HILLSBOROUGH COUNTY, Fla. – Before the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee unanimously voted Friday to recommend Johnson & Johnson's COVID-19 vaccine candidate for emergency use, members heard from medical professionals and stakeholders from across the country. Once again, one of them was board-certified pediatrician Dr. David Berger. Berger was previously selected to speak before the committee on the Pfizer and Moderna vaccines.
What You Need To Know
- Dr. David Berger addressed the FDA's advisory committee
- Berger told members he was frustrated with the lack of information on the Johnson & Johnson vaccine candidate available to presenters ahead of time
- The board-certified pediatrician also said more information is needed on the vaccines and pregnant women
“What I’m calling for, really, is open transparency and the recognition and statement of things that we know and we don’t know and just to acknowledge that," said Berger, whose practice, Wholistic Pediatrics & Family Care, is located in Tampa.
Berger began his remarks by telling the committee he was significantly frustrated with the presentation process. He said, as with the hearings on the Pfizer and Moderna vaccines, presenters were required to submit their presentations before they had access to complete data.
“I had to turn in my written comments, as well as my slides, before they even released the data to the general public," Berger said. "I feel if the FDA really wanted to hear from us, they would've given us information more than 48 hours ahead of time."
This time around, Berger's presentation focused on the lack of information on the vaccine's potential impact on pregnancy and fertility. He said his concern in this area isn't just regarding the Johnson & Johnson vaccine, but also Pfizer's and Moderna's.
“There’s been no research that’s been published on either of them. So, that is a concern. I realize that research takes time, and we’re not going to be able to snap our fingers and they’re going to be able to present us this information," Berger said.
When it comes to recommendations from health organizations, the Centers for Disease Control and Prevention says pregnant women may choose to get vaccinated if they belong to eligible groups, like essential workers. The World Health Organization's guidance is similar for the Pfizer and Moderna vaccines – women at high risk of exposure should talk with their doctors to determine if vaccination is right for them. The American College of Obstetricians and Gynecologists recommends vaccines not be held back from pregnant women who meet the criteria.
All note there is very little data on the vaccines and pregnant women.
“For me, it all comes down to informed consent," Berger explained. "So, a person can consent to do something, but they must be informed to give informed consent. And that means having as much information as they possibly can at the time.”
Pfizer announced earlier this month it's conducting a study to test the safety and efficacy of its vaccine in pregnant women.