The approval was reportedly given after assessing data from Phase I and II and animal challenge study.
Bharat Biotech's coronavirus vaccine Covaxin has received approval for carrying out Phase III trials on October 22, reports suggest.
The approvals were reportedly given after assessing data from Phase I and II and animal challenge study.
Phase III is likely to start next month, Business Today reported. The report said an expert committee met on October 20 to give its nod to Phase III trials and suggested some 'minor amendments' in the protocol.
Bharat Biotech had applied to the Drugs Controller General of India (DCGI) seeking permission for the crucial Phase III of trials on October 2, NDTV reported.
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.
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 across the country, the report said.
The potential vaccine against COVID-19 is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Phase I of Covaxin’s clinical trial involved 375 volunteers. Interim data from Phase I has not been made public yet.Two doses of the Covaxin vaccine candidate are to be administered with a gap of 14 days between them.