WASHINGTON (dpa-AFX) - Last month the U.S. Food and Drug Administration (FDA) had approved the CAPVAXIVE vaccine for pneumococcal infections in at-risk children aged 2 years or older. However, recent confusion in authorization committees within the U.S. Health Department may impede distribution of the vaccine.
CAPVAXIVE is a 21-valent conjugate vaccine acting against various strains of Streptococcus pneumoniae, that first received FDA approval on June 17, 2024, for the prevention of pneumonia in patients aged 18 or older. The vaccine is indicated for individuals at higher risk to acquire S. pneumoniae infections, potentially leading to pneumonia, meningitis, or bacteremia.
Developed and marketed by Merck and Dohme LLC, the single-shot vaccine is generally administered alongside the yearly 'flu-shot' recommended for children and adults in the U.S.
However, the past few months have seen a significant number of changes within the U.S. Health Department's structure and functioning, resulting in certain modifications to the recommended pediatric vaccinations list issued by the Centre for Disease Control (CDC).
The CDC's Advisory Committee on Immunization Practices (ACIP) usually releases a comprehensive list of all recommended vaccines for infants on a biyearly basis, to allow coverage of new vaccines through medical insurance. However, the last list was issued in 2025 and is yet to receive an update.
In June last year, all ACIP members were replaced by appointees personally chosen by the U.S. Health Secretary. In March 2026, however, the memberships of the new committee were revoked by a federal judge, essentially disbanding the ACIP and delaying the addition of recently approved vaccines to the list of recommendations.
This places an additional burden on families of children who face an increased risk of contracting pneumococcal infections due to congenital diabetes, heart, kidney, liver, or lung disorders. If the administration of CAPVAXIVE is required for an infant patient - as established by a medical professional - the vaccine will have to be sourced and supplied completely at the institutions' cost.
It thus remains unclear at this point as to how the vaccine will be recommended and covered by insurance for children at risk for pneumococcal illnesses in the United States.
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