Dr. Reddy's Denied Permission To Conduct Phase 3 Trial Of Single-Dose Sputnik Light Vaccine In India: Sources

After launching Sputnik V, Russia introduced its new single-dose COVID vaccine called Sputnik Light in May. It is yet to be approved by the European Medicines Agency (EMA) and the US FDA.

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New Delhi: The Central government's Subject Expert Committee (SEC) denied permission to Dr. Reddy's Laboratories for conducting Phase 3 trials of Sputnik Light in India, news agency ANI credited sources as informing.

Sputnik Light is developed by the Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology, and the Russian Direct Investment Fund (RDIF).

"The SEC has denied permission to Dr. Reddy's to conduct phase-3 trials on the Russian vaccine Sputnik Light in India," sources told ANI.

After launching Sputnik V, Russia introduced its new single-dose COVID vaccine called Sputnik Light in May. The RDIF had earlier said that the Russian Sputnik Light vaccine demonstrates 78.6 percent to 83.7 percent efficacy among the elderly, according to real-world data collected by the Ministry of Health of the Buenos Aires province (Argentina).

It is also yet to be approved by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA).

Besides Sputnik Light, Serum Institute of India (SII) too had to face a disappointing development as an expert panel of the central drug authority recommended against granting permission to conduct the phase 2/3 trial of Covovax vaccine on children aged two to 17 years.

The SII had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country," a source said, as quoted by PTI.

The SII has been asked to submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials on children, it was reported.

It was announced last month that NVX-CoV2373 demonstrated 100 percent protection against moderate and severe disease, and 90.4 percent overall efficacy, in its Phase 3 trial.

Meanwhile, Indraprastha Apollo in Delhi began administering the Sputnik V vaccine for beneficiaries in a staged manner from June 30. As of Thursday, around 1000 persons have been administered the said vaccine, Indraprastha Apollo stated,

The spot registration and walk-in facility for the Russian vaccine are currently restricted and beneficiaries are urged to register and make appointments through the CoWIN app for the same.