What does it mean that the Pfizer vaccine has full FDA approval?

On August 23, the FDA issued full approval to the Pfizer COVID-19 vaccine, now known as Comirnaty. The vaccine has been fully approved for use in individuals age 16 and older, with a two-dose regimen spaced at least three weeks apart. The full approval by the FDA means that the Comirnaty vaccine now has the same level of approval as other vaccines routinely in use in the U.S., such as vaccines for hepatitis, measles, chicken pox, and polio.

On top of the rigorous testing and trials that went into Emergency Use Authorization of the Pfizer vaccine, the FDA analyzed additional and follow-up data from the ongoing clinical trial to determine the safety and effectiveness of Comirnaty, including:

  • The analysis of effectiveness data from approximately 20,000 vaccine recipients and 20,000 placebo recipients age 16 and older, which found that overall, the vaccine was 91% effective, with 77 cases of COVID-19 occurring in the vaccine group and 833 COVID-19 cases in the placebo group.
  • The analysis of safety data in approximately 22,000 vaccine recipients and 22,000 placebo recipients age 16 and older. More than half of participants were followed to monitor safety for at least four months after the second dose; approximately 12,000 vaccine recipients have been followed for at least 6 months.
  • Rigorous evaluation of safety surveillance data regarding myocarditis and pericarditis. Data demonstrated an increased risk for vaccine recipients, which was higher in males under 40, particularly males 12-17. Comirnaty prescribing information will include information about this risk, and in addition to these analyses, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis in vaccinated individuals. It is important to note that reports of these complications are rare, and most patients who received care responded well to treatment.

The vaccine also continues to be available for adolescents age 12 through 15  and for the administration of a third dose in certain immunocompromised individuals (read more about booster doses here.)

Added August 23, 2021