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The Drug Controller General of India (DCGI) on Sunday, January 3, approved Bharat Biotech's coronavirus vaccine 'Covaxin', and Oxford-AstraZeneca's 'Covishield' manufactured by Serum Institute of India for restricted emergency use authorisation (EUA).
The DCGI, in a press conference, on Sunday said that it accepted the recommendations of Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) that approved the restricted emergency use of both the vaccines earlier this week.
With this, India is all set to get at least two vaccines in the next few days. As of now, Bharat Biotech is conducting Phase-3 clinical trials of Covaxin and has successfully recruited 23,000 volunteers. The Phase-3 human clinical trials of Covaxin began mid-November.
Bharat Biotech is targeting 26,000 volunteers and it is the country's first and only Phase-3 efficacy study for a COVID-19 vaccine.
Soon after the DCGI nod, Prime Minister Narendra Modi took to Twitter to congratulate the Pune based Serum Institute and Hyderabad based Bharat Biotech and thank the scientists who were working to achieve the feat.
A decisive turning point to strengthen a spirited fight!— Narendra Modi (@narendramodi) January 3, 2021
DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.
Congratulations to our hardworking scientists and innovators.
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 fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.— Narendra Modi (@narendramodi) January 3, 2021
PM Modi further thanked the doctors, police, sanitation and medical staff and other frontline workers, and hailed them as Corona warriors.
Serum institute CEO, Adar Poonawalla also thanked the government and PM Modi for their support and informed that the COVISHIELD vaccine will be rolled out in coming weeks.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK— Adar Poonawalla (@adarpoonawalla) January 3, 2021
The approval of vaccines comes in the light of the infection by mutant strains of the virus that first emerged in the United Kingdom. India has reported more than 20 cases of the new strain.
Ten cases of the mutant strain have been detected in Delhi, 10 in Bengaluru, one in West Bengal, three in Hyderabad, and five in National Institute of Virology, Pune.
On December 29, when over 20 cases of the new strain were reported, Bharat Biotech asserted that Covaxin would be effective on the contagious mutant strain as well. Chairman and Managing Director Krishna Ella said that the vaccine's protein components would take care of the mutations of the virus SARS-CoV-2.
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