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Health regulator Anvisa cited lack of consistent and reliable data for rejecting the import of the vaccine. Sputnik V producers slammed the decision as "political."
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.
"Anvisa's delays in approving Sputnik V are unfortunately of a political nature and have nothing to do with access to information or science," the official Sputnik V Twitter account said.
It pointed to a recent US government report that said Washington had tried to persuade Brazil not to use Sputnik.
"The United States Department of Health, in its 2020 annual report several months ago, publicly stated that the United States health attache 'persuaded Brazil to reject the Russian vaccine against COVID-19,'" the account added.
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.
am/rt (efe, Reuters)