President Vladimir Putin named Sputnik V “the best vaccine in the world”, and the Russian media regularly offered record exports of the vaccine abroad.
However, is it a safe and effective vaccine against COVID-19? DW tries to separate the facts from the propaganda.
What is Sputnik V?
Developed by the State-run Gamaleya Research Institute for Epidemiology and Microbiology in Moscow and funded by the Russian Direct Investment Fund (RDIF), Gam-COVID-Vac is a viral vector vaccine similar to that developed by AstraZeneca and Johnson & Johnson (J&J). Vector vaccines are easier to administer than mRNA vaccines, which must be stored at very low temperatures.
In a vector vaccine, harmless viruses, such as inactive cold viruses, enter the genetic code for ear proteins – which the SARS-CoV-2 pathogen uses to attach itself to human cells – in the body. The body of a vaccinated person will recognize and respond to them as foreign substances by creating antibodies and specific T cells, both of which are important for immunity.
What is unusual about Sputnik V, however, is that two different types of cold virus, or adenovirus, are used for the first and second shot – rAd26 (which J&J also uses) and rAd5, respectively. This combination is supposed to prevent the second shot from neutralizing the immunizing effect from the first time and preventing the desired scratching effect.
How effective is Sputnik V?
In principle, it is possible to use two different vectors because it provides a higher effectiveness of the vaccine. The efficacy of other vector vaccines such as AstraZeneca (76%) and J&J (85.4%), which use only one vector, is much lower than that of the mRNA vaccines by BioNTech-Pfizer (95%) and Moderna (94 , 1%).
However, it is difficult to pinpoint the effectiveness of Sputnik V. It was approved for use in Russia in August last year before the state security review was completed. Eight months after the government’s approval, there is still no reliable data on the vaccine. Russia has not yet provided essential primary data to an independent drug testing authority.
Sputnik V was first approved for use in Russia last August
In September, British medical journal The Lancet partial results published from Sputnik V’s phase 1 and 2 trials. However, the two studies on safety, tolerance and immunogenicity included only 38 participants each. According to the findings, a strong immune response and no serious adverse side effects were detected.
International experts had strong doubts about the results – and not just because of the size of the pilot groups. Several researchers pointed out a number of oddities: although the different participants received very different forms of the vaccine, the study found that everyone had exactly the same antibodies in their blood on different days. They said it could not be a coincidence that the participants all had the same levels of T cells fighting the SARS-CoV-2 virus. About forty scientists from Europe, the United States, Canada and even Russia have signed an open letter raising concerns that data could be manipulated.
On February 2, Russian scientists released interim results of Phase 3 trials in The Lancet. They said more than 18,000 participants received two doses of the vaccine with an interval of three weeks, claiming that the efficacy was 91.6% without serious side effects. Once again, their international colleagues reacted with skepticism, pointing out that an independent evaluation could not have taken place if the primary data had not been published.
According to a new study released on April 3, Sputnik V is also effective against the B.1.1.7 variant first detected in the United Kingdom and the B.1.351 variant first detected in the South. Africa has been identified. However, this was not confirmed by a standard peer review process.
What are the risks?
In early April, the EU observer claims that four people died and six other serious health complications after being vaccinated with Sputnik V. In response, the Russian Federal Health Service, Roszdravnadzor, denied that there was a direct link to the vaccine.
Roszdravnadzor said there are no adverse side effects other than typical reactions after vaccination such as flu-like infections, skin irritations, headaches and fatigue.
The European Medicines Agency (EMA) launched an ongoing review in early March to look at data available from ongoing studies, to assess the efficacy and safety of Sputnik V. it requires access to a complete data set. The EMA intends to obtain the information in Russia in an accelerated review process, but Russia’s response so far has been reluctant.
Where has Sputnik V been approved for use?
According to DW’s research, Sputnik V has been approved in 60 states, including India, Mexico, Iran, Ghana, Sri Lanka and Serbia, as well as in the Palestinian territories and Republika Srpska, in Bosnia-Herzegovina.
Although Sputnik V has not yet received EMA approval, EU member states have granted Hungary and Slovakia national approvals. It is already being used in Hungary to vaccinate citizens, but in Slovakia the authorities have not yet approved the use of the 200,000 doses delivered by Russia.
It is difficult to find out with certainty which countries Sputnik V. approved and started using, including Argentina, Serbia, San Marino and of course Russia itself. According to Our World in Data, on April 12, about 8.8 million people, 6% of the population, received at least one shot in Russia – a rather low figure in international comparison.
Some countries have already ordered the vaccine and are conducting trials, but have not yet approved the vaccine. Brazil has already ordered about 76 million doses of Sputnik V in anticipation.
Will the EU start using Sputnik V?
There is growing interest in the Russian vaccine in Europe, although the European Commission is not currently negotiating future supply contracts, as was the case last year with BioNTech-Pfizer and AstraZeneca. The Czech Republic, Germany and Austria are trying to secure doses of Sputnik V via bilateral channels, but have insisted that the vaccine be used only after the EMA has given permission.
Although the EMA has already launched its ongoing review of Sputnik V, it will only be able to start the approval process after the first results of scientific and clinical trials have been evaluated. It can take weeks, if not months.
Russia hopes to supply 50 million doses to the European Union from June and also plans to build manufacturing sites in Europe. But Thierry Breton, who heads the European Commission’s vaccination task force, remains unconvincing.
“It normally takes many months to build up and push up the corresponding production. It is simply too late to use Sputnik V for our purpose of getting all Europeans vaccinated by the summer,” he told the German weekly. The mirror last week.
Additional reporting: Uta Steinwehr
This article has been translated from German