Brazilian regulator refused permission to import Sputnik V vaccine against COVID-19

The Brazilian health regulator on Monday rejected a request from several states in the country to import the Russian vaccine Sputnik V against the coronavirus, whereas there is a lack of technical data to verify its safety and efficacy.

“We will never allow millions of Brazilians to be exposed to products without proper verification of the quality, safety and efficacy or, at a minimum, in the face of the serious situation we are going through, that there is a favorable relationship between risk and benefits “. said Antonio Barra Torres, president of the National Health Surveillance Agency (Anvisa).

The five directors of Anvisa followed the recommendation of the agency’s technical area, which identified various “uncertainties” regarding the safety and effectiveness of the immunizer., which has not yet been approved by the European Medicines Agency (EMA) or the US FDA (Federal Food and Drug Administration).

The refusal to import Sputnik V does not imply a definitive analysis of the vaccine, and Anvisa, who received an order in late March for emergency use of the Russian immunizer, has not released its findings citing the lack information.

The vaccine, a viral vector, is used in many countries besides Russia, including Mexico, Argentina and Venezuela.

In February, the magazine Lancet reported that the Sputnik V was 91.6% efficient, dispelling any doubts about its reliability.

But the technicians of Anvisa They said publication in the prestigious scientific journal does not meet the same requirements as approval from regulatory bodies.

“A health assessment is different from an assessment carried out by a scientific journal. A review does not aim to recommend or not the use of a vaccine, nor the commitment to verify good clinical practice, nor does it presuppose access to all the raw data and reports ”of the study, said Gustavo Mendes, one of the technical directors of Anvisa.

In order to speed up your vaccination plans, a dozen states in the north and northeast of Brazil have signed contracts with the Russian Sovereign Fund (RDIF), which financed the development of Sputnik V, to acquire more than 30 million doses.

The rejection of their import orders is “a portrait of this moment, of what has been possible to analyze until now,” said Bara Torres.

The federal government has acquired an additional 10 million.

“I hope that indeed the Sputnik V vaccine process will take your information into account and resolve compliance issues quickly, as millions of people need access to safe and effective vaccines.Another director of Anvisa, Meiruze Freitas, added.

In addition to the two vaccines applied since January (Coronavac and AstraZeneca), the Brazilian regulator has already authorized the use of immunizers Janssen, from the American pharmaceutical company Johnson & Johnson, and Pfizer-BioNTech, which have not yet arrived. in the countryside.

According to the Gamaleya Center, the Russian Institute for Epidemiology and Microbiology that produced the Sputnik V vaccine has been approved by more than 60 countries.

Although it has yet to receive the green light from the European regulator, Germany announced last week that it planned to purchase 30 million doses of the vaccine.

Brazil, out of 212 million inhabitants, accumulates more than 390,000 deaths from COVID-19 and has so far managed to vaccinate 27.3 million with the first dose and 11.6 million with the second.

With information from AFP

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