The UK is poised to become the first country to approve Pfizer Inc. and BioNTech SE’s Covid-19 vaccine, ahead of a long line of countries waiting for protection from the coronavirus.
Clearance is possible as soon as early next week, according to a person familiar with the situation, who asked not to be identified because the process is confidential.
The UK had long signaled it would move fast on any promising vaccine candidate, and British doctors have been put on standby for a possible rollout before Christmas. Russia and China have cleared vaccines for general use, but they’re unlikely to be adopted in the US and Europe.
The British government last week invoked a special rule allowing its drug regulator to bypass the European Union counterpart as the country prepares for the Brexit transition period to conclude at the end of this year. And the UK’s Medicines and Healthcare Products Regulatory Agency has started its own accelerated review.
“We hope, subject to the regulatory approvals, to be in a position to be able to have rolled out the vaccine sufficiently by, say, the spring to enable us to have a big change in the way we approach things,” UK Foreign Secretary Dominic Raab told the BBC’s Andrew Marr show Sunday. Raab said he hoped that vaccine roll-out could begin “before Christmas,” with life returning to something “akin to normal” by spring 2021.
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Earlier this week, the MHRA said it had the data it needed to assess whether the Pfizer vaccine meets required standards and would “make a decision in the shortest time possible, without compromising the thoroughness of our review.” The shot was 95% effective in a clinical trial of almost 44,000 people, with no significant safety problems so far.
An MHRA spokesperson declined to comment. Pfizer said in a statement that it doesn’t speculate on how long the review process will last or how it will end. A BioNTech representative didn’t immediately have a comment.
The first injections could take place from December 7, the Financial Times reported earlier.
The news that the UK could approve a vaccine comes as Nadhim Zahawi, a junior minister for the Department of Business, was appointed as minister overseeing the rollout of Covid-19 vaccines.
The UK has ordered enough doses of the two-shot Pfizer-BioNTech vaccine to immunize 20 million people, though that volume almost certainly won’t be available right away. The companies also have deals to supply hundreds of millions of shots to Europe, the US, Japan and elsewhere.
The Pfizer-BioNTech shot has raced to the head of the line after delays to trials of a vaccine from AstraZeneca Plc and the University of Oxford, which has also shown some promising signs in preliminary results from broad studies.
Another one, from Moderna Inc., has also demonstrated effectiveness in late-stage trials. The UK government has secured another 2 million doses of Moderna’s vaccine, talking its total to 7 million.
Peter Openshaw, professor of experimental medicine at Imperial College London and a government adviser, said he would be “surprised” if a vaccine becomes available as soon as next week.
“I know that the regulators are looking very hard and they’re doing everything they can to scrutinize all the data,” Openshaw told the Marr show. “I wouldn’t be too surprised if an announcement would be made within the next two weeks, possibly even as early as next week, but we’ll have to wait and see.”