FDA au­tho­rizes Pfiz­er-BioN­Tech Covid-19 vac­cine

The first Covid-19 vac­cine has ar­rived in Amer­i­ca.

The FDA is­sued an emer­gency use au­tho­riza­tion for the Pfiz­er-BioN­Tech vac­cine late Fri­day, mark­ing a his­toric turn­ing point in the fight against a dead­ly pan­dem­ic, but that one will still leave a long road ahead as the Big Phar­ma and fed­er­al of­fi­cials try to scale up and roll out lim­it­ed dos­es while the virus con­tin­ues to rav­age the US.

The EUA comes 24 hours af­ter a com­mit­tee of out­side ex­perts vot­ed 17-4 to rec­om­mend the agency au­tho­rize the vac­cine. In a 44,000-per­son Phase III tri­al, the vac­cine was 95% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 and did not trig­ger se­ri­ous ad­verse events, al­though it did in­duce mild symp­toms such as headache and fa­tigue. The da­ta was pub­licly re­viewed by the FDA and pub­lished in The New Eng­land Jour­nal of Med­i­cine.

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