- EU regulators say vaccines safe for elderly
- JNJ chief scientific officer says will apply for emergency approval in US
- WHO team finally visits Wuhan
- Tokyo and surrounding area hint at closures of bars, restaurants
- Thailand's tourism industry hit
- India new cases continue to decline
- China reports 52 new infections
* * *
Regulators in Germany yesterday warned that the Pfizer-BioNTech vaccine shouldn't be administered to minors or those older than 64. It appears the comments have sparked some kind of a battle between European regulators, as the European Medicines Agency, the top medical regulator in the EU, tells the public that the Pfizer-BioNTech vaccine is safe for older people, as a Europe-wide review found, with no link between the shot and any kind of enhanced risk.
A Europe-wide review found no link between the shot and the deaths of elderly people exposed to the vaccine. However, the EMA review found no new side effects.
In the US, JNJ released its first COVID vaccine data, while its chief scientific officer, Dr. Paul Stoffels, appeared on CNBC to confirm that the company plans to apply for emergency-use approval in the US immediately, and hopes to have supplies of the vaccine being doled out within weeks.
But nevertheless, new cases and hospitalizations are already starting to decline, as new cases reported in the US were under 156K yesterday, while hospitalizations fell by 3K, with big declines across the major outbreak states.
In other news, the WHO team finally made its way to Wuhan on Friday, and visited the Hubei Provincial Hospital of Integrated Chinese and Western Medicine, where many early cases of the virus were located.
Zhang Jixian, director of the hospital's department of respiratory and critical care, has been described by Chinese state media as the first to report the virus after examining an elderly couple in late 2019 whose CT scans showed differences from typical pneumonia.
With vaccines a big topic again Friday morning following the Novavax news Thursday night and the JNJ news Friday morning, WHO's CoVax program said it plans to ship enough vaccines to cover 3% of the population of the developing world as of Friday.
In Japan, the governors of Tokyo and its three neighboring prefectures of Kanagawa, Chiba and Saitama have agreed to consider asking restaurants and bars to shut down operations if the central government decides to extend the monthlong COVID-19 state of emergency beyond Feb. 7. The local governments are considering asking them to close early. Tokyo just reported 868 new infections, down from 1,064 a day earlier, as the capital tries to slow the spread of the virus.
Thailand's tourism industry is now being hit with a number of business closures and job losses as it suffers through yet another wave of COVID-19 infections while pleading with the government for aid. At least 1MM workers in the country's hospitality sector have been laid off so far, according to one trade group.
India, meanwhile, reported 18.9K cases over the past 24 hours, up from 11.7K the previous day, bringing the country total to 10.72MM. It also reported 163 deaths due to the virus, bringing the country's total confirmed deaths to 154K. Meanwhile, India has vaccinated about 2.93MM people against COVID-19 since it started vaccinations on Jan. 16.
Here's some more COVID-19 news from overnight:
- The Serum Institute of India, the world's biggest vaccine maker, has applied with local authorities for permission to conduct a small domestic trial of Novavax's COVID-19 vaccine (Source: Nikkei).
- South Korea has delayed until Sunday any easing of social distancing measures because outbreaks involving mission schools are threatening to undermine efforts to keep new infections under control ahead of the Lunar New Year holidays (Source: Nikkei).
- China reports 52 new infections for Thursday, down from 54 cases a day earlier. Of the new ones, 36 were locally transmitted infections. Asymptomatic cases, which China does not classify as confirmed COVID-19 cases, rose to 42 from 28 a day earlier (Source: Nikkei).
* * *
As we first reported yesterday, now that cases of the South African variant have found their way to the US, there's about to be a lot more talk about the 501. V2 variant/mutant, especially now that the latest vaccine data from JNJ has confirmed what Moderna's follow-up study appeared to suggest: vaccines aren't nearly as effective against the mutating virus as public health officials have promised.
What does good cybersecurity look like in 2022?
The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated
The post What does…
The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated at a rapid pace, with companies racing to integrate cloud-based platforms and telehealth services to expand the delivery of modern healthcare. Combined with the sudden arrival of COVID-19, this perfect storm of events handed cybercriminals an opportunity to exploit weaknesses in fledging systems and processes.
Pharma companies hold masses of vital data sets, from classified intellectual property to proprietary information about drugs and clinical trial developments. The value of such data is not lost on cybercriminals. This was illustrated in 2021, amid growing awareness of the pharma industries’ efforts to develop and distribute COVID-19 vaccines. According to cybersecurity firm Critical Insights, the number of cybersecurity breaches in healthcare reached an all-time high in 2021, exposing an unprecedented amount of protected health information.
Cyber attacks can be highly damaging, both financially and to a company’s reputation. Therefore, it is essential that necessary steps are taken, both at a company and individual level, to understand and prevent the risk of cyber threats. But what does good cybersecurity actually look like? To help navigate the complex world of digital crime, Adarma’s threat consultant Mike Varley, KnowBe4 lead security awareness advocate Javvad Malik, CEO and founder of CyberSmart Jamie Akhtar, and senior engineer at Trend Micro Simon Walsh offer their insights into key trends and best practises for pharma companies.
Why is the healthcare industry a particular target for cyberattacks?
Javvad Malik (JM): Historically cybercriminals were after money, so they often ignored healthcare providers. However, with increasing sophistication within the criminal economies and the ability to monetise data through ransomware, other means of extortion, or resale, healthcare providers have become an almost ideal target for criminals.
Simon Walsh (SW): Despite statements from would-be attackers to the contrary, the healthcare and pharma industries became prime targets during the COVID pandemic, particularly for ransomware operators, as we saw during the breach of the Irish Healthcare Service Executive in May 2021.
There are several reasons for this: they’re seen as easy targets because of their relative lack of security maturity; the COVID pandemic-induced strain they’re already under makes them more likely to pay the ransom; and the fact that the data they hold – patient records – is extremely valuable and opens additional paths to extortion.
Jamie Akhtar (JA): Many healthcare providers have weak or limited defences. These range from poor staff awareness of threats to creaking, outdated operating systems and tech, but whatever the reason, cybercriminals are aware that many healthcare providers make for easy pickings.
Mike Varley (MV): We can expect to see a rising number of ransomware attacks on the healthcare sector. Healthcare is recognised as national critical infrastructure, which makes it an attractive target to malicious foreign entities looking to create chaos and harm. Similarly, when human life is put at risk by an attack, organisations are more likely to pay up, so attackers often view these structures as a quick pay-day.
Where do you see the most mistakes being made in healthcare when it comes to addressing cyber threats?
JM: Perhaps the biggest mistakes or challenges healthcare faces when addressing cyber threats are having outdated or unpatched software running, being too quick to purchase or adopt internet-connected devices without demanding rigorous security testing, and, finally, the lack of security awareness and training amongst IT staff.
SW: Security maturity and the ability to successfully detect and withstand attacks comes from understanding cyber risk and building and developing a cyber security strategy around that understanding. This of course needs to be adopted and driven by the board and C-level executives and too often this is not the case, with a lack of understanding and investment resulting in a weakened security posture.
Over-reliance on security technology without adequate human oversight further weakens this posture. The Irish hospitals who successfully prevented the attack in May 2021 were those who not just detected stages of the attack but also understood what those detections meant and acted as a result.
Developing a human oversight function – for example a Security Operations Centre – in house is costly, difficult, and takes time. So, for many in the healthcare/pharma industry, the quickest route to success on this front is working with the correct partner who will provide that function.
JA: There are two areas in which most organisations, not just healthcare providers, could be doing better. Many aren’t doing the simple things that can thwart most cyber-attacks. For example, regularly updating software and operating systems, using strong passwords and MFA, developing clear policies for staff to follow, and ensuring security tools are configured properly.
On top of this, employee awareness of cyber threats just isn’t widespread enough. An organisation can have the best cybersecurity software around but, if an employee doesn’t know what a phishing email looks like and clicks a malicious link, it’ll be hacked just the same. The way to counter this is basic cybersecurity training. It doesn’t have to be comprehensive, just enough to help your people make informed choices.
What trends are you seeing in cybersecurity at the moment?
JA: The most worrying trend is the rise in supply chain attacks. Cybercriminals have worked out that the best way to target large enterprises with solid defences, is to attack a smaller, less well-defended supplier who can give them a backdoor in. As a result, we’re seeing more major attacks originate in this way.
Alongside this, phishing continues to be the single most common form of attack. Due to the general lack of awareness in the working population, many organisations are still struggling to contain the threat.
MV: Increasingly I think we will see healthcare sector organisations turning to managed security service providers who have the expertise, capability, and technology to deal with an increasingly complex and harmful cyber landscape.
The healthcare sector is expected to provide an elevated level of cyber protection and with a shortage of cyber talent and the prohibitive cost of establishing a Security Operations Centre internally, organisations will need a trusted security partner that can provide that level of proactive protection.
What advice would you give to companies looking to improve their cybersecurity policies, both on a company-wide scale and individual basis?
JA: Above all, make them clear and easy to follow. Avoid technical jargon, where possible, as this will only disengage people. And, explain why the company has adopted the policies it has; your staff will find it much easier to follow them if they know why. Also, store them somewhere that’s easy to access from anywhere. There’s little use in a policy if it’s buried deep in a shared drive where nobody reads it.
MV: Cybersecurity policies should be informed by a threat-led approach. Regular threat modelling will highlight what threats you are facing and how adversaries are likely to target your organisation. With this information on areas of commonality, your security teams can focus on implementing layered security and monitoring.
Your policy should consider asset awareness. As basic as it sounds, it can be easy for a small handful of assets to fall under the radar within vast enterprises, which leads to out-of-date operating systems and software.
JM: Organisations should look to take a data-driven approach. That means, that in addition to following what is occurring externally in terms of attacks, they should look through a year or two worth of internal security logs to see what was the root cause of the incidents during this time period.
Once the root causes have been identified, they should be prioritised, and then controls be put in place to address those specific root causes. Those should inform the cybersecurity policies and tailor them to the specific risks the organisation is facing.
SW: For companies, start at the top and ensure that the board and C-level executives are capable of understanding and assessing risk. This will drive investment in cyber strategy and improve your chances of mitigating that risk. Human oversight of security-related activity in the organisation is also fundamental.
For individuals, heightened awareness and ongoing education are key. We all have a role to play in cyber-security as 100% reliance on technology is unfortunately never enough.
The post What does good cybersecurity look like in 2022? appeared first on .link pandemic covid-19 testing
Monkeypox cases are rising. Should we be worried?
The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan
The post Monkeypox cases are…
The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark a few days ago and the UK top of the table with 56 as of yesterday.
Top of the list of concerns is how the virus – which does not spread easily between humans and requires skin-to-skin contact – is spreading so quickly in so many countries in Europe, the Americas and Australia where the disease is not endemic.
There is speculation that monkeypox may be being spread between sexual partners, even though it is not normally considered a sexually-transmitted infection. Thankfully, there have been no deaths reported so far, although the WHO notes monkeypox has a fatality rate of between 3% and 6%.
While health authorities are on alert, the WHO said it thinks the outbreak can be contained and that the overall risk to the population remains low. It also stressed there is no evidence that a viral mutation is responsible for the unusual pattern of infections.
Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19.
Several countries including Belgium and the UK are already advising a three-week quarantine period for anyone who contracts the virus and their close contacts.
The increasing case numbers in the current monkeypox outbreak are certainly concerning,” commented Dr Charlotte Hammer, an expert in emerging infectious diseases based at the University of Cambridge in the UK.
“It is very unusual to see community transmission in Europe – previous monkeypox cases have been in returning travellers with limited ongoing spread. However, based on the number of cases that were already discovered across Europe and the UK in the previous days, it is not unexpected that additional cases are now being and will be found, especially with the contact tracing that is now happening.”
Vaccines and drugs are available
Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts.
Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses.
There’s also a licensed antiviral drug for monkeypox. SIGA Technologies’ oral drug Tpoxx (tecovirimat) is approved for smallpox, monkeypox and cowpox in Europe, and in the US and Canada for smallpox, although it can be used off-label for the other disease. The US FDA also approved a new intravenous form of the drug last week.
The WHO says there is no need for widespread vaccination, as other control measures like isolation of patients should be enough to curb the spread and in any case supplies of vaccines are limited.
Monkeypox causes symptoms similar to but milder than smallpox, typically beginning with fever, headache, muscle aches and exhaustion. It is transmitted to people from various wild animals, such as rodents and primates, and is usually a self-limited disease with symptoms lasting from two to four weeks.
In 2003, the US experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa. The Centers for Disease Control and Prevention (CDC) is making some Jyneos vaccine reserves available for close contact inoculations, including healthcare workers tending to patients.
The UK Health Security Agency (UKHSA) said yesterday it had identified 36 additional cases of monkeypox in England, and that vaccination of high-risk contacts of cases is already underway.
“A notable proportion of recent cases in the UK and Europe have been found in gay and bisexual men so we are particularly encouraging these men to be alert to the symptoms,” said the agency’s chief medical advisor Dr Susan Hopkins.
“Because the virus spreads through close contact, we are urging everyone to be aware of any unusual rashes or lesions and to contact a sexual health service if they have any symptoms.”
The post Monkeypox cases are rising. Should we be worried? appeared first on .cdc disease control covid-19 vaccine fda rna dna spread deaths quarantine transmission africa canada europe uk world health organization
CDC Now Recommends COVID Testing For All Domestic Air Travel, Including The Vaccinated
CDC Now Recommends COVID Testing For All Domestic Air Travel, Including The Vaccinated
Authored by Jack Phillips via The Epoch Times,
In an update on the agency’s website, anyone traveling within the United States may want to consider “getting tested as close to the time of departure as possible,” and no more than three days before a flight. It previously only recommended testing for people who have not received COVID-19 vaccines or up-to-date booster shots.
The CDC update is also recommending that people take a test before or after a trip if they went to crowded spaces “while not wearing a well-fitting mask or respirator.”
In April, a Florida federal judge struck down the CDC mandate that required people to wear masks inside airports or on airplanes. Justice Department officials have signaled they will challenge the rule, implemented after President Joe Biden took office in early 2021, in court.
A spokesperson for the agency told AFAR Magazine on May 19 that “COVID-19 vaccines are effective at preventing severe disease and death,” but added, “since vaccines are not 100 percent effective at preventing infection, some people who are up to date can still get COVID-19.”
“People who are up to date with their COVID-19 vaccines may feel well and not have symptoms but still can be infected and spread the virus to others,” the spokesperson said.
In January of this year, the CDC also implemented a change to its international travel rule, requiring plane passengers aged 2 and older to show a negative COVID-19 test from no more than a day before boarding a flight or proof of recovery from COVID-19 within the previous 90 days. Foreign nationals have to show proof of COVID-19 vaccination as well.
Neither the CDC nor the White House has given any public indication of when the mandatory testing rule for international travelers will be relaxed. Travel groups have pushed for that rule to be removed for months now.
In a letter to the White House, a group representing more than 250 organizations called for an end to the rule, saying it’s only caused “slow economic recovery of the business and international travel sectors.”
After the federal judge’s order was handed down last month, the CDC issued a new recommendation that people inside airports and airplanes wear masks, despite nearly all major airliners having scrapped enforcement.
And during a news briefing last week, CDC Director Rochelle Walensky, who has been criticized for her agency’s messaging during the COVID-19 pandemic, said that people living in counties that the agency deems to have high COVID-19 transmission should wear masks in indoor settings.
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