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.
The trial is designed to assess the vaccine’s safety, tolerability, and immunogenicity in healthy Indian adults—data that will be critical for advancing to subsequent phases of development.
Inactivated Salk Polio Vaccine Gets Marketing Nod
In the same meeting, the SEC evaluated the Phase II/III clinical trial report submitted by Serum Institute for its Inactivated Salk Polio Vaccine (Adsorbed). The trial, titled:
“A Phase II/III, multicenter, double-blind, randomized, active controlled study to evaluate safety and immunogenicity of SII Inactivated Salk Polio Vaccine (Adsorbed) in comparison with SII Licensed Inactivated Poliovirus Vaccine (IPV),” was closely reviewed by the committee.
Based on the clinical data submitted, the SEC recommended the grant of manufacturing and marketing permission for the Inactivated Salk Polio Vaccine (Adsorbed), marking its entry into the commercial phase.
Serum Institute of India Pvt. Ltd., headquartered in Pune, is among the world’s largest vaccine manufacturers by volume. Known for producing affordable and globally accessible vaccines, SII has played a crucial role in addressing public health challenges in India and across the globe. Its portfolio spans vaccines for measles, rubella, influenza, COVID-19, meningitis, rotavirus, and now, expanded pneumococcal and polio indications.
