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Pfizer Files COVID-19 Vaccine Application to FDA

Friday, November 20, Pfizer applied to U.S Health Regulators for emergency use of authorization of its COVID-19 vaccine.

Pfizer CEO Albert Bourla announced that the companies filed for an emergency use authorization with the US Food and Drug Administration later that day, soon after announcing that the vaccine was found to be 95% effective at preventing COVID-19 in a late-stage trial.

The FDA said it would hold a meeting of the advisory committee on Dec. 10 at which members would discuss the vaccine.

The agency declined to predict how long its review would take, although both Pfizer and U.S. Health Secretary Alex Azar has said the FDA could authorize the vaccine in mid-December.

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