Pfizer Vaccine Fully Approved by the US FDA

The Food and Drug Administration (FDA) formally approved the Pfizer COVID-19 vaccine last August 23, 2021. The widely anticipated decision replaces the emergency use authorization for the vaccine that was issued by the agency last December.

Comirnaty, Pfizer’s mRNA vaccine against COVID, is the first COVID-19 vaccine to be subjected to a full review by the U.S. regulator. It is also the first to get an approval that puts the vaccine on par with other marketed vaccines.

The full approval can potentially make it easier for employers, the military and universities to mandate vaccination. It may also reassure those who are hesitant about the vaccine.

"While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," acting FDA Commissioner Janet Woodcock said in a statement.

Safety and Effectiveness Data of Pfizer Vaccine Approved

The U.S. regulator analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients who did not have evidence of a COVID infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.

The most commonly reported side effects by those who received the Pfizer vaccine in the clinical trial were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine has also shown effectiveness in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Increased Risks Associated With Pfizer Vaccine Evaluated

The FDA has also conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine. It has identified that the data demonstrate increased risks, particularly within the seven days following the second dose.

The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.

Approval Could Lead to More Vaccinations

According to a poll led by the Kaiser Family Foundation last June, 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once one receives full approval from the FDA.

"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," Woodcock said. "Today's milestone puts us one step closer to altering the course of this pandemic in the U.S."

The FDA's full approval applies to people 16 and older. Those between ages 12 and 15 can still receive the vaccine under the existing emergency use authorization.