BRASILIA (Reuters) – Brazil’s health regulator Anvisa lacks the information necessary to evaluate the safety and efficacy of Russia’s Sputnik V vaccine, the agency said in legal documents seen by Reuters on Friday.
The documents were sent to the nation’s Supreme Court as part of an emergency request by the northeastern state of Maranhao to import the vaccine.
In the documents, Anvisa lists various types of data that it lacks, including mass trial results and quality assurances, saying that it does not have sufficient information to carry out a “positive benefit-versus-risk analysis of the vaccine.”
The documents are enclosed in a court case being overseen by Justice Ricardo Lewandowski, who on Tuesday gave Anvisa 30 days to make a decision on an emergency import request.
Brazil is currently suffering through its worst period of the coronavirus pandemic, with more daily deaths than anywhere else in the world.
While the country’s vaccination effort has been faster than some countries in Latin America, it is well behind many developed countries and continues to miss its own inoculation targets due to a shortage of doses.
As a result, the governors of several northeastern states have pushed for the import of the Sputnik V vaccine, developed by Moscow’s Gamaleya Institute.
The vaccine’s representatives in Brazil did not immediately respond to a request for comment on Friday.
