Russia on Tuesday said its Sputnik V coronavirus vaccine was 95% effective and would be cheaper and easier to store than some alternatives, as the global race heats up to develop a shot, even as some experts raised questions over the low number of cases reviewed.
The vaccine will cost less than $10 a dose and be available in international markets from February 2021, said its developer Gamaleya Center and the Russian Direct Investment Fund, the latest in a flurry of breakthroughs as several vaccine makers worldwide published preliminary data showing high efficacy rates in the last three weeks.
Countries are hoping to begin inoculating their populations by year’s end or in early 2021 to stop a pandemic that has claimed the lives of nearly 1.4 million people.
In statement on Tuesday, the vaccine’s developers said preliminary data after trials involving thousands of volunteers showed “an efficacy of the vaccine above 95%” after a second dose.
“We are ready to start deliveries of Sputnik V to foreign markets, thanks to partnerships with manufacturers in India, Brazil, South Korea, China and four other countries,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) that has invested in production and promotion of the vaccine, told a virtual news conference..
Russia was one of the first to announce the development of a vaccine in August — dubbed Sputnik V after the Soviet-era satellite — but before the start of final clinical trials.
The interim clinical trial data – Tuesday’s was the second when the trial hit 39 infections — has found no unexpected adverse events during the trials and the monitoring of the participants is ongoing. The interim data will be published in a peer-reviewed international medical journal following the completion of Phase 3 trials.
Russian citizens will be vaccinated free. “Sputnik V is now available for civil use in Russia, specifically for high-risk groups. Following the completion of the current Phase III trial, the ultimate goal is to voluntarily vaccinate approximately 70% of the population to end the pandemic in Russia. To this end, Russia is launching mass production of Gam-COVID-Vac using multiple production sites within the country,” said Dr Alexander Gintsburg, director general of the Gamaleya Scientific Research Institute, Moscow, in an email interview.
India is set to begin adaptive Phase 2/3 clinical trials this week following a partnership between Hyderabad-based Dr Reddy’s Laboratories and RDIF in September. As part of the partnership, RDIF is supplying 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
Experts said the initial data appeared promising. “All the vaccines – whether mRNA or adenoviral – are looking promising from initial data. The most important part will be ability to prevent severe cases, deaths and ability to block asymptomatic infections to prevent transmission. This will be known better as we look deeper and wait longer to see how long the protection lasts,” said Dr Anurag Agrawal, director of the Institute of Genomics and Integrative Biology, New Delhi.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform – similar to the Oxford-AstraZeneca vaccine — that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally during the past two decades. It uses two different human adenoviral vectors that allows for a stronger and longer-term immune response as compared to the vaccines using one or the same vector for two doses, the Gamaleya Institute said.
“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 defense mechanisms against the second one making the vaccine less effective,” said Gintsburg.
The vaccine can be stored at between two and eight degrees Celsius, they develop said, referring to a freeze-dried formulation that will also be rolled out.
Pharma giants Pfizer and BioNTech announced that their virus vaccine is 95% effective, while US company Moderna said last week early results showed its candidate was 94.5 percent effective. On Monday, Oxford-AstraZeneca announced their candidate too was up to 90% effective.
Western experts have in the past expressed concern over Russia’s vaccine, fearing that its development could be rushed.
“Over 50 countries have expressed interest in obtaining Sputnik V based on its currently known safety and efficacy profile, with preliminary applications already received for over 1.2 billion doses. RDIF has already announced several agreements with partners from India, Mexico, Brazil, Nepal, and Uzbekistan,” said Dr Gintsburg.
Under current agreements, Sputnik V vaccine to be produced in India, Brazil, China, South Korea and other countries, for 500 million people per year, starting from 2021.
The first international deliveries of the Russian Sputnik V vaccine will be made in January 2021 based on the existing partnerships with foreign manufacturers, said RDIF.