Pfizer: Vac­cine can­di­date won’t be ready for ap­proval un­til late Novem­ber

The Washington Post - - THE CORONAVIRU­S PANDEMIC - BY CAROLYN Y. JOHN­SON carolyn.john­son@wash­

Phar­ma­ceu­ti­cal gi­ant Pfizer on Fri­day dashed prospects for a coron­avirus vac­cine be­ing ap­proved be­fore the elec­tion with an open let­ter ex­plain­ing the com­pany would not ap­ply for reg­u­la­tory clear­ance for its vac­cine can­di­date un­til the third week of Novem­ber at the ear­li­est.

Pres­i­dent Trump has for months sug­gested a vac­cine could be im­mi­nent, rais­ing con­cerns that po­lit­i­cal pres­sure could force a vac­cine through the reg­u­la­tory process pre­ma­turely so that it would be ap­proved by Elec­tion Day with­out ev­i­dence that it is safe and ef­fec­tive. Fri­day’s an­nounce­ment from Pfizer, which de­signed its trial to al­low ear­lier and more fre­quent peeks at the data than the oth­ers in late-stage test­ing, puts those con­cerns to rest.

Chief ex­ec­u­tive Al­bert Bourla wrote in the let­ter that while the com­pany projects it may have enough data to de­ter­mine whether the vac­cine is ef­fec­tive in Oc­to­ber, there will not be suf­fi­cient safety fol­low-up to sat­isfy cri­te­ria laid out by the Food and Drug Ad­min­is­tra­tion un­til late Novem­ber.

“A key point that I’d like to make clear is that ef­fec­tive­ness would sat­isfy only one of the three re­quire­ments and, alone, would not be enough for us to ap­ply for ap­proval for pub­lic use,” Bourla said. “Safety is, and will re­main, our num­ber one pri­or­ity.”

The let­ter was wel­comed by Eric Topol, a physi­cian-sci­en­tist at Scripps Re­search Trans­la­tional In­sti­tute who joined other ex­perts in writ­ing to Bourla in late Septem­ber, ask­ing the com­pany not to seek au­tho­riza­tion for a vac­cine be­fore late Novem­ber. Topol re­cently had a vir­tual meet­ing with com­pany ex­ec­u­tives to ex­press his con­cerns and said he was frus­trated they would not an­swer di­rectly whether they would seek broader use of a vac­cine be­fore Nov. 3.

Bourla’s em­pha­sis on hav­ing data in Oc­to­ber “is what got many of us con­cerned, whether it was in­ad­ver­tently play­ing into the po­lit­i­cal pres­sure or just be­cause the in­cen­tives were aligned,” Topol said. “I thought [the let­ter] was very good. I wish it had been done po­ten­tially even ear­lier.”

Bourla made clear that while the com­pany won’t seek ap­proval un­til reach­ing the safety thresh­old, it could an­nounce data on whether the vac­cine can­di­date works be­fore the elec­tion.

Pfizer’s trial will ul­ti­mately in­clude 44,000 study sub­jects, with half re­ceiv­ing two shots of its ex­per­i­men­tal vac­cine and the other half re­ceiv­ing placebo in­oc­u­la­tions. Nei­ther par­tic­i­pants, study in­ves­ti­ga­tors nor com­pany ex­ec­u­tives know who re­ceived a vac­cine and who did not. But pe­ri­od­i­cally through­out the trial, an in­de­pen­dent com­mit­tee is ex­am­in­ing the data to see whether the vac­cine is pro­tect­ing par­tic­i­pants from in­fec­tion, as demon­strated by far fewer cases of covid-19, the dis­ease caused by the virus, in those get­ting the shots than those re­ceiv­ing a placebo.

“In the spirit of can­dor, we will share any con­clu­sive read­out (pos­i­tive or neg­a­tive) with the pub­lic as soon as prac­ti­cal, usu­ally a few days af­ter the in­de­pen­dent sci­en­tists no­tify us,” Bourla wrote.

The FDA in Oc­to­ber is­sued guid­ance ex­plain­ing the cri­te­ria for an emer­gency use au­tho­riza­tion, say­ing a vac­cine given to healthy peo­ple will be held to a higher stan­dard than the typ­i­cally low thresh­old that a med­i­cal prod­uct “may be ef­fec­tive” for emer­gency use. The agency put forth a re­quire­ment — de­spite White House ob­jec­tions — that vac­cine can­di­dates must have a min­i­mum of two months of fol­low-up data on half of the par­tic­i­pants in the study.

Pfizer will not have such data un­til the third week of Novem­ber. Moderna, a biotech­nol­ogy com­pany, will not have enough safety data to ap­ply for reg­u­la­tory au­tho­riza­tion un­til two days be­fore Thanks­giv­ing, ac­cord­ing to spokesman Ray Jor­dan. Two other late-stage vac­cine tri­als, from As­trazeneca and John­son & John­son, are paused be­cause of po­ten­tial safety con­cerns and have pre­vi­ously pre­dicted read­outs from their tri­als around the end of the year.

White House spokesman Judd Deere said the Trump ad­min­is­tra­tion has ex­pe­dited de­vel­op­ment of safe and ef­fec­tive treat­ments and vac­cines that nor­mally would have taken years.

“The Pres­i­dent con­tin­ues to be op­ti­mistic that we will have one or more vac­cines very soon, be­fore the end of the year,” Deere said in an email.

As it has be­come clear that a vac­cine is al­most cer­tainly out of reach be­fore the elec­tion, Trump has piv­oted to talk­ing about an ex­per­i­men­tal treat­ment that he re­ceived, mon­o­clonal an­ti­bod­ies, which he com­pared to a cure.

“I heard about this drug. I said, ‘Let me take it,’ ” Trump said in a video posted to so­cial me­dia shortly af­ter he re­ceived an in­fu­sion of the lab­o­ra­tory-made an­ti­bod­ies. “If I didn’t catch [coron­avirus], we’d be look­ing at that like a num­ber of other drugs. But it did a fan­tas­tic job. I’m go­ing to get for you what I got. I’m go­ing to make it free.”

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