The Russian Direct Investment Fund (RDIF) has recently signed a pact with the Dr. Reddy’s laboratory, India for the manufacture and distribution of over 100 million doses of the COVID-19 vaccine named Sputnik V developed by Russia.
The human adenovirus-based vaccine candidate is currently undergoing phase 3 trials, and its distribution in India is subject to regulatory approval.
“The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.”the RDIF said in a statement.
Sputnik V is a viral two-vector vaccine based on the human adenovirus or the common cold virus that is fused with the spike protein of SARS-CoV-2 to stimulate an immune response. The recombinant adenovirus type-5 (Ad5) and adenovirus type-26 (Ad26) were both used as vectors in the vaccine. The Ad26 based vaccine is recommended to be used initially and the Ad5 vaccine has to be used on the 21st day to boost response.
The vaccine candidate was developed by the Gamaleya Research Institute of Epidemiology and Microbiology, and registered on 11 August 2020 by the Russian Ministry of Health. It was approved for distribution in Russia, even before phase 3 had started despite having been tested only in a small number of people in early-stage clinical trials that lasted two months, which is unlike a standard clinical trial that took a year or more of clinical assessment for proof of vaccine safety and efficacy against the disease.
The studies from phase 1 and phase 2 of the vaccine candidate concluded to be safe and to have produced immune response even though the trial was only conducted in 76 participants. The findings are published in the journal The Lancet.