The Brazilian health regulator Anvisa on Monday denied permission to import the Russian-made Sputnik V COVID-19 vaccine citing “inherent risks”, “serious” defects and lack of information on its its safety, quality and effectiveness.
On request by state governors, Anvisa’s five-strong board examined the documentation presented and voted unanimously not to approve the Russian vaccine.
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Reuters in its report quoted Ana Carolina Moreira Marino Araujo, general manager for health monitoring, stating that technical staff had highlighted “inherent risks” and “serious” defects, citing a lack of information guaranteeing its safety, quality and effectiveness.
Gustavo Mendes, the medicines and biological products manager of Anvisa, confirmed the development saying that the board noticed a crucial issue – the presence of adenovirus in the vaccine, which could produce a “serious” defect.
About 14 states in Brazil had appealed for an urgent import of Sputnik to counter a growing wave of COVID-19 infections. According to the latest data available, the country has over 14 million recorded cases with a death toll approaching 400,000.
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Russian made Sputnik V covid-19 vaccine has been approved in several countries around the world with scientists claiming 97.6% effective against the deadly virus against Covid-19 in a “real-world” assessment based on data from 3.8 million people.