FDA To Consider COVID-19 Pills: When They Could Be Available In Florida

FLORIDA — 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. Florida doctors could then 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 Florida, which is home to over half a million people age 85 and up — the age group the most likely to get very sick from COVID-19, according to the Centers for Disease Control and Prevention.

In Pfizer's studies, adults taking the its COVID-19 drug had a 10-fold decrease in virus levels compared with those who took a 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
• 1st Case Of Omicron Variant In Florida Confirmed In Tampa
• What's Going Around FL? Flu, 'Super Cold,' COVID-19