Sputnik Light: No Need For Phase 3 Trial In India, Dr Reddy's Can Submit Russian Safety Data

COVID-19 Vaccination: The move by Central government's Subject Expert Committee (SEC) can potentially speed up the approval and eventual rollout of single-dose Sputnik Light vaccine in India.

Representative Photo

New Delhi: Dr. Reddy’s on Thursday revealed that the government panel has told the pharma firm that it doesn’t need to conduct Phase 3 trials and only requires to submit Russian safety data for approval in India.

This update comes after reports quoted sources as saying that the Central government's Subject Expert Committee (SEC) had denied permission to Dr. Reddy's Laboratories for conducting Phase 3 trials of Sputnik Light in India.

However, as per the new inputs, the SEC of the Central Drugs Standard Control Organisation (CDSCO) has told Dr. Reddy’s Laboratories that it doesn’t need to do a separate Phase 3 trial of Sputnik Light in India. It only required to submit the Russian Phase 3 immunogenicity, safety, and efficacy data for approval in India.

The move can potentially speed up the approval and eventual rollout of the single-dose Sputnik Light COVID-19 vaccine in the country.

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).

Now, if approved in India, the country will get its first single-dose Coronavirus vaccine with Sputnik Light amid the ongoing vaccination drive.

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.

(With Agency Inputs)