Better Living Through Well Being
Will COVID-19 eventually become like the common cold? This was the subject of a recent NPR Morning Edition story. There are some infectious disease experts who consider the omicron surge a kind of silver lining that may enhance overall public immunity and make the virus easier to live with. In the beginning of this pandemic the overall health strategy was to flatten the curve of transmissions and infections. When that did not seem to be working out some hoped that herd immunity could make a difference. The new hope now is something called endemicity. This is where the virus is still around but faded into the background of our daily lives, becoming more predictable and less threatening.
In reality, other health experts say, it is not recommended to go about without vaccination and other protective measures. The omicron variant of COVID-19 does seem to be milder in most cases than other variants of the coronavirus, but it can still be deadly and leave people who have recovered from their initial infection with long COVID. They point out “the next variant could just as easily be nastier and even better at outsmarting our immune systems, and any immunity we get from omicron could fade.” It may still be too early to predict that we are in a progression of this virus becoming benign.
For now, they say, the best thing the country needs to do is to double down and do everything possible to blunt the damage as omicron tears across the nation.
Current vaccines for the SARS-CoV-2 coronavirus that causes COVID-19 disease work quite well against severe disease or death but have serious limitations such as waning of the neutralizing defense mounted by mRNA vaccines afer a few months. Pharmaceutical companies are working on keeping up with emerging variants, such as the most recent omicron, but there is a clear need for a vaccine that would be variant-proof and effective against the entire coronavirus family. A truly universal coronavirus vaccine would not only protect against SARS-CoV-2 but also all other coronaviruses, both known and yet to emerge.
Scientists have long worked toward a pan-vaccine for viruses like HIV-1, influenza, malaria, and Epstein-Barr, but none has made it through all rigorous clinical trials. Finding such a universal vaccine for any class of virus would be a big leap for medicine and science.
Kate Jetelina in her news blog, “Your Local Epidemiologist” brings recent news from clinical trial results of a “super vaccine” or pan-coronavirus (pan-CoV) vaccine, a variant-proof COVID-19 vaccine.
The Walter Reed Army Institute of Research (WRAIR) recently published preclinical study results show having a variant-proof pan-coronavirus vaccine may be getting close to becoming reality. If found successful, the fight against COVID-19 and other coronaviruses beyond will be forever changed.
The scientists at WRAIR have been developing the vaccine with an aim to not only address the current pandemic, but to act as a “first line of defense against variants of concern and similar viruses that could emerge in the future.” They say the vaccine offers a flexible approach to targeting multiple variants of the virus that causes COVID-19 and potentially other coronaviruses as well.
"The accelerating emergence of human coronaviruses throughout the past two decades and the rise of SARS-CoV-2 variants, including most recently omicron, underscore the continued need for next-generation preemptive vaccines that confer broad protection against coronavirus diseases. The threat from COVID-19 continues as it evolves, and eventually there will be other emerging disease threats.
Our investment in developing a next generation vaccine is an important step towards getting ahead of COVID-19 and future disease threats," said Dr. Nelson Michael, director of the Center for Infectious Diseases Research at WRAIR.
Researchers have discovered a new system of cell-to-cell communication in the body. Small vesicles called exosomes collect microRNAs that are secreted from cells and regulate metabolism in other cells at a distance. These scientists have known about this third communication route, in addition to the more well-known nervous system and hormone secretion routes, for about five years, but they are only now discovering how cells decide which microRNAs to put into their exosomes.
Back in 2017, the lab showed that fat tissue is a major source of exosomes containing microRNAs and that these microRNAs circulating in the bloodstream can regulate how the liver handles glucose and other respects of metabolism.
In their recent paper published in Nature, the researchers showed that modifying the sequence codes in the microRNAs coming from fat could increase their ability to be secreted by the fat, taken up by the liver and regulate liver metabolism. The outcome of this research could improve gene therapies and other metabolic diseases by using the easily accessible subcutaneous fat to target improved metabolism in the liver, brain, pancreas, kidneys, or other tissues.
Other articles of interest in this TMIS eNewsletter for Winter 2022:
* Researchers study how the immune system responds to mRNA vaccination against SARS-CoV-2 by strengthening T-cell activation and not just antibodies to the virus.
* Johnson & Johnson COVID-19 vaccine demonstrated greater T-cell response against omicron variant after heterologous boosting regimen in South African study.
* Anti-omicron neutralizing antibody has finished phase I trial in China.
* Pfizer-BioNTech COVID-19 vaccine booster authorized for expanded use for younger population by FDA.
* Company improves and expands access to antiviral drug Ritonavir oral tablets in China.
* Ultra-rapid COVID-19 test delivers analysis in less than 17 minutes with ability to test delta and omicron variants.
* Company leverages vast portfolio of COVID-19 testing options to enable consistent supply despite rapid test shortages.
* Bestselling self-help author and psychiatrist offers antidote to the psychological malaise caused by COVID-19.
* Dieticians forecast transformations in eating habits fueled by the pandemic, from the rise of online shopping to a focus on food as medicine for health and immunity.
* Key to Life Supply helps teach kids to grow their own food.
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From the Front Page of TMIS News
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Cracking the code for a new system of cell-to-cell signaling
Control of most bodily functions depends on the ability of cells to talk to each other. We have long known about two routes for cell-to-cell communication: the nervous system and the secretion of hormones. Over the past five years scientists recognized an important third route of communication based on exosomes--tiny sacs or vesicles containing protein and RNA molecules that cells secrete into circulation where they can be taken up by other cells to regulate metabolism.
Many labs are focusing on exosomes carrying microRNAs. These are very short RNAs that can regulate the ability of other longer RNAs that make different cellular proteins and control cell function. Thus, microRNAs affect many aspects of cellular behavior in health and disease.
Scientists at Joslin Diabetes Center now have discovered how cells pick a collection of microRNAs for their exosomes, said C. Ronald Kahn, MD, a Joslin senior investigator and professor of medicine at Harvard Medical School. "Our work offers a major insight into this new mechanism of cellular communication, because it breaks the code of why cells secrete some microRNAs and why they retain others," said Kahn, corresponding author on a Nature paper describing the work.
SARS-CoV-2 vaccination creates a strong, persistent T-cell response
New Brunswick, New Jersey
Scientists have harnessed T cells to better understand the immune response to mRNA vaccines against SARS-CoV-2, the virus that causes COVID-19. The findings from St. Jude Children's Research Hospital and Washington University in St. Louis were published in Cell. The findings suggest that some aspects of the immune response to mRNA vaccines remain robust six months after vaccination.
Much of the research on immune response to mRNA vaccination has focused on antibody levels, which can be measured by a blood test. However, this is just one aspect of immunity. Researchers wanted to better understand the specificity and structure of the T-cell response to vaccination.
Researchers focused on a certain kind of T cells in the lymph nodes, which facilitate antibody development in vaccinated individuals. The team used samples from Washington University as well as from the St. Jude Tracking of Viral and Host Factors Associated with COVID-19 cohort. The cohort was established in 2020 with hospital St. Jude employees who volunteered to have their immune response to SARS-CoV-2 infection and vaccination monitored.
"Our study lays out a new way of discovering what the T-cell responses are directed against in SARS-CoV-2, and found a surprisingly large T-cell response that is likely shared by over half the world," said co-corresponding author Paul Thomas, Ph.D., St. Jude Department of Immunology. "If your immune system is putting this much effort into seeing that particular piece of the virus, we need a better understanding of that interaction to get a full picture of how the immune system reacts to vaccination."
Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant
New Brunswick, New Jersey
Johnson & Johnson has announced new preliminary results from the South African Phase 3b Sisonke study which showed that a homologous (same vaccine) booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against COVID-19-related hospitalization. The study, conducted by the South African Medical Research Council (SAMRC), showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant. During the months studied (mid-November to mid-December) the frequency of Omicron increased from 82 to 98 percent of COVID-19 cases in South Africa as reported by GISAID, an initiative that provides COVID-19 data.
A second, separate analysis of the immune response to different vaccine regimens, conducted by Beth Israel Deaconess Medical Center (BIDMC), demonstrated that a heterologous booster (different vaccine) of the Johnson & Johnson COVID-19 vaccine in individuals who initially received the BNT162b2 mRNA vaccine generated a 41-fold increase in neutralizing antibody responses and a 5-fold increase in CD8+ T-cells to Omicron by four weeks following the boost. A homologous boost with BNT162b2 generated a 17-fold increase in neutralizing antibodies and a 1.4-fold increase in CD8+ T-cells by four weeks following the boost. Both neutralizing antibodies and CD8+ T-cells were higher four weeks after the boost with the Johnson & Johnson vaccine than with the BNT162b2 vaccine.
The increase in CD8+ T-cells generated by the Johnson & Johnson vaccine may be key to explaining the high levels of effectiveness against severe COVID-19 disease and hospitalization in the Sisonke 2 study, as the Omicron variant has been shown to escape neutralizing antibodies.1
Breakthrough Discoveries on Novel Features of Omicron Variant and An Anti-Omicron Antibody JMB2002
Joint research results from Biologics of Jemincare and Shanghai Institute of Materia Medica (SIMM) of Chinese Academy of Sciences (CAS) has confirmed that JMB2002, an anti-SARS-CoV-2 neutralizing antibody (NAb) discovered by Biologics of Jemincare is still effective against the Omicron variant of SARS-CoV-2.
A team of scientists led by Dr. Su-Jun Deng from biologics of Jemincare R&D Center, and another team of scientists from SIMM of CAS, led by Professor H. Eric Xu and Dr. Wanchao Yin, not only confirmed the binding and pseudovirus neutralization activity of JMB2002 against Omicron variant, but also solved the structures of Omicron spike protein in complex with ACE2 and JMB2002 respectively. Joint research efforts revealed the mechanisms of increased infectivity and immune escape of the Omicron variant at molecular level, and demonstrated the unique binding mechanism of JMB2002 differing from all reported NAbs. Detailed findings of novel features of Omicron variant and JMB2002 have been published on bioRxiv preprint website (Reference 1).
The latest research results indicated that JMB2002 had high binding activity to the Omicron variant and showed potent Omicron pseudovirus neutralization function. It is encouraging considering that most approved and clinical-stage SARS-CoV-2 neutralizing antibody drugs have lost their neutralization activity or have shown significantly reduced neutralizing potency due to multiple mutations of the spike protein in Omicron variant.
Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine
Silver Spring, Maryland
The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:
* Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
* Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
* Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
This action expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include its use in individuals as young as 12 years of age.
The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.
The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series. These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.
The FDA is also authorizing the use of a single booster dose five months after completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 Vaccine.
Ascletis Expands Ritonavir Oral Tablet Production and Announces Oral Direct-Acting Antiviral Pipeline Against SARS-CoV-2 Virus
Ascletis Pharma Inc. has announced the expansion of the production of ritonavir oral tablets and oral direct-acting antiviral R&D pipeline for the treatment of SARS-CoV-2 infection. The Company's COVID-19 pipeline currently includes (i) ritonavir oral tablet (100mg), an authorized product, (ii) ASC10, an oral RNA dependent RNA polymerase (RdRp) inhibitor and (iii) ASC11, an oral 3-chymotrypsin like protease (3CLpro) inhibitor.
The Company owns the only authorized ritonavir oral tablet in China, which passed bioequivalence study. The Company's ritonavir oral tablet was approved in September, 2021 by China National Medical Products Administration (NMPA). As a pharmacokinetic booster of multiple antiviral protease inhibitors, a low dose ritonavir oral tablet (100mg) is a component of oral direct-acting antiviral drug Paxlovid (Nirmatrelvir+ritonavir). The Company applied the sophisticated formulation technology to significantly increase the human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the ritonavir oral tablets produced by the Originator, AbbVie. The Company is planning to file generic drug applications for registrations in multiple countries in the world. Ritonavir oral tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand
Faster Than Ever Before: Ultra-Rapid COVID-19 RT-PCR Testing
With the arrival of the Omicron variant in the United States, fast and accurate COVID-19 testing is key to provide answers so organizations can take necessary precautions to stay safe.
World Wide Clinical Labz, a CLIA and COLA Certified Laboratory, and Baebies Inc. have teamed up to offer ultra-rapid RT-PCR testing for COVID-19. The Baebies FINDER 1.5 testing platform delivers the speed of a rapid antigen test and the accuracy of an RT-PCR lab test with the technology to streamline and miniaturize the conventional RT-PCR Process. Compared with conventional RT-PCR testing results which are typically reported after at least 24 hours, FINDER 1.5 provides rapid results with an on-cartridge analysis time of less than 17 minutes with the ability to detect Delta and Omicron variants.
"We've seen about a 30% increase in people coming in to get tested. It's been pretty busy," the company's President Michael Clemmon said. "Most people are coming in to get prepared before they see loved ones. A lot of people want to make sure that they are not infected before they go and spend time with family," he adds.
1health Helps Organizations Bridge the Testing Supply Gap
San Francisco, California
1health, a nationwide network of clinical laboratories and kit providers, is helping employers overcome testing supply issues with consistent, timely, and competitively priced COVID-19 testing solutions.
The spread of the Omicron virus has put a strain on the US COVID-19 testing supply chain with organizations ramping up their test demand to safeguard employees and individuals pulling on tests as case numbers soar.
To help make tests more available to the public, the Biden administration recently announced their intent to purchase 500 million COVID-19 testing kits, which they will provide for free to American citizens1. However, 500 million kits amounts to less than 2 tests per citizen. Therefore, while the solution will help individuals, it will not help organizations looking to support ongoing testing programs to minimize their population's risks. Further, the initiative will pull rapid tests from an already strained supply chain making it even more difficult for organizations to source the tests they need.
Dr. Keith Ablow Offers 22 Ways to Change Your Life in 2022
Dr. Keith Ablow, founder of www.pain-2-power.com, the life coaching and consulting platform he started in 2019, is offering 22 Ways to Change Your Life in 2022.
Dr. Ablow graduated Brown University with a degree in neurosciences, awarded with highest honors. He also graduated the Johns Hopkins University School of Medicine. He completed a pastoral counseling program at Liberty University and a residency in psychiatry at the New England Medical Center Hospitals. Prior to beginning www.pain-2-power.com he was the medical director of a private psychiatric practice, a psychiatric hospital and a mental health center in Massachusetts.
The Covid-19 pandemic makes it extremely important to jumpstart your life," Dr. Keith Ablow said. "The physical impact of Covid-19 has been obvious, but the dramatic and persistent psychological of Covid-19 cannot be overstated. More than ever before in my lifetime, people need help generating momentum to move forward with confidence and passion to improve their self-esteem, rebuild their relationships and move boldly to capture the levels of success they deserve."
Dr. Keith Ablow is a New York Times bestselling self-help author and psychiatrist who developed Pain-2-Power.com life coaching to fuel comebacks and empower people to take the steps necessary to confidently pursue the next, successful chapters of their life stories or the stories of their business ventures. He has appeared on over 1,000 national television broadcasts, including the Today Show, Good Morning America, CBS This Morning, 20/20, Inside Edition, Fox & Friends, Dr. Oz and Oprah.
A Decade of Dietitian Insights Forecasts a Future of Food Innovations
New York, New York
From TikTok, online food shopping, and snacking, to eating for health and immunity, the latest data reveals a wave of change resulting from the pandemic. The 10th annual Pollock Communications and Today's Dietitian "What's Trending in Nutrition" survey provides an in-depth look at the trends for 2022 and beyond, as well as a flashback to the past decade. With 1,173 Registered Dietitian Nutritionists (RDNs) responding, this is the most comprehensive collection of data from nutrition experts actively working in the field. RDNs agree that the shift from low-carb to high-fat diets like the ketogenic diet is the most surprising change from the past decade, followed by plant-based eating, which is emphasized by the 2022 Top 10 Superfoods. Rising in popularity over the years and accelerated by the pandemic, health and immunity will be the biggest trend in the next decade that will shape changes in the food industry, continuing to fuel an era of food innovations.
"With the focus on health and immunity in the next decade, and the increased popularity of plant-based eating, nutrient-dense options will be an important part of consumer diets, as they embrace food as medicine to help prevent disease," says Louise Pollock, president of Pollock Communications. "In addition, there will likely be an increased interest in functional foods containing ingredients that provide health benefits beyond their nutrient profile."
Due to COVID-19, the majority of RDNs say online food shopping is here to stay and consumers continue to snack more as a result of working from home and seeking comfort from food. TikTok lands in the top three on the list of nutrition misinformation sources with RDNs citing social media as the biggest supplier of inaccurate nutrition news, followed by friends and family, and celebrities. Here's a closer look at the findings.
Key to Life Can Help Teach Kids to Grow Their Own Food
The future and very survival of the human race rests squarely on the shoulders of the next generation. In order for them to be able to properly take over the reins, we need to give them the tools they need for success. Thankfully, Key to Life Supply has the solution! The very first step in that process is to teach them to grow a portion of their own food. As the old saying goes "Give a man a fish, feed him for a day; teach a man to fish and you feed him for a lifetime."
We must take this same approach when it comes to our children. In order for children to prosper for generations to come, they must be able to feed themselves without traveling great distances and consuming vast amounts of non-renewable resources in order to do so. The easiest way to achieve this is to teach our children to grow their own food. This doesn't mean planting acres and acres of land. It means taking advantage of the available resources like sunlight and water in order to grow simple fruits and vegetables to feed not only ourselves but our surrounding community. It means planting plants that our children can grow in abundance with very little maintenance so that they never have to rely on grocery stores for their food ever again. Imagine a world where the furthest you have to go for 50% or more of your groceries can be down the street or even in your apartment complex!
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