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The Brazilian health regulator says phase-3 trial of the Bharat Biotech vaccine is not concluded yet, and use depends on results of trial being conducted in Brazil.
Science’s COVID-19 reporting is supported by the Heising-Simons Foundation.
A confusing and unusually nasty fight broke out this week over the safety of a Russian COVID-19 vaccine known as Sputnik V after a Brazilian health agency declined on Monday to authorize its import because of quality and safety concerns. The stakes escalated yesterday when the Twitter account officially associated with the vaccine said “Sputnik V is undertaking a legal defamation proceeding” against Brazil’s regulators.
In an online press conference several hours later, the Brazilian Health Regulatory Agency (Anvisa) defended its decision, maintaining that documentation from some of the Russian facilities making Sputnik V shows that one of its two doses contains adenoviruses capable of replication, a potential danger to vaccine recipients. The vaccine uses two different adenoviruses, which cause the common cold, to deliver the gene for the spike protein of SARS-CoV-2, the virus that causes COVD-1
April 27, 2021 Russian Covid-19 vaccine Sputnik V - A health worker opens a package containing several doses of the Coronavirus vaccine Sputnik V. Brazil s National Health Regulation Agency (Anvisa) has declared itself against the import of the Russian Covid-19 vaccine Sputnik V. - Jesus Vargas/dpa
Russian Covid-19 vaccine Sputnik V - A health worker opens a package containing several doses of the Coronavirus vaccine Sputnik V. Brazil s National Health Regulation Agency (Anvisa) has declared itself against the import of the Russian Covid-19 vaccine Sputnik V. - Jesus Vargas/dpa
Brazil s National Health Regulation Agency (Anvisa) has declared itself against the import of the Russian Covid-19 vaccine Sputnik V.
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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.