Single-Dose Sputnik Light Approved for Phase 3 Transition Trials in India

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Sputnik Light has received approval from the Comptroller General of Medicines of India.

New Delhi:

Single Dose COVID-19 Vaccine Sputnik Light Today Received Approval From The Subject Matter Expert Committee (SEC) Of The Comptroller General Of Drugs Of India (DCGI) To Conduct Phase 3 Transition Trials in India.

Last year, Dr Reddy’s laboratories, based in Hyderabad, partnered with the Russian Direct Investment Fund (RDIF) to conduct Phase 3 trials of the vaccine. After the company submitted data on safety, immunogenicity and efficacy, the SEC authorized the trials to be conducted in India, according to a statement from the Central Drugs Standard Control Organization.

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“The committee noted that the company has now presented the safety and immunogenicity as well as longevity of antibodies, which provides a measure of the persistence of antibodies in participants,” the statement added.

In May, Dr Reddy’s CEO Deepak Sapra told The Bharat Express News the company would have talks with the government and the regulator in June for an immediate launch. But in July, the expert committee refused to grant an emergency use authorization for Sputnik Light, ruling out third-phase trials of the vaccine developed by the Russian institute Gamaleya. The committee said it had found no “scientific justification” for conducting the trials.

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According to the makers of Sputnik Light, the vaccine was shown to be 79.4% effective. If the vaccine is approved in India, Sputnik Light could be the first single-dose vaccine to be used in the country.

In Russia, the vaccine has been approved for people over 60 years old. The pharmaceutical company said the vaccine does not cause serious side effects.

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