstraZeneca is on top of the decision by several European countries last week to implement an age restriction for the vaccine due to a lack of efficacy data in people over the age of 65 and Switzerland’s rejection of AstraZeneca’s application for regulatory approval until more data is received. 

WHO Director General Dr Tedros Adhanom Ghebreyesus at the body’s biweekly press briefing. on Monday: “Yesterday, South Africa announced that it was putting a temporary hold on the rollout of the Oxford AstraZeneca vaccine. After a study showed it was minimally effective at preventing mild to moderate disease caused by a variant first identified in South Africa.

“This is clearly concerning news. However, there are some important caveats, given the limited sample size of the trial, and the younger healthier profile of the participants. It’s important to determine whether or not the vaccine remains effective in preventing more severe illness.”

 

Dr Mariângela Simão, WHO Assistant-Director of Access to Medicines and Health Products.

The World Health Organization (WHO) expects to make a decision next week on whether to issue emergency use licenses for the AstraZeneca/Oxford COVID-19 vaccine being produced by the Serum Institute of India (SII) and South Korea’s SK Bioscience on 15 February, according to Dr Mariangela Simão, the organisation’s assistant director general of Drug Access, Vaccines and Pharmaceuticals.

The WHO had only received the full dossier from SII on 15 January, and the SK Bioscience dossier last week, Simao told the biweekly WHO COVID-19 press conference on Friday.

Meanwhile, the two Chinese vaccine manufacturers, Sinopharm and Sinovac, both have COVID-19 vaccines in very advanced stages of WHO’s Emergency Use Listing process, with a decision expected in early March. 

“We have a team of inspectors in China since the second week of January. They are waiting for their quarantine to finish and then they will start inspections next week,” said Dr Simão.

Sinopharm’s full dossier has been accepted for review, while WHO is expecting additional data from Sinovac today and again at the end of February. 

Of the two vaccines, Sinopharm yielded efficacy results between 79.3% and 86% in Phase 3 multi-country trials and has been approved in China for general public use. But Sinovac, on the other hand, yielded wildly varied efficacy scores ranging from 50.3% – 91.3%.

Sinovac applied for conditional approval in China on Wednesday and said that the preliminary results showed an “efficacy rate [that] meets the standards of the WHO and the guiding principles for Clinical Evaluation on Preventive COVID-19 Vaccine (tentative) issued by the NMPA [National Medical Products Administration, China’s medicines regulatory agency].” 

Companies Can Issue Voluntary Licenses to Speed Up Manufacture, Says Tedros

However, the WHO is concerned that vaccine supply is still lagging way below demand and Director General Dr Tedros Adhanom Ghebreyesus urged companies and countries to use the options available to increase manufacturing capacity, particularly as 130 countries have not yet started vaccinations.

“Countries are ready to go. But the vaccines aren’t there,” said Dr Tedros. “We need countries to share those once they have finished vaccinating health workers and older people. But we also need a massive scale up in production.”

He praised last week’s announcement by Sanofi that it would make its manufacturing infrastructure available to support production of the Pfizer/ BioNtech vaccine. 

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

“We call on other companies to follow this example. Companies can also issue non-exclusive licences to allow other producers to manufacture their vaccine, a mechanism that has been used before to expand access to treatments for HIV and hepatitis C. The COVID-19 technology access pool or C-TAP enables the voluntary licencing of technologies in a non exclusive, and transparent way by providing a platform for developers to share knowledge, intellectual property and data,” said Tedros, stressing that this would help to build additional manufacturing capacity in Africa, Asia and Latin America.

Meanwhile, WHO Chief Scientist Dr Soumya Swaminathan said that one of the top research priorities was whether different vaccines could be combined – for example, the Pfizer and Moderna vaccines that are both mRNA two-dose vaccines, or  “even more interesting would be to combine two different platforms so inactivated vaccine followed by an mRNA spike protein”.

“Information about vaccines both from the rollouts that are happening now in countries and observational studies, but also more randomised clinical trials are going to be needed to look at questions like the duration, and the gap between doses, as well as the combining different vaccines,” said Swaminathan, indicating that the Coalition for Epidemic Preparedness (CEPI) had already issued a call for applications from researchers to examine these questions.

Dr Soumya Swaminathan, WHO Chief Scientist.

The WHO officials welcomed the fact that the new infections were reducing in many parts of the world, but Dr Maria Van Kerkhove, COVID-19 technical lead, said this could not be ascribed to vaccine rollouts alone.

The decline was “due to a combination of factors, most notably the public health and social measures” such as active case finding, using rapid antigen-based tests, isolation of cases, and good clinical care.

“What is really critical is that countries that are reducing transmission continue to take all measures they can to drive down transmission,” stressed Van Kerkhove. “Individuals have a role to play in this, with physical distancing that must continue, the wearing of masks, making sure that you open windows, you avoid crowded spaces. All of these actions are driving down transmission.”

In regard to the push for the anti-parasitic drug ivermectin to be repurposed for treating COVID-19, Van Kerkhove said that the WHO “haven’t made a recommendation on the use of ivermectin, but we’re closely following the research that is ongoing related to this drug, which has shown some promising results in some trials for the treatment of COVID-19.”

However, Swainathan said that ivermectin had not been prioritised for inclusion in the solidarity trial, which fastracks potential treatments and warned that small studies were open to misinterpretation. 

China Joins COVAX, Commits To Supply Vaccines to LMIC Countries

In another move to “make vaccines a global public good,” China has officially joined the COVAX Facility, a WHO co-led mechanism to ensure the equitable distribution of COVID-19 vaccines, and has committed 10 million doses of vaccines to low- and middle-income countries, China’s Foreign Ministry Spokesperson, Wang Wenbin, announced on Wednesday. 

“We attach great importance to Director-General Tedros’ call to vaccinate priority populations in all nations within the first 100 days of this year,” said Wang Wenbin. “We also attach great importance to the difficulties facing the practical implementation of COVAX, in particular the huge vaccine supply gap in February and March.”

It has not yet been revealed exactly which Chinese-developed vaccines are committed to COVAX and the prices of the vaccines are currently unclear, but China pledges to “offer its vaccines at fair and reasonable prices,” said the Foreign Ministry Spokesperson. 

Over 24 countries have signed vaccine deals with Sinopharm and Sinovac so far, most of them low- and middle-income countries. Most recently, China decided to donate 100,000 doses of a Chinese-developed vaccine to the Republic of the Congo and to forgive US$13 million in public debt.

Sinopharm and Sinovac vaccines have already been exported to countries that have authorized the vaccines for emergency use, including the United Arab Emirates, Indonesia, Turkey, and Brazil. 

China is currently providing vaccine aid to 13 developing countries, including Pakistan, Palestine, Sierra Leone, Zimbabwe, Myanmar, and Brunei, according to Wang Wenbin. And the country plans to assist another 38 developing countries with vaccines.

China is also encouraging domestic vaccine companies to conduct joint vaccine R&D and production with foreign partners, an effort which is encouraged by WHO.

Decision on Olympics Will Be Made With Correct Data

Responding to Japan’s declaration that the Olympic Games would go ahead later this year, Dr Michael Ryan, executive director of Health Emergencies, said that  “there is a collective desire around the world to move ahead with the Olympics” as it is  “a massive, important symbol of unity and solidarity around the world”. 

Dr Mike Ryan, WHO Executive Director of Health Emergencies Programme.

“What I do know is that the government of Japan, the organising city of Tokyo, and the International Olympic Committee have been working diligently together,” said Ryan. “And I’m absolutely sure that they’re taking every ounce of data into consideration as they move towards the Olympics. We work with them. We input to their taskforce on risk management. We will continue to do so. 

“The desire to have the games is a laudable desire, and the will to move forward is laudable as well. But I am sure, the government of Japan will take all of their data into account as they move towards the games and they will make the correct decision on behalf of the people of Japan, the athletes and potential spectators.”

Image Credits: Sinopharm, WHO.