India’s drug regulator refuses to grant emergency use authorization to Covid vaccine Sputnik Light | Corona’s vaccine Sputnik Lite is not approved for emergency use, drug regulator asks for data of Phase-3 trial in Russia

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  • India’s Drug Regulator Refuses To Grant Emergency Use Authorization To Covid Vaccine Sputnik Light

New Delhi/Hyderabad2 hours ago

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India’s drug regulator has refused emergency approval to Russia’s vaccine Sputnik Lite. The authority has also rejected the need to conduct Phase-3 trials of this single-dose vaccine. A meeting of the Subject Expert Committee (SEC) was held on this issue.

As per the recommendations of the committee, Sputnik Lite and Sputnik-V have the same component-1. The safety and immunity data of Sputnik V has already been obtained from trials conducted on the Indian population. It has also got approval from the Drug Controller General of India. Then the incomplete data and justification for conducting separate and uniform trials does not seem right.

Dr. Reddy’s Laboratories had sought approval
The SEC’s recommendations were uploaded on the website of the Central Drug Standard Control Organization (CDSCO) on Thursday. Dr. Reddy’s Laboratories had given a proposal to DCGI. In this, there was a demand for market authorization of Sputnik Light. For this, the data of Phase 1 and 2 trials conducted in Russia and the protocol for conducting Phase 3 clinical trials in India were presented.

The subject expert committee of CDSCO considered this application. Thereafter, the committee recommended that the firm should submit the safety and efficacy data of Phase-3 trial of Sputnik Lite for market authorization of the vaccine. This trial has taken place in Russia but, its data has not been given.

Sputnik Light 79.4% Effective Russia’s Sputnik V is being used in 60 countries of the world except Europe and America. Moscow’s Gamleya Research Institute, which made Sputnik V, has developed a single-dose vaccine called Sputnik Lite. It is 79.4% effective in fighting corona infection.

Effective on all strains of Corona
7000 people have been included in the Phase-3 trial of this vaccine. Trials took place in Russia, UAE and Ghana. Its data was analyzed after 28 days. The results found that this vaccine is effective against all new strains of the virus. Its data is showing that it is more effective than many other double dose vaccines.

Sputnik Light is so special…

  • Its overall efficiency is 79.4%. In 100% of people who received the vaccine, antibodies increased up to 40-fold after 10 days.
  • All those who received the vaccine developed an immune response against the S-protein of the corona virus.
  • Due to the single dose of this vaccine, the vaccination rate can be increased in countries with large populations.
  • Sputnik Light can be stored at 2 to 8 degree temperature. This will make it easier to transport.
  • People who have had corona infection before, this vaccine is also effective on them.
  • After getting the vaccine, the risk of serious effects of corona will be reduced. In most cases, the patient will not need to be hospitalized.

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