NEW DELHI, Sept 16 (PTI): The Russian Direct Investment Fund is collaborating with Indian pharma giant Dr Reddy’s Laboratories to conduct clinical trials of the Sputnik V vaccine against COVID-19 as well as its distribution, RDIF CEO Kirill Dmitriev said on Wednesday.
The RDIF is in talks with Indian regulators to ensure that all the requirements for clinical trials are being met, he said.
“The RDIF and Dr Reddy’s Laboratories Ltd, a global pharmaceutical company with headquarters in India, have agreed to supply 100 million doses of the Russian Sputnik V vaccine and collaborate on clinical trials and distribution of the vaccine in India,” Dmitriev told PTI in an email interview.
The deliveries could begin as early as November 2020 after the registration of the vaccine by regulatory authorities in India if all goes well, the RDIF chief said. This is subject to successful trials and the regulator’s approval.
An RDIF official said Phase 3 trials will be conducted in India and an announcement on this is expected soon.
The Russian sovereign wealth fund also issued a statement quoting G V Prasad, co-chairperson and managing director of Dr Reddy’s Laboratories as saying, “We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II results have shown promise, and we will be conducting Phase-III trials in India to meet the requirements of the Indian regulators.
Sputnik V vaccine, he said, could provide a “credible option” in the fight against COVID 19 in India.
The Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and RDIF.
It uses a two-vector technology. It does not contain live human adenoviruses, but human adenoviral vectors, or genetically modified viruses, which are unable to reproduce and are completely safe, Dmitriev said.
Through the use of two different vectors – based on human adenovirus serotypes Ad5 and Ad26 – in two separate shots, it is possible to achieve a more effective immune response, Dmitriev said.
He said additional clinical studies of Sputnik V will be conducted in several countries, including Brazil, India, Saudi Arabia, Egypt, United Arab Emirates (UAE) and Belarus.
Unlike western companies, Dmitriev added, RDIF will not require the inclusion of clauses on legal protection against possible negative consequences of the vaccine when working with India and other partners.
“We are confident in the safety and validity of the human adenovirus platform. Our Indian partners have opted for a guaranteed safe and efficacious vaccine, understanding the benefits of human adenoviral vector technology.
“We are also in talks with India’s regulators to ensure that all the requirements for clinical trials are being met,” Dmitriev added.
Russia, he said, is well aware of Indian companies’ excellence in drug manufacturing and considers it an important asset in its plans to scale up Sputnik V production worldwide.
Apart from Dr Reddy’s Laboratories in India, the RDIF has signed supply agreements with Mexico’s Landsteiner Scientific for 32 million doses and with Bahia state in Brazil for up to 50 million doses, Dmitriev disclosed.
Earlier this month, a research paper on the results of Phase 1 and Phase 2 clinical trials of the Sputnik V vaccine was published in The Lancet, demonstrating no serious adverse effects and a stable immune response in participants.
Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are going on. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020, the RDIF said in its statement.
Dmitriev said Phase 1 and 2 of the Sputnik V trial had 76 participants.
“It seems smaller in size compared to 1,077 people that, for example, AstraZeneca (the Oxford vaccine) had in its Phase 1-2 studies. However, the design of the Sputnik V trial was much more efficient and based on better assumptions,” he said.
Vaccine testing typically begins with lab and animal model studies before going on to different stages of human trials.
The human testing phase comprises many phases.
Phase 1 trials are small-scale, usually involving a few participants, to assess whether the vaccine is safe for humans.
Phase 2 trials often involve several hundred subjects, and mainly evaluate the efficacy of the vaccine against the disease.
The final, Phase 3, involves thousands of people to further assess the efficacy of the vaccine over a defined period of time, and can last several months.