FDA Director Suggests Pregnancy and COVID Vaccination Decision Should Be Personal

Recent developments have seen U.S. health authorities reconsider their stance on COVID-19 vaccination during pregnancy. On May 30, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the federal government would no longer officially recommend COVID-19 vaccines for healthy pregnant women, marking a significant shift in public health policy. This change has sparked widespread debate among medical professionals.

Dr. Marty Makary, a prominent figure at the Food and Drug Administration (FDA), expressed during a recent interview that the decision regarding vaccination for pregnant women should be made collaboratively between the woman and her healthcare provider. He noted that the existing data on COVID booster shots in pregnant women is mixed, and therefore, a personalized approach is preferable.

The decision to skip a formal recommendation was made without a review from the CDC’s usual panel of vaccine experts, leading to questions about the transparency and scientific backing of this new stance. Despite this, the CDC has yet to update its website to reflect the change in guidance. This could impact insurance policies, as many insurers rely on CDC recommendations to determine vaccine coverage.

Pregnant women are generally considered more vulnerable to severe illness from COVID-19, raising concerns among obstetricians. Dr. Beverly Gray from Duke Health reaffirmed her support for recommending the vaccine, citing evidence that it reduces miscarriage risk, hospitalizations, and severe outcomes in pregnant patients. She expressed concern that the sudden policy shift could cause confusion and undermine trust in scientific guidance.

Not all experts agree with the new direction. Dr. Jesse Goodman, a former FDA scientist, stated that multiple studies have demonstrated the benefits of COVID vaccines in pregnancy. Similarly, Dr. Paul Offit highlighted that pregnant women are 1.5 to 2 times more likely to face hospitalization or death from COVID-19. He emphasized that the evidence overwhelmingly supports vaccination during pregnancy.

The American College of Obstetricians and Gynecologists (ACOG) responded critically, describing the move as "extremely disappointing" and affirming that the science still clearly indicates the risks of COVID infection during pregnancy.

This policy change was made without direct input from the CDC and has raised concerns in the medical community about the potential implications for maternal and fetal health. For more information on COVID-19 vaccination during pregnancy, visit the CDC's official site.

Source: https://medicalxpress.com/news/2025-05-fda-chief-covid-vaccine-pregnancy.html