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)