Anvisa: Adenovirus replication in Sputnik V attested in documents

Brazil’s watchdog responded to entities responsible for vaccine

Published in 30/04/2021 - 14:50 By Jonas Valente - Brasília

The president of Brazil’s national drug regulator Anvisa, Antônio Barra Torres, made a statement on the watchdog’s social media on Thursday (Apr. 29), rebutting the criticism from the laboratories and institutions responsible for the development of vaccine Sputnik V.

The request for the import of 66 million doses of the shot was denied on Monday (26). Anvisa listed a number of issues, among which the alleged presence of adenoviruses capable of replicating in the body of patients who receive the jab.

On Thursday morning, the developers of the Russian vaccine wrote on Twitter they intend to take Anvisa’s assessment to court. “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,” the message reads.

In the statement, Anvisa sought to rebut the argument from Sputnik V developers and reinforce the evaluation conducted by its technical team as well as the decision to deny imports. Anvisa’s president and the agency’s Management-General for Medications Gustavo Mendes said that the information on adenoviruses capable of replication could be found in the document submitted by the laboratory itself.

“Anvisa has been accused of lying, working unethically, and producing fake news on the identification of replicating adenoviruses in documents on the Sputnik V vaccine. The information on the presence of replicating adenoviruses can be found in the documents submitted to Anvisa by the developer of vaccine Sputnik V,” Barra Torres declared.

Gustavo Mendes advocated for the team responsible for vaccine analysis, who, he said, boasts wide experience in the matter. Mendes argued that proposals are examined chiefly based on the vaccine’s safety. In the assessment, the team is said to have found signs of the presence of adenoviruses with replication capacities both in the documents and in the tests.

“The sequence of the evaluation starts when the company states that the manufacture process of RAD5SCov2 particles—one of the key particles in this case—may produce replicating particles, those that will spread through the body. That’s not expected from a vaccine. The vaccine is made up of two types of adenovirus. For one, a justification is presented for non-replication; for the other, it is not,” Mendes said.

Meeting with Gamaleya Institute

Manager Gustavo Manager added that replicating adenoviruses were found in the finished product—not in the intermediary phases of manufacture—at a rate said to be 300 times superior than the largest limit allowed by the US Food and Drug Administration (FDA).

Mendes reported that a meeting was held between Anvisa’s technical staff and that of Gamaleya Institute, tasked with the development of Sputnik V, on April 23. As part of the statement, a video was displayed showing Anvisa experts questioning the matter on the replicating adenoviruses and why the issue had not been addressed.

The video shows what is believed to be the voice of representatives from the Russian institute admitting that the adjustment would take time. In the dialog registered, Sputnik V representatives seem willing to answer the questions posed by Anvisa specialists. According to Gustavo Mendes, the agency sent the inquiries in writing, but the answers received from Gamaleya Institute were reported not to cover the questions.

Sputnik V team

On its Twitter account, the team responsible for Sputnik V interpreted the statement as an admission that Anvisa did not find replicating adenoviruses in the inoculation, but was concerned about the Russians’ theoretic regulatory limit for this parameter.

In a press conference with journalists after the pronouncement, Anvisa’s director-president responded to the messages from Sputnik V. “There is no interpretation. It is written and it has been said in the video shown. No, they present documents [about what] would be the maximum acceptable value, which is an understanding that conflicts with the FDA and what has been found in the samples, and what has been found is superior to zero,” Barra Torres said. He added that, if no changes are made in the vaccine, its use cannot be authorized in Brazil.

União Química

União Química, the Brazilian company that forged the partnership for the production of Sputnik V, published a letter to Anvisa’s president on Wednesday (28). In the document, the firm asks what doses of the vaccine were analyzed and argues that no Sputnik V vaccine was officially provided to Anvisa either by itself or by a Russian partner.

In the letter, União Química states tat Gamaleya Institute denied having found any replicating adenoviruses in any batch of the inoculation. The company believes that Anvisa’s statements on replicating adenoviruses are false and reiterates that a subsidiary of the Russian Direct Investment Fund (another institution in the consortium assembled for vaccine production) will file a lawsuit.

On the topic, Barra Torres declared during the presser that the agency makes no use of laboratories, adding that the analysis is based on papers sent by vaccine developers. There are “a number of issues other than the adenoviruses” in the process, he pointed out.

Translation: Fabrício Ferreira -  Edition: Fábio Massalli / Nira Foster

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