India to produce 100 million Sputnik V doses starting 2021
India will produce over 100 million doses a year of the Russian COVID-19 vaccine Sputnik V starting 2021, under an agreement between the Russian Direct Investment Fund (RDIF) and Hyderabad-based Hetero Biopharma, Hindustan Times reported. The RDIF and the Gamaleya National Center of Epidemiology and Microbiology have jointly developed the vaccine, which has been found to have an efficacy of at least 91.4%.
B. Murali Krishna Reddy, Hetero Labs Limited Director (International Marketing), told HT, "While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients." "This collaboration is another step towards our commitment in the battle against COVID-19 and realizing the objective of the 'Make-in-India' campaign," Reddy said.
Further, an application has been submitted by RDIF to the World Health Organization (WHO) for Emergency Use Listing (EUL) and prequalification of Sputnik V, HT quoted the Gamaleya institute's Director General Alexander Gintsburg as saying. EUL streamlines the process to allow the use of new or unlicensed products during public health emergencies. Incidentally, the EUL procedure for the Oxford-AstraZeneca's vaccine has begun.
Dr. Poonam Khetrapal Singh, WHO's regional director for Southeast Asia, said, "There's now real hope that vaccines—in combination with other tried and tested public health measures—will help to end the pandemic." "The urgency with which vaccines have been developed must be matched by the same urgency to distribute them fairly," she said, stressing the importance of continued actions to reduce transmission and mortality.
Sputnik V—the world's first registered vaccine COVID-19—is an adenoviral vaccine, which uses two adenovirus vectors (rAd26 and rAd5). Among the leading vaccine candidates, Sputnik V is the only one using two different vectors for different shots. With vaccines that use the same vector for both shots, the immune system's defense mechanism may be triggered for the second dose, making the vaccine less effective.
The vaccine is undergoing Phase III clinical trials in Belarus, the UAE, Venezuela, etc. In India, Phase II/III combined trials have been approved. Earlier this week, a second interim analysis of the vaccine's trials involving 40,000 participants was released, finding the vaccine safe and effective. The vaccine was found 91.4% effective seven days after the second dose and over 95% effective 14 days later.