COVAXIN: India's first COVID-19 vaccine candidate gets nod for human trials -- read details
The Phase I and Phase II clinical trials of the potential vaccine for COVID-19 would start across India in July.
COVAXIN -- India’s first vaccine candidate against COVID-19 -- has got the nod for human clinical trials from the Drug Controller General of India. It is developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month. The collaboration with the ICMR and the NIV was instrumental in the development of the vaccine, the company said in a release.
This comes as World Health Organization chief Tedros Adhanom Ghebreyesus warned that the COVID-19 pandemic is not even close to being over.
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley in Hyderabad, a release said.
The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020, according to the release.
Chairman and Managing Director of the company Dr. Krishna Ella said: "We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine.
"The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," he said.
Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.
Results from these studies have been promising and show extensive safety and effective immune responses, the release added.
Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries.
COVID-19 PANDEMIC 'NOT EVEN CLOSE TO BEING OVER'
The COVID-19 pandemic is not even close to being over, World Health Organization chief Tedros Adhanom Ghebreyesus told a briefing on Monday. Tedros said that, six months after China first alerted the WHO to a novel respiratory infection, the grim milestones of 10 million confirmed infections and 500,000 deaths had been reached.
"Most people remain susceptible, the virus still has a lot of room to move," he said.
"We all want this to be over. We all want to get on with our lives. But the hard reality is that this is not even close to being over. Although many countries have made some progress globally, the pandemic is actually speeding up."
The head of the WHO's emergencies programme, Mike Ryan, said that tremendous progress had been made towards finding a safe and effective vaccine to prevent infection, but there was still no guarantee the effort would succeed.
In the meantime, countries could fight the spread of the disease by testing, isolating confirmed cases and tracking their contacts, he said.
He singled out Japan, South Korea and Germany for their "comprehensive, sustained strategy" against the virus.