On June 15, Pfizer announced that research found that Paxlovid, a COVID-19 tablet, did not significantly reduce the risk of hospitalisation or death in people with a typical risk of acquiring serious infections.
The findings could mean that the antiviral is only used in high-risk patient groups when it has been proven to be effective.
Pfizer announced that enrollment in the study of standard-risk patients would be halted after Paxlovid revealed a “non-significant” 51 percent risk reduction.
The results will be incorporated into a full FDA approval application for the medicine in high-risk patients.Pfizer stated that the findings would have no impact on their sales forecast for the year 2022.
The FDA approved Paxlovid in December for the treatment of people who are at high risk of severe COVID sickness.
The Biden administration said in April that it would purchase 20 million courses of the medicine from Pfizer and set up a plan to distribute them to states, community health centres, and other physicians.
According to a new Israeli study, Paxlovid reduced hospitalizations for older patients but not for younger patients.
Pfizer announced a new Paxlovid study on clinicaltrials.gov this month, which would assess the drug’s safety and tolerability in a small group of pregnant women in their second or third trimester. A trial in children with Paxlovid is also being studied, and a trial in adults with impaired immune systems will begin soon.
Pfizer released preliminary findings from the research in December, suggesting that Paxlovid failed to relieve symptoms in so-called “standard risk” patients and did not reduce the risk of hospitalisation or death in a statistically meaningful way.
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