On Monday, August 23, the Pfizer-BioNTech Covid-19 vaccine received full approval from the United States Food and Drug Administration (FDA) for use in individuals 16 years of age and older. Pfizer’s vaccine, now marketed as Comirnaty, is still under emergency use authorization (EUA) for individuals aged between 12 and 15.
Comirnaty is the first coronavirus vaccine to receive full FDA approval. The licensing may boost vaccine confidence among the public, help increase inoculation rates and launch vaccine mandates among employers and universities when cases are surging due to the Delta variant, report Ben Guarino, Laurie McGinley, and Tyler Pager for the Washington Post.
When Covid-19 cases surged last year, the FDA issued an emergency use authorization for Pfizer's vaccine on December 11, 2020, based on safety and effectiveness data from ongoing clinical trials involving 36,000 individuals. Today’s approval was based on clinical trials consisting of 44,000 individuals. Pfizer’s two-dose vaccine was administered to half of those individuals, who were monitored for safety and vaccine efficacy during a six-month follow-up period, the Post reports. The biopharmaceutical company plans on monitoring all participants for a total of 24 months.
“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” says Pfizer’s chief executive Albert Bourla to the Post. “I am hopeful this approval will help increase confidence in our vaccine.”
Full vaccine approval is permanent, unless unexpected side effects develop. FDA approval allows the manufacturers to advertise their vaccines and continue selling them after the pandemic ends. The full licensure may also enable doctors to use the vaccines as booster shots, reports Umair Irfan for Vox.
Currently, booster shots have emergency use authorization for immunocompromised individuals, per an FDA statement. During a White House press briefing on August 18, U.S. officials announced that adults who received a two-dose vaccine would be eligible for a third booster dose eight months after receiving their second dose, reports NPR's Pien Huang, Sydney Lupkin, and Carmel Wroth. The booster vaccine roll-out is set to begin on September 20.
Currently, Covid-19 vaccines from Moderna and Johnson & Johnson are distributed under EUA, report USA Today’s Jorge L. Ortiz and N’dea Yancey-Bragg. Moderna—the second most distributed vaccine in the U.S.—filed for full FDA approval on June 1. According to the Post, Johnson & Johnson is planning on filing for full approval for their single dose vaccine later this year.
Now that Pfizer’s vaccine was granted full approval, other pharmaceutical companies cannot ask for emergency use authorization because this type of approval is only reserved for drugs and vaccines when no FDA-approved options are available, reports Nicole Wetsman for the Verge.
Pfizer-BioNTech is planning on applying for FDA approval to use their coronavirus vaccine as a booster shot. The company is expected to submit data supporting its safety and effectiveness as a booster shot as early as next week, reports Noah Weiland and Sharon LaFraniere for the New York Times.
“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,” says FDA commissioner Janet Woodcock in a statement.
“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 adds. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”