Brazil: the regulator opposes the import of the Russian vaccine Sputnik V

Brazil’s Health Regulatory Agency (Anvisa) on Monday opposed a request by several states in the country to import the Russian Sputnik V vaccine against Covid-19, believing it had no data to ensure its safety and effectiveness.

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“We will never allow millions of Brazilians to experience a product without proper quality, safety and efficacy testing, or at least in the face of the grave situation we are experiencing, a favorable relationship between risk and benefit. ”Said Antonio Barra Torres, President of Anvisa.

The agency’s leadership followed the advice of its experts, noting the “uncertainty” about the vaccine, which has yet to be approved by the health agencies of the European Union (EMA) and the US (FDA).

The refusal to import Sputnik V does not mean a final analysis of the vaccine, and Anvisa, which received a request for an emergency use of the Russian formula in late March, did not publish its findings, citing a lack of information.

Sputnik V is already in use in several countries besides Russia, such as Mexico, Argentina or Venezuela. According to the Gamaleïa Institute, which created this formula, it has already been approved by more than 60 countries.

In February, the prestigious medical journal Lancet reported that the vaccine was 91.6% effective, dispelling doubts about its reliability.

But Anvisa experts said that publication in a prestigious scientific journal does not meet the same requirements as regulatory bodies for possible approval.

“Photo of the moment”

In an effort to accelerate vaccination plans, a dozen states in the north and northeast of Brazil have signed contracts with the Russian Sovereign Fund (RDIF), which funded the development of Sputnik V, to purchase more than 30 million doses. The federal government has ordered 10 million.

The rejection of their import orders is “a photograph of the moment that could be analyzed so far,” Bara Torres said.

“I hope that in fact the Sputnik V vaccination process adapts its information and quickly addresses compliance issues as millions of people should have access to safe and effective vaccines,” added another Anvisa leader, Meyruz Freitas.

In addition to the two vaccines in use since January (Coronavac and AstraZeneca), the Brazilian regulator has already authorized the use of Janssen vaccines by the American pharmaceutical company Johnson & Johnson and Pfizer-BioNTech, which have not yet arrived in the country. …

In Brazil, with a population of 212 million, more than 390,000 people have died from Covid-19, and so far 27.3 million people have been successfully vaccinated with the first dose and 11.6 million with the second.

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