The Russian vaccine would be in November: new study shows that it produces antibodies, and is 100% safe

This morning – late in Russia – scientists from the Russian Direct Investment Fund (RDIF) and the Gamaleya National Research Center for Epidemiology and Microbiology in Russia announced at an online conference the publication in the medical journal The Lancet, of the results of the clinical trials of Phase I-II of the Russian vaccine Sputnik V against the coronavirus.

On August 11, the vaccine had been registered by the Russian Ministry of Health, becoming the first drug against Covid-19 to be registered in the world. However, the absence – until today – of a related study led to a series of criticisms from the international community, to which was added the questioning of researchers in Chile.

“With this publication we answer all the questions from the West that have been diligently asked during the last three weeks, frankly with the clear objective of tarnishing the Russian vaccine“, said Kirill Dmitriev, Director of the RDIF, which has endorsed the procedure.

Likewise, scientists defended their vaccination registration ahead of time, because the initial internal samples showed great efficiency, and it was registered with all the rules of the Russian health authorities.

According to scientists, full studies of the vaccine trials will be presented in September in primates, Syrian hamsters and transgenic mice, in which the vaccine showed a 100% effective protection. In October-November, meanwhile, the publication of the first results of the phase 3 post-registration clinical studies, already in progress, with the announced participation of 40,000 volunteers, is scheduled.

In the online conference held to a hundred media in the world -among them La Tercera-, The researchers highlighted the advancements of their drug, noting that Sputnik V is distinguished from other vaccines because the results of phase 1 and 2 clinical investigations “Showed no severe adverse events, while the incidence in other candidate vaccines ranges between 1% and 25%”. In fact, they mention that the number of participants in the clinical trials of the Russian vaccine who received two injections “is 4 times greater than the number of subjects who received two injections in the AstraZeneca / University of Oxford trials”.

In the two trials carried out in June-July of this year, based on 76 volunteers, “at 100% of the participants the Sputnik V vaccine generated a stable cellular and humoral immune response. At the same time, the level of virus neutralizing antibodies in vaccinated volunteers was 1.4 to 1.5 times higher than the level of antibodies in people who had already recovered from Covid-19 ″, they said.

“In comparison, the level of antibodies in the volunteers who received the vaccine AstraZeneca / U. of Oxford was roughly equal at the antibody level of those who had already overcome a coronavirus infection. It should also be noted that in the Sputnik V clinical studies, T-cell immunity was formed in all volunteers, manifested in cells that ensure the identification and destruction of cells infected by SARS-CoV-2″ The researchers added.

Another advantage has to do with the effectiveness of the human adenoviral vector platform, despite concerns about the possible presence in those vaccinated with pre-existing immunity to human adenoviruses.

In this sense, the researchers said that the optimal safe dose was determined, which allows to achieve an effective immune response in 100% of those vaccinated, even in those who have recently had a adenovirus infection. “This reduces the urgency to develop new vaccines based on platforms that have not been studied and that have not been tested for many years,” mention the scientists.

However, in the scientific journal The Lancet they also mention that “large long-term trials are needed that include a placebo comparison and greater control to establish the long-term safety and efficacy of the vaccine in preventing Covid-19 infection ”.

According to the World Health Organization, there are 176 ongoing vaccine projects around the world, with 34 in the clinical trial phase to be tested in humans. Among these, eight are in phase 3, the most advanced.

According to scientists, it is expected that after mass vaccination in Russia, the manufacturing method can be sent to other countries for production. in November.