Covaxin was already approved by India’s Central Drugs Standards Control Organisation (CDSCO) for restricted use in an emergency in clinical trial mode
Bharat Biotech Covaxin vaccine vial 5ml. (Credit: Srikanth Ramakrishnan/BESTpedia/Wikipedia.)
Bharat Biotech International has received The Drug Controller General of India (DCGI) approval for its Covid-19 vaccine, Covaxin, for emergency use in children aged 12 to 18 years.
The biotechnology company has conducted Phase 2/3 trials of the vaccine in children aged two to 18 years to obtain the emergency use authorisation.
The Subject Expert Committee (SEC) had recommended the use of Covaxin for children in this age group, in October this year.
In the trials, Covaxin has shown superior safety and immunogenicity results in children, the company said on Twitter.
The approval follows Indian Prime Minister Narendra Modi’s address to the nation, announcing the administration of Covid-19 booster doses to frontline workers starting from 10 January 2022.
Also, individuals aged 15 to 18 years would start receiving Covid-19 vaccinations from 3 January 2022, in the wake of the rise in Omicron variant cases in India.
Modi said: “From the point of view of precaution, the government has decided that healthcare and frontline workers should start getting a precaution dose.”
Covaxin was already approved by India’s Central Drugs Standards Control Organisation (CDSCO) for restricted use in an emergency, in clinical trial mode.
Last month, it was granted Emergency Use Listing by the World Health Organization (WHO).
Bharat Biotech’s Covid-19 vaccine was 77.8% effective against symptomatic Covid-19, according to an analysis published in The Lancet, in November this year.
Covaxin is the second Covid-19 vaccine to receive regulatory approval in India, in the current age group, following Zydus Cadila’s needle-free vaccine ZyCoV-D.