COVAXIN phase 2/3 trials for 2-18-year-olds recommended by expert panel

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Ramya Patelkhana

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Last updated on May 12, 2021, 11:03 am

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In a bid to extend the country's vaccination drive to include people below 18 years, an expert panel on Tuesday recommended Hyderabad-based Bharat Biotech's COVID-19 vaccine COVAXIN for phase 2/3 clinical trials on children and adolescents aged two to 18 years. The trials would be conducted on 525 subjects across numerous sites, including AIIMS-Delhi, AIIMS-Patna, and Meditrina Institute of Medical Sciences, Nagpur, among others.

Children likely at higher risk in possible third wave: Experts

Notably, this development comes amid reports that the possible third COVID-19 wave in India is likely to be dangerous for children. Experts say that the first wave affected older people, and in the ongoing second wave, youngsters are getting more infected, while the third wave could see more infections in children. Hence, ensuring vaccination of children is crucial to prepare for the third wave.

Expert panel's nod for COVAXIN trials on those below 18

The approval by the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) came after the expert panel deliberated in detail on Bharat Biotech's application that sought permission to initiate phase 2/3 trials. The COVAXIN maker sought to conduct the trials to assess the safety, reactogenicity, and immunogenicity of its vaccine in those aged between two to 18 years.

Should submit phase-2 safety data before proceeding to phase-3

"The committee recommended for conduct of proposed phase 2/3 clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group," PTI quoted a source as saying. Bharat Biotech should "submit the interim safety data of phase 2 clinical trial along with DSMB (data and safety monitoring board) recommendations to the CDSCO before proceeding to phase 3," added the source.

Centre dismissed false claims regarding COVAXIN for those above 12

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Earlier on February 24, the SEC deliberated on the proposal by Bharat Biotech following which the vaccine maker was directed to submit a revised protocol for the clinical trials. Recently, false claims have been doing the rounds on social media that the Centre has approved COVAXIN for those aged above 12 years. However, the government dismissed these claims, clarifying that the news is fake.

COVAXIN is currently being administered only to adults

To note, COVAXIN is one of the vaccines that are being administered as part of India's vaccination drive. It is currently being used only in adults. The vaccine has been developed indigenously by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR).