TAMPA, Fla. — The country marked a major milestone in the continued fight to end the pandemic with the FDA granting full approval to Pfizer’s COVID-19 vaccine. It comes at a time when health experts are pleading to communities to get vaccinated as COVID-19 cases are still on the rise.
The FDA says the vaccine will now be marketed as Comirnaty, for the prevention of COVID-19 in people 16 years of age and up, though it says the vaccine also continues to be available under emergency use authorization (EUA), including for people 12 through 15 and for a third dose in certain immunocompromised individuals.
On Monday, President Joe Biden stressed the importance of getting vaccinated.
“Let me say this loudly and clearly: if you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you've been waiting for is here,” said Biden.
Dr. Steven R. Smith, AdventHealth’s Chief Scientific Officer, explained there is a rigorous process the FDA goes through to approve medications and vaccines.
“It means that all the manufacturing data has been reviewed, that the safety data has had additional levels of review after the EUA, or the emergency use authorization,” said Dr. Smith. “This is the gold standard that can, we believe, convince people that these are safe and efficacious vaccines.”
Doctors hope the seal of approval will persuade some people on the fence to get the vaccine. According to the Kaiser Family Foundation, 3 in 10 unvaccinated adults said they’d be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to get full approval from the FDA.
Health experts also say there weren’t any shortcuts taken in the process either. Dr. Michael Teng, an associate professor at USF Health, explains by necessity, it’s gotten done fast.
“We don’t want to be sitting around in a pandemic for five years, which it normally takes a vaccine to get through 5-10 years,” said Dr. Teng. “We can’t afford that. People are dying. People are in the hospital. Our physicians and healthcare workers are overworked. We’re seeing families just torn apart because of this virus.”
While some health departments in the Tampa Bay area said they’d have no way of forecasting if this move would drive the numbers up, others told ABC Action News they stand ready should they see an increase in those wanting to get the vaccine.
“Many of us are already vaccinated, but for those who are a little skeptical, this should give you a lot more confidence,” said Teng.