DETROIT – On Monday, the U.S. Food and Drug Administration gave full approval to the Pfizer-BioNTech COVID-19 Vaccine, which will now be marketed as Comirnaty.
The vaccine is fully approved for individuals 16 years of age and older, but is available to individuals 12 through 15 years old under emergency use authorization.
Health officials hope the FDA’s full approval may encourage those still hesitant to get vaccinated to go out and get the vaccine.
A Kaiser Family Foundation survey found that full approval made a difference to three out of 10 people. The FDA approval involved more than just a review of the initial data submitted for the emergency use authorization.
More than half of the original trial participants were followed for safety outcomes for at least four months and overall about 12,000 recipients were followed for at least six months.
As part of the full approval process, effectiveness data was studied in about 40,000 vaccine and placebo recipients and the vaccine was found to be 91% effective in preventing COVID-19 disease.
The full approval is only for people 16 years old and older. Use in the 12-15 age group is still under emergency use authorization. The approval doesn’t have any effect on children younger than 12 as those studies remain ongoing.
Moderna has submitted its application for full approval about a month after Pfizer. It is expected Moderna could get full approval sometime in September.
Johnson & Johnson said it will submit its application later this year. The review would then take a few months from there.