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Mistake To Recommend COVID-19 Vaccines For All Children: Top Danish Health Official

Mistake To Recommend COVID-19 Vaccines For All Children: Top Danish Health Official

Authored by Zachary Steiber via The Epoch Times (emphasis…

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Mistake To Recommend COVID-19 Vaccines For All Children: Top Danish Health Official

Authored by Zachary Steiber via The Epoch Times (emphasis ours),

COVID-19 vaccines should not have been recommended for all children aged 5 and up, a top Danish health official has said.

Director of Denmark's National Board of Health Søren Brostrøm addresses a press conference to explain why the AstraZeneca vaccine is stopped in Denmark, in Copenhagen, on April 14, 2021. (Philip Davali / Ritzau Scanpix / AFP via Getty Images)

Søren Brostrøm, the director general of the Danish Health Authority, told TV 2 that it was a mistake to broadly vaccinate children based on the knowledge that has accumulated since late 2021.

Children aged 5 to 15 were advised to get a vaccine then, as the Omicron variant of Covid-19 became dominant around the world.

I want to look all parents of children who have vaccinated their child in the eye and say, ‘You did the right thing and thank you for listening,'” Brostrøm said.

“But at the same time—and this is the important thing to maintain confidence—I will admit and say that we have become wiser and we would not do the same today. And we will not do that in the future either,” he added.

Studies on the effects of the vaccines have shown that they confer little protection against infection from the virus. Research has also increasingly indicated that the vaccines do not protect well against severe disease in children, who are largely at little risk from severe outcomes if they get the virus.

Denmark’s new vaccine strategy recommends adults get vaccinated but specifies different advice for children.

Children and adolescents only very rarely have a serious course of COVID-19 with the Omicron variant, which is why the offer of primary vaccination for children between 5 and 17 years will not be a general offer, but can be given after specific medical assessment,” authorities said on Wednesday.

At the same time, Brostrøm encouraged adults to get vaccinated and, if they already have received a primary series, to get a booster, and if they’ve already received a booster, to get a second booster due to waning protection against Omicron.

He said the country did well amid the pandemic in the winter of 2021 even though it removed restrictions due to vaccination. “The strategy for the coming winter is also that the vaccines should get us through a new wave without restriction,” he said in a statement.

Like many nations, Denmark offers Pfizer and Moderna COVID-19 vaccines. Both have two-dose primary series.

As of June 15, approximately 85 percent of Danes have received one vaccine dose, about 77 percent have received two or three doses, and about 66 percent have received four doses, according to the Danish Vaccination Register.

About 40 percent of children have been vaccinated.

Tyler Durden Thu, 06/23/2022 - 20:20

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How prepared is biopharma for the cyber doomsday?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.
Perakslis, who was head of Takeda’s R&D Data…

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One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Eric Perakslis

He had not. While he was knee deep in the review, a ransomware later known as WannaCry ripped through the globe at breakneck speed, descending on a quarter million computers in more than 150 countries. One of the hardest hit groups was the United Kingdom’s National Health Service, which saw tens of thousands of devices — computers, MRI scanners, blood-storage refrigerators and other equipment — compromised, bringing many hospitals to a standstill for several days. By the time the NHS sorted through the rampage, government officials estimated the attack had cost them £92 million, or $120 million, both in direct costs and lost output — including more than 10,000 canceled appointments.

For Perakslis, looking back, the coincidental timing was almost eerie. But having first called on the healthcare industry to take cyber threats seriously in 2014, Perakslis had already warned others something like this could happen.

“I wasn’t surprised at all,” he told Endpoints News. “It’s not validation. It’s just like … I hate to be right.”

Five years and a pandemic later, as the whole world got a crash course on battling a highly contagious virus, the issue of defending oneself against malicious, insidious cyberthreats appears to have quietly taken root in biopharma. It came largely thanks to a confluence of factors, from the new reality of remote work to realizations about how dangerous it could be when, say, the rollout of a lifesaving vaccine is compromised.

Even as some warn industry is woefully unprepared for coordinated attacks, in many ways, drug developers are heeding the call to pay serious attention.

“I actually think that most of the pharmas are getting there,” said Perakslis, who’s since moved to the chief science and digital officer role at Duke Clinical Research Institute. “Do I think they’re meeting the threat? No. But I think they’re doing a good job trying to get there.”

Multiple biopharma companies declined to comment, citing the fear of becoming a target. But experts offered advice on how to navigate the ever-evolving threats of cybersecurity, which can ripple well into the future, in an industry where security is tough in a connected ecosystem of universities, research centers, labs, patient groups and hospitals.

“We need to focus on really defining and explaining what we need to protect,” said Kathryn Millett, a researcher at the UK-based NGO Biosecu.re.

War, crime and others

In 2017, Merck fell victim to NotPetya, an attack instigated by the Russian government that affected multiple big companies. But the aftermath of the attack continued to generate new headlines in 2022.

A court ruled earlier this year in the pharma giant’s favor, deciding that it should be awarded $1.4 billion in insurance payout for the damages it suffered when the malware wiped out years of research, disrupted sales operations and crippled Gardasil 9 production facilities, forcing the company to dip into the US national stockpile.

Bob Maley, chief security officer at the cyber risk monitoring service firm Black Kite, describes it as a “watershed moment.”

It was useful not just in illuminating what could happen when a drugmaker gets swept up in a large-scale cyberattack, but in helping define what people mean when they talk about cyberthreats in the biopharma space. For one, NotPetya illustrated the difference between cybercrime, where the ultimate goal often is to extort money, and cyberwar, which is always meant to be destructive.

“Those things do happen, but I think that for most business purposes, that kind of event — there’s not much we can do about that,” Maley said, referring to NotPetya. “If those state actors decided they’re going to do something in a cyber warfare, they’re going to do it.”

Other, more mundane kinds of attacks, though, can be just as devastating. The potential consequences vary widely, as do the points or modes of attacks, straddling the precarious line between the corporeal and the digital.

Jean Peccoud

The sheer range of possibilities for cyberattacks in life sciences led a group of researchers to propose the term “cyberbiosecurity” in 2017 “as a formal new enterprise which encompasses cybersecurity, cyber-physical security and biosecurity as applied to biological and biomedical-based systems.” Although that was credited by some for kicking off the conversation, Jean Peccoud, a synthetic biology researcher and professor at Colorado State University who co-authored that paper, noted it’s still a broad definition.

“This is a loosely defined field,” Peccoud said in an email to Endpoints.

Depending on who you are and what you are working on, the concerns could be vastly different. Peccoud himself, for instance, believes what’s unique to life science is the “dual representation of DNA sequence”: They exist as both molecules and as computer records, and translating or even transcending the two is increasingly convenient. That’s why for him, the scariest thing that could happen would be a biosecurity incident caused by an engineered organism, possibly with malicious DNA sequences designed in software, which could affect people’s health.

Some may be most worried about confidential data getting leaked; others may fear getting brought to a standstill when hackers lock down operations, demanding a ransom. For many, the nightmare scenario happens when attackers are lurking within company data, and no one knows about it — giving bad actors free reign to tamper with, to take an extreme example, the formula or quality control tests for a drug and thereby endangering patients.

“The state of play as it stands is that the problem of cyberbiosecurity itself is so large and nebulous that we cannot yet provide any clear messaging, guidance or solutions,” Millett of Biosecu.re said.

With bigger data…

While the threats of cyberattack are ubiquitous, security researchers, advocates and vendors have long warned that biopharma was a much greater target than other sectors.

“These industries offer an attractive target for cyberattacks because of their substantial investment in research and development, valuable intellectual property, connected IT and operational networks, and sensitive stores of data,” an MIT group wrote in 2018.

Emil Hewage

Emil Hewage is co-founder and CEO of BIOS Health, a Y Combinator-backed startup striving to personalize neural medicine through real time reading of patients’ neural code.

“In the discovery ecosystem we generate every week more data than that has been generated by public research efforts,” he said. “So we’re talking about many terabytes of brand new data sets per week.”

BIOS is but one player riding on a tidal wave of new discovery technologies generating data at unprecedented scale, which is often accompanied by the requisite analysis tools to interpret them. At the same time, research, development and manufacturing operations are all turning to more sophisticated technologies and data systems to measure and monitor performance on an ever-growing list of indicators.

Kelvin Lee

“The growing emphasis on cybersecurity is occurring at the same time that the industry is arguably changing to one driven by data,” said Kelvin Lee, director of the Manufacturing USA National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), in an email.

Biopharma companies are also somewhat unique in how they are entangled in a complex ecosystem of universities, research centers, labs, patient groups, hospitals and more. That’s not to mention regulators, who impose an additional layer of compliance requirements.

“It’s not just a matter of number of systems, but also number of integrations between those systems,” said Adin Stein, head of engineering operations, IT and cybersecurity at cell therapy developer Lyell.

Then there are more ways for hackers to target companies. Businesses in general have been using more devices and connecting them, exponentially expanding the number of what security folks call “attack surfaces.”

“This is more data to lose or more subtle ways for that to be extracted and exhibited privily now,” Hewage said.

Perakslis and Peccoud also both point to a concept in the cyber space known as asymmetry: For any corporation, cybersecurity is a cost that executives try to minimize. Hackers, on the other hand, stand to gain immensely from an attack, and one person can theoretically take down an entire company (even though they usually work in groups these days).

The good thing about general problems is that general solutions exist, such as employee training and cyber hygiene.

At Black Kite, Maley said his team has gone through a long list of recommended cyber practices to try and predict which companies are most at risk of becoming victims of ransomware.

“What we found was that the bad actors, out of all those hundreds of things that could be exploited, they were only exploiting a very small subset,” he said. “What’s shocking to me is so few things that a company could do to reduce their likelihood of being a victim, for some reason, they just don’t do.”

They include patching the systems on old servers to get rid of vulnerabilities, configuring emails so that it’s harder for hackers to send phishing emails, mandating multi-factor authentication and asking employees not to use the same passwords for everything — lest their login information end up on the dark web and become easy keys for hackers in attacks dubbed credential stuffing.

“Basic, basic, basic kind of things,” Perakslis said. “It doesn’t protect you from the really hard stuff. But again, it’s like driving without a seat belt, you know. Seat belts are not going to keep you out of an accident. But it’s dumb if you get into an accident, you didn’t have one on.”

Building defense

When Kathryn Millett at Biosecu.re first conducted a pilot survey of biotech and cybersecurity leaders, all respondents agreed that cyberbiosecurity risks posed a “real and current threat.” In a follow-up survey that’s still ongoing, she’s heartened to find that the awareness has “trickled down to lab practitioner level.”

“I think there’s been enough sort of news out there, you know, and enough big stories that biotech is really taking notice, and recognizing that there’s a lot at stake and they don’t want to be part of that story,” Stein, the Lyell exec, observed.

Even if biopharma companies don’t go around boasting about it, plenty of signs point to a greater emphasis on cybersecurity. Big Pharma is increasingly bringing chief information officers into the executive suite when in the past they might have reported to the CFO. By Perakslis’ count, budgets are also increasing.

A report by cybersecurity solution provider Fortinet last year found that 98% of pharmaceutical companies surveyed “experienced at least one intrusion,” and around half of them saw between three and five intrusions. But importantly, business-critical data or intellectual property were among the least impacted.

Troy Ament

“With the uptick of these intrusions in general, companies have likely gotten better about protecting business-critical data, but that’s not to say cyberattacks targeting these pharmaceutical organizations are not serious, but it is possible that data is better segmented to prevent cascading impact if an intrusion happens,” said Troy Ament, Fortinet’s chief information security officer.

Lee, the NIIMBL director and University of Delaware professor, noted that while the leading pharma companies are sophisticated in the space, performance is also uneven.

“Smaller companies in the field that have just a few years of experience usually do not have strong cybersecurity protocols or the funding to invest in third-party analysis and compliance services,” Alex Zhavoronkov, co-CEO of the AI drug discovery company Insilico, wrote to Endpoints. “This sometimes worries me a lot.”

At companies that do allocate enough resources, cybersecurity often consists of three pillars: cutting-edge technology that cements every system update patching vulnerabilities; outside experts who provide intelligence and an assessment of risk levels; and a framework to integrate the handling of cyberattacks into the rest of the risk management system.

“One of the best cybersecurity strategies starts with assuming you’ve already been hacked because what happens when you’re hacked, you’re going to look for data that’s leaving,” Perakslis said, and he noted companies are getting better about using real time threat surveillance data to identify and jump on issues.

Alex Zhavoronkov

Biopharma could also learn from other industries, Maley said, learning from case studies such as the breach experienced by Colonial Pipeline, where a mix of exposed remote access ports and credential stuffing led to catastrophe.

For smaller players, Hewage noted, it’s best to start thinking about cybersecurity before they lay their hands on sensitive data. Alternatively, Zhavoronkov noted Insilico decided to lower the risk by minimizing the amount of patient data its platform relies on — while carefully following compliance protocols demanded by Big Pharma partners and engaging providers to perform stress tests.

“I think as you think about particularly emerging biotech, one of the key lessons that I’ve picked up on through the community is the idea of security by design,” Stein said. “It is easier to put a security program in place and develop a culture of security than it is to go back and retrofit.”

Still, no defense is permanent.

“While the industry has certainly taken notice, being on alert never ends,” Ament said.

Culture of secrecy

After a cyberattack, biopharma companies are reluctant to share what happened with other drugmakers, losing what could be teaching moments. Maley said what to disclose has been an issue even going back to a 2006 cybersecurity conference that he attended.

“We’re still talking about it 16 years later,” he said.

To this day, Merck has kept public statements about the NotPetya attack to a minimum. And while others, from Dr. Reddy’s to Roche to Bayer to more recently Novartis, have reported cyber intrusions, they often don’t offer any details beyond whether any sensitive data were compromised.

There are legitimate reasons for staying mum, Perakslis said: “One of the important reasons is that you would never give an adversary your playbook.”

There are also few laws requiring disclosure, while board members do have a fiduciary responsibility to shareholders — which often means to limit bad press.

“I think most companies when they experience these things, one of the first questions that management asks is, well, who do we have to tell? Not who should we tell,” Maley said.

But conversations do happen, Stein said, where specifics are kept confidential and lessons are shared, whether through speaking engagements at conferences, consulting vendors or contributing to the creation of industry standards.

“I wouldn’t assume that if you’re not hearing from a particular organization, they’re not contributing very heavily to quite complex discourse,” said BIOS CEO Hewage. “And in some senses, it’s best to trust really heavily peer reviewed and vetted, industry wide conversation.”

Government agencies can sometimes play that middleman role. The US Department of Homeland Security, for instance, has established Information Sharing and Analysis Centers for early information sharing; the Department of Health and Human Services set up the Health Sector Cybersecurity Coordination Center to do something similar and alert stakeholders to threats; and the UK is also reviewing its biosecurity strategy.

That said, it is nearly impossible to truly tell how prepared a certain company is against cyberattacks — and even with options for sharing, companies tend to be selective about what they say. As a pharma insider told Endpoints, “There’s no prize for naiveté.”

Finding a balance

Even those who are most steeped in cyberbiosecurity advocacy tend to acknowledge that cybersecurity cannot, and should not, be the sole focus of biopharma companies. Their stated mission, after all, is to develop new vaccines and treatments for diseases.

With all the other projects, plans and needs vying for attention, Perakslis said it’s all a matter of prioritization and resource allocation — thinking through how much money to spend on things that are likely but low impact, versus those that are unlikely but high impact.

Understanding the risks and impact thoroughly, then, becomes key.

Finding reference in other areas, Peccoud noted that the aviation industry has an incident reporting system that’s essential to develop its safety culture. Voluntary reporting is shielded from prosecution, which, along with the National Transportation Safety Board, provides material that can be discussed in training or to develop regulation.

“Without transparency the bad guys will always have the edge,” he said.

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Preventing the next pandemic: Learning the lessons

In the first of a three part series, Ben Hargreaves looks at what the odds are of another
The post Preventing the next pandemic: Learning the lessons appeared…

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In the first of a three part series, Ben Hargreaves looks at what the odds are of another pandemic arising in our lifetimes and what can be done to lower the risk of this happening again.

The current pandemic is still very much underway. The question is, as one study was recently entitled, whether the current phase brings the world closer to the end of the pandemic or just to the end of the first phase? What is clear is that due to vaccines and therapeutics, the critical early phase of the pandemic is over. As the article suggests, what could lie ahead is a process of learning how to live with a persistent circulation of the virus and, with this, consistent spikes of cases, likely occurring periodically and more often in the winter months.

With the current pandemic refusing to dissipate, the discussions around future pandemics become more difficult to countenance. As identified very early into the current pandemic by the WHO, there is the risk of fatigue arising over long-term global health crisis response, which becomes an issue when acknowledging that the current times we’re living through could happen again. Research has suggested that in any given year there is a 2.5 to 3.3% chance of a pandemic on the scale of COVID-19 occurring. Not only this, the expectation is that such events are becoming more likely, with estimations that the probability of outbreaks such as the current pandemic will likely grow three-fold in the next few decades.

Pharma invested

The acceptance that there will potentially be another pandemic within many people’s lifetimes underlines the importance of using the emergence of COVID-19 to better protect ourselves against the next threat. Although it’s come at a high cost, the world is now in a strong position to prepare itself, with the lessons from the current pandemic still fresh in mind.

One clear benefit is that the pharmaceutical industry has proven that it is able to develop and safely deliver vaccines in a much shorter timeframe than usual. A typical vaccine development timeline takes between five and 10 years; the vaccines approved for COVID-19 emerged much more quickly.

Though the next pandemic could prove to be a more complicated target to vaccinate against, the success of the vaccines and the financial gains that were achieved would see companies eager to engage in development. Already, the industry is seeing greater research and funding being diverted back into vaccine development, with mRNA vaccines holding particular interest. This should see a pipeline of vaccine candidates better stocked than on the emergence of COVID-19, if this can be sustained into the future.

Global governance

However, the work required to prevent the next pandemic is far broader than vaccines and therapeutics, which are essentially the last defence. In the future, the entire global health system will need to change to become more resilient, which requires many individual changes but can be broken down it smaller, logical actions that have outsized outcomes. One such action is simply coordination at the highest levels.

There were warning signs prior to COVID-19 that a pandemic could be possible, with the outbreaks of Zika and Ebola viruses, both of which have occurred intermittently for years but had attained wider notoriety after bigger outbreaks in the last decade. Despite this, coordinated efforts on the response to the current pandemic lacked cohesion – many countries adopted different methods of combatting the spread of the virus and containment. Once vaccines were on the market, countries competed against one another for access, thereby denying them to the countries without the economic firepower to match.

A recent report for the G20 group of nations, on preventing the next pandemic, concluded: “It requires establishing a global governance and financing mechanism, fitted to the scale and complexity of the challenge, besides bolstering the existing individual institutions, including the

WHO as the lead organisation. A primary one is training and hiring adequate levels of health workers.”

The report broke down four major gaps that need to be addressed, on a global and national level, to be able to respond more quickly, equitably and effectively when further pandemics occur:

  • Globally networked surveillance and research: To prevent and detect emerging infectious diseases
  • Resilient national systems: To strengthen a critical foundation for global pandemic preparedness and response
  • Supply of medical countermeasures and tools: To radically shorten the response time to a pandemic and deliver equitable global access
  • Global governance: To ensure the system is tightly coordinated, properly funded and with clear accountability for outcomes

Spending money to save money

The hiring of additional healthcare workers, the build-out of surveillance systems, support provided for R&D into infectious diseases, and the creation of a stockpile of medical countermeasures all require funds. This is a major question of the report for world leaders: Whether there is the appetite for further funding into pandemic preparation? The global economy has taken and continues to feel the financial blow of COVID-19.

However, the report calls for more public funding to be put into health in the coming years, with the authors stating that approximately 1% of GDP must be committed by low- and middle-income countries. In terms of funding for international efforts for preventing the next pandemic, the figure is estimated at $15 billion per year, sustained for the coming years. Compared to the sums spent on vaccines and therapeutics during the current pandemic, the investment is far lower and will help boost what the report calls, “a dangerously underfunded system.”

Beyond all action is a tactic for mitigating pandemics that is known as primary prevention. Fundamentally, this means going before all of the previously discussed methods to tackle the virus at the root cause.

Research has called for greater emphasis to be put on elements that prevent virus spillover, where a virus jumps species. The authors identify three areas where a difference can be made: reduced deforestation, better management of the wildlife trade and hunting, and better surveillance of zoonotic pathogens before any human is infected. The authors suggest that even a 1% reduction in risk of viral zoonotic disease emergence would make any efforts in this direction cost-effective. They end their study, stating, “Monothetic ‘magic bullets,’ including diagnostic tests, treatments, and vaccines, failed to control COVID-19 as it spread around the globe and exacted the largest health and economic toll of any pathogen in recent history. This makes plain that we cannot solely rely upon post-spillover strategies to prevent a similar fate in the future.”

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FTSE 100 gains as commodity-linked stocks bounce back

The commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3% UK’s FTSE 100 gained on Monday, as an easing of COVID-19 restrictions…

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The commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3%

UK’s FTSE 100 gained on Monday, as an easing of COVID-19 restrictions in China brought relief to commodity prices, lifting shares of major oil and mining companies.

As of 0704 GMT, the commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3%.

The risk sentiment improved after a Wall Street rally late last week and a rebound in copper and iron ore prices on Monday, boosted by an easing COVID-19 restrictions in Shanghai and relaxed testing mandates in several Chinese cities.

The burst of global enthusiasm for equities has put a spring in the step of the FTSE 100 at the start of the week, Hargreaves Lansdown analyst Susannah Streeter said.

Mining stocks led gains on the FTSE 100 index, with Anglo American, Rio Tinto and Glencore rising more than 3%, after Group of Seven leaders pledged to raise $600 billion private and public funds in five years to finance needed infrastructure in developing countries.

It is hoped this scheme, seen as a counter to China’s Belt and Road Initiative, will set off a spurt of spending and demand for commodities around the world, Streeter added.

Among individual stocks, CareTech surged 20.8% after the UK-based provider of care and residential services agreed to be acquired by a consortium led by Sheikh Hoidings in an 870.3 million pounds ($1.07 billion) deal.

Carnival Corp jumped 5.6%, extending its Friday gains after the leisure travel company forecast a positive core profit for the current quarter despite surging costs.

London-listed shares of Rio Tinto added 2% after a U.S appeals court ruled that the federal government may give the UK copper miner a right to lands in Arizona.

BAE Systems inched up 0.4% after the defence company received a $12 billion contract from the U.S Department of Defence.

The post FTSE 100 gains as commodity-linked stocks bounce back first appeared on Trading and Investment News.

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