FDA To Make Decision On COVID-19 Pills From Merck, Pfizer: When Will They Be In NJ?

NEW JERSEY — 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, New Jersey 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 will be welcomed in New Jersey, where coronavirus cases are surging in many school districts and hospitalizations are on the rise. 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.

"The numbers themselves… they are going up and they are staying there," said Gov. Phil Murphy about an increase in COVID case numbers in the state during a news conference on Monday. "Note also a jump in the overall rate of transmission while holding steady over the past several days at 1.41 it still denotes a significant progression of the virus."

Murphy added that the "overwhelming numbers of these new cases are among the unvaccinated." He noted the additional stress on the healthcare system and the need for vaccinations.

"The one thing that we need know can not happen is we can not allow our healthcare system to get overrun. So every positive case we take very seriously," said Murphy. "We can afford high positive case numbers as a general matter but we can not breach the capacities in our hospitals. I say that as a numeric matter, never mind the fatigue in these institutions. The irresponsibility of not getting vaccinated among other fallouts are unnecessarily stressing nurses, doctors and healthcare staff. It just doesn't need to be that way."

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 the pill 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. "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."

— Additional reporting by Mark Hand

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