1.5 lakh doses of Sputnik V land in India
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India moved a step closer to having a third vaccine in its immunisation drive against COVID-19 when the first consignment of Russia’s Sputnik V landed in Hyderabad on Saturday.
Reach and the approval
- Based on the human adenoviral vector platform, the Russian vaccine received emergency use authorisation in India last month. The efficacy of Sputnik V has been reported to be 91.6%.
- Sputnik V will join Covishield and the indigenous Covaxin that are being used in the country since January.
- In 2020, Russia had become the first country to officially register a Covid-19 vaccine and declare it ready for use.
- The vaccine has been called Sputnik V, named after the first artificial Earth satellite, Sputnik-I
- launched by the Soviet Union.
- It is the first Covid-19 vaccine to be approved.
- However, a Chinese vaccine had been cleared for „limited use‟ before this.
- It is an adenovirus vector vaccine approved to be administered only on soldiers of the
- People‟s Liberation Army.
- The Russian vaccine has outrun other Covid-19 vaccines like Oxford-AstraZeneca, Moderna and
- Pfizer which are still in trials.
- India's Covaxin has been approved for human clinical trials. Another Indian vaccine
- ZyCoV-D has entered phase I/II of clinical trials.
- This vaccine has been developed by Moscow‟s Gamaleya Institute in collaboration with the
- Russia‟s defence ministry.
Concerns Regarding the Vaccine
- Experts expressed concerns over the safety and efficacy of the vaccine due to its extremely fast
- production and lack of published data on the vaccine.
- Russia has only made public the results of phase-I of the clinical trials, which it claimed were
- successful and produced the desired immune response.
- The human trials, which take several years in normal circumstances, have been completed in
- less than two months for Sputnik V.
- The late-phase human trials are important because the vaccine‟s efficacy can differ on different
- population groups.
- Russia, however, has claimed that this was made possible due to the fact that its Covid-19 vaccine candidate closely resembled a vaccine for Middle East Respiratory Syndrome (MERS) disease,caused by another coronavirus, that had already been tested extensively.
Use in India
- Russia has claimed that around 20 countries have shown interest in the Sputnik V vaccine,including India.
- India was also partnered with the USA for development of Covid-19 vaccine.
- The approval for a vaccine is given by the Central Drugs Standard Control Organisation(CDSCO).
- The Central Drugs Standard Control Organisation (CDSCO), under Directorate General of Health Services ,Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India.
- Under the Drugs and Cosmetics Act, 1940, CDSCO is responsible for approval of Drugs,
- Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality ofimported Drugs in the country and coordination of the activities of State Drug Control
- Organizations by providing expert advice.
- CDSCO can ask Russia to conduct late-phase human trials, usually both phase-2 and phase-3,on an Indian population.
- This is the usual requirement for all vaccines developed outside of India.
- CDSCO can also give emergency authorisation without late-phase trials, considering the extraordinary situation.
- The drug remdesivir was granted similar emergency approval to be used as a therapeutic on novel coronavirus patients.
- However, this is unlikely as vaccines are given to a large number of people, and the risks involved are much higher.
- There are also issues in manufacturing the vaccine as there is no agreement for its
- production in India right now.
- 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 but there is none with Russia.
SOURCE: THE HINDU