JACKSONVILLE, Fla. — In recent years for COVID vaccines the FDA made decisions based off clinical trial evidence and recommendations from experts.
But for the fourth dose, that wasn’t the case.
“What they did is took observational data from around the world especially Israel and that data showed that the protection of the vaccine booster starts to wane after six months," said Dr. Michael Koren, CEO at Jacksonville Center for Clinical Research.
Koren says that’s when the FDA authorized the fourth dose six months after the third dose if you are a high-risk person.
“That’s why some doctors are arguing like we should’ve done this systematically. Its great to think that was good but wouldn’t it be better to prove that was good and that’s where the controversy lies," said Koren.
Here’s the issue.
“What we don’t know is whether or not the original formulation of the wild type virus as a booster is efficient or whether not every six months the booster should be updated depending upon the strain that is actually in the communities that are being vaccinated," said Koren.
He says many people are uncomfortable with the idea of knowing that there was no clinical trial for the fourth dose.
“Maybe it doesn’t have to be as massive as the first clinical trials but certainly doing something that it safe in a population of patients is something that many people thought was the appropriate way to go about things," said Koren.
Currently the Jacksonville center for clinical research is running clinical trials on the fourth dose looking at the effectiveness and the safety of it.