U.S. Clears Merck’s Covid Pill as It Weighs How to Ration Pfizer
(Bloomberg) -- The U.S. has cleared its first two Covid-19 treatment pills, and now comes another hurdle -- deciding who should get which one.
Merck & Co.’s molnupiravir was authorized Thursday by the Food and Drug Administration for use in adults at high risk of severe cases who have no other treatment option, though it is not recommended for pregnant women. Still, the U.S. will soon have 3 million courses available.
Meanwhile, Pfizer Inc.’s Paxlovid -- authorized earlier this week --showed stronger clinical trial data with President Joe Biden hailing the pill as “a promising new treatment.” It will be available in limited quantities at first as Pfizer grinds through a months-long manufacturing process.
Regulators are signaling they prefer Pfizer’s pill, which they’ve bought more of, but the U.S. will have a lot more early on of Merck’s pill, which regulators say is better than no treatment. The coming weeks will see states and physicians hash out who gets what.
The U.S. will have hundreds of thousands of Merck courses available immediately, and 3 million by the end of January, or roughly its entire order, the government has said. Conversely, the U.S. is expected to receive just 265,000 courses of the Pfizer treatment by the end of January, up to 2 million a month by spring and a total of 10 million by July. The initial shipment is just 65,000 courses, or about 3,180 for New York, for instance.
Biden, speaking to ABC News this week, acknowledged that the Pfizer supply “won’t be enough to get to all the hospitals” at first but that the government has ordered all that Pfizer can make so far. “If people get the shots, they get their two shots and a booster, they’re not going to be in a position where they actually need such a pill,” he said.
The National Institutes of Health’s guidelines committee is putting together a list of recommendations on how to allocate treatments, and the U.S. government will distribute the pill through channels that have been used for existing treatments -- sending them on a per-capita basis to states while also sending them to other entities, like federally qualified community health centers, in a bid to minimize any race gap in availability.
But it will ultimately be up to doctors to prescribe who gets Paxlovid at first and who gets an alternative like the Merck drug.
“It almost certainly will be a physician writing a prescription for someone who’s within the first three days of notable symptoms of Covid, and is in a high-risk group to get it,” Anthony Fauci, Biden’s chief medical adviser, said Wednesday, before the Merck authorization. “It’s, obviously, a very difficult situation when you have a limited supply.”
Celine Gounder, a physician who advised Biden’s transition team on Covid, said she believes Merck’s pill has “limited utility” and is worried about a shortage of Pfizer. Even if doctors prioritize Paxlovid’s use for seniors with underlying medical conditions, for instance, “I am very concerned about the lack of supply. It’s not nearly enough to meet the need,” she said.
The NIH recommendation will also weigh whether another treatment may be more appropriate, Fauci said, such as Merck, remdesivir or a monoclonal antibody. The recommendation will target the most high-risk, which “is what you want this to be for, since we have a limited supply, that we would have a prioritization of what the best approach would be,” Fauci said.
Molnupiravir, developed with partner Ridgeback Biotherapeutics LP, was authorized by the FDA Thursday morning for use in some cases. Merck is to be used among adults, and not among pregnant women, and for people “for whom alternative COVID-19 treatment options authorized by FDA are not accessible,” the agency said, a much narrower window of eligibility than it set for Pfizer.
There may be situations in which Merck’s drug might be more appropriate for a patient than Pfizer’s, said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “It is a question of availability, but it’s also a question of appropriateness of the patient for the specific drug,” Cavazzoni said.
In a clinical trial, Pfizer’s pill showed an 89% reduction in hospitalization for patients who received the medicine within three days of developing symptoms, compared to patients who got a placebo. None of the patients treated with the drug died. Merck’s latest trial results showed that its pill reduced the risk of hospitalization or death among adults with mild-to-moderate disease by 30%. That was less than a previous estimate of 48%.
Production of Pfizer’s pill takes six to eight months, according to Jeff Zients, Biden’s Covid-19 response coordinator. “So, supply of this product will ramp up over the next several months,” he said. The U.S. has offered Pfizer help, including wartime powers of the Defense Production Act, but the company hasn’t yet needed it.
“Unfortunately, it is really a quite complicated and complex synthetic process,” Fauci said of the Pfizer manufacturing process. “Hopefully we’ll be able to shorten that process by working closely with them.”
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