Trial of Bharat Biotech’s Covaxin in the 2-18 years age group is likely to begin in the next 10-12 days. This was stated today by VK Paul, member of NITI Aayog (Health)while speaking to the media today. Drugs Controller General of India (DCGI) had last week approved Covaxin for Phase II/III clinical trials in that age group.
“I have been told that trials will begin in the next 10-12 days,” Dr VK Paul said on Tuesday during a press briefing on Covid-19.
This is the first time in India that a Covid-19 vaccine will be tested on children.
The clinical trials involve two Covid-19 vaccine shots injected on day 0 and day 28.
Covaxin received the Drugs Controller General of India’s (DCGI) nod to conduct clinical trials in children on May 11. DGCI acted on the recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation’s (CDSCO), which green lighted the trial under certain conditions.
Bharat Biotech approached the central drug regulator with a proposal for conducting clinical trials in children within the age group of 5-18 back in February. The proposal was rejected and the company was asked to produce the data of the vaccine’s efficacy in adults first.
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