Russia's Sputnik V COVID-19 Vaccine Manufacturer Sues Brazilian Authorities

Illustration of Sputnik V. vaccine (Wikimedia Commons / Casa Rosada)

JAKARTA - Russian COVID-19 vaccine developer Sputnik V has announced plans to file a libel suit against Brazilian health regulator Anvisa.

The Anvisa Council on Monday this week denied the Brazilian state's request to approve the import of Sputnik V. Anvisa manager for pharmaceuticals and biological products Gustavo Mendes said there was evidence the adenovirus used in vaccines could reproduce, which he called a serious flaw.

Adenovirus, a category of viruses that can cause various diseases in humans such as the common cold, is sometimes reused as a viral vector for vaccines.

Such viral vectors are often used to transport genetic material for proteins, in this case, from the novel coronavirus, to elicit an immune response from vaccinated individuals.

However, global health guidelines warn against 'replication-competent adenoviruses' (RCA) that can multiply in a patient's body, possibly creating a negative reaction.

Denis Logunov, who developed Sputnik V at Russia's Gamaleya Institute, denied that the two adenoviruses used to produce vaccines could replicate a day after Mendes' statement.

The official Sputnik V Twitter account on Thursday quoted Mendes, who cited the Gamaleya Institute test results at a public hearing on Monday as a basis for refusing an import permit.

"Following the recognition of Brazilian regulator Anvisa that they did not test the Sputnik V vaccine, Sputnik V carried out a defamation process in Brazil against Anvisa, for deliberately spreading false and inaccurate information", said Sputnik V.

"Anvisa made false and misleading statements without testing the Sputnik V vaccine", the statement said.

In a press conference on Thursday, Anvisa officials dismissed the grave accusations and insisted the Gamaleya Institute documents themselves mark the potentially risky RCA levels in the finished vaccine.

"The data presented by the Gamaleya Institute show the presence and acceptance of the replicating virus in the finished product", said Mendes.

"Those specifications are 300 times higher than the highest threshold we could find", he added.