Health regulator Anvisa cited lack of consistent and reliable data for rejecting the import of the vaccine. Brazil is currently battling a devastating second wave of coronavirus.
Brazil’s health regulator Anvisa voted against importing the Russian Sputnik V coronavirus vaccine on Monday.
The health regulator said that due to lack of “consistent and reliable data,” its board had unanimously decided to recommend against the import of Sputnik V.
About 14 states in Brazil had appealed for an urgent import of Sputnik to counter a growing wave of COVID-19 infections.
The country has over 14 million recorded cases with a death toll approaching 400,000.
Anvisa said that it wasn’t flexible in terms of “product safety.”
Gustavo Mendes, the medicines and biological products manager of Anvisa, said that a crucial issue the board noticed was the presence of adenovirus in the vaccine, which could produce a “serious” defect.
The decision follows a previous statement from Anvisa, expressing “critical issues” around the effectiveness of the vaccine.
Sputnik approval around the world
Sputnik V has been approved in several countries, including India. However, the EU hasn’t yet followed suit, saying it needs more information on the tests and manufacturing process of the jab.
Russian scientists claim that the vaccine is 97.6% effective against COVID-19, based on data collected from 3.8 million people in a “real world” assessment.