GSK gets CDSCO panel okay for marketing Inactivated Influenza Vaccine for those above 64
New Delhi: Granting the permission of local clinical trial waver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to pharma major GSK Pharmaceuticals for marketing Inactivated Influenza Vaccine (Split Virion) IP for people above 64 years of age.
However, the approval came with the condition that the firm should conduct a Phase IV clinical trial in the country.
Inactivated Influenza Vaccine (Split Virion) IP is sold by GSK Pharmaceuticals under the brand name FLUARIX-TETRA which is indicated for active immunisation of children from age group 6 months to adults up to 64 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
FLUARIX-TETRA provides active immunisation against four influenza virus strains (two A subtypes and two B lineages) contained in the vaccine.
Hemagglutinin is an antigenic glycoprotein found on the surface of the influenza viruses and is responsible for binding the virus to the cell that is being infected.
FLUARIX-TETRA induces humoral antibodies against haemagglutinins. These antibodies neutralise influenza viruses.
Specific levels of haemagglutination-inhibition (HI) antibody titre post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titres have been used as a measure of vaccine activity. In some human challenge studies, HI antibody titres of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.
At a recent SEC meeting held on 02.07.2021, the firm presented its proposal for grant of marketing authorization of Inactivated Influenza Vaccine (Split Virion) IP for the extended age group with local clinical trial waiver.
GSK's proposal for marketing authorization and local clinical trial waiver of Inactivated Influenza Vaccine (Split Virion) IP for the extended age group was thoroughly examined by the committee at a recent SEC meeting in matters for Biologicals & PAC proposals.
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 trial in the country.
In addition to this, the committee also directed the firm to submit the Phase IV clinical trial protocol for approval.