Mankind inks pact for Sputnik V sale in India2 min read . Updated: 19 Oct 2020, 08:25 AM IST
- The pact with Mankind Pharma is expected to supplement the one with Dr Reddy’s Laboratories, but unlike Dr Reddy’s, Mankind will not be conducting the clinical trials
NEW DELHI : Russian Direct Investment Fund (RDIF) has signed a pact with Delhi-based pharmaceutical company Mankind Pharma for marketing and distribution of its Sputnik V vaccine, two sources in the know of the matter said.
“It depends on how many doses they will give Mankind. RDIF has pacts with Russian and Korean manufacturers for around 50 million doses so far. Talks with Indian manufacturers are also ongoing. Mankind will get the doses once the approvals are in place and the doses are supplied," one of the sources said, adding that a formal announcement is likely to be made later this week.
Queries sent to Mankind Pharma were unanswered at the time of publishing. A spokesperson for RDIF decline to comment on the development.
The pact with Mankind Pharma is expected to supplement the one with Dr Reddy’s Laboratories, but unlike Dr Reddy’s, Mankind will not be conducting the clinical trials. Last month, Dr Reddy’s and RDIF, Russia’s sovereign wealth fund, had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. Under the pact, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
The new partnerships comes on the back of an announcement by Dr Reddy’s on Saturday that they have received an approval from the Drug Controller General of India (DCGI) VG Somani to conduct an adaptive phase 2 and 3 clinical trial for the Sputnik V vaccine in India.
The multi-centre, randomised controlled trial will study the safety and immunogenicity of the vaccine, developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, in the Indian population.
Dr Reddy’s, however, did not give details on how many participants it plans to enrol and across how many sites.
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 seamless Phase 2 and 3 clinical trials 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.
Gamaleya had conducted phase 1 and 2 trials 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.
The DCGI had asked the company to conduct proper monitoring for humoral and cell mediated immune response during the trial. While humoral immune response includes immunity provided by antibodies, 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 undergoing phase 3 clinical trial in Russia, with the developers planning to enrol 40,000 participants. Phase 3 trial for the vaccine was also started in the UAE last week.