Anvisa, the Brazilian health regulator, on Monday rejected importing the Russian-made Sputnik V COVID-19 vaccine asked by state governors battling a deadly second wave of the virus that is hitting Latin America’s largest nation.
Anvisa’s five-strong committee voted collectively not to approve the Russian vaccine after technical staff had highlighted “inherent risks” and “serious” defects, mentioning a lack of information confirming its safety, quality and effectiveness.
Ana Carolina Moreira Marino Araujo, general manager for health monitoring, told that taking into account all the documentation performed, data collected at in-person inspections and information from other regulators, “inherent risks” were too great.
According to Anvisa’s medicines and biological products manager Gustavo Mendes, a significant issue was the presence in the vaccine of the adenovirus that could reproduce, a “serious” defect.
The Sputnik V shot has been accepted in several countries around the world. Russian scientists say it is 97.6% effective against COVID-19 in a “real-world” evaluation based on data from 3.8 million people, Moscow’s Gamaleya Institute and the Russian Direct Investment Fund said last week.
Still, like Anvisa, the European Union has not yet accepted the vaccine, saying it needs more information on the tests and manufacturing process.
Brazil’s vaccination program has been ruined by delays and acquisition failures, turning the country into one of the world’s most dangerous COVID-19 hotspots this year and pushing the national health system to the verge of a breakdown.
As far as 27.3 million people in Brazil, equal to 13 per cent of the population, have taken the first dose, according to health ministry data.
Brazil has recorded 14.4 million confirmed cases of the virus and almost 400,000 deaths since the onset of the pandemic over a year ago, much of that in the last few months.
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