Pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE:500124) (NYSE:RDY) and Russia's sovereign wealth fund Russian Direct Investment Fund (RDIF) Saturday jointly announced the receipt of approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.
The multi-centre and randomized controlled study of Sputnik V vaccine will include a safety and immunogenicity study. RDIF shall supply 100m doses of the vaccine to Dr. Reddy's upon regulatory approval in India.
On 11 August 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform.
Currently, the Sputnik V is undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week, concluded the companies.
Virbac expands presence in Japan with Sasaeah acquisition
Pfizer reveals strong efficacy data for ABRYSVO in older adults against RSV
US CDC advisory committee backs Valneva's chikungunya vaccine
Takeda and Biological E. Limited join forces to combat global dengue threat
SK bioscience 'SKYTyphoid' receives WHO prequalification certification
ImmunityBio advances cancer vaccine trial for Lynch syndrome participants
AstraZeneca boosts vaccine portfolio with acquisition of Icosavax
Ultimovacs gains EMA Orphan Drug status for UV1 cancer vaccine in mesothelioma