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.
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.