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However, CDSCO officials said that the provision was soon withdrawn and revised by the drug licensing authority. The sources privy to the development said 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.
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.