FDA Advisory Committee Recommends Nirsevimab Vaccination for RSV in Infants

The FDA Antimicrobial Drugs Advisory Committee (AMDAC) voted in a 21 to 0 decision to recommend the Sanofi and AstraZeneca nirsevimab vaccine to immunize infants against the respiratory syncytial virus (RSV). The vaccine would protect infants from RSV should the FDA approve it. The news comes one month after the first RSV vaccine was approved by the FDA for older adults, marking a continued breakthrough in treatment for the virus.

“We are delighted that the [AMDAC] has unanimously recognized the favorable benefit risk profile of nirsevimab as the first preventative option against RSV for a broad infant population,” Iskra Reic, executive Vice President of Vaccines and Immune Therapies at AstraZeneca, said in a press release.¹

The FDA AMDAC found that nirsevimab had a “favorable benefit risk profile for the prevention of [RSV] lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.” AMDAC also found there was support for nirsevimab in children up to 2 years, with the committee voting 19 to 2 to support the favorable risk profile of the vaccine in the age group.

Nirsevimab would be the first vaccine that would target RSV infection in infants should the FDA approve the vaccine for general use. The vaccine would use monoclonal antibodies to give protection for RSV, with a specific target in preventing LRTD. The vaccine would primarily serve children aged 2 years and younger, although children on the older end of that spectrum would only receive it should they still be vulnerable to severe RSV in their second RSV season.

The vaccine would protect all infants regardless of health at birth and whether the child was preterm. The vaccine would be a single dose that would be given at the start of RSV season or at the infant’s birth. The review for the vaccine will be expedited, according to the FDA. The vaccine could be available in the United States by the 2023-2024 RSV season if the FDA reviews the application before the Prescription Drug User Fee Act date.

“We look forward to continuing to work with the FDA to complete their expedited review and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants,” said Reic.

The AMDAC approved this recommendation due to new data from the phase 3 MELODY trial published in the New England Journal of Medicine.² The study found that nirsevimab “demonstrated high and consistent efficacy against RSV LRTD sustained through the entire RSV season.” The safety profile for nirsevimab was also found to be consistent throughout all trials. Adverse events were found to be similar between the nirsevimab vaccine and the placebo; these included rash, injection site reactions, and fever.

“We are encouraged by the Advisory Committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden,” said Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, according to the same press release.

Reference

1. FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants. News release. Sanofi. June 8, 2023. Accessed June 12, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-06-08-21-19-00-2685235

2. Muller WJ, Madhi SA, Nunez BS, et al. Nirsevimab for prevention of RSV in term and late-preterm infants. N Engl J Med. Published online April 20, 2023. doi:10.1056/NEJMc2214773