Serum's Salk Polio Vaccine Approved for Commercial Use

The Securities and Exchange Commission (SEC) has granted manufacturing and marketing approval for Serum Institute of India’s (SII) Inactivated Salk Polio Vaccine (Adsorbed) to be used commercially. This decision is a significant milestone in vaccine manufacturing in India and could have far-reaching impacts on public health and disease prevention efforts across the country. The SEC recommendations underscore the Serum Institute’s expertise in vaccine production, further solidifying its eminent position in the pharmaceutical industry and setting the stage for enhanced immunization strategies and healthcare advancements in India.

These decisions were announced during a meeting of the Subject Expert Committee (SEC) on Vaccines, under the aegis of the Central Drugs Standard Control Organization (CDSCO), held on May 22, 2025. The meeting was conducted in a hybrid mode, accommodating both physical and virtual participants.

In the same meeting, the SEC also recommended a Phase I clinical trial for the Serum Institute’s 21-valent Pneumococcal Conjugate Vaccine (Adsorbed), colloquially known as SIIPCV21. This recommendation follows a detailed deliberation on the proposed protocol for the trial, which is a Phase 1, prospective, randomized, two-arm, active-controlled, double-blind study. The trial aims to evaluate the safety, tolerability, and immunogenicity of the SIIPCV21 vaccine in healthy Indian adults.

The Phase I trial is an essential early step in the development of the SIIPCV21 vaccine. It is designed to assess the vaccine’s safety, tolerability, and immunogenicity in healthy Indian adults. The data collected during this trial will be critical for advancing to subsequent phases of development, where the vaccine’s efficacy and broader implications for patient health will be further explored.

The SEC’s approval of the Inactivated Salk Polio Vaccine (Adsorbed) for commercial use came after a detailed evaluation of the Phase II/III clinical trial report submitted by the Serum Institute. The report provided comprehensive data on the vaccine’s safety and efficacy, contributing significantly to the approval decision.

These developments at the Serum Institute showcase the rapid advancements in biotech and the potential for life-saving innovations. The approval of the Polio vaccine and the proposed trials for the Pneumococcal vaccine demonstrate India’s commitment to developing cutting-edge biotech solutions, particularly in the area of disease prevention and public health.

The SEC’s recommendations and approvals are not only a testament to the Serum Institute’s capabilities but also a reflection of the broader positive trends in India’s biotech sector. As the country continues to innovate in vaccine manufacturing and cell therapy, these developments could potentially pave the way for more robust public health strategies and healthcare advancements in the future.