The Centre has 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 authorisation 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".
The vaccine has been hit by controversy since it was recommended for restricted emergency use by the subject expert committee. It's approval for Covid immunisation programme has drawn flak from public health advocacy groups, researchers, scientists and activists in the domain.
The concern with the vaccine largely remains on its approval without the data from phase III clinical trials which regulate efficacy of the drug. So far, any data proving its efficacy has not been published in the public domain.
(With inputs from IANS)
