Several Brazilian states have requested the import of the Russian Sputnik V 2019 coronavirus disease (COVID-19) vaccine, but health regulators rejected it today, saying they did not have the necessary data to confirm the vaccine’s safety and effectiveness.
We will never expose millions of Brazilians to a product whose quality, safety and efficacy have not been properly validated,” said Antonio Barra Torres, director of Brazil’s National Health Surveillance Agency (Anvisa), “and we are now in a critical situation where the benefits must at least be proven to outweigh the risks. “
The National Health Surveillance Agency added that its experts have warned of the “uncertainty” of the vaccine.
Neither the European Medicines Agency (EMA) nor the U.S. Food and Drug Administration (FDA) has approved the “satellite-V” vaccine.
Brazil’s National Health Surveillance Agency received a request for emergency use of the Satellite-V vaccine last month. However, the agency has not yet published its findings on the vaccine, nor has it listed the specific information they determined was missing.
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