KANSAS CITY, Mo. — The Food and Drug Administration on Monday issued full approval to the two-dose Pfizer COVID-19 vaccine.
Health officials said they hope final approval will help those who haven't gotten the vaccine yet to feel more confident.
"The fact that it has full approval is potentially a game changer," said Anthony Fehr, assistant professor of Molecular Biosciences at the University of Kansas.
The FDA's final approval comes months after the first Americans started getting their shots. Pfizer, Moderna, and Johnson & Johnson all started out with emergency use authorization, or EUA, from the FDA.
"We just have more data and really a stringent look at the process and people longer term. I guess what they're saying is that they looked at the virus for six months now, instead of two months," Fehr said.
Health officials want people to know that this doesn't mean the vaccine is any different now than it was before.
"This is just the final stamp. It's the same recipe. It's not Pfizer 2.0; this is the vaccine and it's been safe the whole time," said Chip Cohlmia, the communicable disease prevention manager at the Jackson County Health Department.
Cohlmia said FDA approval is a rigorous process and he expects the other vaccines will get final approval soon.
"It's like Pfizer got their assignment in first. They started their trial first, they got everything in first, it's been reviewed," Cohlmia said. "To have Pfizer get the approval, it doesn't mean that Moderna and J&J are not safe, they're definitely still approved by EUA."
RELATED | White House vaccination coordinator: FDA approval 'gold standard' for vaccine safety, effectiveness
Scientists did not start from scratch when developing this vaccine, and the process happened quicker than other vaccines because of the threat the virus presented globally.
"Things like Operation Warp Speed allowed for multiple elements of vaccine trial to happen maybe at the same time. Or, normally, it goes in specific orders and this time it can happen all at once. Sometimes they combine separate parts of those so they can analyze data at the same time as something else," Cohlmia said. "There are ways in which final approval is shortened but in the end, the FDA has gone over everything and said, 'No, it's safe.' We've still gone over our entire processes. It's just a little bit different in terms of order in which everything was done."
Fehr runs a lab that researches coronaviruses. He and many other researchers across the world say COVID-19, or SARS-CoV-2, spreads quickly, even without symptoms, and can easily get into a person's upper airways.
Fehr said the original SARS outbreak in 2003 was stopped after about six months because the virus didn't spread until people were noticeably sick. So when people were quarantined, that was the end.
"It just gives us more credence to say you need to get the vaccine," Fehr said.
Health officials are still encouraging people to call with any questions to make an informed decision.
—
