London Daily

Focus on the big picture.
Wednesday, Oct 15, 2025

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

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.

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 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.


But many of those countries lack strong expertise for judging the safety and efficacy of new drugs and vaccines, and they tend to follow the leads of the World Health Organization, the FDA, or the European Medicines Agency. None of these organizations have yet given a green light to use Sputnik V.

The EMA announced a “rolling review” of Sputnik V on April 3. But on Monday, German Chancellor Angela Merkel said that insufficient information had yet been provided for the European Union to authorize the vaccine. Nevertheless, two EU members, Hungary and Slovakia, have started using Sputnik V. But Slovakia rejected a batch of the vaccine earlier this month after its “characteristics and properties” were found to be different from the shots described in the Lancet paper.

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.


Even before this week’s dispute, Russia’s donations of the vaccine to developing nations before the world’s leading regulatory authorities approved it had alarmed some experts. One concern is that many of these countries lack good systems to look for adverse events such as the rare but very serious blood clots triggered by the similar vaccines made by AstraZeneca and Johnson & Johnson.

“This creates a lot of concern for us in the global vaccine community,” Peter Hotez of the Baylor College of Medicine in Houston, who has been heavily involved in developing vaccines for countries without strong healthcare infrastructure, told BuzzFeed News.

Even if the cold viruses used in the Sputnik V vaccine are able to reproduce, it is unlikely to cause serious illness unless the recipients are badly immunocompromised, like some patients with HIV or organ transplants. But failure to completely inactivate the viruses would be a red flag against the manufacturing of the Sputnik V vaccine.

“It’s a big nyet-nyet,” Moore said.

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.

“There is not, in this institution, any person that has any interest or joy in denying the import of any vaccine,” Torres says in the YouTube video.

Possible viral replication isn’t the only concern about Sputnik V. In October, four senior AIDS researchers noted in a letter to the Lancet that a decade ago they had abandoned a clinical trial of an HIV vaccine using an inactivated Ad5 virus for safety reasons: In men who had previously been infected with Ad5, the vaccine actually increased susceptibility to infection with HIV.

“On the basis of these findings, we are concerned that use of an Ad5 vector for immunisation against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine,” the scientists wrote.

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

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

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

Despite the emerging concerns about the safety of Sputnik V, the vaccine is still in demand in many countries battling COVID-19. The RDIF announced that it will start shipping the vaccine to India, which is now in the grip of a devastating coronavirus outbreak, on May 1. Turkey announced on Friday that it had authorized the vaccine for emergency use.

The RDIF did not immediately respond to requests for further comment on the safety concerns or the threats of legal action against Anvisa.

“I think we’ve expressed our position in tweets and other statements,” Gleb Bryanski, the RDIF’s director for special projects, told BuzzFeed News.

Comments

Sid 4 year ago
If you take any of the jabs for a flu that everyone except for fat high blood pressure people and have a chance of over 99 % of living you are a idiot. This is thinning the world of low IQ people

Newsletter

Related Articles

0:00
0:00
Close
ScamBodia: The Chinese Fraud Empire Shielded by Cambodia’s Ruling Elite
French PM Suspends Macron’s Pension Reform Until After 2027 in Bid to Stabilize Government
Orange, Bouygues and Free Make €17 Billion Bid for Drahi’s Altice France Telecom Assets
Dutch Government Seizes Chipmaker After U.S. Presses for Removal of Chinese CEO
Bessent Accuses China of Dragging Down Global Economy Amid New Trade Curbs
U.S. Revokes Visas of Foreign Nationals Who ‘Celebrated’ Charlie Kirk’s Assassination
AI and Cybersecurity at Forefront as GITEX Global 2025 Kicks Off in Dubai
DJI Loses Appeal to Remove Pentagon’s ‘Chinese Military Company’ Label
EU Deploys New Biometric Entry/Exit System: What Non-EU Travelers Must Know
Australian Prime Minister’s Private Number Exposed Through AI Contact Scraper
Ex-Microsoft Engineer Confirms Famous Windows XP Key Was Leaked Corporate License, Not a Hack
China’s lesson for the US: it takes more than chips to win the AI race
Australia Faces Demographic Risk as Fertility Falls to Record Low
California County Reinstates Mask Mandate in Health Facilities as Respiratory Illness Risk Rises
Israel and Hamas Agree to First Phase of Trump-Brokered Gaza Truce, Hostages to Be Freed
French Political Turmoil Elevates Marine Le Pen as Rassemblement National Poised for Power
China Unveils Sweeping Rare Earth Export Controls to Shield ‘National Security’
The Davos Set in Decline: Why the World Economic Forum’s Power Must Be Challenged
France: Less Than a Month After His Appointment, the New French Prime Minister Resigns
Hungarian Prime Minister Viktor Orbán stated that Hungary will not adopt the euro because the European Union is falling apart.
Sarah Mullally Becomes First Woman Appointed Archbishop of Canterbury
Mayor in western Germany in intensive care after stabbing
Australian government pays Deloitte nearly half a million dollars for a report built on fabricated quotes, fake citations, and AI-generated nonsense.
US Prosecutors Gained Legal Approval to Hack Telegram Servers
Macron Faces Intensifying Pressure to Resign or Trigger New Elections Amid France’s Political Turmoil
Standard Chartered Names Roberto Hoornweg as Sole Head of Corporate & Investment Banking
UK Asylum Housing Firm Faces Backlash Over £187 Million Profits and Poor Living Conditions
UK Police Crack Major Gang in Smuggling of up to 40,000 Stolen Phones to China
BYD’s UK Sales Soar Nearly Nine-Fold, Making Britain Its Biggest Market Outside China
Trump Proposes Farm Bailout from Tariff Revenues Amid Backlash from Other Industries
FIFA Accuses Malaysia of Forging Citizenship Documents, Suspends Seven Footballers
Latvia to Bar Tourist and Occasional Buses to Russia and Belarus Until 2026
A Dollar Coin Featuring Trump’s Portrait Expected to Be Issued Next Year
Australia Orders X to Block Murder Videos, Citing Online Safety and Public Exposure
Three Scientists Awarded Nobel Prize in Medicine for Discovery of Immune Self-Tolerance Mechanism
OpenAI and AMD Forge Landmark AI-Chip Alliance with Equity Option
Munich Airport Reopens After Second Drone Shutdown
France Names New Government Amid Political Crisis
Trump Stands Firm in Shutdown Showdown and Declares War on Drug Cartels — Turning Crisis into Opportunity
Surge of U.S. Billionaires Transforms London’s Peninsula Apartments into Ultra-Luxury Stronghold
Pro Europe and Anti-War Babiš Poised to Return to Power After Czech Parliamentary Vote
Jeff Bezos Calls AI Surge a ‘Good’ Bubble, Urges Focus on Lasting Innovation
Japan’s Ruling Party Chooses Sanae Takaichi, Clearing Path to First Female Prime Minister
Sean ‘Diddy’ Combs Sentenced to Fifty Months in Prison Following Prostitution Conviction
Taylor Swift’s ‘Showgirl’ Launch Extends Billion-Dollar Empire
Trump Administration Launches “TrumpRx” Plan to Enable Direct Drug Sales at Deep Discounts
Trump Announces Intention to Impose 100 Percent Tariff on Foreign-Made Films
Altman Says GPT-5 Already Outpaces Him, Warns AI Could Automate 40% of Work
Singapore and Hong Kong Vie to Dominate Asia’s Rising Gold Trade
Trump Organization Teams with Saudi Developer on $1 Billion Trump Plaza in Jeddah
×