All the scientific doubts about Sputnik 5, "Putin's vaccine"

Beyond the cold war proclamations, the international scientific community has expressed doubts about the vaccine solution developed in record time by the Gamaleya Institute in Moscow. First of all because the experimentation is still behind

(photo: Jakub Porzycki / NurPhoto via Getty Images) Two days after the announcement by Russian President Vladimir Putin that he has registered the first vaccine in the world effective against the coronavirus Sars-Cov-2, the scientific reach of the news is rather reduced. On Sputkin 5, the anti Covid-19 drug developed by the Nikolai Gamaleya National Institute of Epidemiology and Microbiology in Moscow, there is in fact such a small amount of information available that we believe that it is neither more promising nor ahead of the more than 200 other vaccine solutions being studied globally.

What we know about the Sputnik 5 vaccine

In addition to the name, evocative of the great space successes of the Soviet Union between the In the 1950s and 1960s, more emphasis was placed on the gossip-like background of the vaccine (it would have been given to one of Putin's daughters) than on scientifically relevant details. According to the reconstruction offered by Nature, the formulation of Sputnik 5 would include two doses to be administered at a certain time apart, consisting of different therapeutic solutions. The first would be based on the recombinant adenovirus Ad26, while the second (which would act as an enhancer of the immune response generated by the first injection) would be based on the Ad5 adenovirus. Curious, however, that both solutions appear similar to others already known to be in the trial phase and developed respectively by US and Chinese pharmaceutical multinationals, and therefore the only novelty of the Russian formulation would consist in the combined use of the two drugs.

From the point of view of the course of the trial, the information currently available suggests that there is at the end of phase 2 (conducted on small samples of people), but that is yet to be conducted the phase 3, the decisive one, to assess the balance of risks and benefits , to determine the effectiveness of the drug and stave off the presence of relevant side effects. According to the official documents provided, in particular, would have received the double dose of vaccine (with a good immune response) a total of 38 people , while the sources of print speak of the 38 civilian volunteers and 38 the military in the first phase, and 100 other people at a later stage. Nature speaks of the 76 volunteers were divided into two groups, referring probably to the same clinical trials, and the information seem to be compatible with other rumors already appeared in July.

the One that obviously lacks, however, is the part of the large-scale experimentation , that what emerges would be started just last week (or this week, according to other sources) on a large sample of citizens of russia, Saudi Arabia, the United Arab Emirates and other countries. Even here, however, lacks confirmation , since there is no experimental protocol to see and all that we are simple ads, oral, or print media.

The competitive advantage that there is

That the race for the vaccine is a matter not only of public health but also of geopolitical competition in the international is certainly not new. No coincidence that the great proclamations, often proving to be too optimistic compared to the real state of the art, have affected many countries in recent months. The same happened in this case with Russia, which has already announced they have already received orders for more than one billion doses by 20 different states from all continents, and has said to be already working for the production of 500 million doses.

From the point of view of the scientific evidence, however, the vaccine Russian seems to be not in advantage compared to the rest of the world , but in fact suffers a certain delay with respect to those who at the moment appears to be more forward. Other competitors, in fact, have already started the phase 3 providing all the related information. And this phase of the trial, for which the Sputnik 5 is just the beginning, is the most complex, and which corresponds to the highest probability of failure. If the conception of a solution to the vaccine, and the first test of non-toxicity are within the reach of many, it is just when it comes to the analysis of the effects on a large scale, the comparison in double-blind, placebo and evaluation of the adverse reactions are less common that may emerge in critical insurmountable. And for this, before you have successfully completed stage 3, it would be advisable to be very cautious with the proclamations.

The approval could be a boomerang

Even if in fact no international authority could prevent Russia to produce and distribute (at least internally) the vaccine, the scientific community is already on alert for the possible damage that a vaccine is not properly tested might generate. The absence of publications and pre-publications on Sputnik 5, in particular, the fear that can be generated side effects such as reactions of asthma or exacerbations of infection in those who received the vaccine, as happened in the past for other solutions candidate against Sars but later excluded for these reasons, during the phase 3. If, at the time the only side effects associated with the Sputnik 5 with fever, headache, and irritation of the skin, only a trial on thousands of people may bring out other reactions less frequent, but more serious.

According to the registration documents made available to the public, the doses will be available starting in January 2021. And the ministry of Health of russia has already formally approved the drug, allowing Putin to claim status as a winner of the race to the vaccine. However, in the four and a half months that are missing are unlikely to be able to complete the phase 3 trial with all the trappings of the case, and for this reason several experts and newspapers speak of a ‘ trial too accelerated’ or “ trial skipped” . In these conditions, to provide for a mass vaccination may constitute a danger to the population even greater than that due to the Sars-Cov-2 , which at the time in Russia has given 900 thousand infections and over 15 thousand deaths .

Finally, some concern was expressed also from the same Russian agency that is responsible for managing the testing of interactions, highlighted by the voice of the director Svetlana Zavidova as in the country is not very efficient in the reporting system of adverse reactions . If indeed the vaccine were problems with the security, in short, the risk is that these do not emerge even.