The subject expert committee on Covid-19 vaccines has recommended the national drug regulator to grant an emergency use authorisation to Bharat Biotech’s Covaxin for the age group of 2 to 18 years, health ministry sources said.
The development is significant as India is just one step away from a Covid-19 vaccine being formally approved for children above the age of 2 years. India’s drug regulator has already approved Zydus Cadila’s DNA Covid-19 vaccine for children aged above 12.
The recommendation of the SEC regarding Bharat Biotech’s Covaxin is based on the pediatric study, that is evaluating the safety, reactogenicity, and, immunogenicity of Covaxin. It is being conducted at six sites across the country in healthy volunteers above the age of 2 years.
The third vaccine that is being tested in children in India is the Covavax that will be manufactured by the Pune-based Serum Institute of India.
The trials of Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine – NVX-CoV2373 – in India is being branded as Covavax by SII. The trials will be conducted across 23 sites across the country.
The fourth vaccine that is being tested in children in India is the Hyderabad-based Biological E’s Corbevax. The trials are expected to take place across ten sites across the country.