The EMA is testing the Russian corona vaccine “Spuntik V” in a rolling approval process. Scientists have discovered suspicious anomalies.
So far, the Russian vaccine “Sputnik V” has not yet been approved in the EU by the European Medicines Agency (EMA). The EMA already signed a “Sputnik V” corona vaccine at the beginning of March rolling approval process started *. Scientists now have more and more doubts about the Russian corona vaccine due to inconsistencies in the data on “Sputnik V”, such as echo24.de* reported.
EMA experts are currently in the course of the “Rolling Review” approval process in Russia because they have many questions about the Russian data submitted so far. They visit clinics where vaccination takes place, production facilities and storage rooms, as reported by the German Press Agency. Health expert Jérôme Lepeintre expects a decision at the EU representation in Moscow in June or July at the earliest. If “Sputnik V” is approved, the vaccine will also be used in Germany.
Scientists doubt data on “Sputnik V” vaccine: there is a lack of transparency
Russia’s vaccination officials have long been criticized for not handling the research figures transparently. Independent experts also assume that Russia can only deliver a small fraction of the doses that it has previously promised internationally. According to official information, Hungary alone received a million “Sputnik” cans. The country was the only EU member to approve the vaccine nationally without waiting for the EMA decision.
Anyone who sees reports on large-scale “Sputnik V” transports, for example to Latin America, on Russian state television quickly gets the impression that the vaccine is conquering the world. Western preparations do not play a role in Russia. Many regions in Russia are even complaining about delivery bottlenecks, as even Kremlin chief Vladimir Putin had to admit. According to Putin, only 4.3 million people have received a vaccination. That is just under three percent of the 146 million inhabitants.
Doubts about “Sputnik V”: Scientists discover abnormalities in vaccine data
In one of the UK medical journal The BMJ In the published letter, the scientists Florian Naudet, Enrico Bucci and other researchers found abnormalities regarding the effectiveness of “Spuntik V”, such as ntv reported. The critical scientists are not vaccine researchers, but medical professionals who have critically examined the data sets submitted for the various test phases. The focus is on statistical abnormalities.
According to the published letter, there are numerous anomalies in the Russian data from the vaccine study by “Sputnik V”. The complete data sets for the various test phases of the vaccine developed at the Gamaleja State Research Center for Epidemiology and Microbiology in Moscow have not yet been published – only their evaluation.
Scientists discover anomalies: manipulated vaccine data for “Sputnik V”?
The doctors had already expressed their first doubts last September. At that time, nine test subjects had exactly the same antibody value after 21 and 28 days. The same thing allegedly happened to seven out of nine subjects using a different version of the active ingredient. The values are repeated in further separate observations.
With regard to the test persons, there are other anomalies: According to the scientists, the pattern of the data presented in September for different test persons, material variants and times does not match natural cell reproduction. The values for antibody formation in different test subjects with different active ingredient variants also showed unnatural patterns.
Other abnormalities concern the effectiveness of the Russian vaccine. In November and December, the manufacturer published three press releases on interim evaluations of the third test phase – in all three press releases the effectiveness of the vaccine “Sputnik V” is 91 and 92 percent. The proportion of sick people in the groups of the vaccinated and the control group is always the same – which, according to the scientist, is very unlikely with a five-digit number of study participants
How ntv reported, the scientists come to the conclusion: “The unusual and improbable high homogeneity of vaccine effectiveness across age groups and various intermediate analyzes gives rise to concerns about the reported data.” On March 12, Naudet and his colleagues raised their concerns to the European Medicines Agency communicated.
“Sputnik V” in Germany: Bavaria and Mecklenburg-Western Pomerania secure their first vaccination doses
When and whether the Russian corona vaccine will be vaccinated in Germany is still unclear. Federal Minister of Health Jens Spahn (CDU) emphasized that approval by the European Medicines Agency (EMA) must first be given. Nevertheless, some federal states started going it alone even before a possible EU approval.
Bavaria signed a preliminary contract for 2.5 million “Sputnik” cans on Wednesday, Mecklenburg-Western Pomerania followed suit on Thursday with an option for one million cans. However, the advance of the countries also met with criticism. Thuringia’s Prime Minister Bodo Ramelow (left), for example, sees the federal government as an obligation for procurement, as a government spokesman said.
Baden-Wuerttemberg * does not want to secure doses of the Russian vaccine “Sputnik V” themselves like Bavaria and Mecklenburg-Western Pomerania. There is a best practice, said Health Minister Manne Lucha (Greens), according to a spokesman on Thursday in Stuttgart. The federal government and the EU took care of the procurement and approval of the vaccines, the federal states were responsible for the vaccination. “I don’t see any reason to change anything,” says Lucha. With regard to the procurement of vaccines, the minister described it as correct “that the federal government and Minister Spahn have now announced bilateral talks with Russia.”
Corona vaccine from Russia: Slovakia and Ukraine criticize and criticize “Spuntik V”
The EU states Hungary and Slovakia have already purchased “Sputnik V” on their own, Hungary issued an emergency license. In Slovakia, the state drug control SUKL published a critical report on the Russian vaccine, which criticized the quality. The vaccine has not yet been used in the country. According to information from Russia, Slovakia had been asked to return the vaccine because of “multiple breaches of contract”, as the state direct investment fund RDIF wrote on Twitter. “Vaccines should save lives and not be used in geopolitical and internal political struggles.”
The chairman of the Standing Vaccination Commission (Stiko), Thomas Mertens, said in the ZDF morning magazine, the published data on “Sputnik V” look “very good”, but he does not know what additional data is available to the EMA. “If the vaccine is tested and approved, I personally would have no objection to it.” Mertens previously described “Sputnik V” as “cleverly built”.
The Ukrainian Foreign Minister Dmitri Kuleba also warned in the picture before the Russian vaccine. “Unfortunately, Sputnik V is not about humanitarian goals. Russia uses it as a tool to increase its political influence. ”Ukraine finds itself in a war with the neighboring country after the Russian annexation of its peninsula Crimea on the Black Sea. *echo24.de is an offer from IPPEN.MEDIA.
List of rubric lists: © Jesus Vargas
#Data #manipulated #Scientists #trust #information #Sputnik #vaccine