SEC Approves Serum's Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine
New Delhi: The Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organization (CDSCO) has recommended the conduct of a Phase I clinical trial for Serum Institute of India's (SII) 21-valent Pneumococcal Conjugate Vaccine (Adsorbed) and granted manufacturing and marketing approval for its Inactivated Salk Polio Vaccine (Adsorbed).
The recommendations were made during the SEC meeting held on May 22, 2025, via hybrid mode.
Phase I Trial Approved for 21-valent Pneumococcal Vaccine
The committee reviewed the proposal titled:
“A Phase 1, prospective, randomized, two-arm, active-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of Serum Institute of India's 21-valent Pneumococcal Conjugate Vaccine (SIIPCV21) in Healthy Indian Adults.”
After detailed deliberation, the committee recommended the conduct of the Phase I clinical trial as per the presented protocol.
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