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Tuesday, May 21, 2024

FDA Grants Approval for R.S.V. Vaccination in Infants

As one of the first lines of defence against an infection that often sends children to the hospital, the Food and Drug Administration (FDA) on Monday authorised a shot to protect newborns and vulnerable toddlers against respiratory syncytial virus (R.S.V.).

At the beginning of the autumn R.S.V. season, the monoclonal antibody shot will likely be made accessible. Pfizer has developed an RSV vaccine to protect unborn children against the virus, and the F.D.A. is now debating whether to provide permission for use of the vaccine in pregnant women.

Beyfortus, developed by Sanofi and AstraZeneca, was given the go light on Monday to treat a condition that may be life-threatening for both elderly people and newborns. According to the CDC, every year there are around 80,000 children less than 5 who get the illness and end up in the hospital.

Even in old age, it may be possible to mitigate the side effects of R.S.V. : Two vaccinations against the virus have been licenced by the F.D.A. in recent months for persons aged 60 and above. The Centres for Disease Control and Prevention estimate that annually between 10,000 and 60,000 persons aged 65 and above die from complications related to this infection. The government determined that more than 21,000 persons in that age range would need to take the GSK vaccination and almost 25,000 would need to take the Pfizer injection to prevent one R.S.V. fatality in one year.

In June, agency advisors voting on whether to approve the antibody injection for babies were unanimous. Report submitted by Sanofi and AstraZeneca to the F.D.A. included the administration of the injection to more than 3,200 newborns. In a trial lasting six months, 79 percent of patients who had severe R.S.V. and needed medical intervention saw improvement.

Advisors at the F.D.A. were more wary of a Pfizer R.S.V. injection for expectant mothers. Concerns over slightly heightened incidence of preterm deliveries among moms who got the vaccination, compared to those who received a placebo, led to a panel voting 10 to 4 in favour of the vaccine’s safety in May.

GSK stopped its study on a similar vaccine after they saw a rise in premature deliveries. Abrysvo, a maternal vaccine developed by Pfizer, is still awaiting a decision from the FDA, but a company spokesman has suggested clearance is expected in the coming weeks.

Jonathan James
Jonathan James
I serve as a Senior Executive Journalist of The National Era
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