Pfizer is eyeing full FDA approval pretty soon.
The pair’s mRNA vaccine is 91.3% effective against symptomatic COVID-19 disease as measured in people who have been immunized with the second dose of the shot for up to six months, the companies said Thursday.
The new efficacy data, plus a safety analysis comprising data from more than 12,000 people who were fully immunized for at least six months, allow the companies to file a drug application with the FDA to turn the shot’s emergency use authorization into a full approval, Pfizer CEO Albert Bourla, Ph.D., said in a statement.
The efficacy level is slightly down from the 95% number the vaccine first posted in the trial. With those data, Pfizer secured an FDA emergency use authorization in December. Since that initial analysis, more COVID-19 cases have accrued, increasing to 927 as of March 13 from the previous 170.
Of the total cases, investigators recorded 850 in the placebo group compared with 77 in the vaccine cohort. Thirty-two severe COVID-19 cases were recorded, all in the placebo group, translating into a 100% efficacy against severe disease for the vaccine.
https://www.fiercepharma.com/pharma/pfizer-biontech-eye-official-covid-19-vaccine-nod-as-efficacy-stands-strong-including