According to a report in the morningstar.com, the FDA has approved AstraZeneca/Sanofi shot that protects infants and toddlers against RSV.
The 2022/2023 winter saw an RSV increase, especially among seniors, that may be under control this year due to the FDA’s recent approval of AstraZeneca and Sanofi’s vaccine.
To healthy individuals, RSV may be an annoying cold. But for infants, the rate is 16 times the annual rate of influenza cases. It is estimated that approximately 590,000 RSV cases involving infants will require urgent care of some type. Each year RSV is the leading cause of hospitalization for infants under the age of one in the U.S.
Thomas Triomphe, Sanofi Vice President, stated that the vaccine’s approval is an unprecedented moment for the protection of infants, their families, and the U.S. healthcare system.
One dose of Beyfortus resulted in consistent efficacy against RSV generally for five months which is the typical RSV season. The most common adverse reaction was a mild rash 14 days after dosing and various moderate reactions after 7 days post-dose near the injection site.
A Contagious Virus
Although 75% of infants in the U.S. are born healthy, an estimated 590,000 RSV disease infants under one year of age require medical care with almost all children infected before they are two years old.
Beyfortus is a single-dose, long-acting antibody developed to prevent RSV in infants through their first RSV season. Beyfortus is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The new vaccine was found to be 78% effective in preventing hospitalizations caused by the RSV virus.
Beyfortus has been granted marketing authorization in the EU, Canada, and Great Britain to prevent RSV respiratory tract infections. The vaccine is currently under regulatory review in Japan and China.