Mysteriet med det ryska vaccinet är nu klarlagt Man har inte godkänt något vaccin för allmän användning. Det ryska vaccinet ska nu gå igenom fas III-tester i vederbörlig ordning och har erhållit certifiering för det. Vad man också har fått tillstånd till är att under undantagslagar som råder under coronapandemin att få vaccinera ett litet urval personer i utsatta riskgrupper:
Russia’s approval of a COVID-19 vaccine is less than meets the press release
Här är från tillverkarens webbsida:
Russia’s approval of a COVID-19 vaccine is less than meets the press release
In a startling and confusing move, Russia claimed today it had approved the world’s first COVID-19 vaccine, as the nation’s Ministry of Health issued what’s called a registration certificate for a vaccine candidate that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to “a small number of citizens from vulnerable groups,” including medical staff and the elderly, a Ministry of Health spokesperson tells ScienceInsider. But the certificate stipulates that the vaccine cannot be used widely until 1 January 2021, presumably after larger clinical trials have been completed.https://www.sciencemag.org/news/2020/08/russia-s-approval-covid-19-vaccine-less-meets-press-release
Här är från tillverkarens webbsida:
CLINICAL TRIALShttps://sputnikvaccine.com/about-vaccine/clinical-trials/
Before the start, of clinical trials the vaccine had gone through all stages of pre-clinical trials with experiments on different types of animals, including 2 types of primates.
Phase 1 and 2 clinical trials of the vaccine have been completed on August 1, 2020. All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine. The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including an analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.
Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) will start on August 12. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to start in September 2020.
The unique substance of the Sputnik V and method of using it has a patent protection in Russia, obtained by Gamaleya National Research Institute of Epidemiology and Microbiology.
