To clarify the issues related to the ongoing disinformation campaign against Sputnik V:
Recent inaccurate and misleading comments by Brazilian regulator Anvisa alleged detection of replicated adenovirus (RCA), a weakened viral particle that does not even cause a common cold, in Sputnik V.
Gamaleya Institute confirms that no RCA was detected in any of the batches of the Sputnik V vaccine. That information was sent to Anvisa on March 26th. (An official letter from the Gamaleya Center dated March 26, 2021 clearly said: “In addition, we would like to inform you that during the release of the vaccine product at the Center site and at the contract site of JBC Generium, not a single batch containing RCA was recorded.”)
Anvisa even though initially said that it detected RCA, admitted that it did not undertake any tests of the vaccine and was referring to a regulatory limit in Russia on potential RCA presence.
Gamaleya Institute clarified to Anvisa that the limit used for quality control of the Sputnik V vaccine is much stricter than the allowed regulatory limit in Russia and corresponds to the strictest standards of the world regulators. That strict limit has been confirmed by 64 of the world’s regulators that authorized Sputnik V and allows to ensure the quality of the vaccine as evidenced by its safety and efficacy track record. According to publicly available data from Mexico, Argentina, Hungary and other regulators, Sputnik V showed the best safety track record of any vaccine.
Anvisa did not attempt to clarify any of these issues after their visit and their inaccurate statements could have been avoided simply by asking for Gamaleya Institute to comment.
Gamaleya Institute asks the press not to disseminate incorrect information and to refer to this official statement. Gamaleya Institute regrets that unethical forces continuously attack the Sputnik V vaccine for competitive and political reasons costing lives and undermining the world vaccination program.
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