Bharat Biotech has sought permission from the Drugs Controller General of India (DCGI) for conducting a phase 2/3 study of Covaxin, its indigenous vaccine against Covid-19, as a booster dose for those aged between 2 and 18. The precaution dose of Covaxin and Covishield is being administered to all those above 18 years old and have completed nine months after the second dose.
“The Hyderabad-based firm had on April 29 submitted an application to DCGI seeking permission to conduct phase 2/3 trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged 2 to 18 years,” a source told PTI. The study is likely to be conducted at six sites, including AIIMS Delhi and Patna.
India started vaccinating its healthcare and frontline workers as well as co-morbid senior citizens with a precaution dose on January 10. In March, all aged above 60 became eligible for the shot once the co-morbidity clause was removed. On April 10, India began administering the precaution jabs to all aged above 18 at private vaccination centres.
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