Bharat Biotech's Covaxin gets approval for phase 2 and 3 trials on 2-18 years-olds
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
FollowThe Subject Expert Committee (SEC) on Wednesday gave its nod to Bharat Biotech for the phase 2 and 3 human clinical trials of its Covid-19 vaccine Covaxin to be conducted on 2 to 18-year-olds, according to a report by ANI, quoting sources.
If the trials of Covaxin proves the efficacy of the vaccine in children, it will boost India’s vaccination drive to eliminate the Covid-19 pandemic from the country. As of now, the vaccine is only permitted for the age groups above 18 years of age.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
Presently, there is no vaccine available for Children anywhere in the world. Just a day ago, FDA approved the Pfizer-BioNTech Covid vaccine to be administered to children between the age of 12 years and 15 years. The permission came after the announcement made by the companies in late March that the two-dose vaccine was found to be 100% effective in a clinical trial of more than 2,000 children.
Experts believe that the third wave will soon hit India. During the third wave, only children under the age of 18 would not have been vaccinated, they may become an easy target for the virus, and the age group under 18 might be most affected during the possible third wave.
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