NEW DELHI The Russian Direct Investment Fund (RDIF) has signed a pact with Delhi-based pharmaceutical company Mankind Pharma for the marketing and distribution of its Sputnik V vaccine, two sources with knowledge of the matter said.
“It depends on how many doses you give to humanity. RDIF has deals with Russian and Korean manufacturers for around 50 million doses so far. Discussions are also taking place with Indian manufacturers. Humanity will receive the doses once the approvals are in place and the doses are supplied, “said one of the sources, adding that a formal announcement is likely to be made later this week.
Queries sent to Mankind Pharma received no response at the time of publication. A spokesperson for RDIF declined to comment on the development.
The agreement with Mankind Pharma is expected to complement that of Dr Reddy’s Laboratories, but unlike Dr Reddy’s, Mankind will not conduct clinical trials. Last month, Dr. Reddy’s and RDIF, Russia’s sovereign wealth fund, partnered to conduct clinical trials of the Sputnik V vaccine and its distribution in India. Under the pact, RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s following regulatory approval in India.
The new partnerships follow an announcement by Dr. Reddy’s on Saturday that they have received approval from Controller General of Drugs of India (DCGI) VG Somani to conduct an adaptive phase 2 and 3 clinical trial for Sputnik V vaccine in India .
The multicenter randomized controlled trial will study the safety and immunogenicity of the vaccine, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology of Russia, in the Indian population.
Dr. Reddy’s, however, did not elaborate on how many participants he plans to enroll and at how many sites.
Dr. Reddy’s and RDIF initially planned to conduct only one phase 3 trial of the vaccine, but the subject matter expert committee (SEC) of the Central Drug Standards Control Organization (CDSCO) asked Dr. Reddy’s to will run Phase 2 and 3 clinical trials smoothly in India. rather than just a phase 3 study, because safety and immunogenicity data from phase I / II studies abroad were small and no data was available on Indian subjects.
Gamaleya had conducted phase 1 and 2 trials in Russia of just 76 patients, in which the vaccine was shown to induce a strong immune response among participants. The study was published in The Lancet, a peer-reviewed journal, last month.
DCGI had asked the company to adequately monitor the humoral and cell-mediated immune response during the trial. While the humoral immune response includes the immunity provided by antibodies, the 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 in a phase 3 clinical trial in Russia, and the developers plan to enroll 40,000 participants. The phase 3 trial of the vaccine also started in the UAE last week.
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