The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee on COVID-19 met on Tuesday to discuss Bharat Biotech’s application to perform phase II/III clinical trials in children aged 2 to 18 years to assess the efficacy, reactogenicity, and immunogenicity of Covaxin jabs. Covaxin, a COVID-19 vaccine developed by Bharat Biotech of Hyderabad, has received clearance from an expert panel to perform phase 2/3 trials on children aged 2 to 18 years.
On Tuesday, an expert panel (Subject Expert Committee) recommended the drug maker’s anti-COVID vaccine for phase II/III clinical trials on children aged two to eighteen years, according to news agency PTI.
The trial will be conducted in 525 subjects at different locations, including AIIMS Delhi, AIIMS Patna, and Meditrina Institute of Medical Sciences in Nagpur, according to official sources.
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee on COVID-19 met on Tuesday to discuss Bharat Biotech’s application to perform phase II/III clinical trials in children aged 2 to 18 years to assess the efficacy, reactogenicity, and immunogenicity of Covaxin jabs.
The idea had previously been discussed at an SEC meeting on February 24, and the company had been asked to request a revised clinical trial protocol.
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Adults are being vaccinated with Covaxin, an indigenously produced vaccine by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR).
The drugmaker announced on Tuesday that it will maintain a steady supply of its COVID-19 vaccine, Covaxin, which has been sent directly to 18 states since May 1.
“Since May 1st, COVAXIN has been sent directly to 18 states. We will continue to supply our #vaccine in a steady supply, unwavering in our efforts “In a tweet, Bharat Biotech said.
Andhra Pradesh, Delhi, Bihar, Gujarat, Haryana, Uttar Pradesh, and West Bengal are among the states, according to the Hyderabad-based company.
