Recently, the Indian Council of Medical Research (ICMR) said that three coronavirus vaccine candidates in India are in the clinical stage of the trials. Given that we are almost seven months into the COVID-19 pandemic, and how finding a vaccine can take years, this progress is cause for some cheer, even though there is a long road ahead.
Here’s a list of vaccines that are being trialled in India, and their current status.
The Oxford University candidate has been one of the frontrunners in the COVID-19 vaccine candidates world over. It is called ChAdOx1-S, which is a viral vector vaccine. The Pune-based Serum Institute of India has tied up with the university to run trials of the vaccine in India, and in agreement with AstraZeneca which will manufacture and market this vaccine in India.
The trials ran into a hitch recently when the Drug Controller General of India (DGCI) revoked the approval for phase two and three trials after an adverse effect was reported on a participant in the study by AstraZeneca. The company resumed the trials on September 12 in the UK though, after the Medicines Health Regulatory Authority's green light. Brazil too restarted the trial of the vaccine.
In India too, the trials resumed on Tuesday, with the caveat that the company will have to take extra precautions when screening, give information and take informed consent from the participants. Adverse effects will also have to be scrutinised for closely during a follow-up study that has been done by SII. The institute will also have to submit details of the medication used along with a protocol on how it will handle the situation where adverse effects are reported.
Phase 2-B3 trials of this vaccine have been completed in India, and phase 3 trials – involving 1,500 patients in 14 locations – are set to begin after required clearances, Balram Bhargava Director General of ICMR said.
Hyderabad-based Bharat Biotech’s COVAXIN has completed phase 1 trials, and yielded an “encouraging safety profile”. According to reports, Dr Savita Verma who was the principal investigator of the trial at the Post-Graduate Institute (PGI) of Medical Sciences in Rohtak, the subjects of the trial did not see adverse effects. Phase 1 involved 375 volunteers and was done at 12 institutes in the country.
This vaccine is being developed in collaboration with ICMR and the Pune-based National Institute of Virology, and uses an inactivated vaccine to build immunity and help create antibodies in the subject. The inactivated vaccine cannot replicate in the subject, however, parts of the virus can still be identified by a healthy immune system, creating antibodies with an immune reaction.
In a yet-to-be peer reviewed study published last week, it was found that COVAXIN has produced a robust immune response in monkeys. The rhesus macaques species, on whom it was trialled, were exposed to the SARS-CoV-2 virus 14 days after the second dose of the vaccine was given to them.
The human trial had commenced in July and while the ICMR had earlier claimed that the vaccine would be ready by August 15, 2020. However, Bharat Biotech clarified that the vaccine, if all goes well, will only be available by early 2021.
The ZyCoV-D vaccine which has been developed and is being trialled by Ahmedabad-based Zydus Cadila had launched its phase 2 trial earlier in August. Chairman of the company, Pankaj Patel said that all the subjects in the phase 1 clinical trial that was done prior were monitored for 24 hours after the dose was administered, and then for a week. The vaccine was found to be safe, he said. The phase 2 trial will involve the vaccine being given to over 1,000 healthy adults.
The approval for the phase 1 and phase 2 studies of the vaccine was given by the DCGI after the animal studies were successful with respect to safety and immunogenicity.
Only ZyCoV-D, COVAXIN and ChAdOx1-S are vaccine candidates that are in the clinical trial stage in India so far.
Earlier this week, Aurobindo Pharma announced a tie-up with the Biotechnology Industry Research Assistance Council (BIRAC), which has been set up by the Department of Biotechnology (DBT) to develop a COVID-19 vaccine. This vaccine will reportedly be developed by its US-owned subsidiary Auro Vaccines, for which a “state of the art” manufacturing facility is being set up. The collaboration will se "establishment of the r-VSV vaccine manufacturing platform for the first time in India under the National Biopharma Mission," per a PIB release.
Panacea Biotech, a Bengaluru-based biotechnology company, has reportedly partnered with American company Refana Inc to make a COVID-19 vaccine. Panacea hopes to produce its COVID-19 vaccine candidate by January 2021, and is expected to have 40 million doses available by early 2021. The eventual target for the next year is pegged at 500 million doses, and one billion doses for 2022.
Gennova Pharmaceuticals, which is a subsidiary of Emcure Pharmaceuticals, had announced in July that it was working on a COVID-19 vaccine candidate. Called HGC019, this vaccine is one of the newer kinds – an mRNA vaccine – which utilises the RNA molecules that guide cells on what proteins to build. In this case, the vaccine will trigger the body’s cells to use the mRNA’s instruction from the vaccine, so as to create copies of the spike protein found on the SARS-CoV-2 virus, and hence trigger an immune response and antibodies to combat it.
Reports state that the Pune-based firm hoped to complete pre-clinical trials and begin clinical trials by October. The company’s CEO Sanjay Singh said that if they get approvals, they should have the vaccine ready by March 2021. The vaccine candidate was developed in collaboration with HDT Bio in the US.
A report from August states that this vaccine showed “safety, immunogenicity, neutralization antibody activity in the rodent and non-human primate models.”
Some other companies including Indian Institute of Science-incubated startup Mynvax, Premas Biotech, Epygen Biotech, Luxmatra Innovations, Biological Evans are also in preclinical development stages of their respective COVID-19 vaccine candidates.
Further, Russian Direct Investment Fund has also signed an agreement with Indian Dr Reddy’s Laboratories to conduct trials and distribution of Sputnik V in India, the Russian COVID-19 vaccine. The agreement between Russian Direct Investment Fund and states that Dr Reddy’s Laboratories will be supplied with 100 million doses of the vaccine. It could enter India as early as the end of this year if regulatory approvals for phase 3 clinical trials are given by DCGI.
While the first batch of the Sputnik V vaccine has already been released in Russia, questions have been raised about its efficacy. A top respiratory doctor in the country – Professor Alexander Chuchalin – even quit the Russian health ministry’s ethics council last month against Russia’s decision to register the vaccine before conducting the phase 3 trials.