Children's Health Defense The U.S. Food and Drug Administration on Monday approved Pfizer’s Abrysvo vaccine, a maternal vaccine meant to protect infants against respiratory syncytial virus, or RSV, through 6 months of age — despite safety concerns, including from the FDA’s own advisers.
The U.S. Food and Drug Administration (FDA) on Monday approved Pfizer’s Abrysvo vaccine, a maternal vaccine meant to protect infants against respiratory syncytial virus, or RSV, through 6 months of age.
The agency approved the vaccine despite concerns raised by members of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) about premature births identified during Pfizer’s clinical trials.
VRBPAC panelist Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia and a frequently cited vaccine advocate, said he doesn’t believe there is enough data to indicate the safety of the vaccine is “reassuring.”
