FDA staff support safety data for Pfizer’s RSV vaccine to protect newborns
By Raghav Mahobe and Mariam E Sunny
May 16 (Reuters) – The U.S. Food and Drug Administration’s staff reviewers said on Tuesday the safety data for Pfizer Inc.’s (PFE.N) experimental respiratory syncytial virus (RSV) vaccine in pregnant women was “generally favorable”.
Pfizer is seeking approval for use of its shot in pregnant women in order to protect newborns to six-month-old babies from complications of RSV disease. If approved, it could become the first maternal vaccine against the virus.
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.
Comments by the staff reviewers come ahead of a meeting of the FDA’s outside advisers on Thursday, where they will provide non-binding recommendations to the health regulator.
If approved by 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 vaccine had shown in its late-stage study it was nearly 82% effective in preventing severe lower respiratory tract illness due to RSV, which is a leading cause of potentially fatal pneumonia in infants as well as the elderly.
The FDA staff also noted the safety and efficacy findings in the vaccine’s development program could be applicable to trans-male individuals who may be pregnant.
Development of effective RSV shots has picked up pace in recent years after researchers were able to better understand the virus’ structure and then stabilize a type of protein found on its surface that could activate the body’s immune response.
Rival GSK (GSK.L) 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.
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