The creators of the Russian vaccine Sputnik V announced hours earlier on Twitter that they had filed a lawsuit.
Brazil's health regulator, Anvisa, said on Thursday that it decided to reject the importation of the Sputnik V vaccine
based on information sent by the Russian developer himself, who threatened to sue the institution for defamation.
"Information on the presence of replicating adenovirus [a live version of one of the viruses used as a vector] is contained in the documents delivered to Anvisa by the developer of the Sputnik V vaccine
," said the president of Anvisa, Antonio Barra Torres.
The creators of the Russian vaccine
Sputnik V announced hours earlier on Twitter that they had filed a lawsuit "for defamation against Anvisa for spreading false and incorrect information."
"Anvisa made incorrect and misleading statements without having tested the Sputnik V vaccine
," underlined the creators of the drug.
Then, Barra Torres summoned the press to "refute serious accusations that impact the confidence and credibility of the Brazilian health authority."
Anvisa was accused of lying, acting unethically and producing false news about the identification of replicating adenovirus in documents dealing with the Sputnik V vaccine
, subject of the decision that did not authorize the exceptional importation of the vaccine
for use by our population.
In addition to other relevant issues that prevented the import authorization of the vaccine
, I can mention among them the absence of information, of studies that portray effects on germ cells," he said.
The collegiate of five Anvisa directors accepted the recommendation of the agency's technical area, which identified various "uncertainties" in relation to the safety and efficacy of the immunizer, which has not yet been approved by the European Medicines Agency (EMA) or the FDA (Federal Food and Drug Administration) of the United States.
The viral vector vaccine
is being used in many countries in addition to Russia, including Mexico, Argentina and Venezuela.
The import order for the Russian vaccine
had been made by governors of the northeast, concerned about the lack of immunizers.
Brazil, where the pandemic already left 400,000 dead, began its vaccination campaign with great delay. So far it uses the Chinese CoronaVac vaccine
and the Swedish-British AstraZeneca
, which suffer from delivery delays.