SIOUX FALLS, S.D. (KELO) — The Food and Drug Administration has given full approval to the COVID-19 vaccine made by Pfizer. KELOLAND doctors are hoping the decision will lift the public confidence in vaccinations as the state battles the most contagious coronavirus mutant yet.
Today the Pfizer COVID-19 Vaccine went from authorized to approved. The difference is a big deal.
The FDA grants emergency use authorizations after it reviews at least two months of results in clinical trials. For full approval, the agency wants to see six months of data to make sure there are no widespread problems.
“The public can be confident that this vaccine meets the FDA’s gold standards for safety, effectiveness, and manufacturing quality that we require for an approved product,” said Dr. Janet Woodcock, Acting FDA Commissioner.
Only about 55% of those eligible for the vaccine are fully vaccinated in South Dakota. Avera’s Dr. Michael Elliot is hoping full approval will prompt more unvaccinated to get the shot.
“There’s nothing left to prove, the FDA has given it full approval,” said Elliot.
The reasons selected by the hesitant have been relatively consistent over the past few months. According to a CBS Yougov Poll In April.
The most common reason for hesitancy is “It’s still too untested or people will wait and see what happens” (53%), followed by general concern about side effects (40%). Some say their hesitancy has to do with reported problems with some vaccines, including news about clots, (36%) while (35%) of those who responded also say they don’t trust the government.
“The studies done on developing a vaccine for the coronavirus were in full swing in the early 2000s, this is not new technology, we didn’t just dream this up last year, the public became aware of it last year, but this isn’t new,” said Dr. Elliot.
The Pfizer vaccine is still available to 12 to 15-year-olds under the “authorized” category. Full approval for this age group will take further study and time.
Vaccine for kids under the age of 12 remains in trials. Experts have been saying it could be available by late this year or early next year. FDA approval also allows Pfizer to market the vaccine, which will be sold under the brand name “Comirnaty.”