Sunday, June 13, 2021

Kovaxin’s clinical trial approved for 2 to 18 year olds

New Delhi: An expert panel on Tuesday recommended a clinical trial of 2 to 18-year-old children for stage II / III of Bharat Biotech’s COVID-19 vaccine covaxine, which has been approved.

Subject Expert Committee (SEC) on Central Drugs Standard Control Organization (CDSCO) Kovid-19 by Hyderabad-based Bharat Biotech to evaluate covaxin vaccination safety, reactogenicity and immunogenicity in children aged 2 to 18 years. This decision has been taken after permission to conduct clinical trials.

This comes amid reports that a possible third wave of COVID-19 virus in the country may put children at risk. According to experts, the first wave of the virus attacked the elderly, the second wave affected more youth and the third wave could be dangerous for children.

AIIMS Delhi, AIIMS Patna and Meditrina Institute of Medical Sciences, Nagpur will have a trial of 525 people.

A source said, “After detailed deliberations, the committee has recommended for the proposed phase II / III clinical trial operation of a fully inactivated corona virus vaccine in the age group of 2 to 18 years, for which the firm The DSMB has asked CDSCO to submit interim safety data for Phase II clinical trials with recommendations before proceeding to Phase III of the study. “

Earlier, the firm was asked to submit a revised clinical trial protocol after the SEC held a meeting on 24 February to discuss the proposal.

Indigenously developed covaxine by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is currently being offered to people over 18 years of age in an ongoing nationwide vaccination campaign against COVID-19.

The center recently dismissed a viral tweet claiming that covaxin has been approved for children over 12 years of age. The tweet claimed that Bharat Biotech’s vaccine, Kovaxin, has been approved for children above 12 years of age. This claim belongs to #Fake. No such approval has been given by the Government of India.

The Press Information Bureau said in a tweet, “Currently citizens over the age of 18 are eligible for COVID-19 vaccination.”

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