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DCGI's Subject Expert Committee (SEC) has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval, according to news agency ANI.

Earlier, the Hyderabad-based manufacturer has proposed the booster dose for those who have been already been innoculated against COVID with Covishield and Covaxin vaccines.

Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50 per cent vaccinated with Covishield and 50 per cent vaccinated with Covaxin).

The interval between the second dose and booster dose will be six months, sources have told. According to the sources, India is expected to get an Intranasal booster vaccine in March, after timely conduction of trials.

Meanwhile, Bharat Biotech International Limited (BBIL),  announced that BBV152 (Covaxin), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group, a press release from the vaccine maker said.

The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021 and received emergency use nod for children aged 12-18 from DCGI recently. In the study, no serious adverse event was reported. A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event, the release said. For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing ( enzyme-linked immunoassay). Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner.

 

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