Russian Vaccine Maker to Sue Brazil After Accusation of Poor Quality Control

A healthcare worker prepares a dose of Russia's Sputnik V Covid-19 vaccine, at a vaccination centre in Moscow on April 26, 2021. (Photo by Natalia KOLESNIKOVA / AFP) (Photo by NATALIA KOLESNIKOVA/AFP via Getty Images)

The Gamaleya Institute, the Russian company responsible for the Chinese coronavirus vaccine candidate Sputnik V, announced on Thursday it would sue Brazil’s health regulators for defamation after they refused to grant authorization for distribution of the product.

The Brazilian National Health Surveillance Agency (Anvisa) issued an extensive statement on Thursday announcing it had rejected requests from several Brazilian states and the federal government to grant emergency use authorization to Sputnik V, the first vaccine candidate developed against the novel Chinese coronavirus to receive approval since the pathogen first began infecting humans. Anvisa stated in its explanation that it had repeatedly requested that the Moscow-linked Gamaleya Institute provide more detailed data on the manufacturing of the vaccine candidate and had not received it.

The statement also claimed that Brazilian officials visited manufacturing plants in Russia and found no uniform standards for quality control and that, in some samples tested in Brazil, doses of Sputnik V carried live adenovirus, a pathogen that causes respiratory infections in people.

Sputnik V uses an inactivated adenovirus — meaning one that cannot reproduce and cause an infection — as a carrier for the spike protein in the Chinese coronavirus, theoretically prompting the human body to create antibodies against the coronavirus without a person having to come in contact with the active virus. Anvisa did not challenge the design of the vaccine candidate, only identifying alleged flaws in the manufacturing process that allow the adenovirus to remain a threat to humans, which also calls into question if the affected doses have any impact on coronavirus immunity.

The official Twitter account of Sputnik V, run by Gamaleya, denied all of Anvisa’s accusations and announced it would engage in legal action against the Brazilian health authority.

“Anvisa made incorrect and misleading statements without having tested the actual Sputnik V vaccine,” the account claimed, “And disregarding official letter [sic] from Gamaleya Inst. that no RCA is present, and only non-replicating vectors are used with E1 deleted. Our legal team will be in touch.”

The account followed up by asserting it would begin a “legal defamation proceeding in Brazil against Anvisa for knowingly spreading false and inaccurate information.”

In a longer reply to the Anvisa statement, Sputnik’s developers accused the Brazilian health oversight agency of making a decision “of a political nature” without regard to “information or science.”

“The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, has confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced,” the statement read. “Existing quality controls ensure that no RCA can exist in Sputnik V vaccine.”

The statement also claimed that Anvisa lied about being denied key data during an official visit to Russian Gamaleya vaccine plants.

On Friday, the Gamaleya Institute went further on Twitter, appearing to accuse the United States of being responsible for Anvisa’s decision.

“In 2020 annual report, US Dep. of Health confirmed that it ‘persuaded Brazil to reject the Russian COVID-19 [Chinese coronavirus] vaccine,'” the Sputnik account claimed. “Efforts to undermine the vaccines are unethical and are costing lives.”

The mouthpiece account linked to a report by the U.S. Department of Health and Human Services (HHS) that described efforts to “mitigate malign influences” in the Americas from countries like Russia, including “using OGA’s [the HHS Office of Global Affairs] Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine.” The report is an overview of activities for 2020 published in January 2021.

At the time, no peer-reviewed data for Sputnik V was available publicly. Russian leader Vladimir Putin, who is not a public health expert, approved use of the vaccine candidate in Russia in August 2020, before the necessary Phase III clinical trials had ended. Anvisa issued a statement that month stating it could not approve the vaccine candidate for use in part because of the lack of adequate Phase III trial data.

Anvisa’s director Antônio Barra Torres responded swiftly to the allegations by the Gamaleya Institute, insisting that the agency was “not closing the door” to the approval of the vaccine candidate and that it gave officials “great sadness” not to be able to approve the product, but that Anvisa had not lied about its lack of access to necessary clinical data.

The initial rejection from Anvisa accused the Russian company of leaving Brazil with “an absence or insufficiency of quality control, safety, and efficacy data.”

“One of the worrying facts regarding the evaluation of the data available so far is that the cells where the adenoviruses are produced for the development of the vaccine allow their replication,” the statement read. “This can lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems.”

In Russia, the statement added, Brazilian regulators found a “lack of validation/qualification of quality control methods” in the factories producing Sputnik V doses and “inadequate” sanitation measures.

Follow Frances Martel on Facebook and Twitter.


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