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
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…
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