The U.K. became the first western country to approve a COVID-19 vaccine, with its regulator clearing Pfizer Inc. and BioNTech SE’s shot ahead of decisions in the U.S. and European Union.
The emergency authorization clears the way for the deployment of a vaccine that’s expected to play a significant role in the global effort to halt the coronavirus. Pfizer and its German partner said in November that the shot, relying on novel technology called messenger RNA, was 95% effective in a final analysis of clinical-trial data.
The vaccine will be available in Britain from next week, according to a government statement. The U.K. regulator, the Medicines and Healthcare Products Regulatory Agency, said on Wednesday that the vaccine “met its strict standards of safety, quality and effectiveness.”
The U.K. had signaled it would move swiftly in approving a vaccine to protect its population, and doctors across the country were put on standby for a possible rollout. For the government, it’s an opportunity to make up for missteps during the pandemic as Britain’s death toll nears 60,000.
Regulators are facing pivotal decisions as companies including Pfizer, Moderna Inc. and the University of Oxford’s partner, AstraZeneca Plc, sprint ahead in a bid to deliver coronavirus vaccines in record time.
EU Application
Pfizer and BioNTech earlier this week sought regulatory clearance for their vaccine in the European Union, putting the shot on track for potential approval there before the end of the year. In the U.S., a Food and Drug Administration panel is set to meet on Dec. 10 to discuss the vaccine.
China has given authorization to its three front-runners for emergency use. Russia cleared a vaccine known as Sputnik V in August, while a second inoculation was approved in October, even as the last stage of trials to establish safety and efficacy are still taking place.
The British government in late November invoked a special rule allowing its drug regulator to move ahead of the EU as the country prepares for the Brexit transition period to conclude at the end of this year.
The U.K. has ordered enough doses of the two-shot Pfizer-BioNTech vaccine to immunize 20 million people. The companies also have deals to supply hundreds of millions of shots to Europe, the U.S., Japan and elsewhere.
The Pfizer-BioNTech shot dashed to the head of the queue after delays to the trials of the AstraZeneca-Oxford vaccine, which has also shown promising signs in preliminary results of broad studies. The U.K. partners have faced questions after acknowledging that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy.
