Bharat Biotech vaccine approved for children above 12 years, Covishield above age 18

Bharat Biotech's anti-coronavirus vaccine 'Covaxin' has been approved for children above the age of 12 years by the Drugs Controller General of India (DCGI). Oxford-AstraZeneca coronavirus vaccine 'Covishield', manufactured by Pune-based Serum Institute of India (SII) has been approved for those above the age of 18. The DCGI had on Sunday approved Bharat Biotech's 'Covaxin' and Serum's 'Covishield' for emergency use in the country, paving the way for a massive inoculation drive.

The permission to both the vaccines -- Bharat Biotech's Covaxin and Serum Institute's 'Covishield' -- has been granted for restricted use in emergency situations. Both the vaccines will be administered in two doses, the DCGi said in the permission letter.

India had on Sunday announced the formal approval for the Oxford-AstraZeneca and Bharat Biotech anti-coronavirus vaccines, saying they will be administered in two dosages each. VG Somani of DCGI said both the firms have been granted permission for "restricted use" in emergency situations.

The approval by the DCGI was given on the basis of recommendations submitted by a coronavirus subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Following the formal approval from the DCGI, questions were raised on the emergency use permission given to Bharat Biotech's coronavirus vaccine without its phase 3 trials. Congress asked the government to explain why mandatory protocols and verification of data were dispensed with while warning the approval could be "dangerous".

However, the DCGI, while announcing approval to Bharat Biotech's vaccine, said Covaxin is "safe and gives a robust immune response". The drug regulator also asserted that no vaccine with even the slightest safety concern would be approved for administration and said the vaccines are 110 per cent safe.

Later on Sunday evening, the DCGI gave licensing permission to Bharat Biotech to manufacture Covaxin. The drug regulator also asked Bharat Biotech to submit its safety, efficacy, and immunogenicity data from the ongoing phase I, II, and Ill clinical trials till the completion of trials.

Meanwhile, Serum CEO Adar Poonawalla has said the Oxford-AstraZeneca coronavirus vaccine 'Covishield' will be sold to the Indian government at Rs 200 per dose and Rs 1,000 per dose to the private buyers.

Adar Poonawalla of the Serum Institute told AP that the first 100 million doses of the Covid-19 vaccine are being sold to the Indian government at a “special price” of Rs 200 per dose, after which prices would be higher.