Brazil Rejects Sputnik V Vaccine, Says It’s Tainted With Replicating Cold Virushttps://arstechnica.com/science/2021/04/brazil-rejects-sputnik-v-vaccine-says-its-tainted-with-replicating-cold-virus/Health regulators in Brazil say that doses of Russia’s Sputnik V COVID-19 vaccine contain a cold-causing virus capable of replicating in human cells.
The unintended presence of the virus in the vaccine 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,” Brazil’s Health Regulatory Agency, Anvisa, said Wednesday in a translated statement.
https://www.gov.br/anvisa/pt-br/composicao/diretoria-colegiada/reunioes-da-diretoria/votos/2021/copy2_of_rextra-7-de-2021/voto-120-2021-dire5.pdfBrazil’s findings raise serious questions about the quality and safety of the vaccine, which is now being used in many countries.
The findings also support concerns of Slovak regulators, who said earlier this month that batches of Sputnik V they received did not “have the same characteristics and properties” as the Sputnik V vaccine that was described in a peer-reviewed publication and found to be 91.6 percent effective.Moreover, quality-control issues weren’t the end of Anvisa’s concerns. In an overall evaluation of the Russian vaccine, Brazil’s regulators found its safety and efficacy were based on insufficient, limited, and sometimes faulty data and analyses.
“Flaws... were identified in all stages of clinical studies,” Anvisa said. The agency also reported that its inspectors who traveled to Russia to assess the vaccine’s production were barred from vaccine facilities at Gamaleya Institute, which developed Sputnik V.
Brazil’s regulators say they reviewed data that indicated there was replication-competent adenovirus (RCA) in every evaluated batch of the second Ad5-based dose of Sputnik V.
In a 21-page report from Anvisa, the regulator wrote - translated from Portuguese on page 8:
“Although international guidelines have established that replicating viruses should not be present in the vaccines, the [Sputnik V developers] set the limit of 1x103 [1,000] RCA per dose of 1x1011 [100 billion] viral particles, which is considerably above the limits allowed in the guidance of the American FDA” for gene therapies.
The US Food and Drug Administration’s guidance for gene therapies states that they “recommend a maximum level of 1 RCA in 3×1010 [30 billion] viral particles.” That would allow for no more than about 3.33 RCA in 100 billion viral particles, not 1,000.
In another report, Anvisa wrote (again translated): “
It is noteworthy that the replicating adenovirus was detected in all batches presented for component II [Ad5-based second dose] of the vaccine and not evaluated in component I [Ad26-based first doses].”The data was enough to worry the regulators, who had a string of questions after seeing this data. Those included: “How long can replicating viruses remain in the human body? In what organs and tissues can they be found? Can they cause any damage to tissues and organs? Can this replicating virus be transmitted to other people? What does it mean in terms of safety for those who receive the vaccine? [Is there] increased risk of adverse events?”
... For now, no Brazilians will be rolling up their sleeves for Sputnik, given the regulator’s concerns. Freitas expressed hope that Russian vaccine developers would be open to their critique and take the necessary steps to address problems “because millions of people need access to safe and effective vaccines,” she said.
But that appears unlikely. In a press release, the Russian Direct Investment Fund (RDIF), which financially backed the development of Sputnik V, called Brazil’s criticisms and vote “political.”
“These allegations have no scientific basis and cannot be taken seriously in the scientific community and among international regulators,” the RDIF said.
The official Twitter account for the Sputnik vaccine, thought to be run by the RDIF, took things a step further, calling Anvisa’s assessment “fake news.” On Thursday, the account tweeted that “Sputnik V is undertaking a legal defamation proceeding in Brazil against Anvisa for knowingly spreading false and inaccurate information.”
Russia touts that “the safety and efficacy of Sputnik V has been confirmed by 61 regulators in countries where the vaccine has been authorized.” However, Brazil’s regulators said that of 51 countries it contacted, only 14 were using the vaccine, and that most of those countries were ones that did not have a tradition of vigilant drug safety monitoring.
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