Better Living Through Well Being
COVID-19 changed the world as we know it this year, and life science companies around the globe have been hard at work for months in the fight against the virus that has no cure. On the road to a vaccine, 16 of these companies have signed a landmark commitment to ensure that people everywhere have access to the eventual vaccines, regardless of their income level. The agreement calls on governments, NGOs and other stakeholders to join the cause and help accelerate the end of the pandemic.
One of these 16 companies, Johnson & Johnson, began exploratory talks in August with the European Commission (EC) to provide its COVID-19 vaccine candidate to European Union (EU) Member States, subject to regulatory approval. As of October, the company has received an Advance Purchase Agreement from the EC to supply 200 million doses of its vaccine to EU Member States following authorization. The agreement provides an option for EU Member States to secure 200 million additional doses, for a total of 400 million doses.
The company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial that started in September. A second Phase 3 study with a two-dose regimen is planned to start later this year. This investigational vaccine is based on the same technology used to develop the Ebola vaccine regimen, and over 100,000 individuals have been successfully vaccinated with it.
Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The company anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
A new surgical mask developed using breakthrough Accelerated Neutral Atom Beam (ANAB) technology is nearing regulatory approval. Through a combination of ANAB with a fine mist spray of colloidal (nano particle) copper applied to its surface, the new mask will have a significantly increased surface area. This will provide an increased barrier area where viruses can interact with copper ions to be trapped and inactivated, both to the healthy person breathing in and from the infected person breathing out.
Because the SARS-CoV-2 (COVID-19) virus is so widely distributed in the air, the main transmission routes are respiratory droplets and close contact. A cough can disperse virus particles 13 to 16 feet (4-to-5 meters) and a sneeze can project them as far as 8 meters away. Use of nano-copper is an ideal way to meet the challenge of having a truly effective surgical mask for this virus. Copper has long been understood to be a powerful anti-microbial element, killing a wide variety of bacteria and virus species. Copper, unlike other metals such as gold, silver, or stainless steel, has a free electron in its outer shell, making it highly reactive and a good conductor. This free electron allows it to bind easier to microbes and result in the release of free radicals that create holes in the viral coating leading to deactivation by destroying the DNA and RNA of the virus.
A series of “real world” challenge tests where COVID-19 viral particles were exposed in aerosol to the surgical mask achieved an endpoint of over 98 percent deactivation upon contact and over 98 percent inhibition of viral transmission through the surgical mask barrier.
Demand for COVID-19 diagnostic testing continues to rise as clinical laboratories face significant staffing shortages and persistent supply chain issues. The Association for Molecular Pathology (AMP) has released results of its SARS-CoV-2 Testing Survey for clinical laboratories. Clinical laboratories across the country are on the frontlines of this pandemic and are doing their best to keep up with the ever-increasing demand for molecular diagnostic testing despite multiple supply chain and personnel shortages. The survey results will be fundamental to informing potential legislation and other initiatives that could significantly improve response to the current and future pandemics.
Survey-based recommendations from AMP include insuring that regulatory requirements for clinical laboratories are not duplicative or burdensome; support for the clinical laboratory workforce; reassessment of type and location of SARS-CoV-2 testing services needed in order to provide acute care, safely reopen businesses and reinvigorate the economy; and reprioritize supply allocation based on real-time clinical testing needs.
Other articles of interest in this TMIS eNewsletter for Fall 2020:
* Global movement “Count Us In” mobilizes citizens to take practical steps that will make a significant impact on climate change by reducing carbon pollution and challenging leaders to act more boldly.
* Breakthrough study points to an alarming trend affecting climate change: Atmospheric nitrous oxide has risen 20 percent from pre-industrial levels and continues to accelerate due to the significant use of nitrogen fertilizers used in worldwide food production.
* Scientists work to unlock the mysteries of the plant microbiome as they come to understand the hugely positive impact that the microbes living in and around the plant can have and how it can be manipulated to improve yields, fight pests and boost crop quality.
* Americans are split over the safety of vaccines; half say they are unwilling and hesitant about getting the COVID-19 vaccine.
* More than 400,000 donated KN95 respirators and 1.1 million donated surgical masks are being distributed to healthcare facilities serving at-risk communities across continental U.S. and Puerto Rico.
* Exclusive Florida-based manufacturer of surgical masks and respirators works to help stop the spread of COVID-19.
* New study finds that pandemic-related isolation is leading to mental and physical health declines among seniors, but many are finding ways to cope.
* Families must weigh many variables to determine the best and safest ways to celebrate the holidays safely this season.
I am grateful to be in a collaborative business with many talented and skilled professionals. Additional feedback and recommendations for our services at TM Information Services are always welcome.
- Mary Michele McLaughlin
From the Front Page of TMIS News
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Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen's COVID-19 Vaccine Candidate
New Brunswick, New Jersey
Johnson & Johnson has announced that the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses.
"The COVID-19 pandemic continues to threaten communities worldwide and we have a responsibility to ensure access to our COVID-19 vaccine as soon as we can. We appreciate the Commission's and the Member States' support for our COVID-19 vaccine candidate and development efforts," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
This contract follows the conclusion of exploratory talks with the EC. The Company is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators.
Separate to the agreement with the EC, as part of the Company's larger commitment to respond to the COVID-19 pandemic, Johnson & Johnson has also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower income countries, with delivery beginning mid next year following approval or authorization from regulators. Recognizing the unique global demand for COVID-19 vaccines, the company is working tirelessly to further expand the number of available doses.
Exogenesis Surgical Mask Reaches Primary Endpoints in COVID-19 Deactivation Challenge Trials
Exogenesis Corporation has announced that a series of challenge tests for the Exogenesis Surgical Mask (ESM) achieved its primary endpoints of trapping and deactivating COVID-19 viral particles in simulated real-world exposures. The Exogenesis Surgical Mask (ESM) is designed to provide protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids. The Exogenesis Surgical Mask (ESM) is not approved for commercial distribution. Management anticipates premarket regulatory filings soon.
Exogenesis proposes combining ANAB technology with colloidal or nano-copper. ANAB is understood to create a nanotopography which results in a significantly increased surface area, 33% more surface area on each fiber. This newly formed nano-surface allows for colloidal (nano particle) copper to bind to the surface and a second ANAB treatment strengthens this bond. This increase in surface area, therefore, results in an increased barrier area in which viruses could interact with colloidal copper ions. Colloidal copper is spray-coated using a fine-mist sprayer onto the exterior surface of the ANAB-treated mask material. This results in a much greater area of coverage, using less copper than weaved fabric. Face masks and respirators treated with Exogenesis' ANABCu would result in the trapping and inactivation of viral particles both to the healthy person breathing in, as well as the infected patient breathing out.
Association for Molecular Pathology Releases Preliminary Results to Second 2020 Nationwide SARS-CoV-2 Molecular Testing Survey
The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, has released the preliminary results of its August 2020 SARS-CoV-2 Testing Survey for clinical laboratories. The anonymous survey was created and administered to monitor, understand, and collect real-time data on laboratories' efforts and experiences during the COVID-19 pandemic response. Compared to the previous April 2020 survey, respondents are experiencing continued supply chain interruptions and are now also facing significant staffing shortages, all while demand for molecular diagnostic testing continues to increase. Survey results are being used to help inform AMP's advocacy and clinical practice programs related to improving future pandemic responses.
AMP's 100-question survey assessed many important aspects of SARS-CoV-2 molecular diagnostic testing, including sample types, patient populations, methodologies, validation, performance, supply chain, public health reporting, laboratory workforce, and reimbursement. The preliminary results included feedback from 113 representatives from US-based academic medical centers, commercial reference laboratories, public health laboratories, and community hospitals. Overall, 54% of the respondents indicated testing demand was currently higher than capacity due to the reopening of local businesses and schools across the country. These laboratories are also anticipating further increases in SARS-CoV-2 testing demand over the next few months with the fall and winter influenza season, as well as the need for more surveillance and screening testing.
Unprecedented Global Movement 'Count Us In' To Mobilize 1 Billion People To Act on Climate Change launches in India
A diverse coalition of individuals and groups spanning culture, sport, entertainment, business and civil society in India has announced their participation in Count Us In, an unprecedented global campaign to inspire one billion people to take practical steps to reduce carbon pollution and challenge leaders to act more boldly on climate. Count Us In is being launched at TED Countdown, a global initiative powered by TED and Future Stewards to champion and accelerate solutions to the climate crisis.
Count Us In features an unparalleled array of promoters, including Indian actor, producer and activist, Priyanka Chopra Jonas, Nobel laureate and American politician, Al Gore, Prince William, His Holiness Pope Francis, and Lisa Jackson, environment and social VP at Apple. Count Us In aunched in India with a diverse community of partners and individuals such as Dia Mirza, Accenture, BT Group, Bombay Natural History Society (BNHS), India Climate Collaborative, The Better India, Yuvaa, FC Goa among others.
There is an urgent need to move beyond the activist community and engage citizens with a significant carbon footprint across the world to combat the threat posed by climate change. Pollution, extreme weather and rising sea levels derived from climate change will increasingly threaten communities and economies around the world, including India, unless we drastically reduce emissions and push leaders to take action. Count Us In answers this call by building the most ambitious citizen-led effort to avert the impacts of climate change. The movement focuses on engaging individuals who are not currently active on climate issues.
Count Us In sets out 16 practical and high impact steps individuals can take to protect the planet from carbon pollution before it is too late. These 16 steps, derived from experts and research at the UN Environment Programme and other partners, provide a practical way for us all, to understand how we can play our part in tackling what can otherwise feel like an overwhelming challenge. The steps include reducing plane travel, walking or cycling short distances, using electric modes of transportation whenever possible, and reducing our food and water wastage.
Breakthrough study confirms global food production poses an increasing climate threat
A study published in Nature and led by an Auburn University researcher has found that rising anthropogenic nitrous oxide emissions are jeopardizing climate goals and the Paris Accord. The significant use of nitrogen fertilizers in the production of food worldwide is increasing concentrations of nitrous oxide in the atmosphere, a greenhouse gas 300 times more potent than carbon dioxide. which remains in the atmosphere longer than a human lifetime.
This finding is part of a study co-led by Professor Hanqin Tian, director of the International Center for Climate and Global Change Research at Auburn University's School of Forestry and Wildlife Sciences and an Andrew Carnegie Fellow. The study was published in Nature, the world's most highly cited interdisciplinary science journal. Tian co-led an international consortium of scientists from 48 research institutions in 14 countries under the umbrella of the Global Carbon Project and the International Nitrogen Initiative. The objective of the study, titled "A comprehensive quantification of global nitrous oxide sources and sinks," was to produce the most comprehensive assessment to date of all sources and sinks of the potent greenhouse gas nitrous oxide.
Tian's Auburn colleagues including Professor Shufen Pan, postdoctoral fellows Rongting Xu, Hao Shi and Yuanzhi Yao and graduate student Naiqing Pan served as co-authors among an international research team of 57 scientists. The study points to an alarming trend affecting climate change: Nitrous oxide has risen 20 percent from pre-industrial levels, and its growth has accelerated over recent decades due to emissions from various human activities.
Unlocking the Plant Microbiome Could Lead to the Next Green Revolution
Plants host complex communities of microbes, which can have a significant impact on crop yields and quality, both positively and negatively. Until recently, it was generally believed that almost all microbes were detrimental or neutral to plant life. However, scientists are now beginning to understand the hugely positive impact that the plant's "microbiome", i.e. the microbes living in and around the plant, can have and how it can be manipulated to improve yields, fight pests and boost crop quality. Industry is not far behind, and the market for agricultural microbiological products is growing rapidly.
Microbes can be formulated into a wide range of different products that could be useful in agriculture, including biostimulants, biopesticides and biofertilizers. As biofertilizers/biostimulants, microbials can be used to enhance nutrient uptake from the soil and improve resilience to drought and disease. Microbes can also make effective biopesticides, either as pathogens that target certain pests, by training the plant's immune system, or by establishing a large population that outcompetes potential problematic microbes.
Americans Split Over Safety of Vaccines; 36% Say They Won't Take COVID-19 Vaccine When Made Available
A new nationwide online poll of 1,006 likely voters, conducted by John Zogby Strategies, finds a significant portion of the population has doubts about vaccines in general. While a slight majority (51%) of American likely voters say they will take the COVID-19 vaccine when available, 36% say no, leaving 14% unsure. In other words, exactly half of the population are unwilling and hesitant about getting the COVID-19 vaccine.
When asked about reasons for not getting the vaccine, the most common answer (59%) is "afraid of vaccine side effects." A follow-up question asked respondents how safe they believe the COVID-19 vaccine would be when made available. While a slight majority (51%) believe it will be safe, 29% report unsafe, and 21% are not sure - keeping consistent with the divide over the question of taking the COVID-19 vaccine.
The most common answer among the nearly three in ten Americans who believe the vaccine will be unsafe, cite "rushed/needs more testing" as a concern.
Medtronic Donates Nearly $1 Million in Personal Protective Equipment to International Medical Corps for COVID-19 Response Efforts
Medtronic plc, the global leader in medical technology, has announced that it has donated nearly $1 million worth of personal protective equipment (PPE) to relief organization International Medical Corps to support its ongoing COVID-19 response efforts in the continental United States and Puerto Rico. The donation includes more than 1.1 million surgical masks and 408,000 KN95 respirators, which are being distributed by International Medical Corps, a long-time partner of the Medtronic Foundation, to more than 15 hospitals and health facilities chosen for their locations in COVID-19 hot spots, or directly to individuals as part of prevention efforts. In addition, these facilities serve underserved and underinsured communities, most at-risk and most affected by this pandemic, particularly as COVID-19 rates are increasing in some key locations.
"When an emergency strikes, Medtronic and the Medtronic Foundation are among the first to be there, helping to ensure that first responders have the resources they need," said Erica Tavares, vice president of Institutional Partnerships and Philanthropy at International Medical Corps. "With their donation, frontline health workers across the country will be able to safely provide healthcare to communities most in need."
"Doctors, nurses and other frontline healthcare workers continue to do heroic work despite the risks to their personal health and the ongoing challenge of maintaining adequate supply of personal protective equipment," said John Liddicoat, M.D., executive vice president and president of the Americas Region at Medtronic. "We recognize and appreciate their tireless efforts and we are proud to support them, together with the Medtronic Foundation, with this donation."
High-quality N95 & PPE Manufacturer in State of Florida, Ramps up Production And Adds 500 Jobs as the CDC Touts Mask Wearing as More Effective Than a Vaccine
Recent Congressional testimony from Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), stating that surgical masks are more effective at stopping the spread of COVID-19 than a vaccine has once again put mask wearing back in the headlines. Miami-based mask manufacturer DemeTECH has disrupted the PPE (Personal Protective Equipment) industry, as one of a handful of companies manufacturing masks in the United States, and the only one to do so in the entire state of Florida.
The CDC's National Institute for Occupational Safety and Health (NIOSH) has granted approval for DemeTECH's N95 filtering facepiece respirator, made at the company's Miami, FL facility. The approval was completed with the support of the staff at NIOSH's National Personal Protective Technology Laboratory who worked arduously to evaluate and get NIOSH-approved products to the market with respect to the processes involved to protect workers.
Known for its innovative wound closure medical devices such as surgical sutures and hernia mesh, DemeTECH ramped up production of American-made surgical masks and expanded to produce N95 respirators when the COVID-19 crisis first struck. Called DemeMASK, the collection utilizes only the highest grade American-made raw materials. In fact, all aspects of the operation are USA-based, from the fabric to the packaging and extending to the machinery used in the factory. This domestic production reduces dependency on obtaining PPE from foreign countries and companies, which was a big issue when the virus first spread in the United States and PPE were nearly impossible for medical staff and consumers to find.
A Mental Burden: New Health Report Details Seniors' Struggle With Social Distancing
While social distancing has been vital in keeping our seniors safe during the COVID-19 pandemic, those measures have had unintended consequences on the population's mental health. These findings are detailed in the new report, "The Effect of Isolation on Older Americans." GoHealth, Inc. has released a report that shows many seniors aren't only feeling lonely. They're experiencing anxiety, depression, sleep changes, among other mental and physical health declines.?
"Mental health can affect people at any stage of their life,'' said Clint Jones, co-founder & CEO of GoHealth. "Whether in adolescence or the golden years, people are struggling, especially during the pandemic, and we have to be more aware, ask questions, and reduce the stigma that creates barriers to much-needed help on the way to recovery." To better understand the pandemic's effects on this group, GoHealth conducted 1,000 online interviews in mid-August 2020. Respondents were Medicare beneficiaries, age 65 and older in various income brackets and geographical regions to guarantee adequate representative sampling. Of these respondents, 80% said the pandemic has impacted how often they see their family or friends, and roughly a quarter have felt a decline in physical health (26%) and/or mental health (25%). 29% feel lonely, of which almost all (92%) are feeling more lonely compared to the beginning of the pandemic.
Aging Life Care Managers Help Families Celebrate The Holidays Safely
San Diego, California
With health experts still cautioning against travel and indoor gatherings of nonhousehold members for people at higher risk of severe complications from COVID-19, many older adults now face the daunting prospect of spending the winter holiday season alone. Families must weigh many variables to determine the best and safest ways to celebrate. Those enlisting the services of an Aging Life Care Manager are at a distinct advantage when it comes to finding ways to safely connect with older loved ones this holiday season.
During normal times, senior care providers, like San Diego's industry-leading Windward Life Care, routinely strive to keep their clients mentally and physically engaged to enhance overall health and well-being. Aging Life Care Managers lead teams of professional home care aides, drawing on a wealth of experience to create an integrated plan of care. Aging Life Care Managers, also called Aging Life Care Professionals or geriatric care managers, are experts with health and human services training who advocate for older and disabled adults, and help families navigate the challenges of aging.
The ongoing pandemic has spurred Aging Life Care Managers to get even more creative in mitigating the effects of isolation for their older and disabled clients who are living at home or in residential care settings.
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