U.K. to Approve BioNTech-Pfizer Covid Vaccine Within Days: FT

(Bloomberg) -- 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 from Dec. 7, the paper said, citing individuals with knowledge of the process said

BioNTech is a German start-up working with the U.S. drug giant Pfizer to develop an inoculation against Covid-19. The U.K. has ordered 40 million doses of the two-shot product, which preliminary data found to be more than 95% effective in preventing disease.

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. Both authorities are running accelerated reviews of a number of possible vaccines being developed by different pharmaceutical companies.

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BioNTech and Pfizer have already submitted data from a large-scale phase 3 trial, which involved more than 43,000 people, 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 five days ago 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 effectiveness, and if they are satisfied the vaccine can be consistently manufactured.”

The government has also indicated that it will use a similar approval procedure for a vaccine being developed by AstraZeneca Plc and the University of Oxford.

Earlier this week U.K. health secretary Matt Hancock told MPs: “If these vaccines are approved, the NHS stands ready to roll them out as soon as safely possible.”

The news that the U.K. could approve a vaccine comes as Nadhim Zahawi, a junior minister for the Department of Business, tweeted on Saturday that he has been asked by Prime Minister Boris Johnson to become the minister overseeing the rollout of Covid-19 vaccines. He tweeted on social media: “A big responsibility & a big operational challenge but absolutely committed to making sure we can roll out vaccines quickly-saving lives and livelihoods and helping us #buildbackbetter.”

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