Home >News >India >Dr Reddy’s, RDIF get DCGI approval for Sputnik V vaccine clinical trial in India
The Subject Expert Committee (SEC) on COVID-19 at the CDSCO has asked Dr Reddy's to submit a revised protocol stating it will have to conduct combined phase 2 and 3 clinical trials of the Sputnik V vaccine.
The Subject Expert Committee (SEC) on COVID-19 at the CDSCO has asked Dr Reddy's to submit a revised protocol stating it will have to conduct combined phase 2 and 3 clinical trials of the Sputnik V vaccine.

Dr Reddy’s, RDIF get DCGI approval for Sputnik V vaccine clinical trial in India

  • The multi-centre, randomised controlled trial will study the safety and immunogenicity of the vaccine developed in Russia
  • Dr Reddy’s and RDIF, Russia’s sovereign wealth fund, had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India

NEW DELHI: Dr Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF) on Saturday announced that they have received an approval from the Drug Controller General of India (DCGI) VG Somani to conduct an adaptive phase 2 and 3 clinical trial for the Sputnik V vaccine in India.

The multi-centre, randomised controlled trial will study the safety and immunogenicity of the vaccine, developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, in the Indian population.

Dr Reddy’s, however, did not give details on how many participants it plans to enroll and across how many sites.

Last month, Dr Reddy’s and RDIF, Russia’s sovereign wealth fund, had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. Under the pact, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.

However, so far, the sovereign wealth fund has not signed a pact for manufacturing of the vaccine in India and are in talks with several Indian vaccine makers for production.

“We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India," RDIF chief executive officer Kirill Dmitriev said in a statement.

Dr Reddy’s and RDIF initially planned to conduct only a phase 3 trial of the vaccine, but the subject expert committee (SEC) of the Central Drugs Standards Control Organization (CDSCO) asked Dr Reddy’s to conduct seamless Phase 2 and 3 clinical trials in India, instead of just a phase 3 study, because the safety and immunogenicity data in overseas phase I/II studies was small and there was no data available on Indian subjects.

Gamaleya had conducted phase 1 and 2 trials in Russia of only 76 patients, wherein the vaccine was shown to induce strong immune response among the participants. The study was published in The Lancet, a peer-reviewed journal, last month.

The DCGI had asked the company to conduct proper monitoring for humoral and cell mediated immune response during the trial. While humoral immune response includes immunity provided by antibodies, cell-mediated response refers to that provided by T-cells.

The Sputnik V vaccine is the world’s first registered vaccine against covid-19 based on the human adenoviral vector platform. It is currently undergoing phase 3 clinical trial in Russia, with the developers planning to enroll 40,000 participants. Phase 3 trial for the vaccine was also started in the UAE last week.

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