In an important step that could bring us closer to the end of the COVID-19 pandemic, the Food and Drug Administration has granted full approval to the Pfizer-BioNTech vaccine for people ages 16 and up.
The three vaccines available in the United States—Pfizer, Moderna and Johnson & Johnson—have been available under an emergency use authorization (EUA) from the FDA. That authorization required extensive testing and proof of efficacy and safety, but full approval is another step beyond that. The designation puts Pfizer’s coronavirus vaccine in the same category as other approved vaccines, such as those that prevent measles, polio and HPV.
Full approval for Moderna and Johnson & Johnson is expected in the coming weeks and months; those manufacturers began the process after Pfizer. The Pfizer vaccine continues to be available to adolescents ages 12 to 15 under the EUA; full approval is expected for that age range in the future, as well as for booster shots.
Public health officials are hopeful that the news will ease the concerns of some unvaccinated people who said they were waiting for the official approval. The approval also eases the path for organizations, including companies, universities and airlines, who wish to mandate vaccines for employees or customers.
“We hear that from people, that they’re waiting until the vaccines have full approval from the FDA, which means they would have reviewed more safety data,” from several months of trials of tens of thousands of people, says David A. Wohl, MD, UNC Health infectious diseases specialist. “This, plus the fact that the FDA has looked at the real-world experience of millions of people vaccinated, shows people how safe these vaccines are—and effective.”
The Difference Between Emergency Use Authorization and Full Approval
The COVID-19 vaccines had to meet rigorous standards to receive EUA, which Pfizer has had since December after submitting data from a clinical trial of thousands of people. EUAs are used in public health emergencies to provide access to medical products that can save lives but have not gone through the full FDA approval process, which takes months or years.
That doesn’t mean steps were skipped in testing the vaccines—all safety measures were followed, and extensive trial data was required for the FDA to give the authorization. Since the vaccines have become available, about 200 million people in the United States have received them. Significant side effects have been extremely rare and are closely studied. Downtrends in the number of cases of severe COVID-19 and death have been dramatic among those vaccinated.
The full approval is based on updated data from the original clinical trial and data from a larger clinical trial population, studied over a longer period of time.
“We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of (the vaccine’s) safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, MD, PhD, the director of FDA’s Center for Biologics Evaluation and Research, in a press release.
The Unvaccinated Can Help End the Pandemic and Protect Themselves
The most important thing any individual can do to protect themselves, their families and their communities is to get vaccinated. With the delta variant ripping through the country, case rates are at or near their peaks in many places and hospitalizations and deaths are increasing, almost always among the unvaccinated. Children under 12, who are not yet eligible for vaccination, and people who are immunocompromised continue to be at risk. Hospitalizations of children are on the rise just as kids begin to return to school.
Reports of so-called “breakthrough infections” need to be understood better.
“The data show us that vaccination continues to reduce the risk of getting infected, decreases the time you are infectious in the event you do get infected, and remains extraordinarily effective at preventing serious COVID-19 and death,” Dr. Wohl says.
Vaccines are supposed to protect you from serious illness, not prevent every single infection.
“They are really effective at keeping people out of the hospital. We’ve seen that,” he says. “You might still get infected, you might get a little bit sick, but the chances of ending up in the hospital if you are vaccinated are really slim. That is not the case for people who are not vaccinated.”
Visit unchealthcare.org/vaccine to schedule a COVID-19 vaccine and for the latest information on the COVID-19 vaccines.