New Delhi, Jan 15: In a major shift of narrative, the 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 Drugs Controller General of India (DCGI).

A letter from the office of the 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 Corona Virus Disease (Covid-19) for age above 12 years when administered in two doses interval of day 0 and day 28".

At the same time, another vaccine, Covishield by Serum Institute of India (SII), was permitted to people above 18 years of age, permission letter to the SII showed.
However, when IANS approached CDSCO with the query upon this, the officials said that the provision was soon withdrawn and revised by the drug licensing authority. The sources privy to the development told that this condition approved for Covaxin was flagged to the drug regulatory authority and soon it was revoked.
"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 surrounded by controversies since it was recommended for restricted emergency use by the subject expert committee of CDSCO. It's approval for Covid immunization programme 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 III 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.

Meanwhile, a series of allegations involving violation of various protocols of human clinical trials have been put forth by trial volunteers of Covaxin in Bhopal's People's Medical College and Hospital, one of the 26 clinical trial sites of the Bharat Biotech's vaccine's phase III trials. - IANS