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Report: Pfizer’s COVID-19 vaccine may get full FDA approval Monday

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Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.
Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

The Food and Drug Administration is aiming to issue full regulatory approval of Pfizer/BioNTech’s COVID-19 vaccine as early as Monday, according to a report by the New York Times.

The regulatory agency had previously set an unofficial internal goal for issuing the approval by early September. Officials who spoke with the Times said that FDA officials were working to finish the approval Friday, but they were still going through paperwork and negotiations with the companies. The timeline could still slip past Monday if the process takes longer than expected, but the agency is on track to grant approval as early as next week, Politico reported.

Currently the Pfizer/BioNTech two-dose mRNA vaccine is being offered in the US based on an Emergency Use Authorization. So far, 200 million doses have been administered in the US alone. Though the vaccine has proven highly effective and safe, the full approval may convince some vaccine holdouts that the shot is, indeed, safe and effective. Previous polling by the Kaiser Family Foundation found that 31 percent of unvaccinated people would be more likely to get their shots if a vaccine earned full approval.

Pfizer and BioNTech submitted an application for full approval—or a Biologics License Application (BLA)—in May and in July the FDA fast-tracked the review of their application. According to the Times, the FDA is also reviewing the BLA for Moderna’s COVID-19 vaccine and approval could come in the following weeks.

In addition to potentially swaying holdouts, the full approval is expected to spur a wave of vaccination mandates—from hospitals, universities, and other employers. Mandates are generally highly successful at boosting vaccination rates. However, full regulatory approval is not necessary for mandates—and many employers have already issued them. In May, May 28, the federal Equal Employment Opportunity Commission determined that employers can mandate COVID-19 vaccination, given reasonable accommodations.

Still, the full approval will come as the country is facing a devastating surge in COVID-19 cases,  which is being driven by the hypertransmissible delta variant. Cases, hospitalizations, and deaths are on the rise—reaching record levels in many under-vaccinated states—and they are almost entirely among the unvaccinated. The surge is only expected to continue to worsen in coming weeks.

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