The authorization of the first medications to blunt the effects of a severe COVID-19 infection was expected to be a game-changer. However, the delayed scale-up in production means the antivirals will not be widely available until well after the destruction of the omicron surge.
The two antiviral medications from Pfizer and Merck — called Paxlovid and molnupiravir, respectively — were authorized by the Food and Drug Administration last month for people at high risk of developing severe infection due to COVID-19. Paxlovid was authorized for people 12 and older, while Merck’s treatment can only be prescribed to adults.
However, doctors and pharmacists say the courses of treatment sent to states so far are just a drop in the bucket. They argue the Biden administration should have planned better by purchasing more supplies and directing manufacturers to begin production in advance.
“To have Paxlovid before the omicron surge would have been really, really helpful, and I think when you look at the way the government had advanced purchase agreements with vaccine manufacturers, some of this should have been also thought about,” said Dr. Amesh Adalja, an infectious disease expert at Johns Hopkins Center for Health Security.
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Antiviral medications will be a powerful bulwark to keep the shaky medical system afloat amid record-high hospitalizations. But to be a game-changer, the medication must be accessible to those who qualify, such as the unvaccinated, the immunocompromised, the obese, and older adults who test positive for COVID-19. Millions of people in the early stages of infection would qualify for the antivirals, but limited supplies severely limit who can benefit from them.
The Biden administration has so far purchased 20 million courses of Paxlovid and enough molnupiravir for 3.1 million people. While the administration purchased those courses of molnupiravir in advance of authorization, it’s still not enough.
Merck’s treatments are expected to be available by the end of the month. However, Pfizer’s first 10 million doses are not likely to become available until the end of June, as the pills take about six to eight months to produce, according to the White House. Jeff Zients, the coordinator of President Joe Biden’s pandemic response team, said in December there would be “265,000 treatment courses of Pfizer available in January, with monthly totals of pills ramping up across the year.” The other 10 million courses of Paxlovid will come by the end of September.
“Because we’re still dealing with hospital capacity concerns, it is frustrating that there’s not enough of [the treatments] because if there were, if we could blanket high-risk populations with Paxlovid when they turn positive, this would really be a way to prevent hospitalizations and it would really make COVID a much easier-to-treat illness,” Adalja said.
Scientists were giddy when the FDA granted emergency use authorization to Pfizer for Paxlovid, which showed an 89% reduction in hospitalization for patients who received the medicine within three days of symptom onset compared with those who received a placebo. People who took the medication after five days also saw a high efficacy rate at 88%.
Meanwhile, Merck’s treatment had a much lower hospitalization and death risk reduction rate at about 30%. The FDA included an important caveat when it authorized Merck’s treatment, noting it should be administered “when alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.”
The Merck treatment will be one of the few available antiviral treatments to combat omicron for a while. Two of three monoclonal antibody treatments that worked against the delta variant have shown to be less effective at fighting severe infection due to omicron.
“There’s frustration in having limited therapeutics overall. Part of that is because of specific mutations, and part of that is because of manufacturing limitations,” said Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists, an organization that represents pharmacists who work in hospitals and ambulatory care centers.
To date, the federal government has made roughly 165,000 courses of Paxlovid and about 700,500 courses of molnupiravir available to states.
The uneven distribution of the limited antivirals means retail pharmacies, ambulatory clinics, and hospital-owned pharmacies frequently have to find out for themselves where the antivirals are available so they know where to send their patients.
“There’s frustration that individual states are determining where the drugs are being shipped,” Ganio said. “And in some states, it’s exclusively to the corner drugstores and community pharmacies, and in other states that include health systems.”
Unlike vaccines, which the Trump and Biden administrations ordered in bulk well before authorization from the FDA in late 2020, the federal government did not strike such deals with antiviral manufacturers. This put manufacturers behind the mark once the FDA granted those authorizations.
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“These are brand-new medications that were just approved with an emergency use authorization that take a long time to manufacture,” said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association. “If I’m a manufacturer before I have an authorization for these products to hit the market, how much of it am I going to make before I have an authorization?”
As more of these treatments become available, the United States can begin limiting hospital admissions. The daily average number of new cases reported has exceeded 800,000 last week, the highest total by far during the pandemic. The rate of new infections has dipped modestly since then, but the true number of cases is likely much higher than reported due to the number of infections diagnosed at home and not disclosed to public health officials.
