Brazil’s health regulator has denied a request from several states to import Russia’s Sputnik V coronavirus vaccine, saying it did not have the data needed to verify the jab’s safety and efficacy.
“We will never allow millions of Brazilians to be exposed to products without due verification of quality, safety and efficacy, or at minimum, facing the grave situation we are now going through, that the benefits will outweigh the risks,” said Antonio Barra Torres, president of federal health regulator Anvisa.
Agence France-Presse report that Anvisa said its experts had flagged “uncertainties” about the jab, which has not yet been approved by the European Medicines Agency (EMA) or the United State’s Food and Drug Administration (FDA).
Anvisa, which received a request last month for emergency use of the Russian formula, has not released its findings, or cited the specific information it determined was lacking.
Russia registered Sputnik V last August ahead of large-scale clinical trials, prompting concern among experts over the fast-track process. But later reviews have been largely positive.
The Lancet medical journal publishing results showing it to be safe and more than 90 percent effective, and yesterday the vaccine’s backers were bullish about data from Hungary which they claim shows it to be more effective than many of the other options.
Brazil has recorded more than 390,000 Covid-19 deaths, the second-highest number globally, behind only the US. But the government has struggled to secure enough vaccine doses for the country’s 212 million people. So far, it has managed to administer over 38 million vaccine doses. But the country’s outbreak has continued to surge, pushing hospitals to the breaking point.
The Sputnik vaccine has so far been approved for use in 60 countries, including more than 10 in Latin and Central America.
Argentina signed a deal with Russia earlier this month to become the first Latin American country to produce Sputnik V shots, and will aim for full-scale production to start in June.