UK poised to be first to approve Pfizer-BioNTech COVID-19 vaccine
London – The U.K. 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 U.K. had long signaled it would move fast on any promising vaccine candidate. Russia and China have cleared vaccines for general use, but they’re unlikely to be adopted in the U.S. and Europe.
British doctors were put on standby for a possible rollout before Christmas. The government invoked a special rule allowing the U.K. drug regulator to bypass its European Union counterpart as the country prepares for the Brexit transition period to conclude at the end of this year. And the U.K.’s Medicines and Healthcare Products Regulatory Agency started its own accelerated review.
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.
On Saturday, an MHRA spokesperson declined to comment. A BioNTech representative didn’t immediately have a comment. Pfizer said in a statement that it doesn’t speculate on how long the review process will last or how it will end.
The first injections could take place from Dec. 7, the Financial Times reported earlier.
The news that the U.K. 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 U.K. 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 U.S., 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.