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Friday, April 25, 2025

COVID-19 pill Paxlovid moves closer to full FDA approval

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769 days ago
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FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. The COVID-19 medication won another vote of confidence from U.S. health advisors on Thursday, March 16, 2023, clearing the way for its full regulatory approval after being used by millions of Americans under emergency use. (AP Photo/Stephanie Nano, File)

FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. The COVID-19 medication won another vote of confidence from U.S. health advisors on Thursday, March 16, 2023, clearing the way for its full regulatory approval after being used by millions of Americans under emergency use. (AP Photo/Stephanie Nano, File)

Pfiz­er’s COVID-19 pill Paxlovid won an­oth­er vote of con­fi­dence from U.S. health ad­vis­ers Thurs­day, clear­ing the way for its full reg­u­la­to­ry ap­proval by the Food and Drug Ad­min­is­tra­tion.

The med­ica­tion has been used by mil­lions of Amer­i­cans since the FDA grant­ed it emer­gency use au­tho­riza­tion in late 2021. The agency has the fi­nal say on giv­ing Pfiz­er’s drug full ap­proval and is ex­pect­ed to de­cide by May.

A pan­el of out­side ex­perts vot­ed 16-1 that Paxlovid re­mains a safe and ef­fec­tive treat­ment for high-risk adults with COVID-19 who are more like­ly to face hos­pi­tal­iza­tion and death due to the virus.

“We still have many groups that stand to ben­e­fit from Paxlovid, in­clud­ing un­vac­ci­nat­ed per­sons, un­der-vac­ci­nat­ed per­sons, the el­der­ly and the im­muno-com­pro­mised,” said Dr. Richard Mur­phy of the De­part­ment of Vet­er­ans Af­fairs.

The FDA said us­ing Paxlovid in high-risk pa­tients could pre­vent 1,500 COVID-19 deaths and 13,000 hos­pi­tal­iza­tions per week.

The pan­el’s pos­i­tive vote was wide­ly ex­pect­ed, giv­en that Paxlovid has been the go-to treat­ment against COVID-19, es­pe­cial­ly since an en­tire group of an­ti­body drugs has been side­lined as the virus mu­tat­ed.

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

The agency asked its pan­el of in­de­pen­dent med­ical ex­perts to ad­dress sev­er­al lin­ger­ing ques­tions in­volv­ing Paxlovid, in­clud­ing which peo­ple cur­rent­ly ben­e­fit from treat­ment and whether the drug plays a role in cas­es of COVID-19 re­bound.

The pan­el agreed with as­sess­ments by both the FDA and Pfiz­er that found no clear link be­tween the use of Paxlovid and re­turn­ing symp­toms, but said more in­for­ma­tion is need­ed from stud­ies and med­ical records da­ta. High-pro­file cas­es drew at­ten­tion to the is­sue last year, in­clud­ing Pres­i­dent Joe Biden and first la­dy Jill Biden.

Be­tween 10% and 16% of pa­tients across mul­ti­ple Pfiz­er stud­ies had symp­toms re­turn, re­gard­less of whether they’d re­ceived Paxlovid or a dum­my pill. Such cas­es “like­ly re­flect nat­ur­al COVID-19 pro­gres­sion,” the FDA con­clud­ed.

The fed­er­al gov­ern­ment has pur­chased more than 20 mil­lion dos­es of Paxlovid and en­cour­aged health pro­fes­sion­als to pre­scribe it ag­gres­sive­ly to help pre­vent se­vere COVID-19. But that’s led to con­cerns of over­pre­scrib­ing and ques­tions of whether some pa­tients are need­less­ly get­ting the drug.

Pfiz­er orig­i­nal­ly stud­ied Paxlovid in the high­est-risk COVID-19 pa­tients: un­vac­ci­nat­ed adults with oth­er health prob­lems and no ev­i­dence of pri­or coro­n­avirus in­fec­tion. But that doesn’t re­flect the U.S. pop­u­la­tion to­day, where an es­ti­mat­ed 95% of peo­ple have pro­tec­tion from at least one vac­cine dose, a pri­or in­fec­tion or both.

The FDA re­viewed Pfiz­er da­ta show­ing Paxlovid made no mean­ing­ful dif­fer­ence in oth­er­wise healthy adults, whether or not they’d been pre­vi­ous­ly vac­ci­nat­ed.

But when FDA teased out da­ta for high-risk adults — re­gard­less of their vac­ci­na­tion or in­fec­tion his­to­ry — Paxlovid still showed a sig­nif­i­cant ben­e­fit, re­duc­ing the chance of hos­pi­tal­iza­tion or death be­tween 60% and 85%, de­pend­ing on in­di­vid­ual cir­cum­stances. Pa­tients in that group in­clud­ed se­niors and those with se­ri­ous health prob­lems, such as di­a­betes, obe­si­ty, lung dis­ease and im­mune-sys­tem dis­or­ders.

With so many dif­fer­ent fac­tors, pan­elists said pre­scrib­ing Paxlovid will re­main a case-by-case de­ci­sion.

Dr. Sankar Swami­nathan of the Uni­ver­si­ty of Utah and oth­er pan­elists stressed the im­por­tance of man­ag­ing po­ten­tial­ly dan­ger­ous drug in­ter­ac­tions be­tween Paxlovid and oth­er com­mon­ly used med­ica­tions.

By MATTHEW PER­RONE

WASH­ING­TON (AP)

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