eClinical Technology and Industy News

Pfizer Covid Vaccine Faces Hurdles After FDA Filing Friday

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Pfizer Inc. and BioNTech SE requested emergency authorization of their Covid vaccine on Friday, and it could take at least three weeks for a U.S. Food and Drug Administration decision as trial data is probed by agency staff and outside advisers.

Shown to be 95 percent effective and without any major safety issues, their vaccine could be the first to be cleared for use, but first it must undergo a thorough vetting. The filing could enable its use by the middle to the end of December, the companies said in a statement.

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