August 04, 2023
2 min read
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Key takeaways:
- AztraZeneca and Sanofi’s monoclonal antibody was unanimously recommended yesterday by an FDA committee.
- CDC director encouraged parents of infants to discuss the option with their providers this fall.
The CDC has adopted an FDA advisory committee’s recommendation of a monoclonal antibody against respiratory syncytial virus in infants.
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.
The CDC has adopted an FDA advisory committee’s recommendation of a monoclonal antibody against respiratory synclinal virus in infants. Image: Adobe Stock
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 decision comes nearly 2 months after the FDA’s Antimicrobial Drugs Advisory Committee voted in unanimous support of the antibody’s, AztraZeneca and Sanofi’s nirsevimab, efficacy 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.
Yesterday, the FDA’s Advisory Committee on Immunization Practices unanimously voted to recommend the antibody for infants aged younger than 8 months born during or entering their first RSV season, for one dose of 50 mg for infants weighing less than 5 kg and 100 mg for infants weighing 5 kg or more.
Children aged 8 to 19 months who are at risk an increased risk of severe RSV disease and entering their second RSV season are recommended to receive one dose at 200 mg.
“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” CDC director Mandy Cohen, MD, MPH, said in a release. “RSV is the leading cause of hospitalizations for infants and older babies at higher risk, and today we have taken an important step to make this life saving product available.”
Data from multiple trials have demonstrated that nirsevimab is approximately 80% efficacious against medically attended RSV after a single dose.
“The [FDA] workgroup felt that nirsevimab use among children aged 8 through 19 months entering their second RSV season or an increased risk of severe disease is probably a reasonable and efficient allocation of resources,” said Jefferson Jones, MD, MPH, a medical officer in the respiratory disease branch in the Division of Viral Disease at the CDC, during the meeting.
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said in a release. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
The FDA recently approved the world’s first two vaccines against RSV, made by GSK and Pfizer for older adults.
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