First shot to prevent RSV in infants moves one step closer to FDA approval

Respiratory illness kills hundreds of babies per year

A Food and Drug Administration advisory panel voted on Thursday to recommend approving a new vaccine for Respiratory Syncytial Virus (RSV) in infants.

The vote signals that the regulator as a whole is likely to approve the treatment, the first of its kind for babies.

The panel voted to recommend the Pfizer-manufactured vaccine, which would be given to mothers while they are pregnant, 14 to 0 based on its efficacy, and 10 to 4 based on its safety.

RSV, a respiratory illness which inflames the airways and clogs them with mucus, is often mild in adults, but can prove deadly to newborns and older adults.

An estimated 300 children under 5 and 10,000 people 65 and older die from RSV in the US each year, according to the CDC.

Dr Jonathan Miller, a pediatrician at Nemours Children’s Health, Delaware Valley, told The New York Times that approval of the vaccine would be a “huge” step ahead of this winter, the season when RSV cases peak.

“I’m thrilled about the prospect of this, as well as about the prospect of other RSV vaccines in the pipeline,” he said. “This looks as if it will be the first one coming our way, and it’s a long time coming.”

A clinical trial of 7,400 people showed the proposed vaccine lowered the risk of severe disease in infants by 82 per cent within three months of birth and 69 per cent after six months, NBC reports.

Participants reported side effects including fatigue, headache, muscle pain, and injection site pain. Participants also recorded a slightly higher rate of preterm births than those who got a placebo, but only by one per cent, which wasn’t considered statistically significant.

The FDA approved the first RSV vaccine, meant for those 60 and up, earlier this month.

Later this month, the agency will consider a Pfizer treatment for older adults, which uses the same formula as the vaccine for pregnant people.