“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic.”

-Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research

On Wednesday, Dec. 22, 2022, the Food and Drug Administration (FDA) issued emergency use authorization for an antiviral pill intended to help treat COVID-19 cases.

Paxlovid, manufactured by Pfizer, is the first antiviral COVID-19 pill authorized for at-home use. According to the FDA, individuals ages 12 and up—weighing at least 88 pounds—should take the prescription-only pill as soon as they are diagnosed with COVID-19 and “within five days of symptom onset.”

The intention is to take the pill before getting sick enough to require hospitalization.

According to data released by Pfizer, Paxlovid treatment cut the risk of hospitalization or death by 88% among high-risk unvaccinated individuals when administered a few days after seeing symptoms.

What’s Next?

The antiviral pill, Paxlovid, has been authorized for use among individuals ages 12 and older who weigh at least 88 pounds. The pill is currently only available through a prescription.

In its statement, the FDA stressed the following points about the antiviral pill:

• It is NOT a substitute for vaccination.
• It is NOT authorized for COVID-19 pre- or post-exposure prevention.
• It is NOT a substitute for treatment among those who need hospitalization.

In other words, the FDA continues to urge all eligible Americans to get vaccinated against COVID-19. Paxlovid treatment is only intended to help reduce the seriousness of COVID-19 infections, not prevent infection in the first place.

Individuals can learn more about COVID-19 vaccines, boosters and the new antiviral pill on the FDA’s website. Anyone who has questions specific to their unique health needs should consult with their primary care physician for guidance.

The content of this News Brief is of general interest and is not intended to apply to specific circumstances. It should not be regarded as legal advice and not be relied upon as such. In relation to any particular problem which they may have, readers are advised to seek specific advice. © 2021 Zywave, Inc. All rights reserved.