What are you rich in…
The results of tests of the Russian Covid-19 vaccine were published in The Lancet magazine
Maria Azarova, Naked Science
Prestigious peer-reviewed medical journal The Lancet, founded at the beginning of the XIX century, published the results of the first two stages of testing Sputnik-V, a Russian vaccine against SARS–CoV-2 developed at the N. F. Gamalei National Research Center for Epidemiology and Microbiology in cooperation with the Russian Direct Investment Fund (RDIF) based on an adenovirus vector (virus, in which the genes responsible for the development of infection are "cut out").
Russia announced the registration of the drug almost a month ago: the vaccine was tested this summer on several groups of volunteers from 18 to 60 years old at the Ministry of Defense and the First Sechenov Moscow State Medical University. The post-registration phase (as the developers call it) begins this week: within the framework of it, Sputnik-V will be introduced to 40 thousand test subjects.
"From June 18 to August 3, 2020, we included 76 participants in two studies (38 in each). In each study, nine volunteers received rAd26-S (recombinant adenovirus type 26 vector) in phase 1, nine received rAd5-S (vector of recombinant adenovirus of the fifth type) In phase 1, another 20 received rAd26-S and rAd5-S in phase 2. Both vaccines were safe and well tolerated. The most common side effects are pain at the injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), as well as pain in muscles and joints (18 [24%]). Most of the adverse events were moderate, and we did not detect any serious adverse events. All participants produced antibodies to the SARS-CoV-2 glycoprotein. <...> Cell-mediated responses were found in all participants on day 28," the Russian scientists write.
As noted in the RDIF press release, today's publication in The Lancet begins a whole "cycle" of articles about Sputnik-V. "In September, a complete study of the vaccine on animals will be presented for publication – on primates, Syrian hamsters, transgenic mice – in which the vaccine showed 100% protective effectiveness (the results on primates and Syrian hamsters were obtained before clinical trials)," the representatives of the foundation promise.
The RDIF also once again stressed that absolutely all the volunteers who participated in the research, the Russian drug against Covid-19 "formed a stable and humoral and cellular immune response." In addition, the specialists did not observe "serious adverse events (Grade 3) according to any of the criteria," despite the fact that their indicator for other candidate vaccines varies from one to 25 percent.
"The level of virus neutralizing antibodies in volunteers vaccinated with Sputnik-V was 1.4-1.5 times higher than the level of antibodies in people who had been ill with Covid-19. For comparison, the British pharmaceutical company AstraZeneca had an antibody level in vaccinated volunteers that was approximately equal to the level of antibodies in patients with coronavirus infection," the press release says.
Publication in The Lancet is important because earlier, just a day before the announcement of registration, representatives of the Association of Clinical Research Organizations (AOKI, it includes companies such as Bayer, AstraZeneca, Novartis and others) an open appeal was issued with a request to "postpone the issue of registration" of the drug until it passes the third phase of human studies and will not represent the "final product". According to AOKI, the first tests were conducted on only a few dozen people, while thousands of volunteers will participate in the last stage.
Among other things, the authors of the appeal cited the example of other 26 candidate vaccines that are being developed abroad and for which there are already "pre-published results of previous phases". "Accelerated registration will no longer make Russia a leader in this race, it will only expose the end users of the vaccine, the citizens of the country, to unnecessary danger," the representatives of the association noted.
It is worth recalling that a few days ago it became known that on August 27, the Centers for Disease Control and Prevention of the United States sent a letter to 50 states asking the governors to speed up licensing of the coronavirus vaccine, as well as to prepare a mass vaccination network.
Portal "Eternal youth" http://vechnayamolodost.ru