Pfizer: Final data on Covid-19 drugs for high-risk adults against hospitalizations and deaths

Pfizer hopes they can eventually deliver the pills, under the name Paxlovid, so people can take them at home before they get so sick they need to go to the hospital. Paxlovid combines a new antiviral drug called nirmatrelvir and an older one called ritonavir.

After a month of follow-up, the study detected 5 hospitalizations and no deaths among the 697 people who took the drug within the first 3 days of symptoms. Of the 682 people who received a placebo, 44 ​​were hospitalized, of which nine died. All of the adults in this study were unvaccinated.

If injected within the first five days of symptoms, the same effect: 88%. These results against a Similar announcements from the company last month, when all the data wasn’t available.

The study also found “viral load decreased by about 10 times at Day 5, compared with placebo,” the statement said.

“This highlights the potential of treatment candidates to save lives around the world, whether they have been immunized or not,” Pfizer CEO Dr Albert Bourla said in a statement on Thursday. Three. “Disturbing emerging variants, such as Omicron, have exacerbated the need for accessible treatment options for people with the virus, and we believe that, if allowed or approved, this potential treatment could be an important tool to help quell the pandemic.”

The company says it hopes the drug will stay active against variants like Omicron – and it appears to do so in lab tests – because the drug blocks an enzyme involved in viral replication. This is different from the mutant protein on the surface of the virus, whose numerous mutations have raised global interest in variation.

Omicron is spreading rapidly.  That's alarming even if it's mild

Pfizer announced it shared this latest data with the US Food and Drug Administration as part of an ongoing emergency use authorization application. “Full study data are expected to be published later this month and submitted to a peer-reviewed publication,” the Pfizer statement added. No date has been determined by the FDA advisory committee that is expected to consider the treatment.

According to the company, a separate, ongoing study also shows that Paxlovid can cut hospital admissions with injections for non-high-risk adults – including unvaccinated adults and those who are vaccinated. have at least one risk factor for severe disease. The latest data showed 10 hospital admissions in the placebo group, compared with three among those taking Paxlovid, which each included nearly 430 people. However, the study was primarily designed to look at the drug’s ability to improve all symptoms for four consecutive days – a criterion the drug failed to meet when compared with the placebo group. No deaths occurred in that study.

Between 20 and 25% of the treatment and placebo groups in each study experienced adverse events, most of which were mild. In the study of high-risk adults, those who were already taking the drug were less likely to have serious side effects or stop taking the medication for those reasons.

A month ago, the Biden Administration announced it will buy 10 million treatment courses worth $5.295 billion. At that time, with FDA approval, the first courses could be delivered by the end of the year. A 5-day course of Paxlovid consists of three pills given twice a day.

Paxlovid is not the only antiviral drug approved by the FDA. Merck’s drug, molnupiravir, was recommended by FDA advisers in an October 13 vote in late November after data showed it reduced the risk of hospitalization or death in adults by 30 percent. high-risk city. This is lower than a previous analysis that suggested it could be around 50%. The FDA has not announced whether it will authorize the treatment.

Remdesivir, sold under the brand name Veklury, is the only antiviral drug approved by the FDA to treat Covid-19. It is injected into a vein, not a pill that can be taken at home.

CNN’s Amanda Sealy contributed to this report.


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