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One of the main issues raised by ANVISA was the existence of replication-competent adenovirus (RCA) which is a fragment of the virus, in the vaccine. This was completely denied by the Gamaleya Institute.
The Sputnik V manufacturer could submit a defamation lawsuit against Brazilian health regulatory agency ANVISA after spreading false information about the vaccine, local media outlets reported on Thursday.
According to Russian agency Sputnik, the manufacturer will reject in court the objections against the vaccine put forward by ANVISA. "The decision of the National Health Surveillance Agency (Anvisa) to postpone the approval of Sputnik V is, unfortunately, of a political nature and has nothing to do with the regulator's access to information or science," the Gamaleya institute said in a statement.
Em sua coletiva de imprensa hoje, a Anvisa confirmou que não encontrou nenhum adenovírus replicante (RCA) na Sputnik V, mas estava preocupada com o limite regulatório teórico russo para esse parâmetro.
"At its press conference today, Anvisa confirmed that it found no replicating adenovirus (RCA) in Sputnik V, but was concerned about the theoretical Russian regulatory limit for this parameter."
"The Sputnik V team addressed the technical issues raised by Anvisa's directors during the April 26 meeting to demonstrate that these allegations have no scientific basis and cannot be taken seriously in the scientific community and among international regulators," the authorities added.
One of the main issues raised by ANVISA was the existence of replication-competent adenovirus (RCA), which is a fragment of the virus, in the vaccine. The Gamaleya Institute completely denied this.
However, during a press conference on Thursday, ANVISA backtracked on its concerns about Sputnik V. "At its press conference today, Anvisa confirmed that it found no replicating adenovirus (RCA) in Sputnik V, but was concerned about the theoretical Russian regulatory limit for this parameter," said the Sputnik V manufacturer via Twitter. "How nice that Anvisa is starting to clear up the confusion it has created," it added.