Brazil’s health authority, Anvisa, said late Monday that it would not recommend the import of the Russian-developed Kovid-19 vaccine Sputnik V.
Anvisa said that critical safety tests were not conducted, and questions remain about the development, safety, and manufacturing of the vaccine.
Data about the vaccine’s efficacy were “inconclusive,” said Gustavo Mendes Lima Santos, manager of medical and biological products, in a lengthy presentation clarifying the health authority’s decision. The presentation stated that there were “important questions” that went unanswered, including concerns about potential adverse events, such as clots.
a Tweet From the official Sputnik V Twitter account – in Portuguese – pushed back on Monday, saying that the developers of the vaccine had shared “all the necessary information and documentation” with Invesha. In another Tweet, It urged Anvisa “we don’t have time to waste – let us start saving lives in Brazil. Together.”
Russia is using Sputnik V in its mass vaccination campaign, and the vaccine has been approved for emergency use in dozens of other countries. Its rollout is entangled in politics and propaganda, President Vladimir V. Putin has approved its use even before the start of the late-stage trial. For months, it was piled on by Western scientists.
The Gamalaya Research Institute, part of Russia’s Ministry of Health, developed the vaccine, also known as Gam-Kovid-Vek. A peer review published in The Lancet in February stated that the vaccine’s efficacy rate was 91.6 percent.
The skepticism of Western experts has focused mostly on its initial approval, not on the design of the vaccine, which has been fueled by decades of research on adenovirus-based vaccines. Other Kovid-19 vaccines are also based on adenoviruses, such as the use of Ad26 from Johnson & Johnson, and a chimpanzee adenovirus by Oxford University and AstraZeneca.
While the developers of Sputnik V have not yet released detailed data on adverse events seen during the trial, the Russian government has been using the vaccine to vaccinate its own citizens for months. Russia has also exported Sputnik V to Belarus, Argentina and other countries, suggesting that any harmful side effects overlooked during the trial have so far been exposed.
As vaccine supply conditions worsened in Europe, the EU drug regulator announced last month that they were reviewing the Sputnik V vaccine after member states announced they would gain a shot on their own.