Pfizer: No shot at OK for vac­cine by mid-Nov.

The Morning Call - - Business -

NEW YORK — Pfizer Inc. can­not re­quest emer­gency au­tho­riza­tion of its COVID-19 vac­cine be­fore the third week of Novem­ber — and that’s if ev­ery­thing goes well, the com­pany’s CEO an­nounced Fri­day.

De­spite Pres­i­dent Don­ald Trump’s re­peated prom­ises of a vac­cine be­fore Elec­tion Day on Nov. 3, sci­en­tists have been cau­tion­ing that it’s un­likely data show­ing a lead­ing shot ac­tu­ally works would come un­til Novem­ber or De­cem­ber.

An­other lead­ing U.S. con­tender, Moderna Inc., pre­vi­ously an­nounced the ear­li­est it could seek au­tho­riza­tion of its own vac­cine would be Nov. 25.

Pfizer CEO Al­bert Bourla has long said it’s pos­si­ble test­ing might re­veal by the end of Oc­to­ber if his com­pany’s vac­cine pro­tects against the coro­n­avirus.

But in Fri­day’s an­nounce­ment, he made clear that ef­fec­tive­ness is only part of the equa­tion.

The vac­cine also must be proven safe. And to qual­ify for an “emer­gency use au­tho­riza­tion,” any COVID-19 vac­cine must track at least half the par­tic­i­pants in large-scale stud­ies for two months af­ter their sec­ond dose, the time pe­riod in which side ef­fects are likely to ap­pear.

Bourla es­ti­mated Pfizer’s 44,000-per­son study will reach that mile­stone in the third week of Novem­ber.

“We are op­er­at­ing at the speed of science,” he wrote in a let­ter posted to the com­pany’s web­site.

The vac­cine made by Pfizer and its Ger­man part­ner BioNTech are among sev­eral lead­ing can­di­dates in fi­nal test­ing.

Even if a vac­cine emerges by year’s end, only lim­ited doses will be avail­able right away.

The U.S. gov­ern­ment is de­cid­ing who would be first in line, al­most cer­tainly health care work­ers, and es­ti­mates there may be enough for wide­spread vac­ci­na­tions in the spring.

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