Tampa pediatrician to FDA advisory board: More data needed on vaccination and pregnancy

There is very limited data about the safety of getting a COVID-19 vaccine as it relates to being pregnant. A Bay Area physician says drug makers and the federal government should be more transparent about the lack of data so expectant mothers can make informed decisions before getting the shot.

"Especially with this new vaccine which really hasn’t been used in anyone who is pregnant yet," said Dr. David Berger with Wholistic Pediatrics and Family Care.

The Tampa pediatrician spoke to the FDA Vaccines and Related Biological Products Advisory Committee at its meeting Friday afternoon. The group was debating granting emergency use authorization to the Johnson & Johnson single-dose COVID-19 vaccine.

Dr. Berger is urging government agencies to be more transparent regarding the lack of scientific data about complications all three shots could cause for a pregnant woman and her unborn baby.

"It comes down to informed consent and making sure that the woman understands this is something that has not been done before, we cannot give you data to let you know that this is safe, we just don’t have the ability to do that," he said.

A COVID-19 vaccine safety update from Monday shows the CDC is tracking more than 30,000 expectant mothers who have gotten the vaccine, saying "No unexpected pregnancy or infant outcomes have been observed related to COVID-19 vaccination during pregnancy."

However, the first clinical trial of the vaccine in pregnant women was just launched by Pfizer about two weeks ago.

"Ordinarily, vaccines are well tested first on healthy people and are never first started off in pregnancy," said Berger.

According to the CDC, pregnant women have an increased risk of higher complications from the coronavirus. The agency currently recommending they speak with their doctors to help decide if they should get a COVID-19 shot.

Berger believes these conversations should be more strongly encouraged, along with a greater emphasis on the lack of concrete information.

"So I’m just suggesting that women make a list what’s the potential benefits of getting the vaccine versus not, and then if they’re choosing to get a vaccine, which vaccine are they most comfortable getting," Berger said.