Centre does U-turn, says Covaxin not for those below 18

Earlier, DCGI had approved shots for chidren above 12 years of age

NEW DELHI: In a major shift of narrative, the Central government has now disapproved the authorisation of Bharat Biotech’s COVID vaccine to people below 18 years of age whereas earlier, it was approved for children above the age of 12 years by the DCGI.

A letter from the office of additional secretary at the Union Health Ministry carrying a comparative factsheet for the two COVID vaccines approved for emergency authorisation revealed that the government has “not recommended” their authorisation to people below 18 years of age. The DCGI, after approving Bharat Biotech’s Covaxin for EUA, had allowed its authorization to children above 12 years of age. The document of permission to the Hyderabad-based pharmaceutical firm signed by the DCGI clearly states that “active immunization against COVID-19 for age above 12 years when administered in two doses interval of day 0 and day 28.” At the same time, Covishield by SII, was permitted to people above 18, permission letter to the SII showed.

However, officials clarified that the provision was soon withdrawn and revised by the drug licencing authority. Sources privy to the development said this certain codition approved for Covaxin was flagged to the drug regulatory authority and soon it was rebuked. “We were flagged about the provision and soon it was revised with a condition that the vaccines would only be administered to beneficiaries above 18 years of age,” a senior official said. Covaxin has been in the spotlight of controversy since it was recommended for restricted emergency use by the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO). It’s approval has drawn flak from public health advocacy groups, researchers, scientists and activists in the domain. The concern with the Coxaxin largely remains on its approval without the data from Phase-3 clinical trials which determine efficacy of the drug. So far, any data proving the vaccine’s efficacy has not been published in the public domain, including any results of an interim analysis. A series of allegations involving violation of protocols of human clinical trials have been put forth by volunteers of Covaxin in Bhopal.