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Better Living Through Well Being


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Better Living Through Well Being

I think it is fair to say most people for whatever reason are relieved to finally be in a new year. This year as the pandemic continues, rather than rush forward with resolutions as we would have in many years past, we look around ourselves and try to see reasons for hope emerging together with a cautious optimism that has us not drawing quick conclusions about what we see unfolding. It is as if we all want to wait to see "what will happen."

We have witnessed healthcare professionals rise to the unrelenting challenges of 2020 with skill, ingenuity, fortitude and compassion. We feel empathy for those who lost loved ones due to COVID-19, and for essential workers who are now coping with the traumatic aftermath of having risked their lives on the frontlines. We have seen people working together in unity and solidarity out of necessity, people extending a helping hand to neighbors and strangers, scientists developing vaccines in record time.

It is a sign of hope that the past year has demonstrated our ability to adapt, yet most of us still have a need and expectation for a level of predictability, stability and control in the world around us that we fear may not be met. The rollout of coronavirus vaccines holds the promise of returning to some sense of normality. Many jobs have been lost and many of those will never come back, but in the new economy unfolding there may be economic opportunities that can be seized, and new forms of working emerging.

I find hope in these words of Francis Collins, Director of the National Institutes of Health, "There is now a light beginning to appear at the end of this long tunnel, with science having risen to the occasion and brought forth solutions that we almost dared not hope for. And yet, here they are."


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Clinical trial results of the Moderna COVID-19 vaccine have been published in The New England Journal of Medicine. The studies, conducted between late July and October 2020, found an overall vaccine efficacy rate of 94.1 percent among 30,420 volunteers. Aside from transient local and systemic reactions, no safety concerns were identified. Phase 3 was a randomized, stratified, observer-blinded, placebo-controlled trial of adults in medically stable condition at 99 U.S. sites.

The Moderna vaccine received emergency use authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and has become the second approved vaccine in the U.S. It is being given initially to vulnerable and exposed populations and is expected to be widely available over the coming months in the U.S., Canada, European Union, Israel, Switzerland, and the U.K. Like the Pfizer vaccine, which was authorized weeks earlier, it is made from mRNA, a new technology tested for many other diseases in the past, but only recently developed for the coronavirus.

While recipients still show strong immune response three months after vaccination, it is not clear how long this efficacy will last. It is also not clear whether people can still transmit the disease to others if they’ve been immunized.

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In view of the clear need for a diagnostic tool that provides information regarding immunity levels and efficacy durations for those who have been immunized, a new ground-breaking clinical trial has been initiated in Israel. This first-of-a-kind trial will map specific biomarkers to type IgM and IgG antibody responses by means of rapid breath test technology. This test will provide a quick indication as to the efficacy of all vaccines on the market, the Pfizer-BioNTech and Moderna vaccines currently in use, as well as many more vaccines that are expected to come on to the market in the near future.

This same breath test technology is also under development for use as a rapid breath test for coronavirus detection. The test is believed to detect both symptomatic coronavirus active carriers and asymptomatic carriers. So far it has been able to detect differences among various test groups: positive subjects, negative subjects, and negative subjects with antibodies for the coronavirus.

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The FDA has issued an alert to clinical laboratory staff and health care providers that they are monitoring the potential impact of emerging viral mutations, such as the one recently found in the U.K., to determine accuracy of all currently authorized molecular tests used to detect the coronavirus. Data analysis is ongoing, but so far the FDA believes the risk of these mutations impacting overall testing accuracy is low. Also, tests that only rely on the detection of multiple regions of the virus genome may be less impacted by genetic variation than tests that rely on the detection of only a single region.

The FDA alert is meant as a reminder that all laboratory tests carry some risk of false negative results even if only minimal. Adverse or suspected adverse events experienced with molecular testing for detection of SARS-CoV-2 (coronavirus) are requested to be submitted through Med Watch, the FDA Safety Information and Adverse Event Reporting program.

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Other articles of interest in this TMIS eNewsletter for Winter 2021:

* Nationwide survey reveals 34 million Americans living with diabetes face challenges to their health resulting from the COVID-19 pandemic due to economic fallout and barriers to healthcare and food

* First of its kind human study reveals strong links between specific gut microbes, diet and health, including obesity, diabetes, and heart disease

* Origins of COVID-19 and the manner in which it spread so quickly

* COVID Alert Network offers free, fully automated track & trace network using technology available on smartphones, no app download required

* Further research into psilocybin opens new doors for treatment as perceptions shift from a potentially dangerous party drug to an approachable medicinal product

* Key areas of risk for global organizations beyond continued impact of COVID-19 include natural disasters, faceless threats, supply chain disruption, cyber attacks, decay of the ‘social contract’ and erosion of domestic political cohesion fueled by social media

* United Nations’ 75th anniversary initiative affirms belief in international cooperation in a post-COVID-19 world

* Demand for farmland continues to drive current land surge in the U.S.

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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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