India will produce over 100 million doses a year of Russia’s coronavirus disease (Covid-19) vaccine Sputnik V beginning 2021 following an agreement between the Russian Direct Investment Fund (RDIF) and Hyderabad-based Hetero Biopharma, according to Dr Alexander Gintsburg, director general of the Gamaleya Research Institute, Moscow.
Sputnik V is based on a well-studied platform of human adenoviral vectors and has demonstrated a 91.4% efficacy rate, according to the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase 3 clinical trials in Russia’s history involving 40,000 volunteers. The results were announced by the Gamaleya Institute and RDIF on November 24.
Phase 3 clinical trials of the vaccine are approved and ongoing in Belarus, the UAE, Venezuela and other countries, and Phase 2/3 have been approved in India. India, along with Brazil, China, South Korea and others, will provide the vaccine to at least 50 countries that have requested over 1.2 billion doses.
“An application has been submitted by RDIF to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of Sputnik V,” Dr Gintsburg said in an email interview with HT. The WHO’s EUL procedure streamlines approvals for the global use of new or unlicensed products during public health emergencies.
“There is 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. While we work towards rolling out a safe vaccine, we must continue the essential public health actions to suppress transmission and reduce mortality,” said Dr Poonam Khetrapal Singh, regional director, WHO South East Asia.
The EUL procedure for the Oxford University-AstraZeneca vaccine has begun. “WHO has had several discussions with Astra following the expression of interest that WHO issued for emergency use listing and prequalification of vaccines. We will receive more clinical data in the coming weeks. There are eight sites – some are manufacturing sites – and we will be analysing the data carefully. We expect to finalise assessments beginning of next year,” said Dr Singh.
Sputnik V is a human adenovirus-based vaccine candidate and the only late-stage adenovirus-based Covid-19 vaccine candidate to use two different vectors for different injections, human adenovirus types Ad5 and Ad26.
In vaccines that use the same vector in both injections, the immune system may launch defence mechanisms against the second one making the vaccine less effective.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has been proven safe and effective with no long-term side effects in more than 250 global clinical trials over the past two decades. Sputnik V uses two different human adenoviral vectors that have been genetically modified not to cause infection to trigger a stronger and longer-term immune response as compared to the vaccines using one or the same vector for two doses.
“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,” said B Murali Krishna Reddy, director, international marketing, Hetero Labs Limited, in a statement.
“While there are many challenges to come beyond vaccine introduction, vaccination is the best opportunity we have to halt the transmission of Covid-19 and minimise its associated morbidity and mortality. Based on the currently available evidence, Sputnik V can play a role in the global fight against Covid-19,” said Dr Gintsburg, on email.
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