Pfizer Gets CDSCO Panel Nod To Conduct Phase III Trial of RSV Vaccine in India, Told to Clarify Subject Criteria
Pfizer
New Delhi: Pfizer has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase III clinical trial of the Respiratory Syncytial Virus Perfusion F Subunit Vaccine. However, this approval is subjected to the condition that the firm should specify the number of subjects with preexisting stable disease.
This came after the firm presented 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”.
The committee noted that the product is approved in various countries namely USA, Europe, Japan, Canada, Brazil, Thailand etc.
Respiratory Syncytial Virus Prefusion F Subunit Vaccine (RSVPref), is a vaccine developed by Pfizer to prevent lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV). It is approved for use in older adults (60 years and older) and for maternal immunization to protect infants from birth through six months of age.
At the recent SEC meeting for Vaccine held on 24th June 2025, the expert panel reviewed the 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 for conduct of proposed Phase III clinical trial with condition that the firm shall specify the number of subjects with preexisting stable disease.
