Pfizer’s Covid-19 Vaccine Receives Full FDA Approval

The U.S. Food ad Drug Administration (FDA) has fully approved the first Covid-19 vaccine. The Pfizer-BioNTech Covid-19 vaccine was formally granted full clearance by the FDA on Monday in a move that many are hoping will help boost vaccination rates nationwide. Now that it has received full FDA approval, Pfizer’s Covid-19 vaccine will be marketed under the name Comirnaty.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA commissioner Dr. Janet Woodcock said in a statement released Monday. “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.”

Pfizer’s vaccine was first cleared for use in individuals age 16 and older in December under an emergency use authorization. In May, the FDA expanded its emergency authorization of the vaccine to include children age 12 and older. And although roughly 60.2% of eligible individuals in the United States are reported by the U.S. Centers for Disease Control and Prevention (CDC) to be fully vaccinated, a number of those who are unvaccinated have expressed concern about obtaining a vaccine that was not fully approved by U.S. regulators.

Separate surveys published by the Kaiser Family Foundation in May and June suggested full FDA approval of a Covid-19 vaccine could ultimately help boost vaccination rates. In June’s survey, the Kaiser Family Foundation found 31% of unvaccinated adults said they would be more inclined to get vaccinated against the virus if one of the vaccines were to be fully approved by 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 Monday. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

According to the FDA, clinical trial data showed Pfizer’s vaccine was 91% effective in preventing Covid-19. While some 12,000 recipients of the vaccine were monitored for at least six months after receiving the vaccine, information on potential longer-term health outcomes is not yet available. Both Pfizer and the FDA, however, have committed to monitoring long-term outcomes. Pfizer has also committed to conducting a pregnancy registry study to continue to evaluate pregnancy and infant outcomes following vaccination.

Pfizer’s Covid-19 vaccine will retain its emergency use authorization for children age 12 to 15. Clinical trials to determine the efficacy and safety of the Covid-19 vaccine in children under the age of 12 are still ongoing with data not expected to be revealed until sometime this fall.

If you think you’re showing symptoms of coronavirus, which include fever, shortness of breath, and cough, call your doctor before going to get tested. If you’re anxious about the virus’s spread in your community, visit the CDC for up-to-date information and resources, or seek out mental health support. You can find all of Romper’s parents + coronavirus coverage here.