US FDA approvals for Pfizer COVID-19 vaccine could happen in November; CEO

By Rahul Vaimal, Associate Editor
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In an open letter to update the status quo on their COVID-19 vaccine candidate and its trials, Mr. Albert Bourla, CEO of American multinational drugmaker Pfizer was optimistic that his firm could seek the US Food and Drug Administration’s Authorization for Emergency Use for the proposed cure in November.

The Pfizer CEO stated that the firm could have sufficient data from its ongoing late-stage trials by the end of this month to know whether its coronavirus vaccine is effective against the COVID-19 virus or not.

The timeline contradicts the one shared by US President Donald Trump who was upbeat about the prospects of having a viable vaccine ready for inoculation before the US Presidential election date of November 3rd.

Earlier US FDA had mandated at least 2 months’ worth of COVID-19 clinical trial data from any drugmaker who seeks any form of approvals to use their COVID-19 vaccine candidate among the public.

Mr. Bourla stated that based on their current trial enrollment and dosing pace, the firm estimates to reach the necessary milestone of having enough data for submission by the third week of November.

Albert Bourla
Albert Bourla,
CEO – Pfizer

“First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards.”

Mr. Bourla updated that Pfizer is unaware of the identity of trial volunteers who have received the vaccine candidate or the placebo. He stated that a committee of independent scientists will review the complete clinical data and will inform the firm if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial.

CEO Albert Bourla believes that the US citizens could get COVID-19 vaccine dosages before the end of the year subject to clearance from the US FDA. Pfizer according to its CEO is prepares to distribute “hundreds of thousands of doses” as and when the approvals happen.