FDA To Consider COVID-19 Pills As Hospitalizations In MD, Nationwide Rise

MARYLAND — The U.S. Food and Drug Administration is preparing to make decisions on COVID-19 pills from Merck and Pfizer, clearing the way for millions of Americans to pick up treatments for the coronavirus at their local pharmacy.

FDA approval could come for both pills by the end of this month. Once approved, Maryland doctors could immediately order the pills directly from medical distributors for their patients.

At least initially, the federal government will put caps on the number of pills physicians can order for their patients.

That approval can't come soon enough in Maryland, where the number of hospitalized COVID-19 patients doubled in the last month. In Pfizer's studies, adults taking the company's drug had a 10-fold decrease in virus levels compared with those on placebo — enough to possibly keep them out of the hospital.

There will be other challenges to maximizing the effectiveness of the drugs. Patients will have to take 30 to 40 pills in a five-day period, and they will need to begin treatment within three days after they are infected.

Health experts worry high-risk patients infected with COVID-19 may not be able to get tested and treated in that three-day timeframe. Studies of a similar drug used to limit the impact of influenza show that only 40 percent of high-risk patients got diagnosed within the three-day window to begin treatment.

Both pills have limited the severity of coronavirus cases, cutting hospitalization and death rates. Study results for the Pfizer pill, which were released Tuesday, showed it reduced combined hospitalizations and deaths by about 89 percent among 2,250 high-risk adults when taken shortly after initial COVID-19 symptoms. That was better than the Merck pill, which reduced hospitalizations and deaths by 30 percent in high-risk adults and was submitted for final FDA approval late last month.

"This is truly a game changer," Dr. Daniel Griffin, an expert on infectious diseases and immunology at Columbia University, told CNN of the COVID-19 antiviral pill. "This is up there with vaccines. It's not a substitute for vaccines; we still want to get people vaccinated. But, boy, this is just another great tool to have."

See Also:

• Pfizer Confirms COVID Pill's Results, Potency Versus Omicron
• Over 1K Hospitalized In MD With COVID-19, Officials Say