Sputnik-V, the Russian vaccine against SARS-CoV-2, produced antibodies in all early-stage trial participantsAccording to the results published this Friday by the prestigious journal of medical dissemination, The Lancet.
The results of the two tests (carried out last June and July) highlighted on 76 participants, showed that 100% of the participants developed antibodies against the new coronavirus and there were no serious side effects.
The most common adverse sequelae were pain at the injection site (58%), hyperthermia or increased body temperature (50%), headache (42%), asthenia or fatigue (28%), and muscle and joint pain (24%). Most of the adverse effects were mild.
In August, Russia registered Sputnik-V –Whose technical name is actually Gam-COVID-Vac, but it was renamed in honor of first satellite of the space race, during the Cold War-, a two step vaccine developed by the IGamaleya Institute of Epidemiology and Microbiology. The vaccine was approved for home use, before data were published or a large-scale trial began.
“The two 42-day trials, involving 38 healthy adults each, found no serious adverse effects among participants and confirmed that vaccine candidates elicit an antibody response,” he reported. The Lancet. It is clarified, however, that “large-scale, long-term trials are needed, including a comparison with a placebo, and further monitoring to establish the long-term safety and efficacy of the vaccine in preventing infection by Covid-19“.
“With this [publicación] we answer all questions from the West that have been diligently done in the last three weeks, frankly with the clear goal of fogging up the vaccine Russian“said Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), the sovereign wealth fund that financed the development of the vaccine.
Last week Russia launched a new trial, more ambitious, for which they were recruited 40,000 volunteers (ages 18 to over 60) who will receive two doses, the second 21 days after the first application.
The study, to be carried out in different medical centers, it is randomized, double blind –That is, neither the professional nor the subject know the origin of the sample– and con placebos. The goal is to measure efficacy, immunogenicity (the ability to produce an immune response), and safety.
Dmitriev said that at least 3,000 people had already been recruited for the trial large-scale vaccine Sputnik-V (now in Phase 3) and that initial results were expected in October or November of this year.
For his part, Russian Health Minister Mikhail Murashko said that the massive inoculation from November or December, with priority for risk groups. Russia wants to produce between 1.5 and 2 million doses monthly by the end of the year, and plans to gradually increase production to 6 million doses a month.
In August, the President Vladimir Putin boasted of registering the “first vaccine against Covid-19 in the world“. Putin had said that the vaccine – which was even given to one of her daughters – was “quite efficient” and that it “generates stable immunity.”
Actually, 176 vaccines against SARS-CoV-2 are being developed worldwide and 34 of them are already being tested in humans, among them: the AstraZeneca vaccine and the University of Oxford (British); those of Sinopharm with the Biological Institute of Wuhan and with the Biological Institute of Beijing, and that of Sinovac (the three Chinese); those of Moderna with the US Institute of Allergy and Infectious Diseases and that of Pfizer-BioNtech (an American-German collaboration).