GSK India has received a positive recommendation from the Subject Expert Committee, SEC, of CDSCO for inactivated influenza vaccine, split virion vaccine. The SEC recommended that permission may be granted for ages more than 64 years.
Inactivated influenza, split virion vaccine sold under brand name Fluarix Tetra in India which helps to protect from influenza (flu). It works by exposure to a small dose of the flu virus which helps the body to develop immunity against the disease. It will not treat an existing flu virus infection.
The types of influenza antigen contained in FLUARIX TETRA may change from one year to another. Each year, the Australian Influenza Vaccine Committee (AIVC) recommends which ones to include. This decision is based on the types of influenza virus thought most likely to occur during the next flu season. Therefore, influenza vaccination is recommended every year.
GSK had presented its proposal for grant of marketing authorization for extended age groups with local clinical trial waiver. After detailed deliberation, the committee recommended that permission may be granted for ages >64 years subject to the condition that the firm should conduct Phase IV clinical trials in India.
SEC recommended that accordingly the firm should submit the Phase IV clinical trial protocol for approval to CDSCO.