US regulator to move quickly on Pfizer/BioNTech vaccine

US regulator to move quickly on Pfizer/BioNTech vaccine

White House turns up pressure on FDA to clear first Covid-19 jab for American use

The US drugs regulator has signalled that it intends to approve the Covid-19 vaccine from Pfizer and BioNTech soon amid White House pressure to quickly fire the starting pistol on the country’s first coronavirus jab.

Stephen Hahn, the Food and Drug Administration commissioner, and Peter Marks, director of the FDA division responsible for overseeing vaccines, said in a statement on Friday that they had informed Pfizer that the regulator “will rapidly work toward finalisation and issuance of an emergency use authorisation”, a day after an advisory group voted to recommend the vaccine receive approval.

The US regulator has also notified the Centers for Disease Control and Prevention and Operation Warp Speed, the government programme to accelerate the development of a vaccine, so that they can prepare to distribute the vaccine, which may be done within 24 hours of receiving authorisation.