Brazil’s top health regulatory body has banned Russia’s Sputnik V SARS-CoV-2 vaccine after samples studied were found to have live adenovirus and manufacturing facilities were found to have poor quality control standards.
The National Health Surveillance Agency (Anvisa) banned Russia’s adenovirus vector variant of a vaccine intended to prevent or reduce symptoms of Coronavirus Disease 2019 (COVID-19), the disease caused by a severe SARS-CoV-2 infection.
Adenovirus vector vaccines work by splicing an inactivated adenovirus, a different class of viruses than corona or influenza viruses, with the spike protein from SARS-CoV-2 in an attempt to simulate an immune response to the real coronavirus. If the adenovirus is inactivated incorrectly and begins to infect host cells and replicate, it can itself cause disease.
In August 2020, Russian President Vladimir Putin approved distribution of Sputnik V in his country even though it had yet to pass Phase III clinical trials. Putin claimed one of his daughters participated in testing of the vaccine, while Russian state media outlet Sputnik said the injection was named after Sputnik 1, the first space satellite created under the USSR, which “triggered global research.”
According to Wikipedia, the original Soviet Sputnik satellite “orbited for three weeks before its batteries died and then orbited silently for two months before it fell back into the atmosphere.”
Anvisa also accused the Gamaleya Institute, which developed the vaccine, of not providing reliable and consistent data about the efficacy of Sputnik V. The Agency made its decision after consulting five other government agencies, it said in a statement.
Brazil also sent inspectors to investigate vaccine production sites in Russia, complaining they found no evidence of any consistency in manufacturing or quality control.
Anvisa said in their statement to the public, “One of the worrying facts regarding the evaluation of the data available so far is that the cells where the adenoviruses are produced for the development of the vaccine allow their replication…This can lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems.”
Sputnik V has not been approved by the EU’s European Medicines Agency (EMA). However, several countries have already begun using the vaccine. Hungary, for example, has given emergency use authorization for Russia’s injection.
In Slovakia, Prime Minister Igor Matovic was forced to resign in March after it came to light that he had secretly arranged to import 200,000 doses of Sputnik V without consulting coalition partners. Matovic is now Finance Minister.
Slovak scientists claimed that the doses sent to their nation were different from what Russia has shipped to other places, an allegation that Moscow denounced as fake news. In April, Slovakia’s drug regulator ruled that some Sputnik V batches manufactured in Russia could not be used because they are “sub-standard,” according to a Euro News report.
However, a significant number of Slovak citizens would prefer the Russian injection over others, something that experts credit to the ethnic ties between the two countries.
“Such positive preference is connected to the positive preference of Russia among Slovaks. 78 percent of Slovaks perceive Russia as their brother nation. Many Slovaks do not perceive Russia as a threat,” Katarina Klingova from the GLOBSEC Policy Institute said to Euro News.
The institute also found the official Slovakian version of Sputnik’s Twitter account is a “propaganda machine” that aims to discredit the authorities.