The government of India 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).
The Central government has now disapproved the authorisation of Bharat Biotech's Covaxin to people below 18 years of age. Earlier, it was approved for children above the age of 12 years by the Drugs Controller General of India (DCGI).#TheAssamTribune #CovaxinAuthorisation pic.twitter.com/BIHMNy0g03
— The Assam Tribune (@assamtribuneoff) January 15, 2021
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However, when IANS approached CDSCO with the query upon this, the officials said that the provision was soon withdrawn and revised by the drug licensing authority.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.