Warning against Russian corona vaccine

There is a lack of data, there is a lack of transparency: The president of the Paul-Ehrlich-Institute, Cichutek, criticized the Russian approval of a corona vaccine in the “tagesthemen”. Experts and governments are also skeptical internationally.

The Paul Ehrlich Institute (PEI), which is responsible for the approval of vaccines in Germany, considers the use of the corona vaccine approved in Russia to be a risk. PEI President Klaus Cichutek said in the “tagesthemen” that Russian vaccine development has shortcomings. “It is necessary to collect statistically significant safety and efficacy data. This seems not to have been done with this vaccine.”

Cichutek is referring to the fact that Russian approval was granted before the completion of the third phase of testing the vaccine. This usually takes several months and involves several thousand test subjects.

No vaccine data published
The newly approved experimental vaccine was developed by the Moscow Gamaleja Institute and tested for the first time on a few dozen volunteers less than two months ago. So far, no scientific results have been published.

Cichutek criticized this lack of transparency. It is common for vaccine developers to publish initial data through the media or scientific publications – “that has not happened here”.

Despite cooperation with the Russian authorities, the PEI had not heard anything about the far-reaching vaccine development before. The approval does not strengthen the confidence in the Russian drug authorities. “Vaccine development takes time. We need a good database to be able to grant approval with a clear conscience and that is what we will stand for,” said Cichutek.

Ministry of Health: No talks with Russia
Internationally, governments and experts have criticized Russia’s actions. A spokeswoman of the Federal Ministry of Health told the newspapers of the Redaktionsnetzwerk Deutschland that no data are known on the quality, effectiveness and safety of the Russian vaccine.

A positive benefit-risk ratio of the vaccine must be proven before it can be widely used. ” In the EU, patient safety is given “top priority”. The ministry says it is not currently holding talks with Russian authorities on the vaccine.

Criticism from the USA
Warnings about the vaccine also came from the USA. “It doesn’t matter if you’re the first with a vaccine. What matters is to have a vaccine that is safe and effective, for the American people and the people of the world,” said U.S. Secretary of Health and Human Services Alex Azar.

Renowned US physicians have a similar view: “Claims of having a vaccine that can be widely used before testing is problematic at best,” said Anthony Fauci, the top expert on infectious diseases in the US. Lawrence Gostin, an expert on global health laws at Georgetown University in Washington, expressed concern that Russia was skipping important steps in the process and “the resulting vaccine may not only be ineffective, but also unsafe.

Israel is considering
Israel on the other hand showed interest in the Russian vaccine, which is to be marketed internationally under the name “Sputnik V”. Israeli Health Minister Juli Edelstein said that there were already consultations. “If we come to the conclusion that it is a serious product, we will also try to start negotiations,” Edelstein said after a report on the news site “ynet”. But he didn’t want to give anyone any illusions: “The vaccine won’t come tomorrow.”

WHO reminds of international standards
The World Health Organization (WHO) emphasizes that potential vaccines must always pass through all test phases before they are put on the market. “There are established practices and guidelines,” said spokesman Christian Lindmeier. In order for a vaccine to be used in Germany, it must be officially approved. Nationally, the PEI is responsible for this. Alternatively, a central European approval can be granted by the EU Commission. This is coordinated by the European Medicines Agency (EMA) with the participation of the PEI. More than 170 vaccine projects are currently underway worldwide, but only six are in the advanced third phase of clinical trials according to the WHO.