Pfizer has secured approval from India's Central Drugs Standard Control Organisation (CDSCO) expert panel to conduct Phase III clinical trials for its Respiratory Syncytial Virus Prefusion F Subunit Vaccine (RSVPref) in the country. The approval came with specific conditions following a comprehensive review of the company's clinical trial protocol.
Regulatory Review and Approval
At the Subject Expert Committee (SEC) meeting for vaccines held on June 24, 2025, the expert panel reviewed Pfizer's Phase III clinical trial protocol titled "A Phase 3 Study in India to describe the safety and immunogenicity of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in adults." After detailed deliberation, the committee recommended proceeding with the proposed Phase III clinical trial, contingent upon Pfizer specifying the number of subjects with preexisting stable disease.
The committee acknowledged that RSVPref has already received approval in various countries, including the USA, Europe, Japan, Canada, Brazil, and Thailand, providing a foundation of international regulatory acceptance for the vaccine.
Vaccine Profile and Indications
RSVPref is a vaccine developed by Pfizer specifically designed to prevent lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV). The vaccine has two primary approved indications: use in older adults aged 60 years and older, and for maternal immunization to protect infants from birth through six months of age.
Clinical Trial Requirements
The conditional approval requires Pfizer to provide additional clarity regarding the inclusion of subjects with preexisting stable disease in their Indian Phase III trial. This specification will help ensure appropriate patient selection and safety monitoring throughout the study, particularly given the vaccine's intended use in older adult populations who may have underlying health conditions.
The Phase III trial in India will focus on describing the safety and immunogenicity profile of RSVPref in the adult population, building upon the existing global clinical data that supported approvals in other regulatory jurisdictions.
