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 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 Corona 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However, when IANS approached CDSCO with the query upon this, the officials said that the provision was soon withdrawn and revised by the drug licensing authority.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 IANS that this certain condition 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 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.
Trial participants in Bhopal, who, incidentally, are also victims of the 1984 gas tragedy, have alleged "severe violations" of the model code of conduct pertaining to trials including absence of consent and no follow-up on their health after developing adverse reactions post the first dose by a particular clinical trial site.
Notably, a 45-year-old trial participant in Bhopal also died nine days after he got the first jab at the People's Hospital, on December 21. However, Bharat Biotech, in a statement, said that the death had been "thoroughly investigated" and was found "not related to vaccine or placebo". The Madhya Pradesh government panel, too, ruled out any "lapses" from the hospital in the death case.