Phase 2,3 trials of Covaxin on children aged 2-18 yrs allowed in India

at 4:37 pm
Vaccine Price

New Delhi (NVI) In a hugely significant development, an expert panel of the government has paved the way for Phase 2 and 3 clinical trials of Covid vaccine ‘Covaxin’ on children aged between 2 and 18 years in India, thus expanding the spectrum of inoculation against the deadly pandemic.

The move assumes significance as there are apprehensions about the third wave of Covid striking the country, during which children are feared to be the most affected.

The trial of the vaccine, developed by indigenously by Hyderabad-based Bharat Biotech, will be held in 525 subjects at various places, including AIIMS (Delhi), AIIMS (Patna) and Meditrina Institute of Medical Sciences, Nagpur, according to officials in the know.

The approval for trials came after Bharat Biotech made an application to the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO), seeking permission to conduct phase 2/3 clinical trials.

The committee deliberated on the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years before giving the clearance, according to the officials.

As of now, Covaxin is being administered to people up to the age of 18 years only.

In the US, vaccination of children as young as 12 years is expected to begin tomorrow after regulators approved the vaccines made by Pfizer and BioNTech for such use.

US President Joe Biden has asked states to make the vaccine available to younger adolescents immediately.