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Anvisa’s five-member council has unanimously decided not to approve a vaccine made in Russia. The decision was made after technical staff pointed out the vaccine’s “risks” and “serious” shortcomings, according to Reuters, based on a lack of information on the vaccine’s safety, quality and efficacy.
Carolina Moreira Marino Araujo, director of Anvisa, says that, based on all the documentation provided, the case-by-case data and the assessments of other surveillance services suggest that the “risks” of this vaccine are too high.
The key issue was that the adenovirus used in the vaccine could have “serious” consequences, says Gustav Mendes, director of medical and biological products at Anvisa.
“We will never allow millions of Brazilians to be affected by the products until we have adequately tested their quality, safety and efficacy,” said Antonio Barra Torres, director of the federal agency Anvisa.
Delphi recalls that in early April Russia entered into a dispute with Slovakia over the Sputnik V vaccine when that EU member reported that the vaccine sent to the country was different from that confirmed by the authorized medical journal The Lancet.
Russia denies such accusations and demanded that Bratislava return 200,000. vaccine dose. The dispute could slow down Russia’s efforts to inject its vaccine into the European Union, Bloomberg reports.
In Slovakia, the Russian drug COVID-19 has even sparked a political crisis.
Itar-Tass / Scanpix
Former Prime Minister Igor Matovich was forced to resign after a scandal over Bratislava’s decision to buy 2 million. Sputnik V dose. This vaccine has not yet been approved by the European Medicines Agency (EMA). The Russian Direct Investment Fund (RTIF), created by the government of the Russian Federation, has asked the Slovak authorities to return a batch of the Russian coronavirus vaccine, Sputnik V, so that other countries can use doses of the vaccine . This information is available on the vaccine microblog from your tweet.
The report claims that the laboratory in Slovakia where the batch of Russian vaccine doses received was tested is not part of the official European Union (EU) network of laboratories, which allegedly violated the terms of the contract.
The Slovak State Institute for Drug Control examined the Russian-made Sputnik V vaccine, which had been purchased by the previous government, and concluded that it was not identical to the one praised by the authoritative journal The Lancet.
The state institute has not made the decision to recommend vaccinating the country’s population with a Russian vaccine because it does not have enough information to do so. This is a joint opinion of the Institute and the Ministry of Health.
It is noted that Slovak inspectors cannot evaluate the vaccine as comprehensively as the European Medicines Agency. The Institute states that studies have been conducted on the sterility, pyrogenicity, pH, transparency, color, abnormal toxicity, specific activity, visible mechanical impurities, specific protein concentration, and appearance of the vaccine. But these tests alone do not allow any definitive conclusions to be drawn about the efficacy and safety of the vaccine.
In Brazil, a record number of deaths from COVID-19 was reached in April.
Brazil hit a sad record for deaths from coronavirus infection on Saturday, and April became the deadliest month since the COVID-19 epidemic began in the country.
According to data published by the Ministry of Health, 67,977 people have died in the country since the beginning of the month, thus surpassing the record of 57,573 deaths registered in March.
In the last 24 hours, 3,076 deaths from coronavirus infection have been confirmed in Brazil, compared to an average of 2,545 deaths per day during the last seven days.
On Saturday, 71,137 new cases of infection were also registered, with a daily average of new cases in the last two weeks that exceeded 60,000.
In Brazil, with 212 million. population, more than 380 thousand have died so far. infected.
Still, despite these data, experts say that the curve for the infection and death rate in Brazil is stabilizing.
The Fiocruz Public Health Institute said on Friday that “the numbers for COVID-19 infections and COVID-19 deaths have stabilized over the past two weeks, which is typical of a new level of transmission.”
So far, Brazil has fully vaccinated only 5.8 percent. its population.
The Health Ministry plans to complete the vaccination of priority groups in September, which include 77 million. people.
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