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FDA advisors endorse Pfizer’s RSV vaccine for neonates, but safety concerns raised


The independent panel of advisors for the U.S. Food and Drug Administration has recommended full approval of Pfizer‘s vaccine for infants, which provides protection against respiratory syncytial virus (RSV). The vaccine has shown promising efficacy data, with approximately 82% effectiveness in preventing severe RSV disease in newborns during the first 90 days of life and around 70% effectiveness during the first six months. However, there are concerns regarding the safety of the vaccine, particularly in relation to an increased risk of premature births among mothers who received the shot.

While some members of the advisory panel expressed reservations about the safety data and potential risks associated with premature births, others argued that there is insufficient evidence to establish a clear causal relationship. Pfizer representatives emphasized that the benefits of the vaccine outweigh the potential risks and that there is no definitive evidence suggesting a risk of prematurity.

The FDA is not obligated to follow the advisory committee’s recommendations, but they typically influence the agency’s final decision. The FDA is expected to make a final decision on the vaccine’s approval in August, just before the onset of the RSV season in the fall.

If approved, Pfizer’s vaccine would be the world’s first vaccine to protect infants against RSV, a significant milestone in the field of medicine. RSV is a common respiratory infection that can cause severe illness, particularly among older adults and young children. The vaccine, administered to expectant mothers, triggers antibody production that is passed on to the fetus, providing protection against RSV from birth through the first six months of life.

Further studies, including post-marketing studies, will likely be conducted to assess the risk of premature births and closely monitor the safety and efficacy of the vaccine.

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