In blow to Donald Trump’s campaign, Pfizer will not seek authorisation for coronavirus vaccine until after US election

Pfizer said the company may know whether its vaccine is effective by the end of October, but won‘t have the safety data until the end of November

Move is a final blow to Donald Trump’s repeated pledges to make a vaccine available before Americans cast votes

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Pfizer’s comments on its timeline raise the possibility of US authorisation of a coronavirus vaccine this year. Photo: Reuters

Published: 11:28pm, 16 Oct 2020Updated: 1:05pm, 25 Nov 2020

This story is published in a content partnership with POLITICO. It was originally reported by Zachary Brennan on politico.com on October 16, 2020.

Pfizer will not seek an emergency authorisation for its coronavirus vaccine until after the election, the final blow to President Donald Trump’s repeated pledges to make a vaccine available before Americans cast votes amid the worst pandemic in a century.

Pfizer CEO Albert Bourla said on Friday that the company may know whether its vaccine is effective by the end of October, but won‘t have the safety data the FDA wants at least until the end of November. Amid rising concerns about political pressure on the agency, the FDA released guidance on emergency authorisations that requires vaccine developers to provide two months of safety data on half of the trial participants following the final dose of the vaccine.

“Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorisation Use in the US soon after the safety milestone is achieved in the third week of November,” Bourla wrote in an open letter.

Moderna, the other company with a vaccine in a late-stage trial with more than 20,000 enrolled, has also said it will not be ready to file for an emergency authorisation before the election. Other vaccines could be ready for FDA review late this year or early 2021, but not by November 3.