Here’s How New Oral COVID-19 Medications Are Being Distributed After EUA
The Food and Drug Administration has granted emergency use authorization for two near oral COVID-19 medications. But when will Molnupiravir and Paxlovid, both authorized for the treatment of mild to moderate COVID-19 with some differences in specifications, be available to pharmacies? Here is information from federal officials and the manufacturers.
WASHINGTON, DC—A few pharmacies received shipments of new oral medications for COVID-19 during the holiday season, but, so far, most are left urging forbearance for novel coronavirus patients seeking them out.
On Dec. 23, 2021, the Food and Drug Administration (FDA) granted Emergency Use Authorization to Merck for its oral antiviral drug Molnupiravir and to Pfizer for its oral antiviral drug Paxlovid, both to treat COVID-19.
Molnupiravir is authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe cases and for whom alternative treatment options are not accessible or clinically appropriate. Paxlovid (nirmatrelvir/PF-07321332 and ritonavir) is authorized for the treatment of mild to moderate COVID-19 in adult and pediatric patients 12 and older weighing at least 40 kg, with positive SARS-CoV-2 tests, who are at high risk for progressing to severe COVID-19, including hospitalization or death.
Distribution of the drugs are being overseen by the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
HHS has said it has purchased about 3 million courses of Molnupiravir. An initial 300,000 courses of Molnupiravir was made available for shipment to states and territories and begann arriving at dispensing sites by the end of December.
The federal government also has purchased a total of 10 million courses of Paxlovid. HHS cautions that availability will be limited at first but will increase significantly in the coming months. An initial 65,000 courses of Paxlovid were made available for shipment to states and territories and began arriving at dispensing sites by the end of December.
With both of the drugs, Initial allocations were determined on a pro rata basis and will be provided to state and territorial health departments for free. Once received, state and territorial health departments are tasked with allocating product to dispensing sites, including pharmacies, physicians’ offices, clinics, hospitals, urgent care centers, and local health departments.
In order to ensure equity, about 15% of the total availability of the drugs will be provided directly by HHS to a subset of 200 Health Resources and Services Administration (HRSA)-funded health centers across all 50 states. That allocation will be separate from the pool of products allocated to states and territories and will focus on increasing equity for vulnerable areas with hard-hit populations.
“The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives,” said Robert M. Davis, chief executive officer and president, Merck. “Because we recognized the promise of molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that molnupiravir, now authorized, can be available to patients here in the U.S. and all around the world more quickly and more equitably than has ever been accomplished before,”
Merck said after EUA was granted that it anticipates shipping molnupiravir to AmerisourceBergen, the sole distributor of molnupiravir, within days. Merck entered into a procurement agreement with the U.S. government and has agreed to supply approximately 3.1 million courses of molnupiravir upon EUA from the FDA.
“Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”
In November, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of Paxlovid, with delivery fulfillment expected to be completed in 2022.