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.
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.
According to Axios, the CDC’s immunization advisory committee is likely to discuss FDA-approved RSV vaccines during its June meeting.
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, told The Defender that while the FDA is not obliged to follow the recommendations of its advisory committees, “it almost always does so.”
The appeal of a maternal vaccine like Pfizer’s is “the way it would create neutralizing antibodies in pregnant women that can be transferred to infants in the womb,” Axios reported.
However, “there are health risks, including preterm births,” Axios added, noting that GlaxoSmithKline Biologicals’ (GSK) recently halted its trial of a similar RSV vaccine for infants. According to NBC News, the GSK vaccine “showed a higher preterm birth rate among some vaccine recipients.”