The vaccine is named after the first Soviet space satellite. The lowest age participants were 18 years old. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries. Sputnik V is one of the three vaccines in the world with efficacy of over 90%. [153] On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V.[154] The EU applicant is R-Pharm Germany GmbH. Sinopharm Group Ltd. alongside the three shots cleared by Europe’s drug regulator -- from . "[54], According to preliminary review by experts,[who?] [61], In the beginning of December 2020, Russian authorities announced the start of a large-scale free of charge vaccination with Gam-COVID-Vac for Russian citizens: the "immunization" program was launched on 5 December 2020 (with 70 Moscow-based medical centers providing vaccinations). The vaccine is named after the first Soviet space satellite. Sputnik V’s efficacy was validated by internationally peer reviewed data published in The Lancet. Sputnik V has not yet been approved for use in the EU, but the body's regulator, the European Medicines Agency, or EMA, started a rolling review of the vaccine last week. [154], Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories,[155] and Mexico. The announcement came in a time of acute vaccine shortages in Europe while the Sputnik V vaccine was still under review by the European Medicines Agency. [9], Emergency mass-distribution of the vaccine began in December 2020 in multiple countries including Russia, Argentina, Belarus, Hungary, Serbia and the United Arab Emirates. [146] On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Gulf region. [9][31], On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm have signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine developed by the Gamaleya Center, and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford. 1.2k. By that moment, the Russian Federation has already received applications from 20 countries for the supply of 1 billion doses of vaccine. The state registration of the vaccine was carried out "conditionally" with post-marketing measures according to the decree of the Government of the Russian Federation. Human adenoviruses are considered as some of the easiest to engineer in this way and therefore they have become very popular as vectors. So why is there still Western resistance to it? For the Soviet satellites, see, Russian Ministry of Health image of Gam-COVID-Vac vials, Sputnik–AstraZeneca COVID-19 vaccine trials, Distribution, vaccination and public perception, Gamaleya Research Institute of Epidemiology and Microbiology, randomised, double-blind, placebo-controlled, multi-centre clinical trial, London School of Hygiene and Tropical Medicine, The London School of Hygiene and Tropical Medicine, National Institute of Allergy and Infectious Diseases, Committee for Medicinal Products for Human Use, "Russia's fast-track coronavirus vaccine draws outrage over safety", "Russia's approval of a COVID-19 vaccine is less than meets the press release", "Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia", "Covid-19: Russia approves vaccine without large scale testing or published results", "Scientists worry whether Russia's Sputnik V' coronavirus vaccine is safe and effective", "Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia", "Russia is offering to export hundreds of millions of vaccine doses, but can it deliver? On 10 December, Deputy Prime Minister Tatyana Golikova announced that approximately 6.9 million doses of the Sputnik V vaccine will enter civilian circulation in Russia before the end of February 2021. It will offer less protection than the two-dose versions, but it is still expected to reach an efficacy of 85%. Registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, romanized: Gam-KOVID-Vak),[2][3] Sputnik V is an adenovirus viral vector vaccine. Russia's Sputnik V vaccine could be produced in Europe for the first time.That's after a commercial deal to produce it in Italy was signed by the Moscow-based RDIF sovereign wealth fund, along with Swiss-based pharmaceutical company Adienne.An agreement will need approval from Italian regulators before production can be launched.It is the latest sign that some EU companies don't want … [164], As of March 2021, RDIF has licensed production in India, China, South Korea and Brazil. Working at full capacity, the factory will produce up to 10 million doses a month. [2] On 4 September, data on 76 participants in a phase I–II trial were published, indicating preliminary evidence of safety and an immune response. Share. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19. Gam-COVID-Vac-Lyo was developed especially for vaccine delivery to hard-to-reach regions of Russia. As of February 2021, over a billion doses of the vaccine were ordered for immediate distribution globally. Patients are asked a few general health questions before getting the vaccine. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus. 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