Russian corona vaccine registered and not approved?

Coronavirus vaccine is only registered and not approved

The Russian corona vaccine was not approved, but only registered, claims the broadcaster “RT Deutsch”. German media reported incorrectly here. The reality is different.

The outcry in the German mainstream was great, according to the Russian state broadcaster “RT Deutsch”. The ARD wrote “high-risk experiment”, the “Süddeutsche Zeitung” “foamed” against the vaccine propaganda. Russian President Vladimir Putin would not have spoken of approval when it was announced

German media had refrained from quoting Putin in full. In the Russian original, it would have said unequivocally: “As far as I know, this morning for the first time a vaccine against the new coronavirus infection was registered worldwide.” Registered – not allowed.

Now, the term “registration” in relation to drugs, medicines, and vaccines is not widely used in German. It is misleading: if a drug is allowed to be manufactured, sold, and used on humans, the correct term for it is “approval”.

“Registration” means “Admission”

They speak of an “approval”
Federal Institute for Drugs and Medical Devices and also the European Medicines Agency. In Germany and the EU, these are the competent authorities who, after examining the evidence for the effectiveness, safety, and quality of the drug, decide whether it can be marketed. And should it be the case, the approval is officially and legally binding “Approval”.

Legally, the “registration” of drugs in Russia means that they can be released onto the market. Article 13 of the Russian Federal Law on the Circulation of Medicinal Products states:
“In the Russian Federation, manufacture, manufacture, storage, transport, import into the Russian Federation, export from the Russian Federation, advertising, dispensing, distribution, delivery, application, and destruction of medicinal products are permitted if they are authorized by an authorized federal body of the Executive branches have been registered. “

decree facilitates admission

On April 3, 2020, the Russian government also passed one
Decree provides for a somewhat simplified approval procedure for medicinal products. This decree relates, among other things, to emergency situations, but also to the prevention and treatment of diseases that pose a threat to people. “RT Deutsch” also refers to this decree.

Among other things, this decree stipulates that a short report on the effectiveness and safety of a drug in the context of clinical research may be sufficient when applying for approval.

Admission can also take place if the documents are not submitted in full. For these cases, the decree provides, among other things, for random checks of the approved medicinal product. Both the reprimand and the decree thus prove the legality of the approval – which has not been questioned in the media reporting.”registration” is an important step

The fact that the state “registration” of a drug is of great importance in Russia is borne out by the open letter from the Association of Organizations Conducting Clinical Research. Several large pharmaceutical companies and research laboratories from Russia and abroad belong to this non-commercial organization.

The day before the approval was granted, this association asked for the “registration” of the vaccine Gam-COVID-Vac to be postponed. Gam-COVID-Vac – that’s the official name of the vaccine.

This is a new vaccine, it has not even been tested on a few hundred people. Not to mention the usual Phase III tests on several thousand research participants, according to the open letter.

“We call on the Ministry of Health of Russia to postpone the question about the approval of the vaccine Gam-COVID-Vac until the phase III clinical research is completed,” the association writes.

Now the continuation of the clinical tests of the vaccine after its “registration” is recorded in the approval certificate. The random quality controls are also mandatory. The head of the research institute Alexandr Ginzburg said the clinical tests after approval – or phase III – could start seven to ten days after approval. Tens of thousands of people should take part in these tests.

mass production should start

That Russia has nothing else to do with the “Sputnik V” vaccine than to make it available for people’s vaccinations – Putin left no doubt in his statement on August 11th.

“I hope we can start mass production in the near future. This is important,” said Putin. Everyone who wanted to – that had to be done voluntarily – should be able to claim the services of the researchers, declared the Russian President.

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