FOR IMMEDIATE RELEASE:
Dr. David Berger of Tampa to Address Pregnancy Safety Concerns with FDA COVID-19 Vaccine Advisory Committee
Questions whether FDA should approve DNA-containing Johnson & Johnson vaccine for women of childbearing age before more information is known about safety for developing fetuses.
TAMPA, Fla. February 25, 2021 — According to Pew Research Center, women of childbearing age in the United States have greater hesitancy about the COVID-19 vaccines compared to men. A contributing factor is likely the lack of data available regarding the effect of COVID-19 vaccines on pregnant women or their offspring, especially as it relates to DNA-containing vaccines like the one Johnson & Johnson is requesting the FDA approve this week.
On February 26, 2021, the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss Emergency Use Authorization (EUA) of the Johnson & Johnson/Janssen Biotech COVID-19 Vaccine. Dr. David Berger will give a presentation regarding continued vaccine hesitancy and safety concerns related to pregnancy and the COVID-19 vaccines (see submitted slide presentation and submitted written comments).
Dr. David Berger, founder and medical director of Wholistic Pediatrics & Family Care in Tampa, Florida, is a Board Certified pediatrician with decades of experience specializing in preconception, pregnancy, and infant and childhood health. He also serves as Senior Medical Advisor of the Vaccine Considerations Project. He previously addressed the committee during their EUA meeting regarding Pfizer on December 10th and Moderna on December 17th.
Dr. Berger has specific concerns about the Johnson & Johnson COVID-19 vaccine for women of childbearing age.
We know the mRNA-based Pfizer and Moderna vaccines do not enter the nucleus of the cell, so they cannot come into contact with human DNA. At this time, we cannot confidently say the same for the Johnson & Johnson COVID-19 vaccine, and this may have safety implications for developing fetuses.
David Berger, MD, FAAP
Although pregnant women and those trying to conceive want pregnancies free of COVID-19 medical complications, they also often want to minimize synthetic chemicals from entering their bodies.
“Researchers are not certain that genetic material from this type of vaccine will not cause issues for pregnant women or developing fetuses,” said Dr. Berger. “For women to be able to make informed decisions, it is critical the scientific community better determine if the various COVID-19 vaccines have differing impacts on a developing fetus.” He intends to tell the FDA that, until more is known, mRNA vaccines such as Pfizer and Moderna may be better options for women of childbearing age who are choosing to get a COVID-19 vaccine.
Dr. Berger will present to the Committee between 1:10 pm – 2:10 pm ET on Thursday, February 26, 2021. The online meeting can be viewed at
Dr Berger also produced a series of YouTube videos on COVID-19 topics important to his patients, and social media campaigns to notify the public about FDA vaccine approval meetings.
Dr. Berger is available for further public comment before or after his committee presentation.
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