Publication: Sunday March 7, 2021 8:02 AM
The European Medicines Agency (EMA) is already reviewing the Russian vaccine for possible approval in Europe. This fact only means one thing: as happened with previous injections, such as those from Pfizer, Moderna or AstraZeneca, the entity will verify in real time, as the data is released, the effectiveness and quality of this antidote against the coronavirus.
For now, this review will continue until enough information is available to submit a formal application for marketing in the EU, for which the EMA does not yet have a set timetable.
However, given these intentions, and especially after the Minister of Health, Carolina Darias, opened the door to its use, the purchase of Sputnik V becomes an increasingly real possibility. Now, how is this vaccine? Will it be used in Spain?
This is the Russian injection
Sputnik V was developed by the National Center for Epidemiology and Microbiology Gamaleya of Russia. According to the EMA, this injection consists of two viruses: Ad26 and Ad5, which belong to the adenovirus family.
Specifically, when it comes to the Russian vaccine, these adenoviruses – COVID-19 is one of them, as it typically affects the lungs, although they can damage other membranes as well – have been altered to contain the gene that produces the disease protein. In other words, giving the injection, says the EMA, does not imply that the virus “can reproduce in the body or cause disease.”
On the contrary, “if the vaccinated person comes in contact with SARS-CoV-2, the immune system will recognize the virus protein spike and will be ready to attack it,” the entity explains. In terms of its effectiveness, as we have indicated, this is something that is still under review.
However, there are already studies that dare to demonstrate its effectiveness. For example, according to a peer-reviewed study published in the prestigious scientific journal “The Lancet”, Sputnik V was able to neutralize the virus in 91.6% of cases. Figures similar to the efficiency of Pfizer or Moderna, reaching 95 and 94.1% respectively. Along with this, like these antidotes, it takes two doses to be effective.
Could it be used in Spain?
The answer is yes. But with one condition that Health has repeatedly insisted on: for its use, the Russian vaccine must have been approved by the EMA. In this sense, last February, Carolina Darias affirmed that the government “will receive with enthusiasm any approved vaccine”: “It is the only margin”, declared the minister.
For this reason, the continuous revision that Sputnik V is undergoing becomes the main key to its rapid use in our country. Specifically, this review process, which has been applied to most coronavirus injections, is different from that of common vaccines.
Unlike what happened with these, where the application had to be finalized before approval, the EMA is now reviewing data as it becomes available from ongoing studies. If this last step is met, the Russian vaccine could be approved in Europe and, therefore, in Spain.
Why not before and now yes?
Technically, Europe has never given its yes. In fact, statements by the European Commission in recent days have come closer to “we’ll see” rather than certification of the use of the Russian vaccine in the old continent.
In this sense, the hypotheses of Eric Mamer, spokesman for the European executive, mainly stand out, who has always established as a red line the fact that the Russian vaccine, if approved, must be produced on the territory of the EU.
“At the time, if the Commission and the Member States decide to negotiate a contract with the makers of Sputnik V, we will communicate it. We are in negotiations with Novavax or Valneva, but not with the manufacturers of Sputnik. this is the situation ”, expressed the president.
Thus, according to the leaders of the committee itself, “there is no obligation for the EC to include it on the list”. Although this contrasts with what is happening in other countries, where precisely the Russian vaccine has become part of the list of options.
Hungary, the Czech Republic and Slovakia are currently inoculating Sputnik V, while Denmark and Austria have already announced that they will cooperate with Moscow on the manufacture and distribution of future vaccines suitable for variants of the virus.
This gap in the east and north of the continent, coupled with the shortage of doses and trade problems with some of the major manufacturers, has caused the Russian antidote to be increasingly beaten at the gates of the European Parliament. Even so, in Brussels, everything remains the same, until the new results of the studies arrive.