Pfizer hopes that its respiratory syncytial virus vaccine will be available to the public by the end of October or the beginning of November.
, which found that the shot was nearly 82% effective at preventing severe disease from RSV in newborns during the first 90 days of life.In May, the FDA's panel of advisors unanimously said the data showed Pfizer's vaccine was effective.But some advisors expressed concerns about safety.
A slightly higher number of premature births occurred among mothers who took the shot compared to those who received a placebo: 5.7% versus 4.7%, respectively.She noted that most premature births occurred 30 days after vaccination, which means"a very close causal relationship between the vaccine and preterm birth couldn't be identified.
The company's post-marketing will also involve evaluating any pregnancy-related complications following vaccination, she added. That includes eclampsia, which refers to seizures that develop during pregnancy or shortly after birth. Pfizer will launch a pregnancy registry that will allow women and obstetricians to call and report any adverse events after receiving the vaccine, according to Gurtman.
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