Brazilian Medical Regulator Denies Defamation Allegations Of Sputnik V Manufacturers

Brazil's Anvisa health regulatory agency has denied the allegations of the manufacturers of Russia's Sputnik V COVID-19 vaccine, who are planning to launch a legal defamation suit against the regulator for spreading allegedly false and inaccurate information about the vaccine

RIO DE JANEIRO (UrduPoint News / Sputnik - 30th April, 2021) Brazil's Anvisa health regulatory agency has denied the allegations of the manufacturers of Russia's Sputnik V COVID-19 vaccine, who are planning to launch a legal defamation suit against the regulator for spreading allegedly false and inaccurate information about the vaccine.

Anvisa's Collegiate board on Tuesday unanimously rejected a regional government request to import the Russian-made vaccine. The Russian Direct Investment Fund, which markets Sputnik V abroad, said it believes the decision may be "politically motivated," citing a US Department of Health report that the United States had attempted to persuade Brazil not to use the vaccine. On Thursday, the manufacturers of Sputnik V said they would launch a legal defamation suit against Anvisa for "knowingly spreading false and inaccurate information."

"Anvisa has been accused of lies, unethical behavior and spreading false news about the discovery of a replicating adenovirus in the documents related to the Sputnik V vaccine ... These are serious accusations that undermine the credibility of the organization," the head of Anvisa, Antonio Barra Torres, said at a press conference.

According to the Brazilian regulator, the main obstacle to the approval of the Russian vaccine imports is the presence in it of replicating adenoviruses, which can cause infections in healthy people after vaccination.

The developers of the drug denied these statements, but Barra Torra said that this information was contained in the documents received from the Russian side.

During the presentation, Anvisa's management showed the pages of documents allegedly provided by the Sputnik V developers, with tables showing the presence of replicating adenoviruses. The Brazilian health regulator also released an audio recording of its meeting with officials from Gamaleya National Center, the developer of the Russian vaccine, which took place on March 23.

According to the audio recording, Brazilian specialists asked the Russian side why the vaccine development process was not reversed when the replicating adenoviruses were discovered. A representative of the Russian laboratory, according to the interpreter, replied that "it would take a long time."

The Anvisa chief denied the allegations of politicization and assured that there are no people in the agency who were "interested or happy" about the denial of permission to import any vaccine or medical product. Anvisa's report on the evaluation of the Sputnik V vaccine has been sent to the World Health Organization and other foreign regulatory bodies, he said.

The Sputnik V vaccine has been approved for emergency use in 60 countries worldwide.