COVID-19 capsule Paxlovid strikes nearer to full FDA approval

WASHINGTON — Pfizer’s COVID-19 capsule Paxlovid gained one other vote of confidence from U.S. well being advisers Thursday, clearing the way in which for its full regulatory approval by the Meals and Drug Administration.

The remedy has been utilized by tens of millions of People because the FDA granted it emergency use authorization in late 2021. The company has the ultimate say on giving Pfizer’s drug full approval and is anticipated to determine by Might.

A panel of outdoor consultants voted 16-1 that Paxlovid stays a secure and efficient therapy for high-risk adults with COVID-19 who usually tend to face hospitalization and demise because of the virus.

“We nonetheless have many teams that stand to learn from Paxlovid, together with unvaccinated individuals, under-vaccinated individuals, the aged and the immuno-compromised,” mentioned Dr. Richard Murphy of the Division of Veterans Affairs.

The FDA mentioned utilizing Paxlovid in high-risk sufferers might stop 1,500 COVID-19 deaths and 13,000 hospitalizations per week.

The panel’s constructive vote was broadly anticipated, on condition that Paxlovid has been the go-to therapy towards COVID-19, particularly since a whole group of antibody medication has been sidelined because the virus mutated.

The U.S. continues reporting about 4,000 deaths and 35,000 hospitalizations weekly, the FDA famous.

The company requested its panel of unbiased medical consultants to deal with a number of lingering questions involving Paxlovid, together with which individuals presently profit from therapy and whether or not the drug performs a task in instances of COVID-19 rebound.

The panel agreed with assessments by each the FDA and Pfizer that discovered no clear hyperlink between using Paxlovid and returning signs, however mentioned extra data is required from research and medical information information. Excessive-profile instances drew consideration to the problem final yr, together with President Joe Biden and first woman Jill Biden.

Between 10% and 16% of sufferers throughout a number of Pfizer research had signs return, no matter whether or not they’d obtained Paxlovid or a dummy capsule. Such instances “possible mirror pure COVID-19 development,” the FDA concluded.

The federal authorities has bought greater than 20 million doses of Paxlovid and inspired well being professionals to prescribe it aggressively to assist stop extreme COVID-19. However that’s led to considerations of overprescribing and questions of whether or not some sufferers are needlessly getting the drug.

Pfizer initially studied Paxlovid within the highest-risk COVID-19 sufferers: unvaccinated adults with different well being issues and no proof of prior coronavirus an infection. However that doesn’t mirror the U.S. inhabitants as we speak, the place an estimated 95% of individuals have safety from no less than one vaccine dose, a previous an infection or each.

The FDA reviewed Pfizer information displaying Paxlovid made no significant distinction in in any other case wholesome adults, whether or not or not they’d been beforehand vaccinated.

However when FDA teased out information for high-risk adults — no matter their vaccination or an infection historical past — Paxlovid nonetheless confirmed a big profit, decreasing the prospect of hospitalization or demise between 60% and 85%, relying on particular person circumstances. Sufferers in that group included seniors and people with critical well being issues, equivalent to diabetes, weight problems, lung illness and immune-system problems.

With so many various elements, panelists mentioned prescribing Paxlovid will stay a case-by-case determination.

Dr. Sankar Swaminathan of the College of Utah and different panelists pressured the significance of managing probably harmful drug interactions between Paxlovid and different generally used drugs.


The Related Press Well being and Science Division receives help from the Howard Hughes Medical Institute’s Science and Instructional Media Group. The AP is solely liable for all content material.


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