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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.


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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.

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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.

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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.

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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


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