The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) is likely to meet sometime this week to consider the emergency use application of the Russian coronavirus vaccine Sputnik V, according to officials aware of the matter, who asked not to be named.
An approval to Sputnik V will add a third inoculation to India’s arsenal of vaccines, which could be crucial in the fight against the pandemic at a time when the country is grappling with a resurgence in cases. The dose, made by the Gamaleya Research Institute, is 91.6% effective in preventing Covid-19, according to clinical trial findings.
“The committee looking into Covid related application could convene any time this week,” said an official in the know of things. During the last meeting on the matter, the experts asked for safety and immunogenicity data from Sputnik V’s phase II/III trials being conducted in India.
Sputnik V’s backers, the Russian Direct Investment Fund (RDIF), has tied up with five India-based pharma companies for production. The latest of these deals was announced on Monday. Virchow Biotech will produce 200 million doses, the RDIF announced.
“Vaccine partnerships are the only way to overcome the pandemic. The world continues its fight against coronavirus and we see a growing interest in Sputnik V vaccine as it is one of the most efficient vaccines available. The agreement with Virchow Biotech is an important step to facilitate the full-scale local production of the vaccine in India and to supply our international partners globally,” said Kirill Dmitriev, chief executive officer f the Russian Direct Investment Fund (RDIF).
{{/usCountry}}“Vaccine partnerships are the only way to overcome the pandemic. The world continues its fight against coronavirus and we see a growing interest in Sputnik V vaccine as it is one of the most efficient vaccines available. The agreement with Virchow Biotech is an important step to facilitate the full-scale local production of the vaccine in India and to supply our international partners globally,” said Kirill Dmitriev, chief executive officer f the Russian Direct Investment Fund (RDIF).
{{/usCountry}}Virchow indicated the production is likely to be for “international partners” of RDIF. “The technology transfer is expected to be completed in the Q2 of 2021 followed by full-scale commercial production of Sputnik V. Virchow Biotech capacities will help facilitate global supply of Sputnik V to international partners of RDIF,” the statement read.
Tummuru Murali, managing director of Virchow Biotech, said, “We are glad to sign a cooperation agreement with RDIF to produce the Sputnik V coronavirus vaccine. Virchow’s proven capabilities in large scale drug substance manufacturing should help meet the global demand for this vaccine. We are also happy to learn of the positive feedback that this vaccine has been receiving from all сountries.”
On Friday, RDIF announced its partnership with Stelis Biopharma, the biopharmaceutical division of Strides, a global pharmaceutical company headquartered in India, to produce and supply a minimum of 200 million vaccine doses.