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Russia’s coronavirus vaccine faces safety concerns in Brazil

Shamil Zhumatov / Reuters

A medical professional holds a bottle of Sputnik V vaccine in Moscow on January 18.

The global drive to accelerate COVID-1

9 vaccination has come in a hurry as Brazilian health officials on Monday recommended a ban on imports of Russia’s Sputnik V vaccine to halt the severe coronavirus outbreak. In a special dispute raised on Thursday, Russian supporters of vaccines have threatened legal action on defamation charges and Brazilian officials have released records and documents supporting their position.

As the coronavirus epidemic continues to rage around the world, furious exchanges have raised questions about the safety of the image and doubts about the manufacturer’s willingness to answer. This has created a headache for dozens of countries that have already accepted Russian vaccine donations, hoping to speed up their vaccination programs.

Anvisa official, Brazil’s health regulator, said on Monday that the document provided by the Gamaleya Research Institute in Moscow did not provide enough information on the safety and efficacy of the Sputnik V vaccine, including information about the vaccine. Any serious side effects, the document also states that the vaccine disabled cold virus relies on an immune response to the coronavirus, which is thought to be ineffective, in fact, can be done.

The finding was shocking to the vaccine experts. If confirmed, production is incomplete and the Sputnik V vaccine is unlikely to receive approval from other leading regulators around the world.

“If that’s true, Sputnik didn’t get the attention,” John Moore, a virologist at Weill Cornell Medical College in New York, told BuzzFeed News.

The Russian authorities reacted furiously to Anvisa’s ruling, “Brazil’s National Health Surveillance Agency (Anvisa) decision to delay approval of Sputnik V is, unfortunately, of its political nature and has nothing to do with the government of Brazil. Access to regulators’ data or science, ”a statement posted on the website series. Up to promote vaccines

By Thursday, things had escalated into bitter public disputes. In response to the Russian plea for publishing “fake news” about Sputnik V Anvisa, it took a very unusual step to release some of the recordings of a teleconference with Gamaleya officials. It has acted proactively, arguing that other vaccines have a worse record of safety, argue with leading virologists commenting on Anvisa’s concerns, and that the vaccine maker will take defamation action against its agency. Brazil for “intentionally spreading false and inaccurate information”

In a presentation posted on the Brazilian government’s YouTube channel on Thursday, Anvisa officials showed some of the Russian documents they reviewed that discuss the existence of the virus that can be propagated. The video also showed part of a three-hour conference call on April 23 where Anvisa officials said they asked for more information. But didn’t get a satisfactory answer

It is unusual for the process of approving a vaccine to be downgraded to public brawl with threats to the law. “I don’t think I’ve ever seen anything like it,” says economist Monica de Boll. And a Brazilian immunologist who works at the Peterson Institute for International Economics in Washington, D.C., told BuzzFeed News.

“If they want to sue us, they sue us,” Anvisa boss Antonio Barra Torres told reporters on Thursday.

The Sputnik V has been controversial from the start. It was approved for use in Russia in August before clinical trials were completed. The bets appeared to have run out in February, however, when a newspaper published in the Lancet medical journal indicated that the vaccine was 91.6% effective in preventing people from getting sick with COVID-19.

The Sputnik V vaccine contains two common cold viruses known as adenoviruses. The first is a virus known as Ad26 and Ad5. The second in the vaccine is modified to create a protein that “blocks” the coronavirus, which forms the foundation of the immune system to prevent the spread of flu. Attack it. Adenoviruses of the vaccine are supposed to lack two major genes needed to reproduce.

This is the same underlying technology behind vaccines made by Johnson & Johnson, which uses a single modified Ad26 virus, and AstraZeneca, which uses two different sizes of adenoviruses that typically infect chimpanzees.

Based on the results of clinical trials, the Russian Direct Investment Fund (RDIF), set up by Kremlin to invest in homegrown companies, has offered vaccines to dozens of countries around the world in massive diplomatic pushes, especially in the developing world. The Sputnik V Twitter account boasts that the vaccine is licensed in more than 60 countries.

But many of those countries lack strong expertise in judging the safety and efficacy of new drugs and vaccines, and they often follow the leaders of the World Health Organization, FDA, or the European Medicines Agency. Using the Sputnik V.

The EMA announced a “round review” of Sputnik V on April 3, but on Monday, German Chancellor Angela Merkel said there was not enough information available for the EU to authorize the vaccine. However, two EU members, Hungary and Slovakia, began taking Sputnik V. Slovakia rejected the vaccine earlier this month after it was found. “Characteristics and properties” differ from the images described in the Lancet paper.

No date has been set for the WHO vaccine review yet. “In Sputnik, we are still waiting, we are still in the back-and-forth process,” WHO spokesman Margaret Harris told a briefing in Geneva on Tuesday, Reuters reported.

So the investigation by Anvisa is Sputnik V’s first major regulatory test.In Thursday’s YouTube video, Gustavo Mendes, Anvisa’s general manager of pharmaceuticals and biological products, showed documents prepared by the Gamaleya Research Institute. Note that the vaccine can contain as many as 1,000 viruses that can be propagated per volume and that less than 100 samples tested. “Those numbers should be zero,” he said.

Even before this week’s controversy, Russia’s donation of vaccines to developing countries before the world’s top regulators shocked some experts. One of the concerns is that many of these countries do not have good systems for finding adverse events, such as rare blood clots. But very serious is caused by similar vaccines from AstraZeneca and Johnson & Johnson.

“This worries us very much in the global vaccine community,” said Peter Hotez of Baylor College of Medicine in Houston, who has made significant contributions to vaccine development for countries without a strong healthcare infrastructure. Speak to BuzzFeed News

Although the cold virus used in the Sputnik V vaccine can be propagated. But it is unlikely to cause serious disease unless the recipient has an immune deficiency, such as some HIV-infected patients or an organ transplant. But failure to completely disable the virus will be a red flag to the production of the Sputnik V vaccine.

“It was a big nymph,” said Moore.

Despite the push from Russia But Anvisa experts are internationally recognized for their thoughtfulness. And for Brazilian regulators to raise concerns as the country grapples with the COVID-19 outbreak, which now kills about 2,500 Brazilians a day driven by the spread of the coronavirus strain. The epidemic is very important. The official death toll in Brazil surpassed 400,000 this week.

“No one at this institution is interested or willing to refuse to import any vaccine,” Torres said in a YouTube video.

The possible viral replication is not the only concern about Sputnik V. In October, four senior AIDS researchers said in a letter to the Lancet that a decade ago they had abandoned clinical trials of the disease. HIV vaccine using disabled Ad5 virus for safety reasons. In men who have previously been infected with Ad5, the vaccine increases their susceptibility to HIV infection.

“Based on these findings, we are concerned that using the Ad5 vector to immunize severe acute respiratory disease coronavirus 2 (SARS-CoV-2) may increase the risk of HIV-1 infection in men. That was similarly vaccinated, ”the scientist wrote.

One of those researchers, Carl Dieffenbach, director of the AIDS division at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, told BuzzFeed News that he would avoid the use of the Ad5-based vaccine in countries such as Africa and Latin America HIV infection is a serious concern.

“I think it’s not necessary,” Dieffenbach said. “Ad26 is a perfectly fine vector in itself. It doesn’t do this. “

In addition to the Sputnik V, Ad5 is also used as a vector for a COVID vaccine made by the Chinese company CanSino, which is licensed for use in countries such as Pakistan, Mexico and Chile.

Despite concerns about the safety of the Sputnik V, the vaccine remains in demand in countries battling COVID-19. RDIF has announced that it will begin shipping the vaccine to India, which is currently under control of the outbreak of COVID-19. The deadly corona virus On May 1, Turkey announced Friday that it had authorized the vaccine for emergency use.

RDIF did not immediately respond to requests for further comment about security concerns or threats of legal action against Anvisa.

“I think we’ve made our stance in tweets and other messages,” RDIF’s Special Program Director Gleb Bryanski told BuzzFeed News.

Marcelo Soares contributed to this report.

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