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While research through the firm found symptoms of a covid “rebound,” the drug reduces hospitalizations and deaths, the researchers said.
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By Carl Zimmer and Christina Jewett
A Food and Drug Administration (FDA) advisory panel on Thursday approved Paxlovid as a remedy for adults with covid who are at the highest risk of progressing to severe illness. This resolution will likely lead to full approval of the drug, which will be used in an emergency. authorization.
The 16-1 vote came after the company published a new study showing that Paxlovid reduced hospitalizations and deaths among vaccinated and unvaccinated people. The company’s researchers estimated, based on covid rates in January, that Paxlovid could “result in 1,500 stored lives and 13,000 hospitalizations averted per week in the United States. “
“I would say that, besides oxygen, Paxlovid has probably been the most vital treatment tool in this outbreak and continues to be so,” said Dr. Richard A. Murphy, infectious disease leader at White River Junction Veterans Medical Center in Vermont. In explanation of vote in favour of the remedy.
Consumers have mainly become involved through reports that other people taking the drug are experiencing a Covid “rebound,” in which symptoms return a few days after disappearing. The research uncovered evidence of rebound among patients who received the treatment, but knowledge also showed that some Covid patients who did not receive Paxlovid also experienced a rebound.
The firm concluded that there was no significant difference in rebound rates between the two teams and that rebounding had no effect on the risk of developing serious illness. At Thursday’s expert meeting, Dr. Stephanie Troy, an FDA researcher. She cautioned that Covid rebound “may naturally be part of the clinical course of Covid-19 in a small subset of patients,” whether or not they are taking Paxlovid.
Currently, only one antiviral drug, remdesivir, is fully approved by the F. D. A. Its use is limited, since patients will have to go to a clinic to receive infusions 3 days in a row. Paxlovid, a pill, can be taken at home for five days. .
Representatives for Pfizer, the maker of Paxlovid, said Thursday that the company continues to administer the drug in immunocompromised or pregnant patients, as well as for the prevention of prolonged Covid.
Another pill, molnupiravir, also has an emergency use authorization as a treatment against covid. But considerations have been raised about its effectiveness, prompting European regulators to advise against its approval there.
In Japan, the antiviral pill, called Xocova, has emergency approval. The drug is in a clinical trial in the United States.
The FDA granted emergency use authorization for Paxlovid in December 2021 with initial knowledge of a clinical trial. In this trial, other unvaccinated people who were at higher risk of contracting severe covid (other people over 60 or suffering from diseases such as diabetes) experienced an 88% relief in their threat of hospitalization.
Pfizer continued this trial and others. In one study, participants were vaccinated and high-risk, or unvaccinated and low-risk. In the most recent analysis, Paxlovid reduced hospitalizations and deaths by 86% of unvaccinated high-risk people.
Among high-risk Americans who were vaccinated, relief was 58%. People who gained immunity to a previous infection also noticed a reduced risk after taking Paxlovid.
The rebound phenomenon drew attention after patients, such as President Biden and Dr. Anthony Fauci, took the drug, tested negative for Covid, and then, a few days later, retested.
The FDA found that a small fraction of other people who took Paxlovid experienced a rebound, as did those who took a placebo. In one trial, they estimated that 8. 3% of other people who took Paxlovid tested positive after an initial negative test, with 5. 7% of patients gaining placebo.
However, the rebound noted in those taking Paxlovid was not linked to longer illness or worsening of symptoms.
“It’s good to know this phenomenon exists, but knowledge shows us that, in a real clinical sense, it doesn’t have much effect on the surface of patients,” said Adi Shah, M. D. , an infectious disease specialist at Mayo Clinic Center who was not on the review committee.
Since December 2021, when Paxlovid won the Emergency Use Authorization, the federal government has delivered more than 12. 5 million doses nationwide. At the advisory meeting, Pfizer said 10 million doses had been taken in the U. S. 14 million worldwide.
However, adoption has been slower than expected. A fear is similar to drug interactions taken by older adults. The F. D. A. Analyse also assessed this problem.
The agency’s researchers found that a “significant” proportion of patients eligible for Paxlovid also take medications (to lower bad cholesterol or to treat high blood pressure) that can lead to interactions. won 147 reports of hospitalizations and six deaths from drug interactions with Paxlovid.
“Drug interactions are a concern” that requires ongoing attention, Dr. Brown said. Lindsey Baden of Harvard Medical School and chair of the expert panel.
Apoorva Mandavilli contributed to the report.
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