On the 3rd of January, the World Health Organization (WHO) welcomed the decision of the Drugs Controller General of India (DCGI) of approving the India made vaccine for emergency use.
On the late evening of the 2nd of January, the DCGI gave emergency use authorization (EUA) to Hyderabad based Bharat Biotech Private Limited’s COVAXIN, a potential candidate of the Novel Coronavirus.
So far, Indian Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) and DCGI approved COVAXIN and Serum Institute of India (SII) made Oxford AstraZeneca vaccine.
The Drugs Controller General of India V.G. 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.
Mr. Somani in a statement said, “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 situation.”
Mr. Somani said the overall efficacy of the AstraZeneca Oxford vaccine was 70.42% and that of the Bharat Biotech’s COVAXIn was “safe and provides a robust immune response”.
V.C. Somani said, “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,”
Dr. Poonam Khetrapal Singh, the Regional Director of the WHO South East Asia Region said, “World Health Organization welcomes India’s decision giving emergency use authorization to COVID-19 vaccines.”
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 millions.
The new approval of the COVID-19 vaccine for EAU is a good news for people who are waiting for the vaccine.
Meanwhile, the Union Health Ministry also assured the launch of the Novel Coronavirus vaccine for the Nation by May 2021.
Until then, the Union Government urged people to be cautious and follow all the mentioned guidelines of the COVID-19.