Source/Disclosures
Disclosures:
Baden, Hunsberger, Jackson, Kotloff and Perez report no relevant financial disclosures.
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Key takeaways:
- FDA advisors voted 21-0 in support of a monoclonal antibody to protect newborns and infants from RSV.
- Two advisors voted against a statement supporting use of the mAb in infants entering their second RSV season.
An FDA advisory committee on Thursday voted in favor of approving the long-acting monoclonal antibody nirsevimab to protect neonates and infants from respiratory syncytial virus.
The Antimicrobial Drugs Advisory Committee (AMDAC) voted 21-0 in agreement that data showed the benefits of nirsevimab outweighed the risks in neonates and infants born during or entering their first RSV season, at an intramuscular injection of 50 mg for infants with a body weight less than 5 kg and 100 mg for infants with a body weight of 5 kg or more.
An FDA committee has recommended the monoclonal antibody nirsevimab to protect newborns and infants during their first RSV season. Image: Adobe Stock
A second question asking if the benefits of nirsevimab outweigh the risks when administered to children up to 24 months of age who remain vulnerable to severe RSV through their second RSV season, 19 members voted “yes” and two voted “no.”
It was the latest in a series of recent regulatory votes supporting drugs that protect against RSV, a common respiratory infection that can cause serious illness, especially in infants and older adults. A surge of RSV stretched hospital capacity late last year, and the virus was part of a winter tripledemic of respiratory diseases, alongside COVID-19 and influenza.
The FDA recently approved the world’s first two vaccines against RSV, made by GSK and Pfizer.
Data from multiple trials has demonstrated that nirsevimab is approximately 80% effective against medically attended RSV after a single dose.
Members cited this efficacy in comments following their votes on the second question, including committee member Federico Perez, MD, MS, an infectious disease physician at Louis Stokes Cleveland VA Medical Center and associate professor of medicine at Case Western Reserve University, who voted “yes ” to both questions.
“This indicates the possibility to protect all infants across the entire season with a single dose, which I find a very powerful intervention,” Perez said.
Karen L. Kotloff, MD, division head of pediatric infectious diseases and tropical medicine and associate director of clinical research at the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, also voted “yes” both times.
“I think that there is a very well burdened burden of severe disease that needs to be prevented,” Kotloff said. “I think that a single dose that’s long acting improves compliance. I think that the data were robust, and they addressed a diversity of relevant risk groups and demographic groups and were very well conducted, and I think that the safety data were also compelling. I also think there are a couple of nuances that will need to be addressed.”
Sally A. Hunsberger, PhD, a biostatistician at the National Institute of Allergy and Infectious Diseases, voted “yes” on the first question but “no” on the second question regarding
“I thought about this a long time and ended up voting no,” Hunsberger said. “I feel like we do need more data on this.”
Mary Anne Jackson, MD, dean and professor of pediatric infectious diseases at the University of Missouri-Kansas City School of Medicine, also voted “yes” on the first question but “no” on the second based on issues with data collected regarding infants with congenital heart issues.
“There’s no question that there’s a very significant burden of disease in both morbidity and mortality in this patient population, but it was a smaller population that was studied, and it wasn’t very well nuanced because many of these patients are undergoing multiple different surgeries during that second year, where they may have a complete exchange of their blood volume and may require redosing,” Jackson said.
“We don’t have the data in their group, but I feel very comfortable about the safety information,” she said. “I understand the [pharmacokinetics] information, but in that congenital heart population, this may need to be” looked at further.
Committee chair Lindsey R. Baden, MD, director of clinical research in the division of infectious disease at Brigham and Women’s Hospital in Boston and a professor of medicine at Harvard Medical School, summarized the consensus following the first vote.
“All committee members were impressed with the conduct of the study and the clean results that were presented,” Baden said. “As all good research points out, there’s still more work to be done, but the committee believes this is an important advance.”
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