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 

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.” 

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.”