Big Pharma Success, Government Failure The U.S. ordered too few courses of the new and promising Covid pills.
First some good news to brighten the holidays: The Food and Drug Administration has approved two oral antiviral drugs for Covid-19. Now the bad news: They will be in short supply this winter.
On Thursday the FDA authorized Merck and Ridgeback Biotherapeutics’ Molnupiravir for adults at high risk of severe illness following its approval of Pfizer’s Paxlovid. Both will be available by prescription with proof of a positive Covid test and should be taken within five days of symptom onset.
Both drugs interfere with virus replication, though by different means. Molnupiravir was found to reduce hospitalizations by about 30% and deaths by nearly 90%. Early results from its trial showed a 50% reduction in hospitalization, though efficacy declined later for unclear reasons. Paxlovid reduced hospitalizations by about 90%.
Both drugs will make living with Covid easier, but they are likely to be rationed this winter. The Biden Administration ordered 10 million packs of Paxlovid in mid-November after strong preliminary trial results. But other countries have put in large orders, and Pfizer says it expects to manufacture 180,000 courses by the end of this year.
Pfizer has licensed the drug to the Medicines Patent Pool to ramp up supply in lower-income countries, but production can take six to eight months. Advance government orders like Operation Warp Speed for vaccines might have accelerated production.
As for Molnupiravir, the Administration has ordered a mere 3.1 million treatment courses. The U.K. has purchased 2.2 million courses for its 68 million citizens. Most U.S. courses will be available by the end of January, but the FDA says the drug should only be used when other authorized treatments aren’t accessible. or clinically appropriate. That may make doctors less likely to prescribe it.
Some experts are talking down Molnupiravir since monoclonal antibodies have shown higher efficacy. But many monoclonals have been blunted by variants including Omicron, and Molnupiravir would have been hailed as a breakthrough medicine before vaccines were available.
Vaccines appear to have reduced the Biden Administration’s urgency to approve and accelerate new treatments, especially antivirals. Officials failed to foresee how vaccine efficacy would wane over time and demand would plateau. They can’t be faulted for that. But they could have hedged by fast-tracking oral treatments, as Operation Warp Speed did by investing in multiple vaccine makers using different technology.
The National Institutes of Health bet heavily on monoclonals, which have been enormously helpful. But it overlooked the importance of other drugs for early treatment to prevent infected individuals from getting sicker.
Pfizer, Merck and Ridgeback have put their own capital at risk for trials and production. But other manufacturers have had little financial incentive to fund large trials on repurposed drugs whose patents have expired. Only this spring did NIH announce that it would fund a large trial on such repurposed drugs as the anti-parasite ivermectin, anti-depressant fluvoxamine and asthma inhaling fluticasone. The results still aren’t in.
Vaccines have saved hundreds of thousands of lives, but many more would be saved if oral treatments like Paxlovid and Molnupiravir were available sooner. The drugs represent a huge pharmaceutical success but a missed government opportunity.
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