NEW DELHI: Russia on Wednesday announced its partnership with Hyderabad-based Dr Reddy’s Laboratories for clinical trials and distribution of its Covid-19 vaccine 'Sputnik V' in India by the year-end.
Under the plan, the Russian Direct Investment Fund (RDIF), which is leading the Covid-19 vaccine project in India, will supply 10 crore doses to Dr Reddy’s upon regulatory approval.
“Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” said a joint statement by the RDIF and Dr Reddy’s.
G V Prasad, Co-Chairman and Managing Director of Dr Reddy’s said that the company will be conducting Phase-III trials in the country to meet the requirements of the Indian regulators. “Sputnik V vaccine could provide a credible option in our fight against Covid- 19 in India,” he said.
Significantly, the development comes days after Union Health Minister Harsh Vardhan said that the government is considering emergency use authorisation of Covid-19 vaccine in India, particularly for senior citizens and people working in high-risk settings.
Sputnik V was found to be safe and effective on a small group of volunteers in Russia in phase 1 and 2 trials, as per a paper recently published in the Lancet. The vaccine candidate is currently under phase 3 trials involving 40,000 individuals.
CEO of the RDIF Kirill Dmitriev said that as India is amongst the most severely Covid-affected countries, the Russian human adenovirus dual vector platform could provide a safe and scientifically validated option to the country in the battle against the pandemic.
“The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”
Sources in the RDIF said that it was planning to approach the Central Drugs Standards Control Organisation shortly to begin late-stage trials in the country, and added that it is also in talks with several other Indian vaccine-makers for large-scale productions.
The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the ministry of health of Russia on August 11 and became the world’s first registered vaccine against Covid-19.
RDIF said that more than 55,000 volunteers have applied to take part in post-registration trials and the first results of these trials are expected to be published in October-November.