Cyber Attackers Leaked Covid-19 Vaccine Data After EU Hack

The European Medicines Agency (EMA) has reported that some of the data on the Pfizer/BioNTech COVID-19 vaccine that was stolen during a cyber-attack in early December 2020 was released online illegally shortly after the attack. 

The leak was discovered during an investigation that was launched into the attack by the EMA and law enforcement. It is claimed that evidence of the stolen data was found on various hacking forums as early as 31 December. The EMA stated yesterday (13 January) that action is being taken by authorities.

The EMA is a decentralized agency responsible for evaluating, monitoring and supervising new medicines introduced to the EU. As such, it is accountable for approving any COVID-19 vaccines. On 9 December 2020, the EMA released a statement alerting that it had been subject to the cyber-attack. 

Pfizer and BioNTech then released a joint statement outlining the nature of the breach: “Today, we were informed by the European Medicines Agency (EMA) that the agency has been subject to a cyber-attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed.”

At the time, it was concluded that only a small number of documents had been accessed, limited to a single IT application as the hackers targeted data relating specifically to the Pfizer/BioNTech COVID-19 vaccine. Nevertheless, according to sources on technology and cybersecurity website BleepingComputer, the threat actors accessed Word documents, PDFs, email screenshots, PowerPoint presentations and EMA peer review comments.

The EMA assured that, despite the breach, its regulatory network is fully operational and that the evaluation and approval of COVID-19 medicines have not been affected by the incident.

THE LARGER PICTURE

The breach of the EMA server is not the only cyber-attack related to COVID-19 vaccines. There has been increasing concern about the safe deployment of the vaccine as cybercriminals attack the vaccine “cold chain”, launching what has been called a “global phishing campaign” against organizations responsible for the transport and sub-zero storage of the vaccine, supposedly in an attempt to gain unauthorized access to private credentials and sensitive information regarding the vaccine’s distribution.

Experian also released a report at the end of 2020 warning of the potential security risks that accompany the technological diversification in healthcare affected by COVID-19. It highlighted the potential risks of overlooking cybersecurity and the increased possibility of misinformation, particularly regarding the COVID-19 vaccine, while Dr Saif Abed also outlined the challenges of cybersecurity during the global mass rollout of the vaccine in a blog for Healthcare IT News.

ON THE RECORD

Responding to the announcement, chief security officer at Cybereason, Sam Curry, called security breaches surrounding the COVID-19 vaccine “diabolical”.

He continued: “Hackers today still see COVID-19 as a strategically valuable asset and it’s likely they will for the foreseeable future. Kudos to the pharma and research companies for working with law enforcement agencies to face these threats head on with advanced cyber tools and improved security hygiene. These companies face a new reality each and every day that motivated hackers will be successful every time they attempt to hack a company because they are well funded and are looking to reap both financial and political fame.

As the protection surface expands to mobile, the cloud and other potential attack vectors, those companies that can detect a breach quickly and understand as much as possible about the hacking operation itself, will be able to stop the threat and minimize or eliminate the risk all together.”

By Sophie Porter

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Bloomberg Quicktake: Now

Hackers posted confidential documents regarding Covid-19 medicines and vaccines on the internet after a data breach late last year at the European Medicines Agency. Timelines related to evaluating and approving Covid medicines and vaccines haven’t been affected, the EMA said in a statement on Tuesday. The agency said it remains fully functional and that law enforcement authorities are taking action on the breach. Caught up in the hack were some documents submitted by Pfizer Inc. and BioNTech SE during regulatory review of their vaccine, approved last month.

The EMA said it would notify any additional entities and individuals whose documents and personal data may have been subject to unauthorized access. Pfizer shares fell 2.2% in New York, with BioNTech’s American depositary receipts down 5.1%. Subscribe to our YouTube channel: https://bit.ly/2TwO8Gm Bloomberg Quicktake brings you live global news and original shows spanning business, technology, politics and culture. Make sense of the stories changing your business and your world. To watch complete coverage on Bloomberg Quicktake 24/7, visit http://www.bloomberg.com/qt/live, or watch on Apple TV, Roku, Samsung Smart TV, Fire TV and Android TV on the Bloomberg app. Have a story to tell? Fill out this survey for a chance to have it featured on Bloomberg Quicktake: https://cor.us/surveys/27AF30 Connect with us on… YouTube: https://www.youtube.com/user/Bloomberg Breaking News on YouTube: https://www.youtube.com/c/BloombergQu… Twitter: https://twitter.com/quicktake Facebook: https://www.facebook.com/quicktake Instagram: https://www.instagram.com/quicktake

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Researchers Warn of Heightened Risk of HIV With Certain COVID-19 Vaccines

As the race to approval of a safe and effective vaccine for coronavirus disease 2019 (COVID-19) continues, a group of researchers is warning some of these vaccines could make patients more susceptible to contracting HIV.

Writing in The Lancet, the researchers are urging caution when it comes to the use of adenovirus type-5 (Ad5) vectored vaccines for COVID-19, recalling their research from a decade ago on an Ad5 vectored vaccine in 2 HIV vaccine trials.

“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,” wrote the researchers. “Both the HIV and COVID-19 pandemics disproportionately affect vulnerable populations globally. Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase their risk of HIV-1 acquisition.”

There are several clinical trials assessing Ad5 vectored vaccine candidates underway, including by China’s CanSino Biologics and California-based ImmunityBio.

The group’s ”cautionary tale” stems from the Step and Phambili phase 2b trials that studied the efficacy of an Ad5 vectored HIV-1 vaccine in preventing HIV infection. Across both international studies, they found that the vaccine actually increased the risk of HIV among the vaccinated men.

The findings from the Phambili study, in particular, have important implications for the use of the vaccines in COVID-19, according to the researchers, as findings from this study showed that heterosexual men receiving the Ad5 vectored vaccine faced a consistently increased risk of HIV infection. Notably, this increased risk appeared to be limited to men, with women not having an observed increase of infection in the study.

In the Step trial, the risk of acquiring HIV was particularly high among men who were uncircumcised and Ad5 seropositive men who reported having unprotected anal sex with a partner who was HIV seropositive or who had unknown serostatus as baseline.

Of note, the vaccine in both studies did not have the HIV envelope. Meanwhile, in another study that used a DNA prime and an Ad5 vector, both of which had the HIV envelope, there was no observed increase in HIV infection.

The reason for the observed increase in HIV risk remains uncertain, although several follow-up studies have suggested a potential explanation, according to the researchers.

“The vaccine was highly immunogenic in the induction of HIV-specific CD4 and CD8 T cells; however, there was no difference in the frequency of T-cell responses after vaccination in men who did and did not later become infected with HIV in the Step Study,” they wrote. “These findings suggest that immune responses induced by the HIV-specific vaccine were not the mechanism of increased acquisition.

Participants with high frequencies of preimmunisation Ad5-specific T cells were associated with a decreased magnitude of HIV-specific CD4 responses and recipients of the vaccine had a decreased breadth of HIV-specific CD8 responses, suggesting that pre-existing Ad5 immunity might dampen desired vaccine-induced responses.”

Other exploratory studies have indicated that the vaccine enhances HIV replication in CD4 T cells or that Ad5-specific CD4 T cells could be more susceptible to HIV infection.

Jaime Rosenberg

Reference

Buchbinder SP, McElrath MJ, Dieffenback C, Corey L. Use of adenovirus type-5 vectored vaccines: a cautionary tale. Lancet. Published online October 19, 2020.doi:10.1016/S0140-6736(20)32156-5

Source: http://ajmc.com

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ENewsTrends

A new paper warns the link between COVID-19 vaccines and HIV risk.

Mayo Clinic

Nearly half of people in the U.S. diagnosed with HIV, the virus that causes AIDS, are over 50, according to the Centers for Disease Control and Prevention (CDC). HIV damages the body’s immune system, and interferes with the body’s ability to fight infection and disease. Does that make it more difficult to fight off COVID-19? Dr. Stacey Rizza, an infectious diseases specialist at Mayo Clinic, says, “We know that anybody who has a suppressed immune system may have an altered response to the virus that causes COVID-19. We know that older people whose immune systems are a little weaker, and people who have medical issues or organ diseases, are going to generally do worse with the infection.

If somebody has HIV and their immune system is weaker, meaning they’re not on therapy, or they’re earlier on in their therapy and their CD4 count is still low, they may be at risk of having a worse reaction to the virus. We will learn more about SARS-CoV-2 on people living with HIV over time.” Read more: https://newsnetwork.mayoclinic.org/di… More health and medical news on the Mayo Clinic News Network. https://newsnetwork.mayoclinic.org/ Journalists: Clean and nat sound versions of this pkg available for download at https://newsnetwork.mayoclinic.org/ Register (free) at https://newsnetwork.mayoclinic.org/re…

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FDA Offers Tips To Avoid Coronavirus Vaccine Scams

Americans are anxiously anticipating approval and public distribution of a COVID-19 vaccine to inoculate the masses and return to normalcy — and scammers are standing by.

Government agencies like the Federal Trade Commission, Department of Homeland Security, and Food and Drug Administration have issued warnings to Americans to be wary of groups or individuals offering COVID-19 vaccines or cures because a vaccine has yet to be approved by the FDA.

So far, the FDA has only approved the antiviral drug remdesivir as a treatment for COVID-19.

“Unfortunately, some people and companies are trying to profit from the challenge of this pandemic by selling unproven products that make false claims, such as being effective against COVID-19,” according to a public service announcement from the FDA. “These fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness and might be dangerous to you and your family.”

Here are a few tips to keep in mind to avoid falling victim, according to the FDA and the Department of Homeland Security, as reported by the AP:

  • Products marketed for veterinary use, or “for research use only,” or otherwise not for human consumption, have not been evaluated for safety and should never be used by humans.
  • Be suspicious of products that claim to treat a wide range of diseases.
  • Personal testimonials are no substitute for scientific evidence.
  • Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”
  • If it seems too good to be true, it probably is.
  • “Miracle cures,” which claim scientific breakthroughs or contain secret ingredients, are likely a hoax.
  • Always consult a licensed medical professional to obtain a COVID-19 vaccine or treatment.
  • Make sure your doctor has been approved to administer the vaccine.
  • Do not buy COVID-19 vaccines or treatments over the internet or through an online pharmacy.
  • Ignore large, unsolicited offers for vaccinations and miracle treatments or cures.
  • Don’t respond to text messages, emails, or calls about vaccines and treatments.
  • Be wary of ads for vaccines and treatments on social media.

The FDA is working to protect Americans from these “unapproved products with false or misleading claims about COVID-19” by issuing warning letters and pursuing seizures, injunctions, or criminal prosecutions against products, firms, or individuals who violate the law.

Similarly, the U.S. Immigration and Customs Enforcement (ICE) said Monday it’s launching new efforts to find and prevent the production, sale, and distribution of unapproved or unauthorized COVID-19 products and drugs.

AdChoices

“Special agents anticipate that criminal organizations will continue to adapt and capitalize on public demand for access to vaccines and treatments as they are developed and approved,” according to an ICE press statement. “With that, the agency expects a surge in illicit attempts to introduce counterfeit versions of approved vaccines into U.S. and global marketplaces.”

This type of criminal activity is not new during the pandemic.

Shortly after the country went into lockdown this spring to stave off the spread of the coronavirus, fraudsters jumped to action, trying to make a buck off the unwitting and anxious. Scammers then peddled highly-coveted items like PPE, test kits, hand sanitizer, and alleged antidotes, while others intercepted stimulus checks.

Read more: Coronavirus stimulus check scams: How to avoid becoming a victim

Since the pandemic’s outset, over 257,800 fraudulent coronavirus-related reports have been filed, amounting to an estimated $190 million in losses, according to the FTC. The majority of activity comes from online shopping and the FTC has come down on counterfeit websites claiming to sell cleaning products, sending over 300 warning letters to companies profiting off of spurious claims and purported COVID treatments.

The Better Business Bureau also issued a warning last month about text and email messages to enroll in phony clinical COVID-19 studies. The message would advertise compensation of up to $1,000 and more if you click on the link to register. The link would either download malware onto your computer or phone or send you to a registration page asking for your personal information.

“No matter how curious you are — or how much you could use an extra $1,200 — don’t click,” the BBB warned. “It’s a scam!”

Stephanie Asymkos is a reporter for Yahoo Money and Cashay, a new personal finance website. Follow her on Twitter @SJAsymkos.

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CBS This Morning

The Justice Department has filed its first enforcement action against alleged coronavirus fraud. It obtained a temporary restraining order Sunday against the website coronavirusmedicalkit.com. Prosecutors say the site claimed to offer consumers access to vaccine kits from the World Health Organization, but there are currently no vaccines for the disease. Anna Werner joins “CBS This Morning” to explain how to avoid the scam and others like it. Watch “CBS This Morning” HERE: http://bit.ly/1T88yAR Download the CBS News app on iOS HERE: https://apple.co/1tRNnUy Download the CBS News app on Android HERE: https://bit.ly/1IcphuX Like “CBS This Morning” on Facebook HERE: http://on.fb.me/1LhtdvI Follow “CBS This Morning” on Twitter HERE: http://bit.ly/1Xj5W3p Follow “CBS This Morning” on Instagram HERE: http://bit.ly/1Q7NGnY Get new episodes of shows you love across devices the next day, stream local news live, and watch full seasons of CBS fan favorites anytime, anywhere with CBS All Access. Try it free! http://bit.ly/1OQA29B Each weekday morning, “CBS This Morning” co-hosts Gayle King, Anthony Mason and Tony Dokoupil deliver two hours of original reporting, breaking news and top-level newsmaker interviews in an engaging and informative format that challenges the norm in network morning news programs. The broadcast has earned a prestigious Peabody Award, a Polk Award, four News & Documentary Emmys, three Daytime Emmys and the 2017 Edward R. Murrow Award for Best Newscast. The broadcast was also honored with an Alfred I. duPont-Columbia Award as part of CBS News division-wide coverage of the shootings at Sandy Hook Elementary School in Newtown, Connecticut. Check local listings for “CBS This Morning” broadcast times.

Dosing Error By Researchers In The AstraZeneca-Oxford University Vaccine Trial Boosted Its Success Rate To 90%

  • AstraZeneca scientist Mene Pangalos says ‘serendipity,’ led to a break through 
  • ‘Mistake’ helped scientists discover half-dose was more effective than a full one 
  • More analysis needed to explain why an initial lower dose was more effective

A dosing error by researchers on the AstraZeneca-Oxford University Covid vaccine trial led to a huge boost in the jab’s success rate, the pharmaceutical company’s vice president has revealed.

Dr Mene Pangalos, head of AstraZeneca’s biopharmaceutical research, said the discovery that giving a half-dose at the start worked better was a lucky accident. He said: ‘The reason we had the half dose is serendipity.’ 

Volunteers were expected to receive two full doses of the vaccine. What happened with these participants would then be compared with the other half of the study group, who received a placebo.

Dr Pangalos said researchers were confused when they noticed volunteers in the vaccine group were reporting much milder side effects, such as fatigue, headaches and arm aches, than they originally predicted.  

He said: ‘So we went back and checked … and we found out that they had underpredicted the dose of the vaccine by half.’

Study results published yesterday showed that Oxford’s vaccine appeared to be up to 90 per cent effective in people who received the vaccine as a half-dose followed up by a full dose weeks later, compared to a lower 62 per cent when they were given two full doses.

Scientists explained this could be because the first smaller dose effectively prepared the immune system by showing it a small sample of the coronavirus, and then the full dose later on triggered a full-blown immune response.

Dr Pangalos said that despite the error the team decided to press ahead with the half-dose group, and to administer the second, full dose booster shot at the scheduled time.

The results showed the vaccine was 90 per cent effective among this group, while a larger group who had received two full doses produced an efficacy read-out of 62 per cent, leading to an average efficacy of 70 per cent across both dosing patterns, Dr Pangalos said.

‘That, in essence, is how we stumbled upon doing half dose-full dose (group),’ he told Reuters. ‘Yes, it was a mistake.’

It is now likely that doctors will be advised to use the 1.5 dose regimen of the vaccine rather than the full two doses because it appears to be more effective.

This will also mean that the jab, expected to cost around £2 per dose, will stretch further.

The 100million doses pre-ordered by the UK, for example, would have covered 50million people using a full two-dose system, but could now stretch to the entire population of 66million.

Although the clinical trial’s early results were published yesterday, the study is not completed.

Oxford researchers said they intend to publish the full results of the trial in a medical journal in the coming weeks and will then submit an application to the drugs regulator, the MHRA, for a licence to use the vaccine on members of the public.

This process could then take days or weeks for the MHRA to decide whether the jab is good enough to use before it can start to be given out – this is currently expected to be completed in December. 

The vaccine uses a harmless adenovirus to deliver genetic material that tricks the human body into producing proteins known as antigens that are normally found on the coronavirus’s surface, helping the immune system develop an arsenal against infection.

Dr Pangalos said more analysis was needed to explain why an initial lower dose bolstered protection. 

One possible explanation was that lower antigen levels to begin with triggered an overall better immune system build-up, he added.  

Oxford University confirmed its cheap, easy to store and simple to deliver jab could be approved by regulators in as little as a fortnight and start to be administered next month. 

Britain has ordered 100million doses, with almost 20million due by Christmas.

Professor Andrew Pollard, head of the Oxford Vaccine Group and a professor who has spent two decades running clinical trials, said that while speed of the Covid-19 vaccine’s development was in some ways extraordinary, 2020 had ‘been a very long year’ since the team started work on the vaccine in January.

That culminated this past weekend, Pollard said, in having ‘an enormous mountain to climb to pull all of the information together’ to be able to issue the early phase three trial results.

He added: ‘The last few weeks have been pretty exhausting. The feeling is absolutely one of extreme fatigue and tiredness at this point.

‘If the results have not met those regulatory requirements, they would have told us just to carry on with the trial. So it was a great relief.’

By Luke May For Mailonline and Sam Blanchard Senior Health Reporter For Mailonline

Source: DailyMail

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