The agency’s management followed the advice of its experts, noting the “uncertainty” about the vaccine, which has yet to be approved by the health authorities of the European Union and the United States.
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Satellite V will have to wait before landing in Brazil. Health Regulatory Agency Anvisa on Monday, April 26, opposed a request by several states in the country to import the Russian vaccine against Covid-19, believing that there is insufficient data to ensure its safety and effectiveness. 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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“We will never allow millions of Brazilians to be exposed to products without proper quality, safety and efficacy testing, or at least in the face of the serious situation we are experiencing, there is a favorable relationship between risk and benefit.” said Antonio Barra Torres, President of Anvisa. The agency’s management followed the recommendations of their experts, noting that “uncertainties” about a vaccine that has not yet been approved by the health authorities of the European Union (EMA) and the United States (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 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.