For starters, the vaccine is no longer classified as “experimental.”
The US Food and Drug Administration has officially approved the Pfizer-BioNTech COVID-19 vaccine, making it the first vaccine fully approved to prevent COVID-19 and serious complications from the virus. While the vaccine has been administered to millions of people in the US since December, it was operating under an emergency use authorization, not full approval.
The FDA also announced that the vaccine will now be marketed as Comirnaty for the prevention of COVID-19 in those who are 16 years of age or older. The vaccine will continue to be available under emergency use authorization, including for those who are aged 12 through 15 years of age, and for the administration of a third dose in some people who are immunocompromised.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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, MD, said in a press release on Monday.
“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” the release continued. Plenty of people, including President Joe Biden, applauded the move and urged those who are unvaccinated to finally get the vaccine.
The news today might seem like just a formality—but full approval actually changes a lot, experts say. Here’s what you can expect now that Comirnaty is FDA-approved.
What does it mean that the vaccine is FDA-approved?
The FDA has a rigorous process to help ensure the American public that when a vaccine is approved, it’s safe for use. This process takes time, which is why the Comirnaty/Pfizer-BioNTech vaccine was previously under an emergency use authorization, the designation currently granted to the Moderna and Johnson & Johnson vaccines.
To reach approval status, the FDA evaluated data and information included in Pfizer’s submission of a biologics license application (BLA). For the COVID-19 vaccine, the BLA builds on the “extensive data and information previously submitted” to win approval for emergency use. This includes preclinical and clinical data and information, along with details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made, the FDA explains.
The FDA then conducts its own analysis of the information in the BLA to make sure the vaccine is safe and effective, and that it meets FDA standards. It’s a long process, but it’s done to ensure that the public can feel confident that something that has FDA approval is safe.
The FDA and Centers for Disease Control and Prevention will continue to monitor the Comirnaty/Pfizer-BioNTech vaccine, and the FDA specifically said that it’s requiring Pfizer to conduct post-marketing studies to assess the risks of heart inflammation (myocarditis and pericarditis) after people are vaccinated.
While not required, the FDA says that Pfizer has committed to doing post-marketing safety studies, including a pregnancy registry study, which will evaluate pregnancy and infant outcomes after people received the COVID-19 vaccine during pregnancy.
What’s different now that the Pfizer vaccine is FDA approved?
A lot, actually. Full FDA approval means that the vaccine is no longer considered “experimental,” as some people have called it. So basically, it’s on par with your annual flu vaccine, the MMR vaccine, and other vaccines you’ve likely had in the past. “This is now just like every other vaccine,” William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, tells Health.
“There may be some people—although I don’t think this will be a large number—who say that it’s not an ‘experimental’ vaccine anymore so, ‘alright, I’ll get it,'” Dr. Schaffner says. “But I don’t expect a huge line to form this afternoon.”
Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, agrees. “Full approval is a great development that will hopefully motivate more people to get vaccinated, as polls have shown that some people were waiting for this approval,” he tells Health.
Full approval should also put to bed concerns that the vaccine isn’t safe, Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, tells Health. One more thing that can happen with FDA approval: Pfizer can now advertise the vaccine. “I’m not sure if there is a need for that, but it’s now able to happen,” Dr. Russo says.
How workplaces, schools, and other facilities will be affected
Many workplaces have been waiting for full FDA approval before requiring that employees get the COVID-19 vaccine, Dr. Schaffner points out. “Institutions, employers, colleges, health care facilities, some governmental institutions, and other venues may indeed now require vaccination,” he says. Some may even mandate the COVID-19 vaccine “as a condition of employment and participation,” Dr. Adalja says.
Dr. Adalja is hopeful this will help convince more people to get the vaccine. “The trajectory of the pandemic in the US is almost entirely determined by the rates of vaccination in the US, so any increase in vaccine rates will be impactful,” he says.
So far in the US, lawsuits that challenge workplace and school vaccination requirements have been turned down by courts, and Dr. Russo says that full approval should completely take those lawsuits and future litigation around vaccine mandates off the table.
What about the other COVID-19 vaccines?
The Moderna and Johnson & Johnson vaccines are still operating under emergency use authorizations, but experts say that will change. “It will be some time before the other vaccines are approved based on their individual time lines, but I anticipate they will be,” Dr. Adalja says.
Dr. Schaffner agrees. “It’s just a matter of time,” he says. “Next will be Moderna and, after that, Johnson & Johnson.”
