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Dec. 22, 2021 – FDA Grants Emergency Use Authorization for Pfizer’s Paxlovid

 

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Paxlovid, which is an oral antiviral treatment for COVID-19 manufactured by Pfizer. The EUA for Paxlovid authorizes its use for the treatment of adults and children over the age of 12 with mild-to-moderate COVID-19 who are at high-risk of severe COVID-19. This EUA represents the first oral treatment for COVID-19 that has been authorized by the FDA. In the EPIC-HR clinical trial, this treatment reduced the incidence of COVID-19 related hospitalization and death by 88 percent compared to placebo. Among the clinical trial participants, 0.8 percent who received Paxlovid died or were hospitalized within 28 days of receiving the treatment, while 6% of the placebo group died or were hospitalized. Side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure, and muscle aches. One of the ingredients of Paxlovid, ritonavir, may cause liver damage, so health care providers should exercise caution when prescribing Paxlovid to patients with pre-existing liver issues. Paxlovid is not recommended for patients with pre-existing kidney issues. Paxlovid is administered as three tablets taken twice a day for five days.

The full EUA can be accessed here.

Pfizer’s press release can be accessed here.

FDA Grants Emergency Use Authorization for Merck’s Molnupiravir

On December 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for molnupiravir, which is a treatment for COVID-19 manufactured by Merck. The EUA for molnupiravir authorizes its use for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 and who are unable to utilize alternate treatment options.

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