GSK gets CDSCO marketing authorization for Rotavirus Vaccine, Live Attenuated, Oral IP

This came in the wake of the proposal presented by GlaxoSmithKline Pharmaceuticals for the grant of Marketing Authorization of Rotavirus Vaccine (Live Attenuated, Oral) IP in India along with the Phase III clinical study results.

The rotavirus vaccination is a live attenuated (weakened) liquid frozen vaccine that stimulates the immune system to create antibodies (proteins) without actually infecting the child. These antibodies protect against rotavirus-induced diarrhoea in the case of infection. Rotavirus infection is a highly infectious sickness caused by a virus that transmits quickly from child to child, primarily affecting babies and young children.

The Rotavirus vaccine contains a live rotavirus strain that is used for the prevention of rotavirus infection, which is the most common cause of severe diarrhoea among young children.

It is given to the baby by mouth. The first dose is given when the baby is around 6 weeks old and the second dose is at least 4 weeks after the first dose (before 6 months old).

Some available medicines for Rotavirus vaccine (Live attenuated, oral) include MSD Pharmaceutical's RotaTeq, Bharat Biotech's Rotavac, Abbott's Rotasure, and Serum Institute Of India's Rotasiil.

At a recent SEC meeting held on 6.08.2021, GSK's proposal for marketing authorization of Rotavirus Vaccine (Live Attenuated, Oral) IP in India, along with the Phase III clinical study results, was thoroughly examined by the committee.

After detailed deliberation, the committee recommended the grant of marketing authorization.