‘Covaxin trials for children between 2-18 years to begin in 10-12 days’: Govt of India

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As the country continues to struggle to vaccinate the population before the possible third wave of COVID-19, in a key development, the Government of India on Tuesday announced that the second and the third phase of the trials of Bharat Biotech’s Covaxin for children aged between 2-18 years will begin in the next 10 to 12 days. The announcement comes a couple of days after the Drugs Controller General of India (DCGI), on the recommendation of the Subject Expert Committee (SEC), gave its nod for trials.

Dr. VK Paul, Member-Health of Niti Aayog while addressing the media earlier in the day, confirmed the news. “COVAXIN has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days, ” he said.

As part of the second phase of the trial, 525 ‘healthy subjects’ at various sites, including AIIMS, Delhi, AIIMS, Patna, and Meditrina Institute of Medical Sciences, Nagpur will be administered two doses of the Covaxin vaccine at an interval of 28 days- on day 0 and day 28 through ‘intramuscular route’, as per the release by the Government of India. 

Phase-1 trials

Recently in conversation with Media BBL founder Dr. Krishna Ella spoke about Covaxin’s phase-1 trials on kids. He said, “We just got permission from Drugs Controller General to conduct trials on 2-18 years. It might take 3-4 months to complete the trials.”

Talking about inoculating children, he said, “Many countries want our vaccine (COVAXIN), including the US. The reason is that this is the only vaccine that can be given to children. The safety pattern is so good that it can be given from a two-year-old child to an 18-year-old as well. Many children carry the virus and they don’t show symptoms. They meet their grandparents and infect them. I think young age kids should be vaccinated at the earliest.”null

Covaxin- All you need to know

Developed by Hyderabad-based Bharat Biotech, Covaxin is based on an inactivated whole SARS-CoV-2 virion. A virus’s disease-producing capacity is inactivated in this method. It is a safe vaccine with mild to moderate symptoms, and as per interim data, has an efficacy of 81 percent if the two doses are taken at an interval of 28 days. 

COVAXIN was granted permission for restricted use in an emergency situation by the DGCI on January 3. Several politicians back then had questioned why Phase 3 trials protocol has been modified for the Bharat Biotech vaccine candidate, urging Health Minister Harshvardhan to clarify the same. Meanwhile, Tharoor stated that the DCGI ‘approval was premature and could be dangerous’, opining that its use should be avoided till full trials are over. Several others have questioned the vaccines due to ‘lack of trust’ in the Modi govt. 

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