COVID-19 treatment pill: When will it be available, and where will it be available?
WASHINGTON - The Food and Drug Administration has now granted emergency use authorizations for two oral antiviral treatment drugs against COVID-19, Pfizer's Paxlovid and Merck's molnupiravir.
Under the emergency use authorization for Pfizer that came on Wednesday, the treatment is for oral use in adults and children 12 years or older who weigh at least 40 kilograms or about 88 pounds and who are at high risk for progressing to severe COVID-19.
However, availability of Paxlovid will be limited at first and the Department of Health and Human Services will begin allocating around 65,000 courses of treatment in the first week of January to all 50 states and territories, as well as government agencies and Health Resources and Services Administration-funded health centers.
According to the Department of Health and Human Services, the initial allocations were made on a pro rata basis, and are being delivered at no cost to state and territorial health departments.
FILE - Medicine pills are seen with the Pfizer logo in the background in this illustration photo taken in Krakow, Poland on Dec. 14, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)
For example, California will receive 6,180 courses, while Missouri, for example, will receive 980 during the first week of allocations.
The Department of Defense, Department of State, Immigration and Customs Enforcement, and the Indian Health Service will also receive allocations of the drug.
Two-hundred Health Resources and Services Administration-funded health centers will receive 9,750 courses of Paxlovid during the first week's allocation, which will help the department's focus on equity.
"State and territorial health departments will allocate product to dispensing sites across their jurisdictions, and the distributor will ship product directly to receiving sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments," the Department of Health and Human Services announcement states.
The department expects that the supply of Pfizer's Paxlovid will increase, as an additional 200,000 courses are expected in January, and shipments will occur every two weeks.
Pfizer announced in November that it would supply the U.S. government with 10 million treatment courses of Paxlovid between 2021 and 2022.
Merck said it expects to begin shipping pills to its distributor AmerisourceBergen within days. Merck has agreed to provide the U.S. government with 3.1 million courses.
According to the Food and Drug Administration, Paxlovid is only available through a prescription and should be taken as soon as possible following a diagnosis of COVID-19 and within five days of symptoms beginning.
"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," Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "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."
Paxlovid is not authorized for preventing COVID-19 before or after exposure, according to the Food and Drug Administration, and is not a substitute for the vaccination.
The Food and Drug Administration is encouraging Americans to receive the coronavirus vaccination if eligible, and it states that it prevents COVID-19 and serious illness from infection of the coronavirus.