The medical trials of Sputnik V vaccine for coronavirus shall be held this month in a number of international locations together with India, confirmed Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) on Monday.
Dmitriev instructed Sputnik that the medical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will start this month.
“The post-registration studies involving more than 40,000 people started in Russia on August 26, before AstraZeneca has started its Phase 3 trial in the US with 30,000 participants. Clinical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month. The preliminary results of the Phase 3 trial will be published in October-November 2020,” mentioned Dmitriev.
Russia was in shut dialogue with the Indian authorities and the main drug manufactures of India concerning the localization of manufacturing of Sputnik V vaccine in India.
On August 11, the Sputnik V vaccine developed collectively by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and have become the world’s first registered vaccine towards COVID-19.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine which fights towards coronavirus illness.
“India has historically been a very important partner of Russia. India is one of the leading countries in production. Around 60 percent of all the vaccines in the world are produced in India. We are in close dialogue with the corresponding ministries and the India government and the leading manufacturer of the country regarding localisation of production of Sputnik V vaccine in India. And we have achieved certain agreements with the leading companies,” Dmitriev mentioned earlier in response to an ANI question on the talks between India and the Russian authorities on Sputnik V vaccine.
“We do recognise India and it’s potential to become one of the support for the production of the vaccine not only in Indian markets but for other countries too. We very much appreciate the well- balanced approach expressed by the Indian partners as from the very beginning they started asking questions how our vaccine works and we appreciate it that they did not try to attack our vaccine but try to understand it,” Dmitriev including that their (India’s) want to know our vaccine obtained to comprehend that their strategy primarily based on the human adenoviral vaccine platform is essentially the most cheap strategy.
On September 4, a medical journal The Lancet has printed the outcomes of medical trials of Phase I-II of the Russian vaccine demonstrating its security and efficacy.
“Phase I-II clinical trials of Sputnik V showed no serious adverse events (SAE, Grade 3) for any of the criteria, while the incidence of serious adverse events for other candidate vaccines ranged from 1 per cent to 25 per cent,” RDIF press observe said.
“In 100 per cent of participants in the clinical trials, Sputnik V generated a stable humoral and cellular immune response. The level of virus-neutralizing antibodies of volunteers vaccinated with Sputnik V was 1.4-1.5 times higher than the level of antibodies of patients who had recovered from COVID-19,” RDIF press observe additional learn.