Dmitriev said that clinical trials in Saudi Arabia, the United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month.
“Post-registration studies involving more than 40,000 people began in Russia on August 26, before AstraZeneca began its phase 3 trial in the US with 30,000 participants. Clinical trials in Saudi Arabia, United Arab Emirates The United States (UAE), the Philippines, India and Brazil will begin this month. Preliminary results of the phase 3 trial will be published in October-November 2020, “said Dmitriev.
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Russia maintained a close dialogue with the Indian government and the country’s major drug manufacturers regarding the location of Sputnik V vaccine production in India.
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On August 11, the Sputnik V vaccine jointly developed by RDIF and the Gamaleya National Research Center for Epidemiology and Microbiology was registered by the Russian Ministry of Health and became the world’s first registered vaccine against Covid-19.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights the coronavirus disease.
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“India has historically been a very important partner for Russia. India is one of the leading producing countries. About 60 percent of all vaccines in the world are produced in India. We are in close dialogue with the relevant ministries and India’s government and the country’s leading manufacturer regarding the location of Sputnik V vaccine production in India. And we have reached certain agreements with the leading companies, “Dmitriev said earlier in response to an ANI query on the talks. between India and the Russian government on Sputnik Vaccine V.
“We recognize India and its potential to become one of those supporting the production of the vaccine not only in Indian markets but also in other countries. We highly appreciate the balanced approach expressed by the Indian partners. From the beginning they started to do questions about how our vaccine works and we appreciate that they didn’t try to attack our vaccine, they tried to understand it, “said Dmitriev.
On September 4, the medical journal ‘The Lancet’ published the results of the Phase I-II clinical trials of the Russian vaccine demonstrating its safety and efficacy.
“Sputnik V phase I-II clinical trials showed no serious adverse events (SAE, Grade 3) for any of the criteria, while the incidence of serious adverse events for other vaccine candidates ranged from 1% to 25%,” RDIF indicated press release.
“In 100% of the participants in clinical trials, Sputnik V elicited a stable humoral and cellular immune response. The level of virus-neutralizing antibodies in volunteers vaccinated with Sputnik V was 1.4 to 1.5 times higher than the level of antibodies of the patients who had recovered from Covid-19 “, reads the RDIF press release.
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