Russia to roll out COVID-19 vaccine for civilian use before WHO approval, Phase III trials

Russian state media has reported that Sputnik V, the ‘first registered COVID-19 vaccine’ in the world was released for public distribution on Monday, 7 September 2020 to the country’s population. Developed by the Russian Gamaleya National Research Center of Epidemiology and Microbiology under Russia’s Ministry of Health of Russia, the vaccine was launched on 11 August. The first batch of the Gam-COVID-Vac (Sputnik V) vaccine against COVID-19 has passed the necessary quality tests in the laboratories of Roszdravnadzor (medical device regulator) and has been released into civil circulation, the Health Ministry said, as per a report by Sputnik News. “[The vaccine] examination is to begin within days… There is a certain procedure of authorizing a batch for civilian use. It must pass the quality check of the medical watchdog Roszdravnadzor,” Denis Logunov, director for research at Gamaleya Institute and the associate member of the Russian Academy of Sciences said, as per a  TASS report on 3 September. “….between 10-13 September, we are to obtain permission to release a batch of the vaccine for civilian use. Respectively, from that moment on the population will begin to be vaccinated,” he added. The Health Ministry will overlook the distribution of the vaccine, and as per the Russian Health Minister Mikhail Murashko, those groups most at-risk for COVID-19 – medics and teachers – will be vaccinated first. “The vaccine’s registration allows for vaccinating the whole population, but the high-risk groups will come first. There are no restrictions as far as others are concerned, but the Health Ministry has set a task of protecting the risk groups in the first place,” Logunov said. While Phase I and II of the clinical trials for the vaccine have been completed, phase III is still pending. Russia only conducted the trials on 38 participants, who were followed for two months, which experts believe is a far too small number for a study. The World Health Organization has also yet to approve the vaccine for human use. WHO spokesperson Tarik Jasarevic said that “Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory,” which for Russia is the  Roszdravnadzor. But Jasarevic added that “WHO has in place a process of pre-qualification for vaccines but also for medicines. Manufacturers ask to have the WHO pre-qualification because it is a sort of stamp of quality. To get this, there is a review and assessment of all required safety and efficacy data that are gathered through the clinical trials. WHO will do this for any candidate vaccine.” With regard to the third phase of the clinical trials, the head of the Russian Direct Investment Fund (RDIF) **Kirill Dmitriev said that**  clinical trials for phase III will begin in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil in September and will include 40,000 participants. Russian officials are in close contact with the Indian government and leading drug manufactures in India, to begin localized production of its Sputnik V vaccine in India. Dmitriev told ANI in an interview that Russia and India are already in talks about the production of the Sputnik V vaccine to meet the demand for the vaccine in India as well as in other countries. Dmitriev told CNBT TV18 that if all goes well, Russia could start delivering COVID-19 vaccine from November this year, with some 30 crore doses produced in India.