TAMPA, Fla. — — Among the public speakers the FDA selected to speak during the Vaccines and Related Biological Products Advisory meeting regarding the Johnson and Johnson COVID-19 vaccine, was a Tampa pediatrician who is pushing for more transparency when it comes to COVID-19 vaccines in pregnant women.
David Berger, M.D., is a board-certified pediatrician at Wholistic Pediatrics and Family Care, and an Associate Professor at the USF College of Nursing. At this point, he’s fully vaccinated against the COVID-19 virus, but he has a message for the FDA when it comes to transparency about the vaccines.
“To say that we know that the vaccines are safe in pregnancy, we just cannot say that because we don’t have any data to support that,” said Dr. Berger.
There also isn't enough data to say that it's not safe, so he’s urging the FDA and other government agencies to make that messaging more clear.
“I want people to be able to say ‘I now have more information, where I can weigh the benefits vs. risks of taking a vaccine,'” said Dr. Berger.
So far, more than 20,000 pregnant women have gotten the COVID-19 vaccine in the U.S.
Both the CDC and the FDA are monitoring those women, and Dr. Anthony Fauci says so far, there are “no red flags.”
Still, vaccine trials in pregnant women are only beginning. Pfizer began their trial, testing the safety and effectiveness of the COVID-19 vaccine in pregnant women, just this week.
“It wasn’t expected that the manufacturers would’ve done these types of studies during their first trials, because that’s not the ways things happen in research. You don’t test kids first, you don’t test pregnant women first, you take and test first healthy people, of various ages, to see what those types of outcomes are,” said Dr. Berger.
As of now, the CDC recommends women who are pregnant or breastfeeding talk with their healthcare provider.
“My recommendation has always been about informed consent. A person needs to be informed in order to consent, and everybody should weigh the benefits and the risks of making a decision to A. should I get one of these vaccines, or should I not, and then if the decision’s made to get a vaccine, which one should I get,” said Dr. Berger.
To watch Dr. Berger's full FDA presentation, click here.