COVID-19: Pfizer 'will apply for Emergency Authorization use' of vaccine after US polls

On October 16, the pharmaceutical firm Pfizer Inc announced that it could file for authorization of the COVID-19 vaccine in the US after its safety data arrives in the third week of November, making clear that it is unlikely that the coronavirus vaccine it’s developing with German partner BioNTech will be available before November 3 US presidential election. This comes as the US Food and Drug Administration made at least two months of safety data a protocol to approve any COVID-19 vaccine for emergency use authorization. 

In an Open Letter, Pfizer Chairman and CEO Albert Bourla said, while millions of population and the governments globally were investing their hopes in a safe and effective COVID-19 vaccine to overcome the pandemic, he would like to clarify about development timelines. Pfizer’s and partner BioNTech’s COVID-19 vaccine focuses on critical public health considerations to ensure safe development and approval, Bourla said in his statement.

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“We are operating at the speed of science,” CEO Bourla said, adding, “We must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo”.

“So let me be clear, assuming positive 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,” Pfizer CEO reiterated. 

Safety remains a top priority

Further, the Pfizer chairman added that a committee of scientists will first review data at key interim analysis points and when the company achieves the final analysis point of the trials that determine the vaccine’s effectiveness with respect to safety and efficacy, the results would be submitted. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November,” Pfizer informed, adding, safety remains a top priority, and the firm will continue to monitor safety data for all trial participants for over two years. The company added that the timeline reflected the best estimate of vaccine availability as it has to be thoroughly studied by the FDA’s own scientists and an expert panel before it is made available to the American people. 

[Albert Bourla, chief executive officer of Pfizer. Credit: AP]

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