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October 16, 2020

Pfizer plans to submit Covid-19 vaccine for FDA approval in late November

By Allie Nawrat

In an open letter, the CEO and chairman of Pfizer Albert Bourla has laid out the company’s timeline for submitting its Covid-19 vaccine candidate to the US Food and Drug Administration for approval or emergency use authorisation.

Pfizer’s Covid-19 vaccine candidate relies on mRNA technology and is being developed alongside German BioNTech. The vaccine is currently being studied in a global Phase II/III study.

“Assuming positive [efficacy, safety and manufacturing] data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” wrote Bourla in the letter.

This means that Pfizer’s Covid-19 vaccine will not be approved before the US election on 3 November. President Donald Trump has been pushing hard over the past few months to have a vaccine approved in time for the election.

In late September, the CEO of Moderna stateed that his company’s mRNA Covid-19 vaccine would also not be submitted for approval until after the US election, at a Financial Times‘ event.

The aim of Bourla’s announcement was  to foster trust among the public about the safety of Covid-19 vaccines; many studies have suggested that vaccine hesitancy is high globally and there are concerns that the Covid-19 vaccines have been rushed. Bourla wrote: “To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas [safety, efficacy and manufacturing].”

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