New CDC vaccine committee OKs Merck RSV shot for infants
The advisory committee on Thursday voted 5-2 to approve the monoclonal antibody-based vaccine for infants younger than 8 months old to protect them during their first seasonal exposure to RSV.
The recommended dosage is one shot of Enflonsia for infants who have not already obtained RSV protection via a vaccine their respective mothers might have received during their pregnancies.
The vaccine's active ingredient is the monoclonal antibody clesrovimab, which Merck created but faced some opposition before gaining the committee's approval recommendation.
Most babies are infected by RSV by the time they turn 2 years of age, which causes cold-like symptoms and affects breathing by restricting airway passages and the lungs, according to the CDC.
About 58,000 children younger than age 5 in the United States annually are hospitalized due to RSV, which kills hundreds of them.
Merck's Enflonsia vaccine is the second RSV monoclonal antibody that is recommended for approval to prevent RSV.
The Food and Drug Administration in July 2023 approved Beyfortus to prevent RSV from causing lower respiratory tract disease in infants. Sanofi and AstraZeneca developed that vaccine.
Thursday's vote was the first by the newly seated advisory committee after Health and Human Services Secretary Robert Kennedy Jr. dismissed the prior advisory committee due to what he called conflicts of interest among its members.
Kennedy fired the committee's 17 members and replaced them with eight others, including some who are regarded as skeptical of vaccines.
Earlier this week, Louisiana's Republican Sen. Bill Cassidy criticized the new panel members, saying they lacked needed experience in microbiology, epidemiology and immunology.
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