(Reuters) -The U.S. Food and Drug Administration’s staff reviewers said on Tuesday safety data appeared generally favorable for administration of Pfizer Inc’s experimental respiratory syncytial virus (RSV) vaccine in pregnant women to protect their newborns.
While a higher number of pre-term births occurred among participants taking Pfizer’s vaccine compared to those in the placebo group, the FDA staff, in the briefing documents, said the difference did not appear to be statistically significant.
The comments by the staff reviewers come ahead of a meeting on Thursday of the FDA’s outside advisers, who provide non-binding recommendations to the health regulator.
If approved by the FDA, the U.S. Centers for Disease Control and Prevention will then need to sign off on the use of the vaccine to make it widely available to pregnant mothers.
Pfizer’s shot could become the first maternal vaccine for RSV, a leading cause of potentially fatal pneumonia in infants as well as the elderly.
Rival GSK recently became the first company to receive U.S. approval for its RSV vaccine for older adults. Pfizer is expecting a decision for its RSV shot for the elderly later this month.
(Reporting by Raghav Mahobe and Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)
