Pfizer Is First Company to File to FDA For COVID-19 Vaccine Clearance

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Exclusive: Pfizer CEO Discusses Submitting the First COVID-19 Vaccine Clearance Request to the FDA

n Friday, Pfizer CEO and chairman Albert Bourla announced that the company has filed a request to the U.S. Food and Drug Administration for emergency use authorization of its, making it the first to do so. In a discussion on TIME 100 Talks, Bourla says that if the FDA authorizes the vaccine, the company will be ready “within hours” from receiving the green light to start distributing the vaccine.

Pfizer capitalized on a partnership begun in 2018 with German company BioNTech, which was founded by a husband-and-wife team of scientists with expertise in a genetic technology called mRNA. The platform is fast and flexible for developing vaccines, since it only requires knowing the genetic sequence of the virus the vaccine will target, rather than growing and manipulating the virus in question.

While he expressed concern about the skepticism and mistrust that many American have expressed about the COVID-19 vaccines, mostly because they were developed so quickly, Bourla says he hopes the completion of the election and the magnitude of the efficacy and safety data start to reassure people. “The problem is that this vaccine, and the pandemic in general, became the focal point of political debate,” he says. “It was discussed in political rather than scientific terms.

 

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