International scientific recognition of the effectiveness …

Data on the efficacy, immunogenicity (ability to induce an immune response) and the safety of the Sputnik V vaccine have been published in the journal The Lancet, one of the most prestigious scientific publications at international level. In the article, the scientific team of Gamaleya Research Center in Epidemiology and Microbiology reported the results obtained from a mid-term review of its phase III clinical trial. This event is central because Russian technology, perhaps like no other, he was discredited by the hegemonic media and by the voices of the opposition who questioned his qualities to immunize the Argentine population. As a news product, this afternoon Alberto Fernandez spoken by phone with Vladimir Poutine, thanked him for his help and congratulated him on making a “vaccine of excellence”. His peer announced that Russia was increasing its production and promised to honor the agreed commitment: the acquisition by Argentina of a total of 20 million doses.

Alexander Gintsburg, director of the Gamaleya Center, said in this regard: “The publication of data, peer-reviewed internationally, with the results of clinical trials Sputnik V is a great success in the global battle against the COVID-19 pandemic. The safety and high efficacy of the Russian vaccine is demonstrated by the strong scientific data presented. ” Kirill Dmitriev, Executive Director of the Russian Fund for Direct Investment, commented in turn: “It’s a beautiful day in the fight against the COVID-19 pandemic. Data published by The Lancet demonstrates not only that Sputnik V is the world’s first registered vaccine, but also one of the best“Said the referent of the government body that finances the production of the drug.

What results were published in The Lancet after being peer reviewed? Essentially three, related to efficacy, immunogenicity and safety. In terms of efficiency, it was 91.6%, making it part of the selected group of options which – along with others such as Pfizer and Moderna (95%) – achieved a percentage above 90%. A very high number if we take into account the fact that other vaccines, such as influenza, which make up the mandatory schedule barely affect 60%. To achieve this result, the Center tested 19,866 volunteers, who received the first and second doses. An encouraging aspect of the published study is that the efficacy in the group of adults over 60 years (2144 volunteers) reached 91.8% and, indeed, did not differ statistically from the group between 18 and 60 years.

In relation to the immunogenicity, among the cases analyzed, more than 98% of the volunteers demonstrated the presence of a humoral immune response (antibody) and 100% of a cellular immune response. In this sense, the levels of antibodies detected and generated by the drug were higher than those reported in people who recovered from covid, i.e. the protection offered by the active substance is even greater than that of discharged patients. Compared to security, the third of the pillars that support the success of a technology as complex as a vaccine, the study confirmed that 94% of the adverse events were mild (flu-like symptoms, injection site reactions, headaches and fatigue), while there were no serious adverse events. In this sense, among the volunteers, no strong allergy or anaphylactic shock was detected, which was demonstrated in people who were inoculated with other vaccine platforms, such as Pfizer and BioNTech for example.

“This is important news, but the fundamental thing had already happened. I mean the data on the efficacy and safety of the vaccines had already been received by the regulator, in our case Anmat, ”he says. Daniela hozbor, biochemist and principal investigator at Conicet at the Institute of Biotechnology and Molecular Biology of La Plata. Either way, this highlights: “Making a scientific publication is what allows you to disseminate the work and make the information accessible to anyone who wishes to internalize it. This particular magazine is highly regarded“.

“The data that has been processed by regulatory entities in Argentina is consistent with this publication released today. The efficacy is very good and the side effects are mild to moderate. So there is no surprise, everything is going according to what the Gamaleya Center had planned at the time in our government, but now with detailed information already open to all. Now the fact that they already knew each other before does not take away the joy of a vaccine that is very good», Hozbor reports.

With production slower than expected, every pharmaceutical company around the world is looking for options to be able to fulfill their agreements. Over the past week, the government has entered into discussions with the Russian administration to explore the possibility of manufacturing the doses domestically. This was confirmed by Eduardo Zuain, the Argentine Ambassador to Moscow, who announced that Alberto Fernández’s interest was to move forward in a process of technology transfer. The idea stems from the delays confirmed by the Gamaleya Center: during the last delivery, the Aerolineas Argentinas flight brought only 220 thousand doses, a figure lower than that agreed. However, it should be emphasized that the Russian Federation was guaranteed to comply with the batches of millions of vaccines entrusted to the national government.

At the same time, the health portfolio continues its efforts to acquire one million Chinese vaccines produced by state-owned Sinopharm and awaits the million doses of AstraZeneca (22.4 in total) which will start arriving from Mexico in mid -March. On Monday, Covax, the platform led by WHO and made up of 172 countries around the world, announced that in mid-February, Latin America would start receiving the first batch of 35 million doses. It is worth noting that, as agreed, Argentina is expected to receive throughout the first half of 2021, 9 million doses.

The advantages of Sputnik V

The vaccine developed by Russian science has shown efficiency approaching 92%. It is based on a methodology that combines adenoviral vectors (26 and 5) and, therefore, it is about a technique that has been used in a similar way in vaccine platforms developed in previous years. In addition, as the temperature of storage varies between 2 and 8 degrees, the doses do not involve any need for additional storage (it is not necessary to purchase ultra-freezers operating at a much lower temperature) or logistical obstacles for their transfer.

Which means even more, it is one of the cheapest options in the worldbecause it costs around $ 10 per dose. It should be remembered that although AstraZeneca is worth $ 4 and its commercial value is lower than Sputnik V, Pfizer is worth $ 18 and Moderna 25. Due to its characteristics and excellent results in terms of efficacy, immunogenicity and security has been registered in 16 countries. Besides Russia and Argentina, Belarus, Serbia, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Republic of Guinea, Tunisia and Armenia must be counted. Russia has offered its vaccine to the European Union and, for this, plans to deliver 100 million doses to member countries in the second half of 2021. However, previously it should be cleared for emergency use by the European Medicines Agency (EMA), the regulatory body equivalent to Anmat in this region.

To end the myths

“For months there has been very fierce criticism of this vaccine, criticism that should not have existed. It is not compulsory to publish in magazines, it is a misconception; The important thing, I stress, is that the regulator receives the information. The good thing about its publication is that the clinical trials of the vaccine and the conclusions they addressed have been reviewed by highly qualified and experienced reviewers. They check whether the information is rigorous, whether it is well planned, whether it achieves the results it announces, ”explains Conicet researcher Daniela Hozbor. Then he continues: “The vaccine should not be ideologized because it is an input that must reach the entire population without distinction, if what you want is to achieve the herd effect“.

The publication – in a journal like The Lancet – of the results of the phase III trials helps to dismantle the general skepticism with which the Western scientific community has focused on the Russian product. Timeliness is central because its publication implies that the technology and evidence presented by the Center have been peer reviewed. With this, validity is granted to a work that to date had been the target of constant discrediting speeches of the hegemonic media that discredited the work done by the Eurasian giant. This is not by chance, because, as a coup, what was asked of the opposition was damage the quality of the vaccine with which Argentines were vaccinated, on the basis of the agreement sealed months ago by the government of Alberto Fernández.

Speeches that sought to break through Sputnik V insisted that Russia “had no scientific experience or track record”; “It only sought to make political use of the pandemic”; “That his job was not serious”; “That I no longer had any papers”; “That even President Putin himself did not want to be vaccinated.” Without going so far, Last week, Jaime Duran Barba called Sputnik V a “trout vaccine”. The publication in The Lancet demystifies some of these claims.

To be fair, while this is important news, a publication in a prestigious scientific journal cannot be equated with decades and decades of history. The Gamaleya Center was not inaugurated a few months ago, and it has also not seen the light of day in the wake of the pandemic. On the contrary, was established in 1891 and is so called by Nikolai Gamaleya, a very eminent scientist in the field and a pioneer in vaccine development. From this space, the scientific teams of the institution designed multiple vaccines; the most recent is perhaps the one designed to fight Ebola, which uses adenoviral vectors, very similar to the one currently being tested against covid-19. “The last one they did went through phase III trials with great success and received an international patent from the center. They also had experience with solutions for MERS. I think we can say that they have experience in this area, that they are not improvised, ”says Hozbor.

This previous experience with similar platforms has indeed done wonders to develop Sputnik V at a gallop. When scientists tweaked their vaccines to fight Middle East respiratory syndrome (MERS, detected for the first time in 2012, in Saudi Arabia and transmitted by camels and dromedaries) on the one hand and the Ebola (which caused the epidemic on the African continent in 2017) on the other hand, they did not imagine that in 2020 this accumulated trajectory would serve them to create a technology capable of fighting the pandemic, caused by the new coronavirus. This is how basic science works, the capacities installed, the knowledge gathered, well, sooner or later they have application and impact in everyday life. For this reason, the S&T field must be funded and supported as a state policy, in Russia but also in Argentina.