FDA panel recommends jab for pregnant mothers to prevent RSV in infants

An independent advisory committee to the Food and Drug Administration (FDA) on Thursday voted to recommend a vaccination shot for pregnant mothers which can protect their infants from RSV.

The shot, made by Pfizer, was unanimously recommended by the 14-person panel based on its efficacy as they voted 10-4 to recommend it on the basis of its safety.

If the FDA eventually approves the shot, then it would become the first vaccine that confers protection to babies against respiratory syncytial virus.

Boston Children’s Hospital's Director of the Precision Vaccines Programme Dr Ofer Levy said, “Before the pandemic, RSV was the No. 1 cause of infant hospitalisation in the United States, so this is a big deal.” Levy is FDA's temporary voting member and did not participate in Thursday’s voting.

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Lower respiratory illness which is caused by RSV in healthy adults is generally mid but it can be severe in older adults and babies. Around 300 children stand the risk of losing their lives in five years in the US because of the virus, as per to the Centres for Disease Control and Prevention.

Severe infections can lead to bronchiolitis or pneumonia because of which airways are inflamed and clogged with mucus.

The FDA can take months to approve the shot, but the agency will most probably follow the recommendations of the advisory committee.

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GSK halts trial of RSV vaccine

Pharmaceutical giant GSK last week halted the trial of the RSV vaccine for infants after a higher preterm birth rate was seen in some vaccine recipients.

FDA advisory committee member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia Dr Paul Offit said that the outcome of GSK’s trial was relevant to the study of Pfizer, since both the vaccines are similar.

“I worry that if preterm births are in any way a consequence of this vaccine, that would be tragic in many ways,” said Offit at Thursday’s meeting. He voted against the proposed shot on the basis of its safety.

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Levy stated that close attention is paid by researchers generally to any potential risk of preterm birth among vaccines which are given to pregnant women.

“There’s always the background concern: Are you inducing some inflammation that could be a problem? Because the body reads inflammation as ‘the woman’s no longer safe, let’s get the baby out.’ So you want a fairly bland vaccine,” he stated.

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