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What ingredients does the Russian Sputnik V vaccine have that could be approved in the European Union?

Despite initial reservations and mistrust, the Sputnik V vaccine is already on the table of the European Medicines Agency (AME). The Russian vaccine had a very bad press at first, among other things because of the speed with which they managed to produce it.

Then came the publication of their clinical trials in the scientific journal The Lancet, which showed good protection results against COVID-19.

Then came the production and distribution problems that are slowing down the vaccination process across Europe. Hungary, Slovakia and soon the Czech Republic decided to buy doses of the Russian vaccine without waiting for either the AME or the joint purchasing system of the European Commission, which has caused many conflicts.

Now the AME could approve its use in the EU, although it is not yet clear whether the European Commission will include it in its purchasing program, given the strong tensions with Moscow. Brussels has limited itself to pointing out this Thursday that “there are no negotiations underway to include the Sputnik vaccine in the portfolio” of European vaccination.

Commission chair Ursula von der Leyen went further two weeks ago wondering why Russia is offering millions and millions of doses to countries around the world when vaccination of its own citizens is not making sufficient progress.

What is the Russian Sputnik V vaccine?

The “Gam-COVID-Vac” vaccine technology is similar to that of AstraZeneca, Johnson & Johnson or CanSino. Instead of creating a genetic code identical to that of the new coronavirus like Pfizer or Moderna, an adenovirus modified to include the “spike” glycoprotein, the characteristic peak of the coronavirus, is used as a base, which generates an immune response.

In this case they are human respiratory adenoviruses (AstraZeneca uses a chimpanzee one) and they are also modified to prevent them from reproducing uncontrollably.

The difference in this case is that Sputnik V uses two different adenovirus vectors, Ad26 in the first dose and Ad5 in the second.

The idea is that the first injection generates a certain immunity and in the second, being a new adenovirus, it generates a stronger and longer-lasting reaction, according to the explanation on the official website of the vaccine.

Which ones are your ingredientes?

In addition to this technology, the Sputnik V vaccine requires excipients that preserve and transport the active ingredients. One of the advantages of the one presented by Russia is that it is proposed in a lyophilized or “dry” version, which allows it to be distributed even in the most remote places.

Otherwise, the composition is very similar to that of other vaccines: salts and sugars to stabilize the formula and facilitate its injection into the tissues. The Pfizer and Moderna vaccines, based on messenger RNA technology, also require lipids.

In its liquid version, according to the official leaflet in the hands of the Russian authorities, it consists of:

Tris (tromethamine), an amino used in acid balancing preparations that is present in Moderna’s vaccine.

Sodium chloride (common salt)

Saccharose (a very common type of sugar).

Magnesium chloride hexahydrate. Another very common type of salt that the AstraZeneca vaccine also uses

Ethylenediaminetetraacetic acid (EDTA) It is used as an additive in food and medicine to remove heavy metals, as an anticoagulant, and is also used to prevent bacteria from forming biofilms. It has antimicrobial properties. Also present in the AstraZeneca vaccine and the University of Oxford.

Polysorbate 80. An additive with a detergent effect (dissolves fats). It is also in the AstraZeneca vaccine

Ethanol 95 (alcohol)

Water

The excipients are the same in the two necessary doses.

The liquid version should be kept at -18ºC and the freeze-dried or dry version should be kept between 2ºC and 8ºC.

Safety and side effects

The vaccine has been tested in some 31,000 patients, numbers very similar to those of its rivals (or sisters, depending on how you look at it). Its overall effectiveness is estimated at a more than honorable 91%, more than 90% in all age groups. However, there is less data on the age ranges of 18 to 30 years and over 60.

Regarding side effects, the Russian study is somewhat less rigorous than the rest in collecting data, which is not done systematically. The document published in The Lancet presents results from just over 12,000 patients who have received both doses.

The vaccine is effective especially against the most serious forms of COVID-19.

Older patients seem less prone to serious side effects.

Scientists promise to publish a full study when adverse effect data is processed.

However, the worst propaganda for this vaccine is the Russians themselves who distrust, which is slowing down vaccination. There are Telegram groups to collect and try to compile statistics on side effects and some users report quite violent reactions.

It remains to be clarified whether it is due to the serial distrust among Russians towards their authorities or that the Sputnik V vaccine actually has more side effects than the others. And of course, as for the rest of vaccines, all the long-term data is unknown, from immunity to possible side effects.

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