Bharat Biotech's coronavirus vaccine candidate Covaxin received approval Phase 3 trials on October 22.
Delhi's All India Institute of Medical Sciences (AIIMS) is likely to submit a proposal to the Institute of Ethics Committee to begin Phase 3 clinical trials of Bharat Biotech's coronavirus vaccine candidate Covaxin by early next week.
Bharat Biotech received approval for Phase 3 trials on October 22. AIIMS Delhi is one of the hospitals selected for the final-stage trials to be conducted across India.
"The proposal is being prepared for the Phase 3 trials and within a couple of days we will be submitting it to the institute of ethics committee for approval," Hindustan Times quoted Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi, as saying.
AIIMS plans to recruit between 2,000 and 5,000 participants for the trial, the report said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The Indian Council of Medical Research (ICMR) rules require an ethics committee to oversee clinical research and review the proposal at any site before allowing the trial.
AIIMS ethics committee is likely to take about 10-14 days to grant the approvals.
The third phase of human trials of Covaxin is set to begin at the Indian Institute of Medical Sciences (IMS) and SUM Hospital in Odisha.
The Central Drugs Control Organisation (CDSCO) has given the approval for the third phase trials of Covaxin, said Dr E Venkata Rao, Principal Investigator in the Covaxin human trial and a professor in the Department of Community Medicine at IMS and SUM Hospital.
Bharat Biotech had on October 2 sought the DCGI's permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its vaccine.
In its application, the firm said the study would cover over 28,500 subjects, aged 18 years and above. The study would be conducted at 19 sites in 10 states.
The potential vaccine against COVID-19 is being developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology. Two doses of the Covaxin are to be administered in a gap of 14 days.Click here for Moneycontrol’s full coverage of the COVID-19 outbreak