So much for having a plan, eh? Merck today formally submitted an application for an emergency-use authorization for molnupiravir, its new COVID-19 treatment that shows significant promise, both therapeutically and prophylactically. The FDA will review the Phase 3 study data but is widely expected to approve it, giving doctors their first oral medication to stop the progress of an acute infection:
Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would be the addition of a new and easy-to-use weapon to the world’s arsenal against the disease.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.
An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload in U.S. hospitals and helping to curb outbreaks in poorer countries with weak healthcare systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations. …
Merck and its partner, Ridgeback Biotherapeutic, said they specifically asked the FDA to grant emergency use for adults with mild to moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.
An EUA would unlock the doses Merck has already produced for immediate use, but that’s only 1.7 million doses. Given the necessity of treatment over the winter in cold-weather states, that inventory might not even get us through to Thanksgiving, or possibly Halloween. Merck will likely ramp up production significantly after the FDA approves the EUA request, but Scott Gottlieb asks the obvious question. Why didn’t the government spend the money to buy doses in advance in order to be fully prepared at approval?
"We are dose limited between now and the end of the year," says @ScottGottliebMD on Merck oral COVID anti-viral drug. "My lament is that manufacturing should have been sitting there hot, waiting for this–it's not a Merck problem. This is really the government." pic.twitter.com/Q3LG0uO8zE
— Squawk Box (@SquawkCNBC) October 11, 2021
Indeed it is, and it’s all the more obvious in the success of Operation Warp Speed. Donald Trump and his administration did not wait for Phase 2 testing to start funding vaccine candidates; they threw an enormous amount of money into buying hundreds of millions of doses on spec at the very beginning of the process. They treated the vaccines like a weapons system in a time of war, which is very much what they were. That model accepts losses from development failures in exchange for funding innovation and getting weapons as fast as possible to compete against threats. Operation Warp Speed’s model should have been used with testing as well — a failure in both the Trump and Biden administrations — but the vaccines are a nearly miraculous proof of concept.
In fact, it was so successful that it’s almost unthinkable that the Biden team didn’t follow the model for therapeutics. True, they bought 1.7 million doses up front, but as Gottlieb points out, that’s hardly sufficient even for the front end of the anticipated winter wave. We should have bought tens of millions up front, both for immediate on-hand inventory and to fund Merck’s efforts to have manufacturing ready at the scale necessary on Day 1 for molnupiravir. Instead, Merck will have to scale up after the EUA, which could take weeks or months more, in order to produce the supply necessary to treat and resolve COVID-19 cases in at-risk patients. Priming the pump could have saved a significant number of lives, or at least relieved pressure on demand for infusions of regeneron, which is resource intensive as well as expensive.
It’s yet another example of the lack of strategic or even tactical thinking in the Biden administration. And once again, that lack could end up costing lives.