Brazil's National Health Surveillance Agency (Anvisa) Monday recommended against the import of the Russian-made Sputnik V vaccine to fight the covid-19 pandemic, citing lack of proper documents required for approval as well as other health risks the antidote may imply.
Anvisa's board convened Monday as mandated by Supreme Federal Court (STF) Justice Ricardo Lewandowski, who had given the agency 30 days to rule on the matter and denied subsequent requests to extend the deadline.
A group of Anvisa experts travelled to Russia on April 16 to collect more information about the immunizer and arrived back last Saturday. Until then, Anvisa had informed that there was a lack of technical information on the safety and efficacy of the immunizer.
Brazil's government has been reportedly pressed by the United States not to buy the Russian vaccine, following the interest American geopolitical of not to amplify the influence of Russia in Latin America.
On April 12, the governor of Ceará, Camilo Santana (PT), informed that he would file a lawsuit in the STF requesting the release of 5.87 million doses of the Sputnik V vaccine by Anvisa.
On social media, the governor stated that Sputnik V is already used in about 60 countries, with an efficiency of 91.6%. We will go to all possible instances so that the vaccines we acquire arrive as soon as possible to immunize our population.”
The state made official the purchase of 5.87 million doses on March 19 from the Russian Sovereign Fund. The purchase was part of an agreement by the Northeast Consortium, formed by the nine states in the northeastern region, which established the purchase of 39 million doses of Sputnik V. The purchase was also authorized by the Legislative Assembly of Ceará and the STF, in case of non-compliance of the National Immunization Plan (PNI), of the Ministry of Health.
Sputnik V uses viral vector technology: another virus, scientifically known as adenovirus, carries the genetic material of Sars-CoV-2 into the human body, which stimulates the infection of human cells, and consequently of antibodies, but without the reproduction of the virus.
With the delay of the analysis by Anvisa, Brazil will lose 2 million doses of Sputnik V that would arrive in Brazil by the end of the month. According to the governor of Piauí, Wellington Dias, “unfortunately, Brazil will miss the opportunity to receive the April batch of the Sputnik V vaccine. The delay in the import license is due to the bureaucracy on the part of Anvisa and the bureaucracy of requirements that are provided for by law. The law provides for certification to be submitted by an international regulatory agency. This was done by the states and we still have the requirement for a series of other documents.”
The request for emergency use of Sputnik V was filed at Anvisa on March 25 by União Química.
The executive secretary of the Northeast Consortium, Carlos Gabas, affirmed that the entity filed last Friday (23), a series of documents requested by Anvisa for the release of the vaccine.
The import was also expected by the state government of Maranhão, which submitted documents to the agency. However, Anvisa claimed that there were inconsistencies that made it impossible to analyze the risk-benefit of the vaccine.