SII's Covishield, Bharat Biotech's COVAXIN granted emergency approval, says DCGI
Two COVID-19 vaccines, Covishield and COVAXIN, have been granted emergency approval for use in India, the Drugs Controller General of India (DCGI) Dr. VG Somani said on Sunday. Covishield has been developed by AstraZeneca and Oxford University, and manufactured by Pune-based Serum Institute of India (SII), while COVAXIN has been developed indigenously by the Hyderabad-based Bharat Biotech. Here are more details.
While addressing a press conference, Dr. Somani said, "After adequate examination, the CDCSO has decided to accept the recommendations of the expert committee, and accordingly, the vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in an emergency situation." "Permission is being granted to Cadila Healthcare for the conduct of Phase III clinical trials in India," he added.
Earlier on Saturday, the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) had recommended the grant of emergency approval to COVAXIN. A day earlier, the same panel had recommended emergency approval for Covishield. The nod to COVAXIN was deemed controversial as the recommendation came despite a lack of Phase III trial data indicating the vaccine's efficacy.
Both Covishield and COVAXIN are two-dose vaccines. SII CEO Adar Poonawalla had said last week that Covishield is "90-95% effective" if the two doses are given two-three months apart. Earlier, he had said that India has 40-50 million doses already stockpiled.
Addressing criticism over vaccine approval, the DCGI told reporters, "We would never approve (a vaccine) if there are any safety concerns... The vaccines are 110% safe." "There are some mild side-effects, such as pain on the injection site, mild fever, and allergy. But these are common for every vaccine," he said, declaring the claims of impotency being a side-effect "absolute rubbish."
In a series of tweets, Prime Minister Narendra Modi said the development marked a "decisive turning point to strengthen a spirited fight." "Congratulations India. Congratulations to our hardworking scientists and innovators," he wrote. The PM further said that India will remain "eternally grateful" to the doctors, medical staff, scientists, police personnel, sanitation workers, and all "corona warriors" at the frontlines of the pandemic.
As of Sunday morning, India has reported 1,03,23,965 COVID-19 cases, with a spike of 18,177 new infections reported in the past 24 hours. The total cases include 2,47,220 active infections, while 99,27,310 people have recovered. The death toll has risen to 1,49,435 with 217 new fatalities over a 24-hour period. India is the world's second worst-hit country in the outbreak after the United States.