Coronavirus (Covid-19) Vaccine Covaxin: Even as Phase I human trials of Bharat Biotech’s Covaxin, India’s first indigenous Covid-19 vaccine candidate, are on at most of the 12 sites selected by ICMR across the country, the Post-Graduate Institute (PGI) of Medical Sciences, Rohtak, has claimed “encouraging” results from first part of the tests.
Earlier this week, AIIMS, Delhi, administered the first dose of Covaxin to a 30-year-old man. According to CTRI, the Covaxin phase I and II trials are expected to take one year and three months.
Developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and National Institute of Virology (NIV), Covaxin got the nod for human clinical trials from the Drugs Controller General of India (DCGI) last month. Besides Covaxin, another experimental shot developed by Zydus Cadila has also begun human clinical trials.
An “inactivated” vaccine, Covaxin has been made using particles of SARS-CoV-2 that were killed so that they would not be able to infect or replicate in those injected with it. Injecting particular doses of these particles will help in building immunity by helping the body create antibodies against the dead virus.
💉 ‘Encouraging’ results seen in trials: Rohtak PGIMS
Rohtak PGIMS, which had commenced the first part of Phase-1 trials of Covaxin on July 17 on 50 volunteers, reported “encouraging” results, according to ANI.
Principal investigator of the vaccine trial team, Dr Savita Verma, said six people have already been administered the vaccine under the second part of phase-1.
“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 the vaccine on Saturday under the second part of phase-1,” ANI quoted Dr Verma as saying.
On Friday, human trials of Covaxin had started at AIIMS-Delhi, with the first dose of 0.5 ml of the injection given to a 30-year-old man. He will be monitored for two weeks and then given the second dose, Dr Sanjay Rai, principal investigator of the Covid-19 vaccine trial at AIIMS, told The Indian Express.
The man was kept under observation for two hours and no immediate side-effects were observed so far, the principal investigator said.
AIIMS-Patna has also injected nine participants with the experimental vaccine and plans to vaccinate 18-20 participants in the first round.
💉 Phase I trials to be conducted on 375 volunteers
Among the 375 volunteers, the vaccine will be tested on 100 people at AIIMS. The medical institute has so far received over 3,500 applications for participation in the human trials. The first phase is expected to take over a month to complete following which the second phase will begin with trials on around 750 volunteers across the 12 sites.
In Phase I, the sites will initially vaccinate a small group of people, around 18-20, and then collect data on the vaccine’s safety from this group. The data will then be studied by a Data and Safety Monitoring Board, which will decide whether it is safe to administer the vaccine in humans.
If there are no safety issues observed, the sites will be allowed to continue enrollment and vaccinate more participants as part of the first phase of the trial. The participants will be vaccinated twice in the first phase of trials, fourteen days apart.
💉 Other Covid-19 vaccines in the race in India
At least seven Indian pharma companies are working to develop an antidote against the novel coronavirus. Besides Bharat Biotech and Zydus Cadila, the other firms are Serum Institute, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.
Zydus Cadila’s ZyCov-D vaccine
Along with Bharat Biotech, Zydus Cadila has also kicked off human trials for its ZyCov-D vaccine on July 17 and the first phase of trials is expected to take nearly three months to complete. This is so, because Zydus will vaccinate the participants three times. The second vaccination will take place on the 28th day and the third on the 56th day.
In Phase I and II trials, ZyCov-D will be administered on 1,048 participants and are being conducted at one site — Zydus Research Centre in Ahmedabad.
Oxford University’s Covishield
On the other hand, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the University of Oxford vaccine candidate, has sought permission from the Drugs Controller General of India (DCGI) for conducting Phase II and III human clinical trials, PTI reported.
The Oxford vaccine, which will be named Covishield in India, has shown dual immune response in people aged between 18 and 55 years. Early human testing results have shown the vaccine increased levels of both protective neutralising antibodies and immune T-cells that target the virus.
Adar Poonawalla, CEO of Serum Institute of India, said the cost of the vaccine is estimated to be below Rs 1,000 and might be launched as early as November.