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 experimentation is still behind.

(photo: Jakub Porzycki / NurPhoto via Getty Images)

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 experimentation is still behind

(photo: Jakub Porzycki / NurPhoto via Getty Images)

Two days after the announcement by Russian President Vladimir Putin with great fanfare that he has registered the first vaccine in the world effective against the Sars-Cov-2 coronavirus , 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 under study globally.

What do we know about the Sputnik vaccine 5

In addition to the name, evocative of the great space successes of the Soviet Union at the turn of the fifties and sixties, the vaccine was given more emphasis to the gossip-like background (it would have been administered to one of Putin’s daughters) than to the details relevant to scientific level. According to the reconstruction offered by Nature , the formulation of Sputnik 5 would provide for 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. It is curious, however, that both solutions seem 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 experimentation path, the information currently available suggests that we are at the end of phase 2 (conducted on small samples of people) but that phase 3, that is the decisive one for assessing the risk balance, still has to be carried out. – benefits , determine the effectiveness of the drug and avoid the presence of relevant side effects. According to the official documents provided, in particular, a total of 38 people would have received the double dose of the vaccine (with a good immune response) , while the press sources speak of 38 volunteer civilians and 38 military in a first phase, and others 100 people at a later stage. Nature speaks of 76 volunteers divided into two groups, probably referring to the same clinical trials, and the information seems to be compatible with other indiscretions already appeared in July.

What is obviously missing, however, is the part of large-scale experimentation , which apparently began just last week (or this week, according to other sources) on a large sample of Russian, Saudi Arabian and Emirati citizens. United Arab and other countries. Here too, however , confirmation is lacking , since there is no experimental protocol to consult and all we have are simple oral or print announcements.

The competitive advantage that is not there

That the vaccine race is a matter not only of public health but also of international geopolitical competition is certainly not new. It is no coincidence that the great proclamations, which often turned out to be too optimistic with respect 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 that it has already received orders for more than a billion doses from 20 different states from all continents, and said it is already working on the production of 500 million doses.

From the point of view of scientific evidence, however, the Russian vaccine does not seem to have an advantage over the rest of the world at all , but rather lags behind those who currently seem to be further ahead. In fact, other competitors have already started phase 3 providing all relevant information. And this phase of the experimentation, for which Sputnik 5 is just beginning, is the most complex one and which corresponds to the greatest probability of failure. If the design of a vaccine solution and the first non-toxicity tests are within the reach of many, it is precisely when it comes to the analysis of large-scale effects, the double-blind comparison with a placebo and the evaluation of adverse reactions less municipalities that may arise insurmountable criticalities. And for this, before you have successfully completed phase 3, it would be useful to be very careful with the proclamations.

Approval could be a boomerang

While in fact no international authority could prevent Russia from producing and distributing (at least internally) its own vaccine, the scientific community is already on the alert for the possible harm that an inadequately tested vaccine could cause. The absence of publications and pre-publications on Sputnik 5, in particular, raises concerns that side effects such as asthmatic reactions or worsening of the infection may be generated in those who have received the vaccine, as has happened in the past for other candidate solutions against Sars but then excluded for these reasons during phase 3. If at the moment the only side effects associated with Sputnik 5 are fever, headache and skin irritation , only an experiment on thousands of people could reveal other less frequent but more serious reactions.

According to the registration documents released, the doses will be available starting in January 2021. And the Russian health ministry has already formally approved the drug, allowing Putin to proclaim himself the winner of the vaccine race. However, in the remaining four and a half months it is unlikely to be able to complete phase 3 of experimentation with all the necessary traits, and for this reason several experts and newspapers speak of an ‘ experimentation that is too accelerated’ or directly of a ‘ skipped experimentation’ . Under these conditions, predicting a mass vaccination could represent an even greater danger to the population than that due to Sars-Cov-2, which at the moment in Russia has caused 900 thousand infections  and over 15 thousand deaths .

Finally, some concern was also expressed by the same Russian agency that manages drug trials, which highlighted through the voice of the director Svetlana Zavidova how in the country the reporting system for adverse reactions is inefficient . In short, if the vaccine really had safety problems, the risk is that these do not even emerge.