USA — US FDA has granted approval to Sanofi and AstraZeneca’s Beyfortus (nirsevimab) as a preventive treatment for respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants.

This approval also extends to children up to 24 months old who remain at risk of severe RSV disease during their second RSV season.

Notably, Nirsevimab is the first shot authorized by the FDA to safeguard all infants from RSV, irrespective of their health condition.

Developed through a collaborative effort between Sanofi and AstraZeneca under a 2017 agreement, Beyfortus utilizes AstraZeneca’s YTE technology.

The drug has already obtained approval in the European Union, Great Britain, and Canada, with regulatory applications currently undergoing review in China, Japan, and other countries.

Sanofi plans to make Beyfortus available in the United States ahead of the upcoming RSV season, while pricing details will be shared closer to the season.

RSV is a leading cause of hospitalizations in infants, and until now, the only approved preventive therapy in the United States for high-risk infants was Synagis from Swedish Orphan Biovitrum.

Unlike Synagis, which requires monthly injections, Beyfortus is a long-acting therapy administered once every season, offering infection prevention regardless of additional medical conditions in infants.

In August, the Centers for Disease Control and Prevention’s panel of independent experts will convene to provide recommendations on the administration of the shot by doctors.

Nirsevimab is administered either before or during an infant’s first RSV season, and vulnerable toddlers up to two years old can receive the shot during their second RSV season.

According to the American Academy of Pediatrics, RSV leads to hospitalizations for approximately 1% to 3% of children under 12 months of age in the United States each year.

The approval of Beyfortus follows a positive vote from the FDA’s panel of outside advisers over a month ago.

An FDA review found that Nirsevimab was up to 75% effective in preventing lower respiratory tract infections requiring medical attention in infants and 78% effective in preventing hospitalization.

While Beyfortus has shown efficacy, it comes with warnings and precautions regarding serious hypersensitivity reactions.

Caution should be exercised when administering the therapy to infants and children with clinically significant bleeding disorders, as stated by the FDA.

Last fall, a surge in RSV infections overwhelmed children’s hospitals across the U.S., leading to calls for a public health emergency declaration from the Biden administration.

Nirsevimab is a monoclonal antibody that functions similarly to a vaccine by delivering protective antibodies directly into the bloodstream, unlike vaccines that stimulate the immune system to produce antibodies.

Due to its classification as a drug, there is some uncertainty regarding whether the federal Vaccines for Children program will provide Nirsevimab for free to families facing financial difficulties. This issue is expected to be addressed during the CDC advisors’ meeting in August.

Families may have two options to protect their infants this fall. Pfizer has developed a vaccine that protects infants when administered to the pregnant mother.

Pfizer’s vaccine received a positive recommendation from the FDA’s independent advisors in May, with the agency expected to make a final decision on its approval in August.

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