FDA Expands Approval of Merck’s Capvaxive Pneumococcal Vaccine for High-Risk Children
The FDA expanded approval for Merck’s 21-valent pneumococcal vaccine, Capvaxive (PCV21), to include children and teens aged 2 through 17 who are at increased risk for pneumococcal disease, the company announced Thursday. This expansion applies to pediatric patients who have finished a primary vaccine series but have chronic medical conditions.
Previously approved for adults in 2024, the vaccine is now indicated for high-risk youth. Merck noted in a press release that this is the first pneumococcal vaccine specifically indicated for this population.
Why was Capvaxive approved for high-risk children?
The approval followed data from the phase 3 STRIDE-13 trial. This study included 874 children aged 2 through 17 who had completed their primary pediatric series and suffered from at least one high-risk condition, including diabetes or chronic lung, liver, kidney, or heart disease.
According to Merck, PCV21 compared favorably with the 23-valent pneumococcal polysaccharide vaccine during the trial. The vaccine covers serotypes not found in the 15-valent (PCV15) and 20-valent (PCV20) conjugate vaccines currently recommended by the CDC and AAP for primary series.
How does the ACIP dispute affect vaccine access?
While the FDA has granted approval, the vaccine’s inclusion on the federal immunization schedule remains uncertain. Typically, the CDC’s Advisory Committee on Immunization Practices (ACIP) votes on such recommendations, which then requires insurance companies to cover the vaccine at no cost to the patient.
U.S. District Judge Brian E. Murphy essentially disbanded the ACIP in March by revoking the appointments of 13 members. These members were selected by HHS Secretary Robert F. Kennedy Jr., who had fired all previous members the prior June. Judge Murphy ruled that Kennedy’s selections lacked the necessary expertise required by the committee’s charter.
The judge also blocked a Trump administration overhaul of the CDC’s child and adolescent immunization schedule. In a June 12 social media post, Kennedy stated this decision left the ACIP unable to review newly approved vaccines or issue new recommendations.
What happens next for pediatric recommendations?
The administration has appealed Judge Murphy’s ruling. AAP President Andrew P. Racine, MD, PhD, stated on June 16 that the administration retains the power to restore a lawful ACIP and schedule meetings at any time.
Because clinicians have largely followed the AAP’s vaccine schedule, the organization may act independently. The AAP could include PCV21 in its respiratory disease recommendations in August and September, or in its full childhood immunization schedule in January.
Frequently Asked Questions
Which children are eligible for the expanded Capvaxive approval?
Children and teens aged 2 through 17 who have completed a primary pediatric pneumococcal vaccine series but remain at increased risk due to chronic medical conditions, such as diabetes or chronic heart, kidney, liver, or lung disease.
How does Capvaxive differ from other pediatric vaccines?
According to Merck, Capvaxive covers serotypes that are not included in the 15-valent (PCV15) and 20-valent (PCV20) vaccines recommended for the primary pediatric series.
Will insurance cover the vaccine for children?
Insurance coverage typically requires the vaccine to be added to the CDC immunization schedule. Currently, the ACIP is unable to issue new recommendations due to a federal court ruling regarding committee appointments.
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