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Sputnik V Legal Suit Against the Curious Actions of Brazil’s Regulatory Body

On April 26, Brazil, in a curious development, rejected Russia’s Sputnik V vaccine, saying that the adenovirus would replicate in the body (even though it is engineered to make that impossible). On April 29, Anvisa’s manager of medicines and biological products, Gustavo Mendes, admitted that they actually “did not do a test for a replicated adenovirus.” Later that day, Sputnik V’s official Twitter account announced a legal action: “Following the admission of Brazilian regulator Anvisa that it did not test Sputnik V vaccine, Sputnik V is undertaking a legal defamation proceeding in Brazil against Anvisa for knowingly spreading false and inaccurate information.”

Later, still on April 29, the head of Anvisa, Antonio Barra Torres sounded somewhat apologetic on the April 26 decision to reject Sputnik V: “We made the decision based on the data received…. The provided data can be reviewed, corrected and submitted again.… On Monday, we could not approve [the vaccine] to our great disappointment.… We are not shutting the doors.” Stay tuned for this drama. It seems that the character putting muscle on the Brazilian regulators not to approve a needed vaccine has not appeared openly on the stage.