The Drugs Controller General of India (DCGI) has approved Serum Institute of India’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ for restricted emergency use, informed Dr. VG Somani, the Drugs Controller General of India during a press conference held on Sunday.
Serum Institute of India (SII) sought approval for the ‘Covishield’ vaccine developed by Oxford-AstraZeneca. Bharat Biotech developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune. Serum and Bharat Biotech vaccines have to be administered in two doses. All three vaccines have to be stored at 2-8° C. The drug controller has also granted approval for a phase-III clinical trial for the vaccine developed by another pharmaceutical company, M/s Cadila Healthcare Ltd.
Addressing the media, DCGI VG Somani said, “After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum Institute and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare for the conduct of Phase III clinical trial.”
He further stated that both the firms have submitted data on their trial runs and both have been granted permission for “restricted use”. On the other hand, while replying to queries on the potential risks the vaccines might pose, he said, “We will never approve anything if there’s slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish.”
Meanwhile, soon after the DCGI nod, Prime Minister Narendra Modi tweeted on his official Twitter handle: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfill the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
“We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers, and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” PM Modi added.
Union Health Minister Harsh Vardhan also said, “A watershed moment in India’s famed battle against #COVID19 under the leadership of PM Modi. Our wait for the vaccine is over with Covishield from Serum Institue of India and Covaxin from Bharat Biotech approved for emergency use in India.”