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www.fdanews.com/articles/205953-short-supply-limits-access-to-newly-authorized-covid-19-oral-pills

Short Supply Limits Access to Newly Authorized COVID-19 Oral Pills

December 28, 2021

Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year.

This even though the U.S. government has placed a $5.3 billion order for 10 million treatment courses of Paxlovid (nirmatrelvir, ritonavir) for shipments to states through 2022 and a $2.2 billion order for an estimated 3 million treatment courses of molnupiravir for delivery through early next year (DID, Dec. 23).

It is not yet clear how the new oral antivirals will be priced for the commercial market.

Jeffrey Zients, White House COVID-19 Response Coordinator, acknowledged in a press briefing that deliveries will be slow to start, especially for Pfizer’s Paxlovid.

“We will have 265,000 treatment courses of Pfizer available in January, with monthly totals of pills ramping up across the year and all 10 million treatment courses delivered by late summer,” said Zients, adding that by contrast at January’s end he anticipates the federal government will be able to deliver all 3 million molnupiravir treatments.

But experts and public health officials have expressed concerns that these numbers will not be enough to turn the tide of infection, especially with COVID-19 monoclonal antibodies from Eli Lilly and Roche/Regeneron showing diminished effectiveness against Omicron.

Zients admitted as much during last week’s White House briefing, saying that from “the moment we learned of Omicron, we began assessing our existing monoclonal antibody treatments, and we learned that two of the three existing treatments are not effective against the new variant.”

The government has doubled its supply of GlaxoSmithKline’s COVID-19 monoclonal antibody, sotrovimab, which has demonstrated effectiveness against the new variant, to more than 1 million treatment courses. But it will only be able to supply 300,000 treatment courses in January.

The government has suspended allocations of Eli Lilly’s antibody cocktail, bamlanivimab and etesevimab, etesevimab alone and Regeneron’s REGEN-COV pending new data from the Centers for Disease Control and Prevention on their effectiveness against Omicron. ― Jason Scott