CLEVELAND — Calling a pivotal day in the fight against the coronavirus pandemic, the FDA announced Monday that it granted full approval for the Pfizer/BioNTech COVID-19 vaccine, marking the first time a vaccine for the deadly virus had received the gold standard approval. Physicians in Northeast Ohio said they're hopeful that the full approval of the vaccine will be enough to convince those that have been hesitant.
Previously operating under the FDA's emergency authorization, the Pfizer vaccine has been administered in the inoculations of more than half of the country's 170 million vaccinated people. For individuals between 12 and 15 years old, the vaccine remains under emergency authorization.
"Basically what this means is the FDA has said that we don't need to use it just because we are in a national emergency. This is something that can be safely dispensed for patients," said Dr. Abhijit Duggal, the vice chair for the Department of Critical Care at Cleveland Clinic. "People should feel much much more safe now that the FDA has made the determination that this is something that is both efficacious and safe. It should help us disseminate this information to our population."
Earlier this year, the FDA granted Pfizer a priority review of Pfizer's full approval application and reallocated resources from other parts of the agency to verify and review the hundreds of thousands of pages of documentation and statistics. With full approval, the Pfizer vaccine joins the ranks of other vaccinations that have become commonplace in America, including measles, mumps and rubella. The quick approval doesn't mean the review was any less thorough, said Dr. Amy Edwards, the associate medical director for infection control at University Hospitals.
"It takes longer to collect and submit that kind of efficacy data [for other ailments] because the infections don't happen as frequently. When you're in the midst of a pandemic, it's easy to collect efficacy data because of the speed with which people get infected," Edwards said. "Most people think that vaccines have to be studied for a really long time because of safety data. That's actually not true. If a vaccine is going to have a serious safety event it's going to be in the first days or weeks at the time of the shot. I hear some people say, 'oh, we don't know what's going to happen five years from now.' Nothing is going to happen five years from now because there is no mechanism via which the vaccine could continue to harm your body. It just doesn't exist."
The full approval of the Pfizer vaccine, which will be marketed under the name of Comirnaty, comes as the highly-transmissible delta variant continues to tighten its grip nationwide, particularly in communities with low vaccination rates. The delta variant alone has been enough to cause a noticeable increase in new vaccinations. Edwards is hopeful the FDA approval of the Pfizer vaccine will further increase new vaccinations.
"I hope, I really do hope, that if there are people out there that have just been wavering who are aren't sure, I hope this FDA approval gives them the impetus that they need to get that vaccine and protect themselves," Edwards said. "We've seen those rising vaccine rates as people have become more fearful of the delta variant. I hope this reassurance about the safety and efficacy of the vaccine will add to that and just increase the vaccination rates."
The approval of the vaccine could also spark policy changes on the local, state and national levels. Earlier this summer, Gov. Mike DeWine signed legislation that would temporarily prohibit public schools and colleges in the state from instituting a vaccine mandate for any vaccine that did not yet have full FDA approval. With that approval now in place, the law could become moot, potentially paving the way for more widespread adoption of vaccine mandates.
"When it comes to public policy, you need to look at a lot of things before you can talk about mandates," Duggal said. "I'm sure there's going to be a lot of smart people that are going to get together and come up with what's the right decision for us as a population."
Edwards said from a public health perspective, she is in support of a vaccine mandate given how safe and effective the vaccines have proven to be, the Pfizer vaccine particularly.
"There is no reason that anyone needs to die anymore. We literally have the means to save people's lives," Edwards said. "All they need to do is get a vaccine that is safe and effective."