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Old 04-29-21, 02:23 PM   #7062
Skybird
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The Frankfurter Rundschau writes:


Update from 04/29/21 5:58 p.m .: The developer of the Russian vaccine Sputnik V has announced a defamation lawsuit against the Brazilian regulatory agency Anvisa, which refused to import the vaccine. -

Anvisa had "knowingly distributed false and inaccurate information" about the vaccine, wrote the Russian manufacturer on Thursday in the short message service Twitter. Anvisa justified the import refusal on Monday with a lack of data on safety and effectiveness.-

Sputnik V has not yet been approved in the EU, but the EU Medicines Agency (EMA) has already started a so-called rolling process for the approval of the vaccine. -

First report from 04/29/21 2:45 p.m .: Brasília - A Brazilian health regulator announced in a congressional hearing that the approval of the Russian corona vaccine Sputnik V by other countries does not mean that it meets Brazilian regulatory requirements. -

The reason for this is, on the one hand, that the agency commissioned with the examination did not receive enough data to approve the Sputnik V vaccine. In addition, every single batch of the Russian corona vaccine for which data was available still contained replication-competent adenovirus. -

The adenovirus vector vaccines are made by removing most of the adenovirus DNA information from the virus and replacing it with DNA to make coronavirus antigens. All adenovirus vector vaccines carry the DNA to make the coronavirus spike protein. Important parts of the original genome are removed so that they cannot replicate in the body. -

Because of this, the news that the Sputnik vaccine contains replicating adenovirus came as a surprise to many. Big problems in the vaccinated population are not to be feared, but it remains an unnecessary risk. -

This risk, of course, increases when such a vaccine is used in millions (or more) of people. In the eyes of the Brazilian government, it seems certain that some people could be harmed by this preventable problem. The rally in Brazil now calls into question the entire manufacturing and quality control process of the Russians. -

Cases of counterfeit corona vaccine from Biontech and Pfizer are becoming more and more common. Sputnik V is also affected.
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