Single-Shot RSV Vaccine for Infants Is Under Accelerated Review, May Be Expected Within Months

Infants will soon have a vaccine to protect them from the respiratory syncytial virus (RSV). FDA is currently reviewing the product and will release the results in the fall.

First RSV Vaccine for Infants Is Under FDA Review

Sanofi and AstraZeneca are developing nirsevimab, the first protection option for infants from RSV, when approved. It is safe for a broad infant population, including those born healthy, at term or preterm, or with specific health conditions, as announced by the companies in a press release.

According to Sanofi, nirsevimab delivered consistent protection of approximately 80% against medically attended RSV disease across several trials in healthy term and preterm infants.

The drugmakers said its third phase trial results showed that its single-dose treatment was nearly 75% effective at preventing severe infections in babies throughout the RSV season. The data was published in March 2022 in the New England Journal of Medicine.

On Jan. 5, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season. It is safe for children up to 2 years old who remain vulnerable to severe RSV disease through their second RSV season.

FDA said that it would work to speed up the review and targets to release its decision in the third quarter of the year.

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Nirsevimab Could Significantly Reduce Babies Affected With RSV

Dr. William Schaffner, medical director at the National Foundation for Infectious Diseases, was positive that once nirsevimab is approved, it could significantly reduce the rate of babies hospitalized due to RSV every year, NPR reported.

According to him, the potential influence on ensuring healthy infancy for a very big proportion of infants born in the United States - and even further afield - might be enormous.

Dr. Joseph Domachowske, a pediatric infectious disease specialist at Upstate Medical University Hospital in Syracuse, was part of the earliest phase of the nirsevimab study. According to him, RSV is the leading cause of why infants and young children are hospitalized worldwide. He emphasized that antibody treatment is not a vaccine but what scientists refer to as "passive immunization." The antibodies against RSV circulate in the infants' bodies and protect them against the virus should they be exposed.

He explained that it doesn't cause an immune response or cause the body to develop an immune memory. However, it offers protection for a period of time until it wears off. It is similar to the treatment used to protect immunocompromised patients against COVID.

Domachowske led the COVID-19 vaccine trial for children, and he expects that nirsevimab will receive a green light from regulators and will be available by the next RSV season in the fall.

Nirsevimab has been approved in the United Kingdom and Europe.