India has approved two COVID-19 vaccines — Serum Institute of India's 'Covishield' and Bharat Biotech's 'Covaxin' — for emergency restricted use, regulatory body DCGI said on Sunday. Both vaccines have to be administered in two doses, and have to be stored at 2-8° C.
Over 1.03 crore people have tested positive for coronavirus in India alone, according to latest data . You can track coronavirus cases, deaths and testing rates at the national and State levels here . A list of State Helpline numbers is available as well.
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Zydus Cadila gets DCGI nod to initiate Phase-3 trials for ZyCoV-D vaccine
Drug firm Zydus Cadila on Sunday said it has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D.
The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.
ZyCoV-D was found to be safe, well-tolerated and immunogenic in phase I and II clinical trials, it added.
Covishield, Covaxin approved for emergency use
India's drug regulatory body has approved the use of Oxford's COVID-19 vaccine 'Covishield' and Bharat Biotech's 'Covaxin' for restricted emergency use.
"The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2, and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd," Drugs Controller General of India (DCGI) said in a statement.
Both vaccines have to be administered in two doses, and have to be stored at 2-8° C.
'Covishield' ready to roll out in coming weeks, says SII chief
Serum Institute of India CEO Adar Poonawalla said the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' is ready to roll out in the coming weeks.
Mr. Poonawalla's remarks came soon after after India's drugs regulator approved Covishield for restricted emergency use.
"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," Mr. Poonawalla tweeted. - PTI
"Congratulations India": PM Modi reacts to approval of vaccine use
Prime Minister Narendra Modi welcomed the news of DGCI granting approval to emergency use of two COVID-19 vaccines in India, and said that it "accelerates the road to a healthier and COVID-free nation."
"A decisive turning point to strengthen a spirited fight!," he wrote on Twitter, adding that it shows "the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat."
"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," he added.
18,177 new cases take India's virus tally to 1,03,23,965
India recorded 18,177 new COVID-19 cases cases in a day, while 99,27,310 people have recuperated so far pushing the national recovery rate to 96.15% on Sunday, according to the Union Health Ministry data.
The total coronavirus cases mounted to 1,03,23,965 and the death toll climbed to 1,49,435 with the novel coronavirus virus claiming 217 lives in a span of 24 hours in the country, the data updated at 8 a.m. showed.
The COVID-19 case fatality rate stood at 1.45%. There are 2,47,220 active cases of coronavirus infection in the country which comprises 2.39% of the total caseload, the data stated. - PTI
Bharat Biotech recruits 23k volunteers for COVID-19 vaccine trials
Bharat Biotech has successfully recruited 23,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of its COVID-19 vaccine Covaxin across multiple sites in India, it said.
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the countrys first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India, a press release from the vaccine maker said on Saturday night.