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

On October 16, pharmaceutical firm Pfizer Inc anunced that it could file for authorization of COVID-19 vaccine in US after its safety data arrives in third week of vember, making clear that it is unlikely that coronavirus vaccine it’s developing with German partner BioNTech will be available before vember 3 US presidential election. This comes as US Food and Drug ministration me 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 governments globally were investing ir hopes in a safe and effective COVID-19 vaccine to overcome 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 speed of science,” CEO Bourla said, ding, “We must accumulate a certain number of COVID-19 cases in our trial to compare effectiveness of 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 U.S. soon after safety milestone is achieved in third week of vember,” Pfizer CEO reiterated. 

Safety remains a top priority

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

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

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