FDA in­ter­nal re­view points to im­mi­nent Pfiz­er/BioN­Tech EUA, spot­lights po­ten­tial for sin­gle-dose vac­ci­na­tion

Pfiz­er and BioN­Tech have cleared one of the last hur­dles en route to the first Covid-19 vac­cine au­tho­riza­tion.

On Tues­day, the FDA re­leased its own in­ter­nal as­sess­ment of the com­pa­nies’ vac­cine and tri­al da­ta, find­ing that the in­oc­u­la­tion was al­most cer­tain­ly at least 90% ef­fec­tive and worked sim­i­lar­ly across dif­fer­ent sub­pop­u­la­tions, in­clud­ing the el­der­ly and peo­ple with co-mor­bidi­ties.

The agency al­so found no se­ri­ous safe­ty con­cerns, al­though they did spot­light mild ad­verse events that cropped up in a sig­nif­i­cant per­cent­age of par­tic­i­pants. These da­ta large­ly align with what tri­al par­tic­i­pants have pre­vi­ous­ly re­port­ed pub­licly, lead­ing some ex­perts to cau­tion that while the vac­cine is safe, pub­lic health au­thor­i­ties need to pre­pare peo­ple for symp­toms such as headache and fa­tigue.

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