Pfizer completes safety review for COVID-19 vaccine, will apply for FDA approval

Pfizer completes safety review for COVID-19 vaccine, will apply for FDA approval


Pfizer has completed a safety review of its COVID-19 vaccine and will now be applying for emergency approval from the FDA, the drugmaker’s CEO said Tuesday.

“Our safety milestone has been achieved already, and we are preparing now for submissions,’’ company exec Albert Bourla said, according to CNN.

“I think the questions about the safety at large also have been answered.’’

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Pfizer last week announced that its vaccine appears to be more than 90 percent effective based on a late-stage trial and that the company was on the verge of collecting enough safety data to seek a fast-track approval from the federal government.

Enough data has now been collected to move forward, Bourla said.

The Trump administration has vowed to move as quickly as possible on approving coronavirus vaccines, including Pfizer’s and another developed by Moderna, which appears to have a nearly 95 percent effective rate and could be submitted for review by the US Food and Drug Administration

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