India’s first indigenous vaccine for the novel coronavirus is here- COVAXIN. The experimental vaccine for the treatment of Covid-19 is developed by Hyderabad-based company Bharat Biotech in tandem with Indian Council of Medical Research (ICMR) and the National Institute of Virology. Human trials of covaxin had started at Post-Graduate Institute (PGI) of Medical Sciences, Rohtak on 17th July, with the human trial of the first part of phase-1 of the vaccine showing encouraging results.
Covaxin is an indigenously developed inactivated vaccine. An inactivated vaccine is prepared by growing the virus on a large scale and injecting an inactive form of it (using particles of SARS-CoV-2 that were killed) inside a human body to gain immunity against the virus.
Receiving the official nod from the Drug Controller General of India (DCGI) to conduct Phase I and II human trials, the trials of the vaccine are expected to take one year and three months. AIIMS, New Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting human trials of the Covid-19 vaccine candidate.
Updates we have so far on the new COVID vaccine:
“First part of phase-1 of vaccine trial (Covaxin) has been completed. 50 people across India were administered the vaccine and the results were encouraging. Six people were administered vaccine on Saturday under second part of phase-1,” statement received from Dr Savita Verma, principal investigator of the vaccine trial team.
Earlier in the week, the first dose of 0.5 ml covaxin was given to a man, in his 30s. The man was kept under observation for two hours and no immediate side-effects have been observed so far.
In the first phase, the vaccine would be tested on 375 volunteers and amongst them, 100 candidates will be from AIIMS. Already, over 3,500 volunteers have registered themselves for the trial at AIIMS, with the first phase expected to take over a month to complete. The participants will be vaccinated twice in the first phase of trials, fourteen days apart.
“If the first phase we see if the vaccine is safe and how much of the dose can be administered. Multiple doses will be tried”, said AIIMS Director Dr. Randeep Guleria.
The second phase of the trial would include around 750 volunteers from all 12 sites together, and the age group to be recruited will be between 12-65 years. Phase II will allow the researchers to test Covaxin’s ability to induce an immune response against coronavirus.
The company has stated that results of early studies have been “promising” and show “extensive safety and effective immune responses”.
And finally, with Phase III, the effects of medicine in a larger population will be checked to see its efficacy and therapeutic benefit.
Covaxin is leading as the top contender in the Covid-19 vaccine race in India. There are at least seven other Indian pharmaceutical companies working towards the development of an antidote against the novel coronavirus, including Serum Institute, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E. Bharat Biotech’s Covaxin is also competing with over 100 other vaccine candidates around the world. Some of the other vaccine developments worldwide have entered the human trial phase as well.
