The Chairman and Managing Director of the Bharat Biotech, Dr Krishna Ella said with strong support from the consortia partners and Government, the entire development process was accelerated through national regulatory protocols. The permission for human clinical trials was granted by DCGI after Bharat Biotech submitted results generated from preclinical studies, demonstrating safety and immune response.
Developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), the COVAXIN candidate uses an inactivated strain of the novel coronavirus to prime the body to generate an immune response and fight off the actual virus attack.
For comparison purposes with the FDA's goal for a coronavirus vaccine, the effectiveness of the seasonal flu vaccine ranges from 40 to 60 percent when the vaccine is similar to circulating flu viruses, according to the Centers for Disease Control and Prevention.
"The Ad5-nCoV is now limited to military use only and its use can not be expanded to a broader vaccination range without the approval of the Logistics Support Department", CanSino said, referring to the Central Military Commission department which approved the military use of the vaccine.
The COVID-19 vaccine, developed by researchers at the University of Oxford, led by Irish scientist Adrian Hill, is the "leading candidate" for a working vaccine, the World Health Organization has stated. "Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform". About a dozen vaccine candidates are in early stages of testing in thousands of people.
The project started enrolling volunteers on June 23, and plans to recruit 168 healthy individuals, half of them aged 18 to 59 years old and the other half aged at least 60 years, to evaluate the safety and tolerance of the new coronavirus (SARS-CoV-2) mRNA vaccine.
They also stated that the human clinical trials are scheduled to start across India in July 2020.
More than half of 17 candidate vaccines identified by the World Health Organisation (WHO) that are in clinical evaluation involve Chinese companies or institutes. The number of COVID-19 cases in India now stands at 5,66,840 and counting. The Ministry of Home Affairs has releases Unlock 2.0 guidelines, which will be in force till 31 July.