New Delhi: UK pharma major, GSK has secured a favorable recommendation from theSubject Expert Committee (SEC) of India’s central regulator, CDSCO, for marketing approval of its Respiratory Syncytial Virus (RSV) vaccine: Arexvy.

The positive opinion is supported by the complete report of a Phase III clinical study conducted in India, to establish the vaccine’s immunogenicity in the local population along with one-month safety data.

The trial included participants aged 60 and above, along with adults aged 50–59 who are at increased risk of respiratory syncytial virus-related lower respiratory tract disease.

Arexvy is a single-shot vaccine currently approved for use among individuals aged 60 and above in 68 countries, including 30 countries with expanded approval for the high risk lower age group and more than 13.4 million doses have been administered across the globe.

GSK declined to comment on ETPharma’s request.

Arexvy is the first vaccine approved for older adults and has demonstrated 94 per cent efficacy against the severe respiratory disease.

It uses a lab-made version of F glycoprotein antigen—a key protein found on the surface of RSV—along with with an AS01E adjuvant system (similar to the platform used in GSK’s shingles vaccine) to produce antibodies and build immune response against the virus.

RSV is a major viral pathogen that causes acute respiratory infections among infants and older adults, and is one of the leading cause of bronchiolitis and pneumonia among young children.

However, Dr. Lancelot Pinto, Consultant, Pulmonologist and Epidemiologist, P. D. Hinduja Hospital and Medical Research Centre, Mahim said, “There is a growing realisation that it plays an important role in causing hospitalisations and deaths among those who are elderly and immunocompromised with diseases such as COPD, asthma and interstitial lung disease.”

Source: ET Pharma - May 07,2026