As India faces the second wave of novel coronavirus cases and due to a significant shortage of vaccines as reported by the states of Odisha, Chhattisgarh, and Maharashtra, West Bengal, etc, the expert panel of the country’s drug regulator on Monday approved the use of Russia’s Sputnik v covid 19 vaccine as per the reports.
This comes shortly after DCGI i.e., Drugs Controller General of India’s Subject Expert Committee (SEC) met on Monday to take up the application of Sputnik v emergency use authorization in India.
DCGI will now take up the call to consider SEC recommendation for the third covid vaccine to be available in India amid a shortage of vaccine under emergency use. The first two vaccines that have been earlier approved under emergency use were Serum Institute of India’s locally made Oxford Covid 19 vaccinee “COVISHIELD” and Bharat Biotech’s indigenously developed “COVAXIN”
This is a vaccine that uses two different human common cold viruses (adenovirus) that have been modified so that the gene causing the cold infection is removed and instead replaced with a code to make SARS-COV-2’s ‘spike protein’ (the spikes seen on the surface of the virus, which allow it to penetrate the cell and replicate the same). the human adenoviruses then act as a vehicle to transport this code to the cells when a person is vaccinated. So that the body can develop an immune response in the form of antibodies to protect it in the event the real virus tries to infect.
The vaccine is named after the first Soviet space satellite and was developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology.
The vaccine would be imported from Russia for emergency use in the country.
Last Friday, DCGI sought additional data from drugmaker Dr.Reddy’s Laboratories on its Sputnik V Covid 19 vaccine trial, in its second such request after an initial evaluation in February. In India, Sputnik V trails are on for around 1600 people between 18 and 99 years of age. The Russian Direct Investment Fund (RDIF) has tied up with a host of Indian pharmaceutical players such as Panacea Biotec, Dr.Reddy’s Laboratories, and Gland Pharma for the production of vaccine doses.
Dr.Reddy has been conducting small clinical trials with Sputnik V in India under a deal with Russia’s wealth fund since last September. Several Indian companies have signed a deal to produce and supply over half a billion doses of vaccine. As a result of which the shares price of the dr. Reddy has raised sharply even when the whole of the market was falling.
The efficacy of the same is 91.6% in the interim analysis of phase 3 clinical trial, which included data of 19,866 volunteers in Russia.
The vaccine, deemed as the “world’s first vaccine” to be registered by Russian President Vladimir Putin last August has proven equally effective for all age groups. Alexander Ginsburg, the head of the Gamaleya research institute that developed the vaccine has said that the vaccine has demonstrated the same level of efficacy in all age groups. The virologist said that the same beats other coronavirus vaccines in terms of quality. “The efficiency of the vaccine will be long, maybe up to two years or more” he added.
India has seen a steep rise in corona cases. India has again jumped to the 2nd rank in terms of overall cases. The total number of cases now is 13.6 million and the death toll raised to 1,17,089 recorded. There are still many unrecorded death and cases. The cases per day have also raised to 1.7 lakhs. Currently, there are 2 vaccine candidates available in India being locally manufactured. However, we can expect five more vaccines by Q3 2021.
