Sputnik V soon in Germany? What is known about the Russian corona vaccine

The vaccine from Johnson & Johnson has been approved, another one could soon follow: The EU Medicines Agency is currently examining the Russian vaccine Sputnik V. But how effective is the drug?

Delayed deliveries, too few vaccine doses: The corona vaccinations in Germany are still making slow progress. So it is only natural that a possible replenishment from foreign manufacturers is now being discussed.

Russia has already promised the EU 100 million vaccine doses of its active ingredient Sputnik V. The product is apparently even supposed to be produced in Germany in the course of the year. China is also developing several vaccines that, if approved, could ease the situation in Europe. But what do Sputnik V, Coronavac and others do?

Russia started mass vaccination – despite a lack of safety data

In August 2020, Russia launched Sputnik V, the world’s first vaccine against the Coronavirus authorized. It was developed by the Gamaleya State Institute for Epidemiology and Microbiology in Moscow. First, individual sections of the population, including teachers and doctors, were vaccinated – although relevant tests had been missing until then. The important phase III study, which determines the effectiveness and safety of the drug, is a prerequisite for approval. At least in the EU.

Russia’s approach to vaccinating people with an agent that has not been researched in large clinical studies contradicts customary international standards and has been the subject of sharp criticism. Mass vaccination of the Russian population started at the beginning of December 2020.

How effective and safe is the vaccine?

It was only in February that interim results of the phase III study were published in the renowned specialist journal “The Lancet”. Accordingly, the vaccine is certified to be 91.6 percent effective against symptomatic corona disease. The data are considered meaningful because the study included more than 20,000 test subjects. Nevertheless, some experts criticized the Lancet study. The total number of test subjects is lower than in the studies on the mRNA vaccines by Biontech/ Pfizer and Moderna. This means that the number of those who have become infected is also lower – and that is how the effectiveness of a vaccine is calculated.

There were no serious side effects from Sputnik V in the vaccine group, according to “The Lancet”. How well the corona vaccine protects against the new virus variants is still unclear.

Hungary is already vaccinating with Sputnik V.

Despite the lack of approval from the European Medicines Agency (Ema), Hungary is already using the Russian vaccine. Moscow also sells the vaccine to Serbia, Kazakhstan and Turkmenistan. The vaccine is now approved in more than 40 countries.

Sputnik V: The Russian vaccine has been inoculated since August 2020.  (Source: Reuters / Agustin Marcarian)Sputnik V: The Russian vaccine has been inoculated since August 2020. (Source: Agustin Marcarian / Reuters)

At the end of January, Russia announced that it would be able to supply the EU with 100 million doses of the Sputnik V vaccine in the second quarter. This could vaccinate 50 million people. The Ema has been testing the vaccine since the beginning of March. It is not yet known exactly when approval could take place. Important study results were still missing, according to Ema.

Stiko boss Mertens: Sputnik V “good vaccine”

The Standing Vaccination Commission is already relying on approval of the Russian Covid-19Vaccine in the EU. “This is a good vaccine that will probably also be approved in the EU at some point,” said Stiko boss Thomas Mertens of the “Rheinische Post”. “The Russian researchers are very experienced with vaccinations. Sputnik V is cleverly built.”

As with the Astrazeneca vaccine, Sputnik V is a vector vaccine based on an adenovirus. In contrast to Astrazeneca, however, two different vector viruses are used for the first and second dose. “That is very smart, because it can prevent potential losses in effectiveness due to immune responses against the vectors,” said Mertens.

Spahn is open to vaccines from Russia and China

Federal Minister of Health Jens Spahn (CDU) was also open to the use of a corona vaccine from Russia or China in Germany in the event of successful EU approval. “If a vaccine is safe and effective, regardless of the country in which it was manufactured, then it can of course help to cope with the pandemic,” said Spahn of the “Frankfurter Allgemeine Sonntagszeitung”. The decisive factor, however, is regular approval under European law.

Big advantage: Sputnik V is to be produced in EU countries

First Italy, now Germany: There are already agreements that Sputnik V should also be produced in Europe. This could make it possible to start supplying the European market more quickly after EU approval.

From July the company Adienne Srl. manufacture the vaccine in Lombardy – a subsidiary of the Swiss pharmaceutical company Adienne Pharma & Biotech. This was recently announced by the Italian-Russian Chamber of Commerce in Rome. On March 15, Russia reported that it had agreed to produce Sputnik-V in Germany. Further details about the location are not yet known. Corresponding agreements are already in place with companies in France, Spain and Italy, according to a statement by the Russian vaccine developers.

A hospital employee is vaccinated in Bolivia: The Russian vaccine Sputnik V is used in the South American country.  (Source: Reuters / David Mercado)A hospital employee is vaccinated in Bolivia: The Russian vaccine Sputnik V is used in the South American country. (Source: David Mercado / Reuters)

China: Several candidates – but unclear study results

China is one of the countries with a particularly large number of corona vaccines in development. The most promising vaccines include funds from Sinovac and Sinopharm.

Sinopharm’s active ingredient BBIBP-CorV has already been approved in several countries

In China, one of two vaccine candidates from Sinopharm has already been approved since December 31, 2020: the active ingredient called BBIBP-CorV. The state-owned Chinese biotech company started the phase III study on 30,000 volunteers for BBIBP-CorV in the United Arab Emirates in mid-July. In other countries, including Bahrain and Peru, trials are in progress in the last of the clinical phases.

How effective is Sinopharm’s BBIBP-CorV?

According to the group’s publication on December 29, 2020, the active ingredient showed an effectiveness of 79 percent in an interim evaluation. However, this number must still be viewed with caution, because: Sinopharm has not yet published any more detailed information on the results of the ongoing studies. A study published in the journal “The Lancet” on test phases one and two had previously shown that the inactivated active ingredient stimulates the production of antibodies against SARS-CoV-2 in humans and does not cause any serious side effects.

In addition to China, the United Arab Emirates and Bahrain, where the vaccine is already approved, Jordan, Pakistan and Peru have also announced that they will be deployed. There is already a candidate within the EU:

As Hungary announced, the country has already ordered five million cans despite the lack of approval by the Ema. A separate procedure for testing the vaccine by the Hungarian Medicines Agency OGyEI is no longer necessary there. The reason is a regulation recently issued by Prime Minister Viktor Orbán: According to this, corona vaccines that are not approved in the EU may under certain conditions be vaccinated in the country without being checked by the Hungarian authorities. It is still unclear whether and when a regular approval of the active ingredient under European law could take place.

Inactivated pathogens: This is how dead vaccines work

The Chinese vaccine candidates presented here rely on so-called inactivated viruses. With this technology, the SARS-CoV-2 viruses are removed from infected people, multiplied and killed so that they can no longer make them sick. Such inactivated pathogens are recognized by the body as foreign and stimulate the body’s own defense system. Advantage: The vaccines can be produced quickly and are easy to transport. This process has been used for decades in vaccines against rabies and polio, for example.

Chinese vaccine from Sinovac: Already approved in several countries

The active ingredient from the Chinese company Sinovac, called Coronavac, works like that of Sinopharm with inactivated pathogens. In Brazil, study phase III has been running on around 13,000 volunteers since the end of July 2020 in partnership with the local research institute Instituto Butantan. Phase III studies are also being conducted in Indonesia and Turkey, among others.

Worrying fluctuations in information on effectiveness

The information on the effectiveness of Sinovacs Coronavac varies considerably depending on the country and time and is between 50 and 91 percent. Detailed results from the phase III studies have not yet been published.

Brazil, Chile, China, Indonesia and Turkey are already vaccinating the active ingredient. According to media reports, Hungary has also signed a supply contract with Sinovac. It is still unclear whether the European approval authority Ema will be able to give the active ingredient the green light in the foreseeable future.

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