CNN
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Advisors to the U.S. Food and Drug Administration voted Thursday in favor of a monoclonal antibody designed to protect infants and some young children from RSV.
Members of the Agency’s Antibiotics Advisory Panel found the benefit-risk profile of nircevimab to be favorable in infants, 21 to 0, and in children up to 24 months of age, who are susceptible to severe respiratory syncytial virus infection. Voted 19 to 2.
The FDA will then consider the advisor’s advice and decide whether to approve the treatment.
A monoclonal antibody, nircevimab, was developed by AstraZeneca and Sanofi. It is designed to be administered as a single dose to an infant at birth or just prior to the onset of her first RSV season in a baby, or to a large dose in her second her RSV season in highly vulnerable children. increase.
If approved, it would be the first single-dose prophylaxis against RSV in all infants. Unlike vaccines, where the body reacts and builds immunity over time, monoclonal antibodies take effect immediately.
In trials, nircevimab reduced the risk of RSV-related lower respiratory tract infections requiring medical attention by approximately 75% and the risk of RSV-related hospitalization by approximately 78% compared with placebo. No serious safety concerns were identified. Common side effects included rashes and injection site reactions.
Another monoclonal antibody therapy approved in the US Europe, Palivizumab, or Synagis prevent infection in high-risk infants. With this therapy, infants receive monthly intramuscular injections during RSV epidemics, usually requiring 5 doses.
Last month, FDA vaccine advisers voted in favor of a new vaccine to prevent RSV in infants. The maternal vaccine is a single dose that is given to pregnant women late in pregnancy and causes the production of antibodies that can be passed on. Protects the fetus and protects the baby for about 6 months after birth. Trials show that the Pfizer-made vaccine reduces the risk of infants needing medical attention or hospitalization for moderate to severe infections.
Nearly all children become infected with RSV before the age of 2, according to the WHO. U.S. Centers for Disease Control and PreventionBut last winter, the virus Children’s Hospital Overwhelmed across America. In children, it is often a mild respiratory infection, many adult, According to research that it remains the leading cause of hospitalization for infants;
Globally, 33 million people were infected and more than 3.6 million were hospitalized in 2019 alone. It is estimated that there were 26,300 hospital-acquired respiratory syncytial virus deaths in children under the age of 5, and 101,400 overall. A 2022 study was published in the Lancet.
