Although the Covishield vaccine by the Serum Institute of India and the indigenous Covaxin of Bharat Biotech are the two Covid-19 vaccines that will push the country’s vaccination program in the first phase of inoculation, the Centre is looking at four additional vaccines in the pipeline.
India’s health secretary, Rajesh Bhushan, said Tuesday, “In the coming months, these vaccine makers may also be granted emergency usage authorisation from the Indian drug regulator. After regulatory approvals, India could see more vaccines.”
The next set includes vaccines, the research and development of which is led by Indian companies or are already being produced in the country.
The Union Health Secretary Rajesh Bhushan told a press briefing that the vaccines in advanced clinical tests in India, Zydus Cadila and Russia’s Sputnik V, Biological E and Gennova, were in the pipeline.
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- Sputnik V
Sputnik V made up by the Russian Gamaleya Research Institute of Epidemiology and Microbiology was possibly the only vaccine that has been shown to be safe and effective for more than 90 per cent in the Indian basket.
In cooperation with Dr Reddy’s Laboratories, the trials are performed in India.
While the trials for Phase 2, the trials for Phase 3 begin. Sputnik V recently provided the Indian drug regulator with its Phase 2 trial results. The Ministry of Health has announced that this vaccine will be developed and manufactured in India.
The efficacy of the vaccine is 91.4%, based upon data review at the end-control points for Russian clinical studies, “The vaccine has been claimed to be 91.4 per cent effective in providing protection against Covid-19 and has demonstrated 100 per cent efficacy against severe coronavirus cases.
- Zydus Cadilla’s Zy-Cov-D
The company based in Ahmedabad is in the process of being the next vaccine in India for Covid 19. The company concluded its Phase 2 trials with more than 30 000 DCGI participants in India in December last year and was granted the opportunity to launch its Phase 3 trials at 60 sites.
Zydus Cadilla says that the vaccine is easy to store, transport and inject. The organization claims that they are looking at an intradermal injection (where the vaccine is inserted into the skin and not into the muscle), though noting that it is much less painful.
Packaging could be made in a 10-dose vial shape. The platform is the third generation of a modern vaccine platform where DNA, the antigen material of the virus, the active component of the virus, is inserted into the DNA plasmid.
- Biological E
Biological E is currently working on a protein-dependent vaccine based in Hyderabad. In collaboration with the US Baylor College of Medicine, the BE vaccine is being developed.
However, in India, the company is currently performing its human studies in phase 1. Biological E’s Phase 2 trials will start in March 2021 according to projections from the Ministry of Health.
BE has reported that the Coalition for Epidemic Prepare Innovatives (CEPI) has given $5 million in financing for the production in December last year of its Covid-19 protein subunit vaccine.
The CEPI also intends to explore BE’s supplementary funds to allow 100 million doses to be produced in 2021.
- Gennova vaccine
The first mRNA Covid-19 vaccine from India can be stored at 2-8°C and is the Gennova vaccine contestant. Biopharmaceuticals from Pune have reached the stage of the human trial.
The Phase 1 trials of this vaccine in India have been approved by the Indian drug regulatory bodies, and phase 2 trials may start in March.
The biggest problem in India is the end-user storage of the vaccine that needs a lower temperature. Therefore, Gennova’s vaccine may be useful where storage is a problem.