Is Russian Vaccine going to be Available for Public Use in India? Experts Explain! Details

Russia approved the first novel corona virus vaccine for public use without undertaking the final phase of human trials. Although the Chinese vaccine was approved for limited use earlier, this is the first vaccine that has been approved for public use. 

The Russian vaccine was developed by Moscow- based Gamaleya Institute. Since the vaccine was approved within less than two months, it has raised concerns related to the safety and efficiency of the vaccine. Other vaccine candidates are not expected to be ready before next year. 

Ever since the Russian vaccine got registered officially as the first coronavirus vaccine, Indians are keen to know if it would be available in India. There are two ways in which it could be made available for public use in India. The vaccine candidate could be supplied to the Central Drugs Standard Control Organization (CDSCO) so that they can conduct late-phase human trials. Both the phase 2 and phase 3 trials will have to be conducted on an Indian population and is pretty much the protocol to follow in order to test vaccines developed outside the country. 

Late- Phase human trials are considered to be crucial in the process since the efficacy of vaccine candidates vary depending upon the population groups. The CDSCO for example recently allowed the Oxford University vaccine candidate to conduct clinical trials in India. 

Although CDSCO is empowered to give emergency authorization without late- phase trails, it will be doing so only if the safety and efficacy data is in place and is satisfactory.  There is a possibility of CDSCO approving the vaccine for emergency use. The drug remdesivir recently granted approval for use on coronavirus patients. However, experts think that this option is unlikely to be used in the case of the Russian vaccine. Besides, Remdesivir was pre-approved for other ailments whereas the Russian vaccine is new.

Manufacturing the vaccine in India could also be a concern. More than 50 % of vaccines for all kinds of diseases are being currently manufactured in India. It is expected that the vaccine will be developed in bulk and produced in India. 

According to The New Indian Express’ report, “Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, has already entered into tie-ups with developers to mass-produce their vaccines. Other Indian companies have also done similar agreements. There is no agreement for production of Russian vaccine in India right now.”