GSK Moves Closer to India Launch of RSV Vaccine

New Delhi: In a significant development for adult vaccination and respiratory disease prevention in India, the Subject Expert Committee (SEC) on Vaccines, functioning under the Central Drugs Standard Control Organisation (CDSCO), has recommended grant of new drug permission for the Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted) developed by GSK Pharma after reviewing additional clinical and safety data submitted by the company.

The recommendation came during the re-deliberation of application number BIO/IMP/24/000133, where the company presented stratified clinical data for older adults aged 60 years and above, along with six-month safety data, as sought earlier by the committee.

RSV is a highly contagious respiratory virus that can cause serious lower respiratory tract infections, particularly among elderly individuals, immunocompromised patients, and those suffering from chronic heart or lung diseases. Although RSV is commonly linked to severe illness in infants and young children, it also poses a substantial and often under-recognised health burden in older adults globally.

The recombinant adjuvanted RSV vaccine developed by GSK is intended to strengthen immune protection against RSV-associated lower respiratory tract disease in adults, especially senior citizens who are at increased risk of complications, hospitalisation, and mortality. Adjuvanted vaccines contain substances that help enhance and prolong the body’s immune response, improving vaccine effectiveness in older populations whose immune systems may respond less efficiently.

During an earlier SEC meeting, the company had presented the interim report of its Phase III clinical trial titled, “A Phase 3, randomized, placebo-controlled, observer-blind study in India to evaluate immune response, reactogenicity and safety of a single intramuscular dose of RSVPreF3 OA investigational vaccine when administered to older adults ≥60 years of age and adults 50–59 years of age at increased risk of respiratory syncytial virus lower respiratory tract disease,” along with one-month safety data generated as per the approved study protocol.

At that stage, the committee reviewed the safety and immunogenicity findings from the Phase III trial but decided to defer its recommendation. The SEC had asked the firm to submit the complete Phase III study report, including stratified data for adults aged 60 years and above and six-month safety follow-up data, for further evaluation by CDSCO.

Following submission of the additional data, the committee re-examined the updated safety and efficacy findings in detail before arriving at its final recommendation.

According to the committee minutes, “In light of recommendation of SEC (Vaccine) dated 25.11.2025, firm presented the stratified data of older adults ≥60 years of age along with the six months safety data. After detailed deliberation, the committee recommended for grant of new drug permission.”