FDA Authorizes Pfizer, Merck COVID-19 Pills | Jackson Free Press | Jackson, MS

FDA Authorizes Pfizer, Merck COVID-19 Pills

The U.S. Food and Drug Administration approved Pfizer's new COVID-19 pill, dubbed Paxlovid, which will be available by prescription only to patients ages 12 and older. Photo by Volodymyr Hryshchenko on Unsplash

The U.S. Food and Drug Administration approved Pfizer's new COVID-19 pill, dubbed Paxlovid, which will be available by prescription only to patients ages 12 and older. Photo by Volodymyr Hryshchenko on Unsplash

Two new oral medications for fighting COVID-19 will soon be available for Mississippians fighting against the fast-spreading omicron variant, thanks to emergency use authorizations for each pill this week from the U.S. Food and Drug Administration.

Pfizer’s new COVID-19 pill, dubbed Paxlovid, will be available by prescription only to patients ages 12 and older. The FDA noted that the new oral treatment should be used as soon as possible after diagnosis, and within five days of symptom onset.

“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the Dec. 22 FDA press release. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

The FDA notes that Paxlovid should not be taken for pre-exposure to the virus, and is not a replacement for vaccination. The EUA allows for distribution of 3.1 million courses of the anticovid pill, taken as three pills given twice each day over five days.

One day later, the FDA approved Merck’s new oral treatment, molnupiravir. This medication is for use in patients over eight years of age and when other COVID-19 treatments are not readily available.

Evidence from clinical trials suggests that Paxlovid is significantly more effective at preventing severe disease than Molnupiravir. But although Paxlovid’s effectiveness appears higher, supply issues may result in limited availability of the Pfizer pill, especially in the case of another huge wave of COVID-19.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally,” Cavazzoni said in the FDA’s Dec. 23 press release. “Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death. As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”

Certain risks of side effects mean that pregnant women should consult their healthcare provider before taking molnupiravir.

Email Reporting Fellow Julian Mills at [email protected].

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