The Morning Call

Pfizer seek­ing emer­gency use of its vac­cine in US

If FDA ap­proves shots, some could ar­rive next month

- By Lauran Neergaard Health · Pharmaceutical Industry · Medical Activism · Medicine · Industries · Pfizer · United States of America · U.S. Food and Drug Administration · United Kingdom · National Academy of Medicine · Philadelphia Union · University of Miami · U.S. government · Moderna Therapeutics · Philadelphia · White Plains, NY · White Plains · New York · New York University · Marion, IA

Pfizer said Fri­day it is ask­ing U.S. reg­u­la­tors to al­low emer­gency use of its COVID-19 vac­cine, start­ing the clock on a process that could bring lim­ited first shots as early as next month and even­tu­ally an end to the pan­demic — but not un­til af­ter a long, hard win­ter.

The ac­tion comes days af­ter Pfizer Inc. and its Ger­man part­ner BioNTech an­nounced that its vac­cine ap­pears 95% ef­fec­tive at pre­vent­ing mild to se­vere COVID-19 dis­ease in a large, on­go­ing study.

The com­pa­nies said that pro­tec­tion plus a good safety record means the vac­cine should qual­ify for emer­gency use au­tho­riza­tion, some­thing the Food and Drug Administra­tion can grant be­fore the fi­nal test­ing is fully com­plete. In ad­di­tion to Fri­day’s FDA sub­mis­sion, they have al­ready started “rolling” ap­pli­ca­tions in Europe and the U.K. and in­tend to sub­mit sim­i­lar in­for­ma­tion soon.

“Our work to de­liver a safe and ef­fec­tive vac­cine has never been more ur­gent,” Pfizer CEO Al­bert Bourla said in a state­ment.

Fri­day’s fil­ing would set off a chain of events as the FDA and its in­de­pen­dent ad­vis­ers de­bate if the shots are ready. If so, still another gov­ern­ment group will have to de­cide how the ini­tial lim­ited sup­plies are ra­tioned out to anx­iously await­ing Amer­i­cans.

How much vac­cine is avail­able and when is a moving tar­get, but ini­tial sup­plies will be scarce and ra­tioned. Glob­ally, Pfizer has es­ti­mated it could have 50 mil

lion doses avail­able by year’s end.

About 25 mil­lion may be­come avail­able for U.S. use in De­cem­ber, 30 mil­lion in Jan­uary and 35 mil­lion more in February and March, ac­cord­ing to in­for­ma­tion pre­sented to the Na­tional Academy of Medicine this week. Re­cip­i­ents will need two doses, three weeks apart. The U.S. gov­ern­ment has a con­tract to buy mil­lions of Pfizer-BioNTech doses, as well as other can­di­dates that pan out, and has

promised shots will be free.

Not far be­hind is com­peti­tor Moderna Inc.’s COVID-19 vac­cine. Its early data sug­gests the shots are as strong as Pfizer’s, and that com­pany ex­pects to also seek emer­gency au­tho­riza­tion within weeks.

The pub­lic’s first chance to see how strong the ev­i­dence re­ally is will come in early De­cem­ber at a pub­lic meet­ing of the FDA’s sci­en­tific ad­vis­ers.

So far, what’s known is based

only on state­ments from Pfizer and BioNTech. Of 170 in­fec­tions de­tected to date, only eight were among peo­ple who’d re­ceived the ac­tual vac­cine and the rest had got­ten a dummy shot. Onthe safety side, the com­pa­nies cite re­sults from 38,000 study par­tic­i­pants who’ve been tracked for two months af­ter their se­cond dose. That’s a mile­stone FDA set be­cause his­tor­i­cally, vac­cine side ef­fects don’t crop up later than that.

“We’ll drill down on these data,” said FDA ad­viser Dr. Paul Of­fit of the Chil­dren’s Hos­pi­tal of Philadel­phia.

A few days be­fore the meet­ing, the FDA will re­lease its own in­ter­nal anal­y­sis. That sets the stage for the ad­vis­ers’ day­long de­bate about any signs of safety con­cerns and how the new vac­cine technology works be­fore ren­der­ing a ver­dict.

They’ll rec­om­mend not just whether FDA should al­low broader use of the vac­cine gen­er­ally but if so, for whom. For ex­am­ple, is there enough proof the vac­cine works as well for older, sicker adults as for younger, health­ier peo­ple?

There’s still no guar­an­tee. “We don’t know what that vote’s go­ing to be,” said for­mer FDA vac­cine chief Nor­man Bay­lor.

If there’s an emer­gency green light, “that vac­cine is still deemed in­ves­ti­ga­tional. It’s not ap­proved yet,” Dr. Mar­ion Gru­ber, chief of FDA’s vac­cine of­fice, told the Na­tional Academy of Medicine this week.

That means any­one of­fered an emer­gency vac­ci­na­tion must get a “fact sheet” de­scrib­ing po­ten­tial ben­e­fits and risks be­fore go­ing through with the shot, she said.

There will be a lot of un­knowns. For ex­am­ple, the 95% pro­tec­tion rate is based on peo­ple who de­vel­oped symp­toms and then were tested for the virus. Can the vac­ci­nated get in­fected but have no symp­toms, able to spread the virus? How long does pro­tec­tion last?

That’s why the 44,000-per­son study needs to keep run­ning — some­thing dif­fi­cult con­sid­er­ing eth­i­cally, par­tic­i­pants given dummy shots at some point must be of­fered real vac­cine, com­pli­cat­ing the search for an­swers.

“I’m cu­ri­ous,” said Barry Colvin, 52, of White Plains, New York, who is tak­ing part in that study at NYU Lan­gone Health.

But he’s not in a great hurry to find out which group he’s in. “You need to hang in there for a while to un­der­stand and an­swer a lot of the other ques­tions that re­main un­known.”

Ad­di­tion­ally at least for now, preg­nant women won’t qual­ify be­cause they weren’t stud­ied. Pfizer only re­cently be­gan test­ing the vac­cine in chil­dren as young as 12.

 ?? JERICA PITTS/PFIZER ?? Pfizer keeps its COVID-19 vac­cine in this stor­age fa­cil­ity in Kala­ma­zoo, Michi­gan.
JERICA PITTS/PFIZER Pfizer keeps its COVID-19 vac­cine in this stor­age fa­cil­ity in Kala­ma­zoo, Michi­gan.

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