Advisers to the U.S. Food and Drug Administration (FDA) voiced support on May 18 for Pfizer’s maternal RSV vaccine even after several expressed concerns over premature births.
Outside experts on the Vaccines and Related Biological Products Advisory Committee unanimously said data from two trials run by Pfizer were sufficient to support the vaccine being effective at preventing RSV disease in infants. They also voted 10–4 in the affirmative when asked if the data from the trials were sufficient to demonstrate the safety of the vaccine.
The votes set up FDA clearance for what would be the first maternal vaccine for the respiratory syncytial virus, or RSV….