Some think we are too late to market for Covid. In
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Pfizer’s Covid-19 antiviral may end up hauling in more than $20 billion this year, and help keep many vulnerable people out of the hospital. But new data show the pill doesn’t hold up as well in vaccinated people as the unvaccinated.
Updated data from the company’s Phase II/III trial show the antiviral whiffed on its primary endpoint and offered a non-significant 51% relative risk reduction for hospitalization or death, with five of 576 on the pill in the trial ending up in the hospital or dying, compared to 10 out of 569 on placebo. Meanwhile, a sub-group analysis of 721 vaccinated adults with at least one risk factor for progression to severe Covid-19 and who were taking the course of Pfizer pills also failed to reach statistical significance.
“Due to a very low rate of hospitalization or death observed in the standard-risk patient population, Pfizer has decided to cease enrollment into EPIC-SR and include available data in this month’s planned New Drug Application (NDA) submission” to the FDA, the company said in a statement Tuesday.
Ultimately, the company said the data from standard-risk patients, both vaccinated and unvaccinated, while not all statistically significant, are supportive of efficacy data observed in a prior trial. But while Pfizer CEO Albert Bourla said in a statement that the totality of data on Paxlovid show that it’s beneficial as a “treatment of mild-to-moderate Covid-19 patients with at least one risk factor for progressing to severe Covid-19, regardless of vaccination status,” some physicians are questioning the benefits for those who are vaccinated.
The new data from Pfizer come as the US has been increasingly relying on the Pfizer pill to treat Covid-19 patients. According to HHS statistics on Paxlovid uptake, which are infrequently updated, states have now used as much Paxlovid from mid-May through today as they did from mid-December through mid-May. Part of that uptake spike has been due to an increase in supplies.
https://endpts.com/pfizers-paxlovid-doesnt-st...data-show/