Russian Direct Investment Fund (RDIF) and leading pharmaceutical company Dr. Reddy’s have agreed to cooperate on clinical trials and supply of 100 million doses of the COVID-19 vaccine candidate, Sputnik V, to India. Russia’s sovereign wealth fund announced on September 16 that the delivery of vaccine could start in late 2020 subject to successful clinal trials and regulatory approval from Indian authorities.
RDIF CEO Kirill Dmitriev expressed delight over the agreement with Dr. Reddy’s, saying the partners will receive an effective and safe vaccine to combat coronavirus. Dmitriev said in a statement that Sputnik V will provide India with a safe and scientifically proven tool to fight the coronavirus.
“The human adenoviral vector platform, which is at the heart of the Russian vaccine, has been validated in more than 250 clinical studies over decades and has been found to be safe and free of potential negative long-term effects,” the statement read.
Preliminary results from two early-phase non-randomised trials of Sputnik V showed no major side effects over 42 days and induce antibody responses within 21 days, said the study published in The Lancet earlier this month. The leading peer-reviewed medical journal said that the doctors conducted trials for the two-part vaccine which contains a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector.
The primary outcome measures for the trials were safety and immunogenicity of the potential COVID-19 vaccine and the secondary outcome measures were antigen-specific cellular immunity, also known as T-cell responses, and change in neutralising antibodies. Secondary outcomes from the trial suggested that the vaccines also produce a T cell and neutralising antibody response within 28 days.
“We are delighted to partner with RDIF to supply vaccines to India. The results from Phase 1 and 2 clinical trials have been encouraging and we will begin Phase 3 trials in India to meet the country's regulatory requirements,” G.V. Prasad, co-chairman and managing director of Dr. Reddy’s, said in a statement.