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FDA Moves To Publicize Data On Pregnant Women's Covid Vaccine Side Effects

Vandana Singh
September 10, 2025

Top health officials under the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. are intensifying efforts to gather and publicize data on potential harms caused by COVID-19 vaccines, particularly in pregnant women.

In May, in a social media post, Kennedy said, "As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Kennedy said. "Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children."

FDA Commissioner Marty Makary and vaccine chief Vinay Prasad are seeking to ease privacy protections around vaccine data related to pregnant women, allowing the agency to highlight concerns about possible side effects.

Also Read: Robert F. Kennedy Took Fire From Both Republicans And Democrats Over Vaccine Overhauls: GOP Senators Defend Trump’s Operation Warp Speed

The initiative extends an earlier effort by Makary, who is preparing a report on child deaths allegedly linked to Covid shots.

Studies show that serious side effects from COVID-19 vaccines are rare and that their benefits outweigh risks. Professional groups representing pediatricians and obstetricians continue to recommend vaccination, including for pregnant women.

For example, last month, the American College of Obstetricians and Gynecologists reaffirmed support for COVID-19 vaccination during pregnancy, diverging from Kennedy’s guidance.

Pfizer Inc. (NYSE:PFE), Moderna Inc. (NASDAQ:MRNA), and Novavax Inc. (NASDAQ:NVAX) all defended their vaccines after U.S. President Donald Trump's recent social media call for greater transparency, citing data that confirms safety for high-risk populations and expectant mothers.

Kennedy, a long-time vaccine skeptic who previously described Covid shots as the "deadliest vaccine ever made," has fueled debate about their role in public health, the Wall Street Journal reported.

Before becoming Health and Human Services secretary, he petitioned to remove them from the market. Some GOP lawmakers have criticized his stance, arguing that Operation Warp Speed--Trump's effort during his first term to accelerate vaccine development--was a historic success.

The WSJ report added that the controversy comes as Kennedy's newly appointed members of the Advisory Committee on Immunization Practices prepare to review this year's Covid booster recommendations. The group is also considering adding more vaccine-critical voices and revisiting vaccine guidelines through a panel led by critic Retsef Levi.

The debate over vaccine safety and government transparency has already led to high-profile resignations at the CDC, including Director Susan Monarez, who is set to testify before the Senate's health committee next week.

In August, Kennedy announced on social media that the emergency use authorizations for COVID-19 vaccines have now been rescinded.

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