The U.S. Food and Drug Administration’s approval of the Pfizer vaccine for those 16 and up Monday was enough to ease concerns for some of Cincinnati’s unvaccinated.
“I’m just like a lot of other people: They're scared, you know, to get them because I heard a lot of people having side effects from them,” said Bernice Childres, who received her first vaccine dose at a pop-up clinic in her Cincinnati neighborhood Monday, just a few hours after the FDA announcement.
Some have questioned whether the process was rushed. Tim Schroeder, with Covington, Kentucky-based CTI Clinical Trial and Consulting Services, has 35 years of experience and explained that the approval process did not skip steps.
“What we were able to do is compress steps, not skip steps, but the level of rigor, the level of scientific validity, is the highest it’s ever been,” said Schroeder. “These are the most studied vaccines in the history of the world when you think in terms of hundreds of millions of people who have received these vaccines under the emergency use authorization. In a typical year, when we do vaccine research for the influenza flu vaccine or rodovirus or respiratory syncytial virus, those are studied in a much, much smaller number of subjects for a much shorter period of time.”
The FDA granted Pfizer emergency use authorization for those 16 and up in December 2020. In May 2021, the FDA granted Pfizer emergency use authorization for those 12 and up. August 2021, the FDA approved Pfizer for those 16 and up.
Schroeder expects Moderna approval for those 16 and up in the coming weeks or months, followed by Johnson & Johnson. Then, approvals for those 12 and up. While waiting, he says, scientists will gather data to get emergency use authorization for those 5 and up.
“We have the highest level of confidence in the quality of the data,” said Schroeder.
Out of the counties we cover in Indiana, Kentucky and Ohio, Gallatin, Owen, Switzerland and Adams counties have the lowest vaccination rates. Transmission rates remain high in all the counties we cover. That’s according to the Centers for Disease Control and Prevention.