1.5 lakh doses of Sputnik V land in India

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Context

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.

BIASA BASIC

Sputnik V

  • 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.
Coronavirus: Russia rolls out COVID vaccination in Moscow | News | DW |  05.12.2020
  • 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 

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