A preliminary study on the vaccine that Russia is developing against the coronavirus showed that it develops an immune response without serious undesirable effects, according to the prestigious specialized magazine published on Friday. The Lancet. But larger work is still needed to determine its eventual effectiveness.
The study, conducted by Russian government researchers, was evaluated by a rereading committee of the British medical journal prior to publication.
Russian authorities announced last month that your vaccine, baptized Sputnik V, was entering the third and final phase of clinical trials, but they were not going to wait for the results of this since their intention was to homologate it in September.
The announcement was met with skepticism by many researchers and countries such as Germany and the United States, which questioned its efficacy and safety, mainly due to the absence of public data on the trials conducted so far.
The World Health Organization (WHO) for its part called on Russia to follow the established protocol and comply with “all the phases” necessary to develop a safe vaccine.
The WHO “will not endorse” a coronavirus vaccine if it is not safe and effective, its director general, Tedros Adhanom Ghebreyesus, declared on Friday.
Moscow has denounced these criticisms as an attempt to dismiss the Russian investigation.
President Vladimir Putin went further and claimed that the vaccine, developed by the government and the Gamaleïa Research Institute, guaranteed “lasting immunity” to COVID-19.
Sputnik V actually consists of two vaccines, administered in injections each three weeks apart, the study published in The Lancet detailed.
It is a “viral vector” vaccine: it uses two human adenoviruses – a very common family of viruses, mainly responsible for colds -, which are transformed to add the SARS-CoV-2 virus, which causes covid-19.
When the modified adenovirus enters the cells of the vaccinated person, it manufactures a typical SARS-CoV-2 protein, thus teaching their immune system to recognize and fight it, explains the lead author of the article, Denis Logounov, from the Gamaleïa Institute.
The publication is based on two small studies conducted among a total of 76 adult volunteers, between 18 and 60 years old, in good health. They were carried out between June 18 and August 3 by researchers from the Russian ministries of Health and Defense and funded by the former.
Both concluded that neither of the two components of the vaccine caused “serious undesirable effects” and that its successive administration “generated the production of antibodies” in all participants, including “neutralizing antibodies” to covid-19.
Now “large trials are needed, with a longer follow-up and including comparison with a placebo” to “establish the safety over time and the efficacy of the vaccine in preventing infection with COVID-19,” the authors stated. .
This will be the goal of the phase 3 trial, which will include 40,000 participants, “of various ages and with different risk levels,” they explained.
These results are “encouraging, but on a small scale” and they do not clarify whether the vaccine provokes an immune response among the elderly, the most vulnerable to the coronavirus, reacted Naor Bar-Zeev, a vaccine specialist at the Johns Hopkins Bloomberg School of Public Health, in the United States.
“Proving that covid-19 vaccines are safe will be crucial, not only for their acceptance but also for confidence in vaccination in general,” he added in a comment published in The Lancet.
The study published in the British journal shows that “so far everything is fine”, but an “immune response does not necessarily mean protection against covid-19”, said Brendan Wren, professor of microbiology at the London School of Hygiene and Tropical Medicine.
According to the WHO, There are 176 ongoing vaccine projects in the world, of which 34 are in clinical trials, which means that they began to be tested on humans. Among these, eight are in phase three, the most advanced.