Vac­cine’s early shot

Pfizer bids for emer­gency clear­ance in U.S.

New York Daily News - - NEWS - BY JES­SICA SCHLADEBEC­K

Pfizer took its best shot Fri­day at sup­ply­ing the first ever COVID-19 vac­cine to the U.S. mar­ket, ask­ing reg­u­la­tors for emer­gency clear­ance of its two­dose treat­ment in a pos­si­ble mile­stone mo­ment.

The ap­pli­ca­tion from the phar­ma­ceu­ti­cal gi­ant and its Ger­man part­ner BioNTech was the first of its kind sub­mit­ted to the FDA for rush au­tho­riza­tion of a coron­avirus in­oc­u­la­tion amid the pan­demic.

If the ap­pli­ca­tion is ap­proved, Pfizer could be­gin de­liv­er­ing a lim­ited sup­ply as early as next month for ra­tioned dis­tri­bu­tion to health care work­ers, el­derly pa­tients and peo­ple with un­der­ly­ing med­i­cal con­di­tions.

A se­cond wave of the vac­cine would later be­come avail­able to es­sen­tial work­ers, teach­ers and those in home­less shel­ters and pris­ons, with chil­dren and young adults next.

The re­quest fol­lowed two days af­ter Pfizer and BioNTech said that data from Phase 3 clin­i­cal tri­als con­firmed the vac­cine was safe and 95% ef­fec­tive at pre­vent­ing mild to se­vere COVID-19 in­fec­tions.

“Our work to de­liver a safe and ef­fec­tive vac­cine has never been more ur­gent as we con­tinue to see an alarm­ing rise in the num­ber of cases of COVID-19 glob­ally,” Pfizer CEO Al­bert Bourla said in a state­ment.

“Fil­ing in the U.S. rep­re­sents a crit­i­cal mile­stone in our jour­ney to de­liver a COVID-19 vac­cine to the world and we now have a more com­plete pic­ture of both the ef­fi­cacy and safety pro­file of our vac­cine, giv­ing us con­fi­dence in its po­ten­tial.”

Pfizer and BioNTech also an­nounced Fri­day that they “ini­ti­ated rolling sub­mis­sions” with med­i­cal reg­u­la­tors in Europe and the United King­dom, adding that they planned to “sub­mit ap­pli­ca­tions to other reg­u­la­tory agen­cies world­wide in the com­ing days.”

Pfizer en­rolled nearly 44,000 peo­ple across the U.S. and five other coun­tries in its study, 170 of whom have come down with coron­avirus since clin­i­cal tri­als of the treat­ment be­gan in July.

Only eight of those in­fected re­ceived the vac­cine while the other 162 were given the placebo, in­di­cat­ing the ef­fi­cacy rate of about 95%.

Glob­ally, Pfizer has es­ti­mated it could have 50 mil­lion doses avail­able the end of the year.

About 25 mil­lion doses may be­come avail­able for U.S. use in De­cem­ber, 30 mil­lion in Jan­uary and 35 mil­lion more in Fe­bru­ary and March. Re­cip­i­ents will need two doses, three weeks apart.

The U.S death toll sur­passed a quar­ter-mil­lion peo­ple ear­lier this week, and deaths are hit­ting their high­est level since May. The coron­avirus has killed more than 1.3 mil­lion peo­ple glob­ally, ac­cord­ing to Johns Hop­kins Univer­sity.

At Pfizer’s world head­quar­ters in Mid­town Man­hat­tan (main) sci­en­tists are hop­ing that a grant of emer­gency clear­ance for its COVID-19 vac­cine (top) will en­able the two-shot treat­ment to roll out by De­cem­ber. Test­ing (be­low) has shown 95% ef­fec­tive­ness, the com­pany says.

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