The antiviral COVID-19 drug Paxlovid should receive full Food and Drug Administration approval to treat older adults at high risk for severe outcomes, the FDA’s advisers agreed in a Thursday meeting.
Paxlovid, delivered as a pill, was authorized for emergency use in 2021 for people aged 12 and older. The panel of outside experts voted 16 to one that the drug be approved only for vulnerable adults aged 50 years and older, as requested by its maker, Pfizer, Reuters has reported.
The decision hinged on Pfizer’s clinical trials, in which the drug reduced the rate of hospitalization and death from COVID-19 by nearly 90%. Later studies have found evidence showing that it may be most effective in people at relatively higher risk of hospitalization, including those with chronic disease and who are immunocompromised.
Studies back efficacy
In a study published March 15, the drug was 80% effective in preventing hospital admission or death within 30 days after a positive test for people who received it within five days of symptom onset. And an Israeli investigation published in June 2022 found that both vaccinated and unvaccinated seniors with COVID-19 have lower rates of hospitalization and death when taking the pill.
Another recent study of 44,000 non-hospitalized adults found that, although the overall risk for hospitalization or death for study participants was already very low (1%), Paxlovid reduced that risk by another 44% in patients who were given the drug. In that study, from Brigham and Women’s Hospital in Boston, those patients tended to be older, have more comorbidities and to be vaccinated than those who were not treated with the drug.
Rebound concerns
A standing concern among the drug’s recipients is a rebound in symptoms that has been reported to occur in some patients. The authors of an analysis cited in an FDA briefing document to the voting panel concluded that this effect appears to be the normal course of the disease. Rebound “may occur as part of the natural progression and resolution of COVID-19 disease, irrespective of Paxlovid treatment,” they concluded.
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