Brazil Rejects Sputnik V Vaccine, Says It's Tainted With Replicating Cold Virus (arstechnica.com) 104
Artem S. Tashkinov shares a report from Ars Technica: 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. Russia has unequivocally denied the claim, lobbed legal threats at Anvisa, and accused the respected regulators of being politically motivated to reject the vaccine. Still, Brazil'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. 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 the 51 countries it contacted, only 14 were using the vaccine, and most of those countries did not have a tradition of vigilant drug-safety monitoring.
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. 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 the 51 countries it contacted, only 14 were using the vaccine, and most of those countries did not have a tradition of vigilant drug-safety monitoring.