https://www.ctvnews.ca/health/coronavirus/brazil-health-regulator-rejects-russia-s-sputnik-vaccine-1.5403539
April 26, 2021
BRASILIA -- The Brazilian health regulator Anvisa on
Monday rejected importing the Russian-made Sputnik V COVID-19 vaccine requested
by state governors battling a deadly second wave of the virus that is battering
Latin America's largest nation.
Anvisa's five-strong board voted unanimously not to
approve the Russian vaccine after technical staff had highlighted
"inherent risks" and "serious" defects, citing a lack of
information guaranteeing its safety, quality and effectiveness.
Ana Carolina Moreira Marino Araujo, general manager
for health monitoring, said that taking into account all the documentation
presented, data acquired at in-person inspections and information from other
regulators, "inherent risks" were too great.
A crucial issue was the presence in the vaccine of the
adenovirus that could reproduce, a "serious" defect, according to
Anvisa's medicines and biological products manager Gustavo Mendes.
The Sputnik V shot has been approved in several
countries around the world. Russian scientists say it is 97.6% effective
against COVID-19 in a "real-world" assessment based on data from 3.8
million people, Moscow's Gamaleya Institute and the Russian Direct Investment
Fund said last week.
But, like Anvisa, the European Union has not yet approved
the vaccine, saying it needs more information on the tests and manufacturing
process.
Brazil's vaccination program has been blighted by
delays and procurement failures, turning the country into one of the world's
deadliest COVID-19 hotspots this year and pushing the national health system to
the brink of collapse.
So far 27.3 million people in Brazil, equivalent to
13% of the population, have received a first dose, according to health ministry
data.
Brazil has registered 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.
