2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines | Circulation
3 Stocks For Patient Investors Looking To Build Generational Wealth
InvestorPlace - Stock Market News, Stock Advice & Trading Tips
The best way to get rich is not through get-rich quick schemes — slow and steady wins the race. It is not something to achieve in a single quarter or even a year. You create financial freedom that you can pass on to your children and grandchildren over a lifetime.
The best generational wealth stocks are those that pay dividends. Income-generating stocks have a long history of outperforming not only non-dividend-paying stocks but other asset classes as well.
A Deutsche Bank study showed that over the past 100 years, equities beat out gold by 5.6% per year, housing prices by 6.6%, treasuries by 6.8% and oil by 8.4% per year. Over short periods of time one asset class or another may outperform stocks, but the long-term results prove that if you want to accumulate large amounts of wealth, investing in stocks is the way to go.
And dividend stocks are the best-performing stocks. Several years ago, the asset managers at JPMorgan found that stocks initiating a dividend and then raising their payouts over a 40-year period between 1972 and 2012 returned an average of 9.5% annually, versus just 1.6% non-dividend-paying stocks.
Investing $10,000 in 1960 in income stocks on the S&P 500 and reinvesting the dividends would turn that initial grubstake into $5.1 million today. It is clear that dividend stocks are the generational wealth stocks to buy. Below are three companies that have the potential to make your retirement comfortable and to hand down a rich legacy to your heirs.
Broadcom (AVGO)Source: Piotr Swat / Shutterstock.Com
Best known as a maker of mobile handset computer chips, Broadcom (NASDAQ:AVGO) has more recently pivoted to producing chips for data center infrastructure and its custom accelerators are in high demand. Generative artificial intelligence is what is driving the chipmaker to new heights. Broadcom stock is up 56% year-to-date and has nearly doubled over the past year.
Longer term opportunities for the company come from areas like quantum computing, sensing, measurement and engineering. But AI is piling on profits today. Broadcom anticipates AI chips will bring in $11 billion in sales in 2024 accounting for 25% of the total. That's an increase from 15% of total sales in 2023.
It means Broadcom will be realizing profits to support its dividend for years to come. The dividend of $21 per share yields 1.2% annually. Broadcom has raised the payout for 15 consecutive years and has a 33% compounded annual growth rate (CAGR) over the last 10 years. It's what makes the chipmaker a key component of generational wealth stocks for your portfolio.
American Tower (AMT)Source: T. Schneider / Shutterstock
American Tower (NYSE:AMT) is a specialty real estate investment trust (REIT) that owns cellular towers and leases them to wireless service providers, radio and television broadcast companies under long-term leases. More recently it entered the data center market and owns 28 facilities.
Cell towers are a fairly exclusive club and American Tower is one of the biggest with over 224,000 communications sites. There is also a wide and deep moat in the industry as siting, construction and operation of towers is expensive. According to CSIMarket, AMT owns 63% of the market.
American Tower stock is down 5% in 2024 as fears of a slowdown in network buildout by wireless carriers like AT&T (NYSE:T) and Verizon (NYSE:VZ) weighed on its shares. Yet there is a long tail of opportunity.
Demand for wireless coverage and capacity is increasing as the transition to 5G networks marches on. More and better coverage will be insisted upon by wireless carrier customers. It positions American Tower for future gains.
Because AMT is organized as a REIT, it is required to pay out 90% or more of its profits as dividends. It has raised its dividend by more than 16% annually for the last 10 year while growing free cash flow (FCF) at a CAGR of 12%. That gives it plenty of cash profits to support and raise the payout further in the years ahead.
Eli Lilly (LLY)Source: Jonathan Weiss / Shutterstock.Com
Drugmaker Eli Lilly (NYSE:LLY) is riding the wave of demand for weight-loss treatments to new heights. Shares are up 59% year-to-date and have more than doubled over the past year. Wall Street expects demand for its diabetes and weight-loss drugs Mounjaro and Zepbound to increase exponentially, driving earnings higher. Lilly is expected to expand profits at an astounding 63% CAGR for the next five years.
But the drugmaker is much more than just this fat-fighting therapy. For example, it just announced a $3.2 billion deal to acquire Morphic Holding (NASDAQ:MORF) to gain access to its inflammatory bowel disease treatment. In clinical trials, MORF-057 has blockbuster potential and should solidify Lilly's competitive edge.
The pharmaceutical giant has paid a dividend every year since 1972 and has raised the payout for the past decade at a 10% CAGR. Although the payout yields 0.6% annually, over time the yield on cost increases dramatically. It makes Eli Lilly a generational wealth stock to buy now.
On the date of publication, Rich Duprey held a LONG position in T stock. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.Com Publishing Guidelines.
On the date of publication, the responsible editor did not have (either directly or indirectly) any positions in the securities mentioned in this article.
Rich Duprey has written about stocks and investing for the past 20 years. His articles have appeared on Nasdaq.Com, The Motley Fool, and Yahoo! Finance, and he has been referenced by U.S. And international publications, including MarketWatch, Financial Times, Forbes, Fast Company, USA Today, Milwaukee Journal Sentinel, Cheddar News, The Boston Globe, L'Express, and numerous other news outlets.
More From InvestorPlaceThe post 3 Stocks for Patient Investors Looking to Build Generational Wealth appeared first on InvestorPlace.
Women's Health Research Has A Long, Quiet History Of Exclusion, And It's Still Affecting Our Well-Being
Up until 1993, women were excluded from clinical research and trials—a fact that has had a serious, continual impact on women's health today.
A perfect example? The recent "metals-in-tampons" discovery flooding the news. You heard that right: A study in Environment International found more than a dozen toxic metals—including lead and arsenic—in 14 popular tampon brands. Despite tampons being around since the 1930s, this was the first ever study of its kind. (And while the study didn't involve women directly, it's an example of the ripple effect caused by gender-biased research.)
We don't know whether these ingredients are harmful quite yet, but the finding certainly begs the larger question: Why hasn't this been looked into before? Yes, progress has been made over the last several decades, but it's clear the medical community still has a lot of catching up to do in terms of gender equality and research.
Clinical research and trials are at the heart of all medical advances, as they study things like new drugs or drug combinations, new surgery methods, new medical devices, new ways to use existing treatments, new ways to change behaviors to improve health, and new ways to improve quality of life for people with acute or chronic illnesses.
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While clinical research dates back all the way to Biblical times, the first randomized control trial (testing a treatment for tuberculosis) was carried out in the 1940s. In 1964, the World Medical Association articulated guidelines on using human subjects in research in what's known as the Declaration of Helsinki—which has undergone a series of updates, with the latest being in 2013. However, men were treated as the "medical norm" until 1993—around the time many millennials were born—when Congress passed the NIH Revitalization Act, which mandated the inclusion of women (as well as minorities) in clinical trials.
Why (and how) women came to be included in clinical trialsWomen were historically excluded from clinical trials for a few main reasons, says Sara Crystal, MD, a board-certified neurologist and an advisor to Cove, a telemedicine platform that provides consultation on migraines. Among them: bias; the assumption that there were no significant sex differences in regard to medication response, and therefore no need to study women separately; concern over having to adjust for women's fluctuating hormone levels; and concern over reproductive effects.
The passage of the Revitalization Act had been a long time coming, however. It was largely influenced by the many civil liberty movements taking place, as well as the popularity of powerful literature, like the book Our Bodies, Ourselves, which addressed women's reproductive health and sexuality. Efforts that led to NIH's inclusion policy occurred simultaneously with those to establish the NIH Office of Research on Women's Health, and a full decade prior, in 1983, the Public Health Service Task Force on Women's Health Issues. (In fact, NIH had established the policy for including women in clinical research seven years earlier, in 1986, which urged researchers applying for NIH funding to involve women in their studies.)
Natalie Dipietro Mager, PharmD, MPH, an associate professor of pharmacy practice at Ohio Northern University College of Pharmacy, co-authored a study that examined the history and progress of women's inclusion in clinical trials for prescription drugs. She notes in the study that while there is recognition today of the need to include women sufficiently in clinical trials, in previous decades, the consideration of men overshadowed women in clinical research design and conduct.
Prior to the women's health movement of the late 1960s and 1970s, some medical research practices led to inaccurate understanding of the human body as a whole, says Regine Douthard, MD, MPH, senior program officer with NIH's Office of Research on Women's Health.
"Many clinical trials ran under an unspoken assumption that the only difference between women and men was their sexual and reproductive organs," Douthard explains. "Women were, in essence, considered small men."
"Many clinical trials ran under an unspoken assumption that the only difference between women and men was their sexual and reproductive organs. Women were, in essence, considered small men." — Dr. Regine Douthard
What are the problems created from omitting women from clinical trials?It's easy to sit back and think: This all changed 27 years ago, and we've come a long way since then. While this is true to a degree—a 2019 study found that women today make up about 49 percent of participants in clinical trials—it's impossible to ignore the problems that omitting women from these studies in the past created, many of which still stand today. "It's hard to say that studies have been entirely negated [as a result of women included in clinical trials]," says Dipietro Mager.
One big issue being discovered is that some diseases present differently in men and women. Take heart disease, for example: Men's presentation of cholesterol plaque in the arteries looks different than women's, says Dipietro Mager. As a result, heart disease is underdiagnosed in women. "The bulk of cardiovascular clinical trials research has been predicated to men, and this has, in my opinion, served as a medical disservice to women with cardiovascular disease," says Kecia Gaither, MD, MPH, FACOG, a double board-certified OB/GYN.
There's also data that shows women are treated less aggressively for heart disease than men and aren't taken as seriously in hospitals, she adds, and as a result, women with heart disease are having worse outcomes than men. For example, a study from 2000 found that women are seven times more likely than men to be misdiagnosed and discharged from the hospital while having a heart attack.
A second big issue with omitting women from clinical trials has to do with prescription dosages. There are very few drugs that have overt dosage directions that are different for men and women, says Dipietro Mager. "Because men and women have different composition in terms of body fat, and women in general may have smaller frames than men, we don't know whether there should be a difference in dosage," she says. One of the few prescription drugs that does have differences on the label for men and women is the sleep aid Ambien, with a recommended initial dose of five milligrams for women and five to 10 milligrams for men.
There have also been studies showing how aspirin affects men and women differently. And in 2001, the FDA reported that eight of the 10 prescription drugs it withdrew from the U.S. Market in 1997 were found to have posed greater health risks for women than men.
The future of women's health is tied to clinical trial inclusionThe NIH Revitalization Act of 1993 was a good start to understanding women's health. Since then, the FDA has also implemented a policy of encouraging inclusion in clinical trials (specifically with regard to prescription drugs) to ensure participants are representative of the broad population of patents who will be exposed to these drugs. (FYI: The FDA has jurisdiction over clinical investigations involving FDA-regulated products such as drugs, biologics and medical devices; for clinical investigations conducted or supported by NIH, both the FDA and the U.S. Department of Health and Human Services have joint jurisdiction.)
It's worth noting that in 1977, following the tragedies caused by the use of two prescription drugs for morning sickness that turned out to be damaging to embryos, the FDA had recommended against including women of child-bearing age in early phases of drug testing, except for life-threatening illnesses. A new FDA guideline issued in 1993 was the first time the regulating body lifted the restriction on women, allowing them to be included in early-phase clinical trials. Five years later, the FDA published its final rule requiring new drug applications for drugs and biologics to examine and include data on safety and effectiveness by gender, age and race.
In a draft dated June 2019, the FDA published further guidance on diversity in clinical trials, and has published several other guidance documents on topics such as collection of race and ethnicity data in clinical trials and reporting of age-, race- and ethnicity-specific data in medical device clinical studies. The FDA Center for Devices and Radiological Health also issued guidance around gender-specific evaluation of data on medical devices in 2014. (It's worth noting, however, that while including demographic subgroups as participants is strongly encouraged, there is no statutory requirement by the FDA to include these subgroups as participants in clinical trials.)
Even though these measures have helped grow representation of women in clinical trials, the same study reporting that 49 percent of participants are now women also found that women are still underrepresented in major medical research areas such as cardiovascular disease, hepatitis, HIV/AIDS, chronic kidney disease, and digestive disease. But again, there are signs that things are improving; a new study published in February 2020 reported that among cardiovascular trials conducted between 2010 and 2017, men still predominated overall, but the representation of women varied with disease and trial characteristics, and has improved in clinical trials examining stroke and heart failure.
Now, there are also advocacy groups advocating for women's equality in clinical research. For example, Shikha Jain, MD, FACP, a board-certified hematology and oncology physician on faculty at Rush University Medical Center in Chicago, co-founded the Women in Medicine Summit last year. The summit is a multinational conference that's focused on empowering both women and men to close the gender gap in medical research on a personal and national level. "My hope is that when we move forward and realize more and more the fact that this discrepancy still exists," says Dr. Jain, "that physicians will make a concerted effort and be intentional in including men and women [in clinical trials] equivalently."
What still needs to be doneOne of the main reasons that women still aren't being included often enough in clinical trials is that they simply aren't offered the opportunity as often as men. There might be a preconceived notion that they aren't interested in the trials or don't have the time, "so the challenge is changing the perception that we shouldn't include women in trials," says Dr. Jain.
Dr. Gaither says one way this can be accomplished is by having more education available to the public, whether it be by commercials, radio, or social media, explaining how you can engage in clinical trials. "I believe that the more diverse individuals participate in clinical trials, the better [we can learn] what works best for whom—ultimately improving health for all," she adds.
Equally as important is including minority women, who as a subgroup continue to be vastly underrepresented in clinical trials. "That is a huge, huge issue," says Dr. Jain. However, physicians are working with these populations to bring them opportunities to be part of trials—as well as destigmatize the way trials are perceived in general.
Many patients worry that being part of a clinical trial means they'll be experimented on, says Dr. Jain. But trials differ, and participating in a trial means you'll get the standard of care (or better) with the chance of to not only improving your trajectory in your disease process, but also potentially improving other patients' potential outcomes by learning from your response to the treatment. Also, you don't have to be sick to be part of a clinical trial; many trials are looking for healthy participants. (To find opportunities, check ClinicalTrials.Gov or check with your local health department.)
Natasha Bonhomme, chief strategy officer for Genetic Alliance, a nonprofit health advocacy organization based in Washington, D.C., says that many times, women are still leaving their doctor visits with more questions than answers—and that the public in general is not very knowledgeable about clinical trials, often unaware until someone close to them is hit with a health crisis. "People don't really understand that what we can learn from clinical trials really drives what we get in our healthcare system," Bonhomme says. "A medical intervention doesn't just show up out of nowhere; it takes decades of research, clinical trials, and investment—and that's a great thing, but not a great thing when half the population is basically left out."
The solution to designing more trials that include representative groups has to be a multi-pronged approach. "The impetus is going to be on physicians to educate, on the researchers creating trials to ensure there are intentional ways in which diverse groups of individuals should be recruited, and intentional patients who are asking the important questions and understanding the benefit not only for them but science and medicine in future," says Dr. Jain.
A major upside to leveling the playing field when it comes to clinical trials is an improvement in the entire health-care system. Research shows that investing in women's health, leading to healthier women and children, creates a healthier and more productive society for all. "It's important for us to have as much information as possible, and also to have everyone feel like they are part of the medical and health care system and that it's responding to them," says Bonhomme. "It affects all of us."
The bottom line, says Dr. Jain, is that more conversations need to be had and more work needs to be done. Now that we've identified the lack of inclusion of women in clinical trials in the past as a problem, the important next step is both doctors and patients taking steps to actually implement solutions. "We need to be intentional in how we're moving forward," she says. "The more that it's discussed and addressed, the more we will be actually seeing changes."
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New Clinical Trial Studies Nasal COVID-19 Vaccine
New clinical trial studies nasal COVID-19 vaccine
Updated: 1:14 PM EDT Jul 5, 2024
LAST WEEK WE TOLD YOU ABOUT THE SMITHS AND THEIR DESPERATE EFFORT TO HELP THEIR SON, WHO WAS SUFFERING WITH SEVERE PEDIATRIC LONG COVID. THEIR BANKING ON A NONTRADITIONAL CLINIC IN ARKANSAS, WHICH HAS GIVEN OTHER LONG COVID KIDS THEIR LIVES BACK. BUT GETTING THERE IS NOT EASY. DYLAN SMITH, NOW 14, FELL ILL TO LONG COVID MORE THAN TWO YEARS AGO AND HIS CONDITION HAS SPIRALED DOWN. HE IS NOW BED RIDDEN WITH A FEEDING TUBE AND IN CHRONIC PAIN, BUT HIS PARENTS HAVE HOPE. FAST. FORWARD ONE YEAR FROM NOW, WHAT DO YOU ENVISION? WHAT DO YOU HOPE? OH MY GOSH, I HOPE THAT OUR SON IS RUNNING AROUND THIS HOUSE. UM, I HOPE WE'RE BACK TO A HECTIC SCHEDULE OF WATCHING HIM PLAY SOCCER JUST EVERY DAY NORMAL LIFE. HONESTLY, JUST WATCHING HIM BRUSH HIS TEETH AND WASH HIS FACE. STACY AND MIKE SMITH BELIEVE THAT IS POSSIBLE IF THEY CAN GET DYLAN TO A NONTRADITIONAL MEDICAL FACILITY IN FAYETTEVILLE, ARKANSAS CALLED THE SPIRO CLINIC. THE FOUNDER AND CEO SAYS THEY ARE SEEING GREAT SUCCESS IN TREATING PEDIATRIC LONG COVID. SO FAR, WE'VE HAD 100% SUCCESS RATE. NOW WE'VE HAD FEWER THAN TEN SEVERE LONG COVID CASES. SO IT'S NOT A BIG POOL OF PATIENTS, BUT I'M VERY EXCITED ABOUT THE POSSIBILITY THE CLINIC TREATS SEVERE PAIN DISORDERS SUCH AS COMPLEX REGIONAL PAIN SYNDROME OR CPPS. AND NOW PEDIATRIC LONG COVID 14 YEAR OLD TRISTAN KIM IS A LONG COVID PATIENT WHO HAS BEEN AT THE CLINIC FOR FIVE MONTHS. HE IS NOW ABLE TO EXERCISE ON HIS OWN, EVEN RIDE A SCOOTER. THIS WAS TRISTAN BACK IN JANUARY WHEN HE FIRST ARRIVED IN A WHEELCHAIR. MOM ASHLEY SAYS HIS SYMPTOMS WERE SO HORRIFIC HE QUESTIONED WHETHER HE WANTED TO LIVE. HIS BRAIN FELT LIKE IT WAS ON FIRE. HE HAD VISION LOSS, BLISTERING SKIN, STOMACH PAIN, NAUSEA, A FEELING LIKE HIS BODY WAS BEING CRUSHED. WE HEARD ABOUT SPIRO. WE WEREN'T SURE IT WAS THE RIGHT PLACE, BUT WE KNEW IT WAS A NEUROLOGICAL DISEASE. WE KNEW THAT. WE KNEW THAT WHAT WAS HAPPENING WAS NOT NORMAL, AND THAT A CHILD SHOULD NEVER HAVE TO BE IN THAT KIND OF PAIN. UM, A CHILD SHOULD WANT TO WAKE UP EVERY DAY AND TO NOT WANT TO DO THAT BECAUSE YOU'RE IN SO MUCH PAIN IS NOT THAT'S NOT OKAY. THE TREATMENT IS OUTPATIENT AND LASTS 14 TO 20 WEEKS. THERAPISTS USE AS MANY AS 16 DIFFERENT TECHNIQUES, ALL TREATING THE CENTRAL NERVOUS SYSTEM, DECREASING INFLAMMATION. UH, GLOBALLY, BODY WIDE, AND THEN KEEPING THE BODY VERY CALM. THE NERVOUS SYSTEM SO YOU CAN PUSH VERY HARD ON THE OTHER END AND NOT SEND THAT PATIENT INTO A STATE WHERE THEY HAVE WORSE SYMPTOMS. FOR TRISTAN'S FAMILY, HIS PROGRESS IN FIVE MONTHS IS NOTHING SHORT OF REMARKABLE. ALL IT IS MAY AND HE IS SIGNING IN EVERY DAY AT A ZERO PAIN LEVEL. THIS CHILD HAS ZERO PAIN COMING FROM A CHILD WHO NO LONGER WANTED TO WAKE UP ANYMORE BECAUSE HE WAS SO SCARED TO FACE THE DAY WITH ALL THE PAIN AND IT IT'S MIND BLOWING. IT TRULY IS. SO HE'S GONE FROM SURVIVAL TO PLAYING WITH HIS BROTHERS AGAIN. HE'S HORSING AROUND AGAIN. HE'S SWIMMING IN A POOL. HE'S DOING THINGS THAT WE COULDN'T EVEN IMAGINE HIM DOING FIVE MONTHS AGO. SO WHAT'S THE CATCH? WELL, BECAUSE THE CLINIC IS NOT MAINSTREAM MEDICINE, IT IS NOT COVERED BY INSURANCE AND THE PRICE TAG IS HIGH. STACY ESTIMATES IT WILL COST THEM ABOUT $100,000 FOR THE TREATMENT, AND THE COST OF TEMPORARILY RELOCATING TO ARKANSAS. THE SMITHS ARE GRATEFUL FOR HELP AND SUPPORT FROM THEIR COMMUNITY, BUT THE COST REMAINS A DIFFICULT HURDLE TO OVERCOME, ESPECIALLY SINCE STACY, A TEACHER, HAS BEEN UNABLE TO WORK FULL TIME, IF AT ALL, WHILE CARING FOR DYLAN. WE JUST FOUND OUT ABOUT THE CLINIC IN MARCH AND HIS START DATE IS IN JUNE, SO WE HAVE A SHORT AMOUNT OF TIME TO RAISE A LARGE AMOUNT OF MONEY. THERE'S NOTHING THAT, UM, THAT WE CAN, UH, GET FROM FROM OUR GOVERNMENT OR SOCIAL SECURITY, WHICH IS UNFORTUNATE. DYLAN DOESN'T QUALIFY. AND EVEN WITH SOME OF THE GRANTS, THEY DON'T UNDERSTAND OR RECOGNIZE THIS TYPE OF TREATMENT. BUT STACY AND MIKE WILL NOT GIVE UP UNTIL THEY GET DYLAN TO THE SPYRO CLINIC. IN FACT, THEY PLAN TO TAKE THE WHOLE FAMILY. THREE DOGS INCLUDED, TO FAYETTEVILLE. WE'LL FIGURE IT OUT. WE JUST DON'T HAVE A CHOICE. SO YOU ARE DETERMINED OR YOU DON'T HAVE A CHOICE. I SAID. I WILL LIVE IN A TENT IF I HAVE TO. YEAH, WE WE WILL. UM, WE WILL GET HIM THE TREATMENT. YEAH. WE HAVE TO SAVE HIS LIFE. IF YOU WOULD LIKE TO HELP THE SMITH FAMILY, VISIT THE WEBSITE HOWARD. DYLAN.COM. THERE IS A LINK ON OUR WEBSITE WE HOPE TO FOLLOW DYLAN'S STORY AS HIS FAMILY FIGHTS TO GIVE THEIR CHILD HIS LIFE BACK.
New clinical trial studies nasal COVID-19 vaccine
Updated: 1:14 PM EDT Jul 5, 2024
A trial sponsored by the National Institutes of Health (NIH) is recruiting participants to study a nasal COVID-19 vaccine. The candidate vaccine aims to provide enhanced protection against variants of SARS-CoV-2, the virus that causes COVID-19. One goal of the trial is to evaluate the vaccine's ability to produce local immunity in cells lining the nose and respiratory tract and lower the virus's potential to spread.Related video above: Family fighting to pay for son's unique long COVID treatmentCurrent COVID-19 vaccines are delivered by injection to create antibodies that circulate through the blood and cause a strong immune response. Despite helping recipients avoid serious illness, the vaccine is far from perfect. "While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease," said Jeanne M. Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID). "With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission," Marrazzo said.The candidate vaccine in the clinical trial, MPV/S-2P, uses murine pneumonia virus to deliver a stabilized version of a spike protein that SARS-CoV-2 uses to attach to human cells. By administering it intranasally, researchers aim to have the vaccine produce local immunity in the nose and throat, where infection from respiratory viruses often starts."What we realized is that systemic vaccination — when we inject it and it goes through the body to build up immunity — is not as effective as generating a mucosal, or lining cell, immunity in the nose or in the lungs," Dr. Reynold Panettieri, a professor of medicine at the Robert Wood Johnson Medical School at Rutgers University, told ABC News. "And so, when people can inhale the protein, in this case, the spike protein ... Actually builds up an immune response that's much more robust than that when it is injected."Following pre-clinical non-human primate studies by scientists from NIAID's Laboratory of Infectious Diseases, researchers believe mucosal immunity and improved systemic immune responses will help prevent infection and transmission.The trial will be conducted as part of Project NextGen, led by the Biomedical Advanced Research and Development Authority and NIAID. The Phase 1 trial is currently enrolling healthy adults between the ages of 18 and 64 who meet the eligibility criteria. Trial sites are located in Texas, Georgia and New York.
A trial sponsored by the National Institutes of Health (NIH) is recruiting participants to study a nasal COVID-19 vaccine. The candidate vaccine aims to provide enhanced protection against variants of SARS-CoV-2, the virus that causes COVID-19. One goal of the trial is to evaluate the vaccine's ability to produce local immunity in cells lining the nose and respiratory tract and lower the virus's potential to spread.
Related video above: Family fighting to pay for son's unique long COVID treatment
Current COVID-19 vaccines are delivered by injection to create antibodies that circulate through the blood and cause a strong immune response. Despite helping recipients avoid serious illness, the vaccine is far from perfect. "While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease," said Jeanne M. Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID).
"With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission," Marrazzo said.
The candidate vaccine in the clinical trial, MPV/S-2P, uses murine pneumonia virus to deliver a stabilized version of a spike protein that SARS-CoV-2 uses to attach to human cells. By administering it intranasally, researchers aim to have the vaccine produce local immunity in the nose and throat, where infection from respiratory viruses often starts.
"What we realized is that systemic vaccination — when we inject it and it goes through the body to build up immunity — is not as effective as generating a mucosal, or lining cell, immunity in the nose or in the lungs," Dr. Reynold Panettieri, a professor of medicine at the Robert Wood Johnson Medical School at Rutgers University, told ABC News. "And so, when people can inhale the protein, in this case, the spike protein ... [the body] actually builds up an immune response that's much more robust than that when it is injected."
Following pre-clinical non-human primate studies by scientists from NIAID's Laboratory of Infectious Diseases, researchers believe mucosal immunity and improved systemic immune responses will help prevent infection and transmission.
The trial will be conducted as part of Project NextGen, led by the Biomedical Advanced Research and Development Authority and NIAID. The Phase 1 trial is currently enrolling healthy adults between the ages of 18 and 64 who meet the eligibility criteria. Trial sites are located in Texas, Georgia and New York.
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