FDA Lists VIMKUNYA and CAPVAXIVE Among Vaccines Carrying Active Postmarketing Trial Obligations

Five vaccines currently hold FDA accelerated approvals under active postmarketing requirements, with confirmatory trial deadlines running through 2030, a compliance calendar that regulatory affairs leads and QA directors at affected manufacturers cannot treat as background noise.

The FDA's ongoing infectious disease accelerated approval listing, updated May 2025, identifies VIMKUNYA (Chikungunya Vaccine, Recombinant, Bavarian Nordic) and CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine, Merck) as the two most recently approved products carrying open postmarketing requirements (PMRs). VIMKUNYA, granted accelerated approval on 2/14/2025 for prevention of chikungunya disease in individuals 12 years and older, must complete a randomized, double-blind, placebo-controlled efficacy and immunogenicity study in adolescents and adults by 8/31/2030. CAPVAXIVE, approved 6/17/2024 for prevention of invasive pneumococcal disease in adults 18 and older, carries an observational hybrid effectiveness study (protocol V116-011-00) with a projected completion date of 12/31/2029.

Three legacy products remain on the same listing. Fluad (approved 11/24/2015) and Fluad Quadrivalent (approved 2/21/2020) both carry confirmatory efficacy trial obligations for adults 65 and older, with original projected completion dates of 8/31/2019 and 9/30/2024 respectively, dates already elapsed, signaling that FDA has not yet updated labeling or issued a Federal Register notice to close those PMRs. Gardasil 9 carries a PMR to evaluate efficacy against oral HPV persistent infection in men aged 20 to 45, with a projected completion of 9/30/2026.

Under 21 CFR Part 601 Subpart E and the accelerated approval framework, sponsors are required to conduct confirmatory trials with due diligence; failure to complete PMRs on schedule exposes products to potential withdrawal proceedings. The continued presence of Fluad and Fluad Quadrivalent on the ongoing list, despite elapsed projected completion dates, underscores that FDA's labeling update and Federal Register notice process governs when a product formally exits this registry, not the trial completion date alone.

For regulatory affairs teams managing submission timelines, the distinction between projected and actual PMR closure is operationally significant: products remain listed, and associated compliance obligations remain active, until FDA takes a formal labeling or notice action. The CAPVAXIVE and VIMKUNYA PMR deadlines now anchor the near-term compliance horizon for their respective sponsors.

Source: FDA, What's New Vaccines Blood Biologics RSS Feed via FDA.gov, May 15, 2026.