Russia’s Covid-19 vaccine, Sputnik V: Safety concerns raised by Anvisa, Brazil’s health regulatory agency…


There Are New Safety Concerns About Russia’s COVID Vaccine, Which Is Already Being Distributed Worldwide

“This creates a lot of concern for us in the global vaccine community,” one expert said.Peter Aldhous

BuzzFeed News Reporter

Posted on April 30, 2021, at 3:22 p.m. ET

The global drive to speed COVID-19 vaccination has taken a serious blow since Brazilian health officials on Monday recommended against importing Russia’s Sputnik V vaccine to curb a severe coronavirus epidemic. In an extraordinary dispute that blew up on Thursday, the vaccine’s Russian backers threatened legal action for defamation and the Brazilian officials released recordings and documents supporting their position.

As the coronavirus pandemic continues to rage across the world, the angry exchanges have raised questions about the safety of the shots and doubts about its maker’s willingness to answer them. That poses a big headache for dozens of countries that have already accepted donations of the vaccine from Russia in hopes of accelerating their vaccination programs.

Officials with Anvisa, Brazil’s health regulatory agency, said Monday that documentation provided by the Gamaleya Research Institute in Moscow didn’t provide enough information about the safety and efficacy of the Sputnik V vaccine — including information on any serious side effects. The documents also indicated that the inactivated cold viruses the vaccine relies on to deliver an immune response against the coronavirus, which are supposed to be unable to reproduce, were in fact able to do so.

This finding shocked vaccine experts. If confirmed, it suggests manufacturing was botched and that the Sputnik V vaccine is unlikely to win approval from other leading regulators around the world.

“If this is true, Sputnik is nixed,” John Moore, a virologist at Weill Cornell Medical College in New York, told BuzzFeed News.

Russian authorities reacted angrily to Anvisa’s ruling. “The decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of Sputnik V is, unfortunately, of a political nature and has nothing to do with the regulator’s access to information or science,” said a statement posted on the website set up to promote the vaccine.

By Thursday, things had escalated into a bitter public dispute. To counter Russian claims that it was spreading “fake news” about Sputnik V, Anvisa took the highly unusual step of releasing a recording of parts of a teleconference with Gamaleya officials. The vaccine’s official Twitter account had previously gone on the offensive, controversially claiming other vaccines have a poorer safety recordsparring with a leading virologist who commented on Anvisa’s concerns, and stating that the vaccine’s makers would launch a defamation action against the Brazilian agency for “knowingly spreading false and inaccurate information.”

In a presentation posted on the Brazilian government’s YouTube channel on Thursday, Anvisa officials showed portions of the Russian documents they reviewed that mentioned the presence of viruses that were able to reproduce. The video also showed part of a three-hour April 23 teleconference in which Anvisa officials said they asked for more information but did not receive satisfactory answers.

No date has been set yet for the WHO’s review of the vaccine. “On Sputnik, we are still waiting, we are still in the back-and-forth stage,” WHO spokesperson Margaret Harris told a briefing in Geneva on Tuesday, Reuters reported.

So the review by Anvisa was Sputnik V’s first big regulatory test. In Thursday’s YouTube video, Gustavo Mendes, Anvisa’s general manager for medicines and biological products, showed documents supplied by the Gamaleya Research Institute. These noted that the vaccine could contain up to 1,000 viruses able to reproduce per dose and that tested samples contained fewer than 100. “Those numbers should be zero,” he says.

Despite the pushback from Russia, Anvisa’s experts are respected internationally for being thorough. And for Brazil’s regulator to raise concerns as the nation wrestles with a COVID-19 outbreak that is currently killing around 2,500 Brazilians a day, driven by a highly contagious coronavirus variant, is significant. The official death toll in Brazil passed 400,000 this week.

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