UK to approve COVID-19 vaccine within days
LONDON — The U.K. is about to become the first western country to approve a COVID-19 vaccine, with the independent regulator set to grant approval within days, according to the Financial Times.
The paper reports that deliveries of the vaccine developed by BioNTech SE and Pfizer Inc. will begin within hours of the authorization, citing unidentified government officials. The first injections could take place starting Dec. 7, the paper said, citing individuals with knowledge of the process.
BioNTech is a German startup working with the U.S. drug giant Pfizer to develop an inoculation against COVID-19. TheU.K. has ordered 40 million doses of the product, which preliminary data found to be more than 95% effective in preventing disease.
More than 58,000 people in Britain have died from COVID-19, according to
Johns Hopkins University. That’s the most in Europe and fifth-most in the world behind the U.S., Brazil, India and Mexico.
Vaccines have to be authorized by the European Medicines Agency until the end of the Brexit transition period on Dec. 31. However, the U.K.’s Medicines and Healthcare Products Regulatory Agency can temporarily authorize products if there is urgent public need.
BioNTech and Pfizer have already submitted data from a large-scale phase 3 trial to the U.S. Food and Drug Administration as well as the EMA and regulatory authorities in the U.K., Canada, Japan and Australia.
The MHRA said last week in a statement that it had received the necessary data from BioNTech and Pfizer to review whether the vaccine meets the required standards. It said it will only authorize the supply of the vaccine if it “meets strict standards of quality, safety ... and if they are satisfied the vaccine can be consistently manufactured.”