Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region said, “World Health Organization welcomes India’s decision giving emergency use authorization to Covid-19 vaccines.”
Drugs Controller General of India VG Somani has formally announced the approval for the emergency-use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech.
“CDSCO (Central Drugs Standard Control Organisation) accepts the subject expert committee reform rations on Serum and Bharat Biotech Covid vaccines,” Somani during a press conference. “Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” Somani read out from a written statement.
Somani said the overall efficacy of the AstraZeneca-Oxford vaccine was 70.42% and that of Bharat Biotech’s Covaxin was “safe and provides a robust immune response”.
“We will never approve anything if there is slightest of safety concern. The vaccines are 100% safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” he added.
The subject expert committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) had recommended Oxford-AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use.
Even before getting the approval from the apex drug controller of India, SII stockpiled about 40-50 million doses of the Covid-19 vaccine, which involved a major risk in case its application got turned down by the drug regulator. Overall, Serum’s investment on Covishield is around $100 million.