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FDA advisers vote in favor of Pfizer's COVID-19 pill Paxlovid 

The FDA’s panel of external advisers voted 16-to-1 in favor of the drugs, claiming that its benefits outweigh the risk for some adults with mild-to-moderate COVID-19

Covid-19
Covid-19 | Shutterstock

March 17, 2023 8:49am

Updated: March 17, 2023 8:49am

The Food and Drug Administration (FDA) advisers voted in favor of approving Pfizer’s COVID-19 pill Paxlovid as a treatment for the virus for adults at high risk of progressing to severe disease.

The FDA’s panel of external advisers voted 16-to-1 in favor of the drugs, claiming that its benefits outweigh the risk for some adults with mild-to-moderate COVID-19. The move will likely lead to the drug’s approval. 

“I’d say, besides oxygen, Paxlovid has probably been the single most important treatment tool in this epidemic and continues to be,” Dr. Richard A. Murphy, chief of infectious diseases at Veterans Affairs White River Junction Medical Center in Vermont, said.

The vote came after the agency released a new analysis showing that Paxlovid reduced hospitalizations and deaths among vaccinated and unvaccinated people.

Additionally, the FDA concluded that there are no significant differences in rebound rates between the two groups. The FDA determined that Paxlovid could be used for emergency treatment in December 2021 after Pfizer conducted a clinical trial.

During the trial, the pharmaceutical company determined that unvaccinated people at high risk of contracting COVID-19 saw an 88% reduction in their risk of hospitalization. Similarly, the hospitalization risk among those who were vaccinated fell by 58%. 

Pfizer said on Thursday that the company will continue to study the drug to determine whether it has any negative effects on patients who are pregnant or immunocompromised. 

Currently, only one antiviral drug, remdesivir, has full FDA approval to be used as a COVID-19 treatment.

However, its uses are limited because it requires patients to visit a clinic three days in a row to receive infusions. Another pill, molnupiravir, was also authorized as an emergency COVID-19 treatment, but concerns have been raised about its safety.