Bharat Biotech`s Covaxin gets DCGI nod to conduct clinical trials on children above 2 years

New Delhi: The Drugs Controller General of India (DCGI) has given its approval to Bharat Biotech to start conducting Phase two and three clinical trials of its COVID-19 vaccine Covaxin on children above 2 years old.

The national drug regulator said that it has accepted the recommendation of the SEC “after careful examination” and accorded permission to Covaxin manufacturer Bharat Biotech.

On Wednesday, the Hyderabad-based drugmaker said that it has got the necessary approval from an expert panel for conducting phase 2/3 trials on those aged between 2 to 18 years.

Bharat Biotech's anti-COVID vaccine was recommended by an expert panel (Subject Expert Committee) for phase II/III clinical trials on those aged between two to 18 years.

The company will now conduct trials on 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) said that deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

"After detailed deliberation, the committee recommended for the conduct of proposed phase II/III clinical trial of the whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source was quoted as saying.

Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.

Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. 

The drugmaker on Tuesday said that it will continue the steady supply of its COVID-19 vaccine Covaxin, adding the jab has been directly supplied to 18 states since May 1. 

"COVAXIN has been directly supplied to 18 states since May 1st. Unflinching in our efforts, we will continue the steady supply of our #vaccine," Bharat Biotech said in a tweet.

The states include Andhra Pradesh, Delhi, Bihar, Gujarat, Haryana, Uttar Pradesh, and West Bengal, the Hyderabad-based firm added.