OpinionReview & Outlook Where Are the Next Covid Treatments? Biden’s bureaucracy is an obstacle, as vaccine immunity ebbs.
The worst of the Covid pandemic is over, but danger persists as new virus variants spread that may evade current vaccines and antibody treatments. Yet the Biden Administration is foot-dragging on treatment development and approvals needed to save lives.
The Administration wants Americans to get bivalent booster shots that target the BA.4/5 variants. While these Omicron descendants predominated over the summer and early fall, they have been overtaken in much of the U.S. by new variants that dodge antibodies from boosters, prior infection and monoclonal treatments.
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The Administration’s response has been to implore doctors to prescribe the antiviral Paxlovid. But many patients at highest risk for Covid can’t take the Pfizer drug because they have medical conditions or take drugs that could cause life-threatening interactions. One study found that half of hospitalized patients who die from Covid have a contraindication with Paxlovid. Some patients can temporarily stop taking other medications, but many can’t or would need to be weaned off them. Doctors could be sued if they prescribe Paxlovid to patients with contraindications who later have complications.
The FDA has authorized convalescent plasma for the immuno-compromised, but it is rarely administered because the National Institutes of Health’s clinical guidelines say there’s “insufficient evidence” to recommend it.
But studies have shown substantial benefit from a high-dose treatment when administered shortly after symptoms develop. The NIH and Defense Department helped fund a randomized controlled trial that found convalescent plasma reduced the risk of hospitalization by some 80% when given to patients within five days of symptom onset. Why bother funding studies if NIH ignores the results?
NIH’s resistance to convalescent plasma has perplexed some of the country’s top immunologists, who wrote to the agency last month pointing out its “logically inconsistent” position since it has recommended monoclonal antibodies based on much less evidence. Convalescent plasma “has virtually no contraindications,” “neutralizes the latest variants, adapts to the rapidly-evolving virus, and is desperately needed for immunocompromised patients,” the letter noted.
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The Biden health bureaucracy’s foot-dragging and confusing standards are also impeding new treatments. One example is the Food and Drug Administration’s refusal to consider an emergency-use authorization for a treatment called peginterferon lambda developed by the biotech company Eiger BioPharmaceuticals.
Peginterferon lambda stimulates the innate immune response, which is the body’s frontline defense against viral infections. Covid is dangerous in part because it blunts the body’s natural interferon response. Studies have found that healthy people who become severely ill with Covid harbor genetic mutations that impair their interferon response.
A large controlled trial found peginterferon lambda reduced the risk of hospitalization by 65% when given to patients within three days of symptoms and hospitalization, or death by 89% in unvaccinated patients—about the same as Paxlovid. The drug also has broad-spectrum antiviral impact that could make it effective against the flu, norovirus and other viruses.
Even the NIH noted this summer that “interferon treatment may improve COVID-19 outcomes,” especially in patients with certain genetic factors that impair their ability to clear viral infections. Yet Eiger says it was told by the FDA this fall that its trial results were unlikely to meet the agency’s standards for an emergency-use authorization “in the current context of the pandemic.”
The FDA suggested Eiger perform another large trial and eventually apply for regular approval. In other words, the FDA thinks Covid no longer represents an emergency—at least for authorizing new treatments. Yet in late August the agency authorized bivalent boosters for emergency use without any evidence from clinical trials.
Drug makers, researchers and healthcare providers have expressed exasperation with the Biden health bureaucracy. Numerous biotech start-ups are developing Covid antivirals, but the FDA has insisted their drugs be tested against the standard of care—meaning Paxlovid. But they say Pfizer won’t give them access to its drug to run trials.
Biotech companies working on monoclonal antibodies for immuno-compromised patients are also urging the FDA to authorize treatments based on smaller trials and lab tests such as those that the agency used to authorize vaccines for children. “We’re racing against the clock here,” a Regeneron official last month pleaded to the FDA. Robert Califf, the FDA chief, has been a great disappointment.
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The Administration might not feel the urgency to advance new treatments because its allies in public health and the media focus almost exclusively on vaccines. While the mRNA vaccines have reduced severe illness, their benefits have diminished with the evolving variants.
Biden officials blame Republicans in Congress, as they always do, but the Administration somehow found a way to repurpose some $5 billion from past Covid bills for bivalent boosters. Democrats ran Congress for two years. Why didn’t they appropriate more money for treatments?
We hope political hostility to the pharmaceutical industry isn’t deterring the collaboration that led to vaccine breakthroughs. As immunity ebbs, Americans are going to need more Covid treatments—and soon.
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