‘Sad Day for Babies and Mums’: FDA Panel Recommends Pfizer’s RSV Vaccine for Pregnant Women, by Michael Nevradakis, Ph.D.

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Advisers to the U.S. Food and Drug Administration on Thursday recommended the agency approve Pfizer’s respiratory syncytial virus, or RSV, vaccine for pregnant women, despite concerns about premature births identified during clinical trials.

By Michael Nevradakis, Ph.D., Children’s Health Defense, May 19, 2023

Advisers to the U.S. Food and Drug Administration (FDA) on Thursday recommended, by a vote of 10 to 4, that the agency approve Pfizer’s respiratory syncytial virus (RSV) vaccine for pregnant women, despite questions about the vaccine’s safety.

During Thursday’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, committee members and medical experts raised concerns about premature births identified during Pfizer’s clinical trials.

The FDA is expected to issue a final decision on the vaccine in August. If approved, it would become the first RSV vaccine authorized for pregnant women.

The Centers for Disease Control and Prevention (CDC) must “sign off” on Pfizer’s vaccine for pregnant women prior to it becoming available to the public. …

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