Dr Reddy’s gets DCGI nod to conduct clinical trial for Sputnik V vaccine in India2 min read . Updated: 17 Oct 2020, 04:31 PM IST
- In September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V coronavirus vaccine and its distribution in India
- RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India
New Delhi: Dr. Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, on Saturday announced that they have received approval from the Drug Control General of India (DCGI) to conduct late-stage clinical trials for Sputnik V vaccine in India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.
Earlier in September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.
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 a seamless Phase 2 and 3 clinical trial 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.
Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday, Reuters reported.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “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."
Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates. RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.
On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform.
Gamaleya had conducted a phase 1 and 2 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.
A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.
Interim results are expected to be published in early November.
Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.
Russia has also reached an agreement with the biotechnology department of India's Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.
With inputs from Reuters