Covaxin Clinical Trials For 2-18 Year Age Group To Begin In 10-12 Days, Says Govt

The clinical trials of Bharat Biotech's Covaxin to test its efficacy in children between two to 18 years of age will begin in 10-12 days, top officials said on Tuesday.

The development comes days after India's apex drugs regulator granted permission for conducting the phase II/III clinical trials on children on 11 May, following the Central Drugs Standard Control Organisation's subject expert committee's recommendation, under certain conditions.

Addressing the Union Health Ministry press conference, NITI Aayog's Member Health, Dr V.K. Paul said: "Covaxin has been approved by the Drugs Controller General of India (DCGI) for Phase 2 and 3 clinical trials in the age group of two to 18 years. I have been told that trials will begin in the next 10-12 days."

Approval of clinical trials of vaccine efficacy among children came amid reports from the US and Canada allowing Pfizer-BioNTech for the 12-15 age groups.

Notably, this will be the first time in India that a Covid-19 vaccine will be tested on children.

The announcement came amid reports that new variants are also affecting children.

The clinical trials are expected to be conducted among over 500 participants at various hospitals across the country. AIIMS Director, Dr Randeep Guleria had said that the need of the hour is some quick data and risk-benefit analysis of the vaccine's use in children.

Earlier, a peer-review publication, Clinical Infectious Diseases, had noted that Covaxin demonstrates protection against the new Covid-19 variants.

‘Additionally, a study by the ICMR reported that Covaxin is effective against multiple variants of the Covid-causing SARS-CoV-2 virus, including the double mutant strain found in India and other countries.

The Pune-based National Institute of Virology (NIV) had successfully isolated and cultured multiple variants of concern of SARS-CoV-2 virus including the variants originating from the United Kingdom, South Africa, and Brazil.

The NIV has demonstrated the neutralization potential of the Covaxin against the variants from Brazil and the UK in a study published in the Journal of Travel Medicine in March.

With IANS Inputs