Brazil’s National Health Regulation Agency, Anvisa, on Tuesday declared itself against the import of the Russian COVID-19 vaccine Sputnik V.
The agency lacks “consistent and reliable data,” it said in a statement. The decision was unanimous after about five hours of deliberations.
However, Anvisa director, Alex Machado Campos, stressed that the decision was only a ‘snapshot.’
Shortcomings were identified in both the development and the production of the vector vaccine, based on the data that could be analysed so far, said the statement.
This includes all three phases of the clinical trials of the preparation, it said.
“In addition, there is insufficient or no data on quality control, safety and efficacy,” the agency wrote.
So far, 14 states in Latin America’s largest country have asked for permission to import Sputnik V in view of the dramatic coronavirus situation.
Brazil, with its approximately 210 million inhabitants, is one of the hotspots of the coronavirus pandemic.
According to the Ministry of Health, more than 14 million people have been infected with coronavirus and about 390,000 patients have died in connection with it.
dpa/NAN
