Pfizer confirms possible application of COVID vaccine in November

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Pfizer Inc. said it could apply for emergency use authorization for its COVID-19 vaccine in the United States by the end of November if the vaccine proves effective in a large late-stage trial.Safety reviews will dictate the timing, with the Food and Drug Administration requiring that at least half of people in the study be monitored for two months for side effects. This milestone is expected to be reached during the third week of November, Pfizer CEO Albert Bourla said in an open letter posted to the company’s website on Friday.

“Let me be clear, assuming positive data, Pfizer will apply for emergency clearance in the United States shortly after the safety milestone is reached,” Bourla wrote. A first reading of whether the vaccine is working could come later this month, depending on how quickly the trial subjects – some of whom have received a placebo vaccine – are infected with the virus.

Shares of Pfizer rose 2.5% in pre-market trading in the United States.

Although Bourla’s letter dispels any notion that a vaccine could be cleared for emergency use in the United States before election day – a goal President Donald Trump had been pushing for – the Pfizer CEO’s timeline could give the president a partial victory. If Pfizer is able to say at the end of October that the data shows his inoculation is protecting people from the virus, that could allow Trump to claim that his administration was successful in pushing for a working vaccine by the 3rd. November, whether the FDA reviewed it or not.

Other tests

The American company and its German partner BioNTech SE are on the way to being the first to show the effectiveness of a Covid-19 vaccine. They and the rival vaccine developers are working under a microscope, with almost unprecedented public interest in every detail of their clinical trials. Eli Lilly & Co., Johnson & Johnson, and AstraZeneca Plc have had studies of possible vaccines or treatments delayed due to safety concerns.

The letter confirmed a timeline set by BioNTech CEO Ugur Sahin this week. The partners did not have to stop their late-stage study on security issues, Sahin said.

A group of leading scientists had previously urged Pfizer to wait until at least the end of November before applying for an emergency clearance.



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