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 record, sparring 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.
For the process of vaccine approval to degenerate into a public spat with threats of legal action is highly unusual. “I don’t think I’ve ever seen anything like this,” Monica de Bolle, an economist and immunologist from Brazil working at the Peterson Institute for International Economics in Washington, DC, told BuzzFeed News.
“If they want to sue us, then sue us,” Antonio Barra Torres, head of Anvisa, told reporters on Thursday. “We’ll answer through the correct channels.”
Sputnik V has been controversial from the start. It was approved for use in Russia last August before clinical trials were completed. That gamble seemed to have paid off in February, however, when a paper published in the Lancet, a medical journal, indicated the vaccine was 91.6% effective in preventing people from getting sick with COVID-19.
The Sputnik V vaccine consists of two doses of common cold viruses called adenoviruses; the first dose is a virus called Ad26 and the second Ad5. In the vaccine, they are modified so they make the “spike” protein from the coronavirus, priming the immune system to attack it. The vaccine’s adenoviruses are also supposed to lack two key genes that they need to reproduce.
This is the same basic technology behind the vaccines made by Johnson Johnson, which uses a single dose of a modified Ad26 virus, and AstraZeneca, which uses two doses of a different adenovirus that normally infects chimpanzees.
Buoyed by the results of the clinical trial, the Russian Direct Investment Fund (RDIF), set up by the Kremlin to invest in homegrown companies, has offered the vaccine to dozens of countries across the world in a major diplomatic push, especially in the developing world. The Sputnik V Twitter account boasts that the vaccine has been authorized in more than 60 countries.