Live coronavirus | Zydus Cadila Obtains DCGI Approval to Start Phase 3 Trials for ZyCoV-D Vaccine


India has approved two COVID-19 vaccines – Covishield ‘from the Serum Institute of India and’ Covaxin ‘from Bharat Biotech – for emergency restricted use, regulatory body DCGI said on Sunday. Both vaccines should be given in two doses and should be stored at 2-8 ° C.

Also read: Why people with a previous infection still need the COVID-19 vaccine

More than 1.03 million people have tested positive for coronavirus in India alone, according to the latest data. You can track national and state coronavirus cases, deaths, and testing rates here. A list of State Help Line numbers is also available.

Here are live updates:

Zydus Cadila Obtains DCGI Approval to Start Phase 3 Trials for ZyCoV-D Vaccine

Pharmaceutical firm Zydus Cadila said Sunday that it received approval from DCGI to begin phase III clinical trials of its COVID-19 ZyCoV-D vaccine.

The company will now begin a phase III clinical trial in about 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, he added.

Approved vaccine

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 Matter Expert Committee of the Central Medicines Standard Control Organization (CDSCO) met on January 1 and 2 and made recommendations regarding the proposed Restricted Emergency Approval of the COVID-19 virus vaccine from M / s Serum Institute of India and M / s Bharat Biotech as well as the phase III clinical trial of M / s Cadila Healthcare Ltd, “the Controller General of Drugs of India (DCGI) said in a statement.

Both vaccines should be administered in two doses and should be stored at 2-8 ° C.

‘Covishield’ ready to roll out in the coming weeks, says SII chief

Serum Institute of India Executive Director Adar Poonawalla said Oxford-AstraZeneca’s COVID-19 vaccine ‘Covishield’ is ready to roll out in the coming weeks.

Poonawalla’s comments came shortly after India’s drug regulator approved Covishield for emergency restricted use.

“Happy New Year everyone! All the risks that @SerumInstIndia took in storing the vaccine have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll out in the next few weeks, “Mr. Poonawalla tweeted. – PTI

“Congratulations India”: PM Modi reacts to approval of vaccine use

Prime Minister Narendra Modi welcomed the news that the DGCI granted approval for the emergency use of two COVID-19 vaccines in India and said it “accelerates the path to a healthier and COVID-free nation.”

“A decisive turning point to strengthen an energetic fight!” He wrote on Twitter, adding that it shows “the enthusiasm of our scientific community to fulfill the dream of an Aatmanirbhar Bharat.”

“We reiterate our gratitude to the doctors, medical personnel, scientists, police personnel, sanitation workers and all the warriors of the Crown for the outstanding work carried out, which also under adverse circumstances. We will be eternally grateful for saving many lives,” he added.

Case load update

18,177 new cases bring India’s virus count to 1,03,23,965

India recorded 18,177 new COVID-19 cases in one day, while 99,27,310 people have recovered so far, bringing the national recovery rate to 96.15% on Sunday, according to data from the Union Ministry of Health. .

Total coronavirus cases rose to 1,03,23,965 and the death toll rose to 1,49,435 with the new coronavirus virus claiming 217 lives in a 24-hour span in the country, data updated at 8 a.m. .

The COVID-19 fatality rate stood at 1.45%. There are 2,47,220 active cases of coronavirus infection in the country, which represents 2.39% of all cases, according to the data. – PTI

Vaccine trials

Bharat Biotech recruits 23,000 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 the phase 3 clinical trial of its COVID-19 Covaxin vaccine at multiple sites in India, it said.

Phase III human clinical trials of Covaxin began in mid-November, aiming to be conducted in 26,000 volunteers and is the country’s first and only phase III efficacy study for a COVID-19 vaccine, and the efficacy trial phase III phase ever made for any vaccine in India, said a news release from the vaccine manufacturer on Saturday night.

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