Submit Immunogenicity Data: CDSCO Panel Tells Pfizer on Pneumococcal Polysaccharide Conjugate Vaccine study

New Delhi: Reviewing the Phase III clinical trial report of the 20 valent Pneumococcal Conjugate Vaccine (20vPnC) presented by Pfizer, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm submit the global immunogenicity data of all subjects vis-à-vis the immunogenicity data of Indian subjects and the immunogenicity data of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) I.P., 13 valent of Indian subjects.

This came after Pfizer presented the Phase III clinical trial report of the 20-valent pneumococcal conjugate vaccine (20vPnC) of a study titled ” A Phase III, single-arm, multicenter trial to describe the safety and immunogenicity of a 20 valent Pneumococcal Conjugate Vaccine in Pneumococcal vaccine-naïve adults ≥18 years of age in India’’.

Pneumococcal 20-valent conjugate vaccine is an active immunizing agent used to prevent infection caused by certain types of pneumococcal bacteria (Streptococcus pneumoniae). It works by causing the body to produce its protection (antibodies) against the disease.

At the recent SEC meeting for Vaccine held on July 31, 2024, the expert panel reviewed the Phase III clinical trial report of 20 valent Pneumococcal Conjugate Vaccine (20vPnC) of study titled ” A Phase III, single-arm, multicenter trial to describe the safety and immunogenicity of a 20 valent Pneumococcal Conjugate Vaccine in Pneumococcal vaccine-naïve adults ≥18 years of age in India’’.

After detailed deliberation, the committee recommended that the firm should submit the global immunogenicity data of all subjects vis-à-vis the immunogenicity data of Indian subjects and the immunogenicity data of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) I.P., 13 valent of Indian subjects for further deliberation.

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