Health
Needs and Challenges for COVID-19 Boosters and Other Vaccines in the U.S.
Of the 10 richest countries in the world, the U.S. ranks last in vaccination rates and first in both numbers and rates of COVID-19 deaths.
« Needs and Challenges for COVID-19 Boosters and Other Vaccines in the U.S.
Newswise — The United States Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA), which was immediately endorsed by the U.S. Centers for Disease Control and Prevention (CDC), for new booster shots created to combat the most recent and highly prevalent omicron variants of COVID-19, specifically BA.4 and BA.5. Fortunately, these most recent and very highly prevalent variants, while more communicable, are less lethal.
In a commentary published in The American Journal of Medicine, researchers from Florida Atlantic University’s Schmidt College of Medicine and collaborators, provide the most updated guidance to health care providers and urge how widespread vaccination with these boosters can now avoid the specter of future and more lethal variants becoming a reality.
“Of the 10 richest countries in the world, the U.S. ranks last in vaccination rates and first in both numbers and rates of COVID-19 deaths,” said Charles H. Hennekens, M.D., Dr.PH, senior author, first Sir Richard Doll Professor of Medicine and senior academic advisor, FAU Schmidt College of Medicine. “The dedicated health care professionals in communities and hospitals across the nation continue to try to address existing and new challenges of COVID-19. We must redouble our efforts to promote evidence-based clinical and public health practices, which should include vaccination of all U.S. adults and eligible children based on the most recent FDA and CDC guidance.”
The authors point out that, compared with influenza, the mortality rate from COVID-19 is about 30 times higher. Further, a positive COVID-19 patient is likely to transmit to about six people compared with one or two for influenza. Finally, the boosters will reduce the risk of dying and hospitalization by more than 90 percent.
“The most simple and straightforward newest guidance we can now offer to health care providers is that all individuals ages 5 and older should receive a booster shot,” said Alexandra Rubenstein, first author, clinical research coordinator, Department of Neurology, Boston Medical Center, and an aspiring physician. “Specifically, based on the recent EUAs issued by the FDA and CDC, those 5 and older may receive Pfizer bivalent boosters, and those ages 6 and older may receive bivalent boosters from Moderna. While the absolute risks of severe COVID-19 are low in youths, the benefit-to-risk ratio was deemed to be favorable in a 13-to-1 vote of independent external advisers to the FDA.”
According to the authors, vaccines to prevent common and serious infectious diseases have had a greater impact on improving human health than any other medical advance of the 20th century. Nonetheless, since 2019, the percentages of children in the U.S. vaccinated against common and serious childhood diseases has decreased.
“In the U.S., diphtheria-pertussis-tetanus or DPT immunizations have decreased from 85 percent in 2019 to 67 percent in 2021,” said co-author Sarah K. Wood, M.D., professor of pediatrics and interim chair, Department of Women’s and Children’s Health and vice dean for medical education, FAU Schmidt College of Medicine. “Recently, a young adult unvaccinated against polio in a neighborhood in Rockland County, New York, contracted a paralytic disease raising concerns that the loss of herd immunity may portend new epidemics of avoidable serious morbidity and mortality in the U.S. and worldwide.”
Ironically, the authors note, virtually all Americans would seek effective and safe therapies for any communicable diseases. Most individuals routinely accept major surgery, toxic chemotherapy and/or radiation therapy for cancer, which result in a far greater number of side effects than are caused by vaccinations. The authors encourage health care providers to recommend a COVID-19 booster vaccine to all eligible patients to protect individuals and communities.
Other co-authors are Vama Jhumkhawala, a first-year FAU medical student; and Mark DiCorcia, Ph.D., associate professor of obstetrics and gynecology and assistant dean for medical education, FAU Schmidt College of Medicine, as well as Dennis G. Maki, M.D., Ovid O. Meyer professor of medicine, director of the COVID-19 Intensive Care Unit and an internationally renowned infectious disease clinician and epidemiologist from the University of Wisconsin School of Medicine and Public Health.
Maki and Hennekens served together for two years as lieutenant commanders in the U.S. Public Health Service as epidemic intelligence service (EIS) officers with the CDC. They served under Alexander D. Langmuir, M.D., who created the EIS and epidemiology program at the CDC, and Donald A. Henderson, M.D., chief of the virus disease surveillance program at the CDC. Langmuir and Henderson made significant contributions to the eradication of polio and smallpox using widespread vaccinations and public health strategies of proven benefit.
– FAU –
About the Charles E. Schmidt College of Medicine:
FAU’s Charles E. Schmidt College of Medicine is one of approximately 156 accredited medical schools in the U.S. The college was launched in 2010, when the Florida Board of Governors made a landmark decision authorizing FAU to award the M.D. degree. After receiving approval from the Florida legislature and the governor, it became the 134th allopathic medical school in North America. With more than 70 full and part-time faculty and more than 1,300 affiliate faculty, the college matriculates 64 medical students each year and has been nationally recognized for its innovative curriculum. To further FAU’s commitment to increase much needed medical residency positions in Palm Beach County and to ensure that the region will continue to have an adequate and well-trained physician workforce, the FAU Charles E. Schmidt College of Medicine Consortium for Graduate Medical Education (GME) was formed in fall 2011 with five leading hospitals in Palm Beach County. The Consortium currently has five Accreditation Council for Graduate Medical Education (ACGME) accredited residencies including internal medicine, surgery, emergency medicine, psychiatry, and neurology. The college’s vibrant research focus areas include healthy aging, neuroscience, chronic pain management, precision medicine and machine learning. With community at the forefront, the college offers the local population a variety of evidence-based, clinical services that treat the whole person. Jointly, FAU Medicine’s Primary Care practice and the Marcus Institute of Integrative Health have been designed to provide complete health and wellness under one roof.
About Florida Atlantic University: Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University serves more than 30,000 undergraduate and graduate students across six campuses located along the southeast Florida coast. In recent years, the University has doubled its research expenditures and outpaced its peers in student achievement rates. Through the coexistence of access and excellence, FAU embodies an innovative model where traditional achievement gaps vanish. FAU is designated a Hispanic-serving institution, ranked as a top public university by U.S. News & World Report and a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. For more information, visit www.fau.edu.
Source: Florida Atlantic University
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Lifestyle
Clinical Trials Expand Patients’ Treatment Options
Clinical trials play a crucial role in developing effective treatments for chronic health conditions. They evaluate safety and efficacy, but low enrollment delays drug approvals, limiting patient options.
(Family Features) For health conditions with no cure, effective treatments are the next best option. However, in order to make medical interventions including new drugs, devices, vaccines and lifestyle modifications available, they must undergo a thorough evaluation process to demonstrate their benefits.
Clinical trials are an important part of this process because they provide data for researchers on the effectiveness of various treatments and interventions. However, many myths about clinical trials deter people from enrolling. In fact, more than 70% of clinical trials are delayed at least one month due to unfulfilled enrollment, according to the “Journal of Medical Internet Research.”
Delays create barriers to the drug approval process and result in fewer available treatments for chronic conditions like Crohn’s disease and ulcerative colitis. The experts at the Crohn’s & Colitis Foundation offer these facts about the importance of clinical trials:
- More patients can benefit from clinical trials While hundreds of participants may take part in a trial, the results can lead to new care and treatment options for an entire patient community.
- Clinical trials lead to better and improved medications. For a new treatment to be approved, it needs to demonstrate a meaningful benefit to patients, such as improved outcomes, treating a wider range of symptoms, fewer side effects or more convenience for patients.
- They provide information. Clinical trials provide evidence of a treatment’s effectiveness and safety that can be used to guide patient care.
- Trials test safety and efficacy. Clinical trials are conducted in four phases. During the first phase, the main objective is to assess the safety of a new treatment. Experimental treatments only advance to the next stages if they pass certain safety and efficacy standards
. - They help prevent bias. In a randomized controlled trial, the effects of treatment with a new drug are compared with that of a control group – either a placebo (a treatment that looks identical to the new drug but contains no active medicine) or the current standard of care. Treatment assignments are “randomized,” which means neither the trial doctors nor the participants choose which treatment each participant will receive.
How Clinical Trials Work
Before a clinical trial begins, a research team develops a clinical trial protocol. This is the research plan that describes who can join the trial, which treatments the participants will receive, what questions the researchers will try to answer, how long the trial will last and how participant privacy and safety will be protected.
Conducting clinical research relies on volunteer trial participants. Those interested in joining a clinical trial meet with clinical research professionals to discuss the trial, treatments, eligibility requirements and expectations.
Joining a Trial
If you are interested in participating in a clinical trial, do some research. Your doctor may not be aware of or proactively tell you about trials you may be eligible to join. If you find a clinical trial you may be interested in joining, discuss the trial with your doctor and other health care professionals on your research team.
Foundations supporting chronic conditions can be a good source of information. For example, you can learn more about trials affecting individuals with inflammatory bowel disease by exploring the Clinical Trials Community at crohnscolitisfoundation.org.
Photo courtesy of Shutterstock
SOURCE:
Crohn’s & Colitis Foundation
Lucas A. Berenbrok, University of Pittsburgh; Michael Murphy, The Ohio State University, and Sophia Herbert, University of Pittsburgh
Neighborhood pharmacies are rapidly shuttering.
Not long ago, Walgreens, one of the nation’s biggest pharmacy chains, announced plans to close 1,200 stores over the next three years. That’s part of a larger trend that has seen nearly 7,000 pharmacy locations close since 2019, with more expected in the coming years.
Many community pharmacies are struggling to stay open due to an overburdened workforce, shrinking reimbursement rates for prescription drugs and limited opportunities to bill insurers for services beyond dispensing medications.
As trained pharmacists who advocate for and take care of patients in community settings, we’ve witnessed this decline firsthand. The loss of local pharmacies threatens individual and community access to medications, pharmacist expertise and essential public health resources.
The changing role of pharmacies
Community pharmacies – which include independently owned, corporate-chain and other retail pharmacies in neighborhood settings – have changed a lot over the past decades. What once were simple medication pickup points have evolved into hubs for health and wellness. Beyond dispensing prescriptions, pharmacists today provide vaccinations, testing and treatment for infectious diseases, access to hormonal birth control and other clinical services they’re empowered to provide by federal and state laws.
Given their importance, then, why have so many community pharmacies been closing?
There are many reasons, but the most important is reduced reimbursement for prescription drugs. Most community pharmacies operate under a business model centered on dispensing medications that relies on insurer reimbursements and cash payments from patients. Minor revenue comes from front-end sales of over-the-counter products and other items.
However, pharmacy benefit managers – companies that manage prescription drug benefits for insurers and employers – have aggressively cut reimbursement rates in an effort to lower drug costs in recent years. As a result, pharmacists often have to dispense prescription drugs at very low margins or even at a loss. In some cases, pharmacists are forced to transfer prescriptions to other pharmacies willing to absorb the financial hit. Other times, pharmacists choose not to stock these drugs at all.
And it’s not just mom-and-pop operations feeling the pinch. Over the past four years, the three largest pharmacy chains have announced plans to close hundreds of stores nationwide. CVS kicked off the trend in 2021 by announcing plans to close 900 pharmacy locations. In late 2023, Rite Aid said that thousands of its stores would be at risk for closure due to bankruptcy. And late in 2024, Walgreens announced its plans to close 1,200 stores over the next three years.
To make matters worse, pharmacists, like many other health care providers, have been facing burnout due to high stress and the lasting effects of the COVID-19 pandemic. At the same time, pharmacy school enrollment has declined, worsening the workforce shortage just as an impending shortfall of primary care physicians looms.
Why pharmacy accessibility matters
The increasing closure of community pharmacies has far-reaching consequences for millions of Americans. That’s because neighborhood pharmacies are one of the most accessible health care locations in the country, with an estimated 90% of Americans living within 5 miles of one.
However, research shows that “pharmacy deserts” are more common in marginalized communities, where people need accessible health care the most. For example, people who live in pharmacy deserts are also more likely to have a disability that makes it hard or impossible to walk. Many of these areas are also classified as medically underserved areas or health professional shortage areas. As pharmacy closures accelerate, America’s health disparities could get even worse.
So if your neighborhood pharmacy closes, what should you do?
While convenience and location matter, you might want to consider other factors that can help you meet your health care needs. For example, some pharmacies have staff who speak your native language, independent pharmacy business owners may be active in your community, and many locations offer over-the-counter products like hormonal contraception, the overdose-reversal drug naloxone and hearing aids.
You may also consider locations – especially corporate-owned pharmacies – that also offer urgent care or primary care services. In addition, most pharmacies offer vaccinations, and some offer test-and-treat services for infectious diseases, diabetes education and help with quitting smoking.
What to ask if your pharmacy closes
If your preferred pharmacy closes and you need to find another one, keep the following questions in mind:
• What will happen to your old prescriptions? When a pharmacy closes, another pharmacy may buy its prescriptions. Ask your pharmacist if your prescriptions will be automatically transferred to a nearby pharmacy, and when this will occur.
• What’s the staffing situation like at other pharmacies? This is an important factor in choosing a new pharmacy. What are the wait times? Can the team accommodate special situations like emergency refills or early refills before vacations? Does the pharmacist have a relationship with your primary care physician and your other prescribers?
• Which pharmacies accept your insurance? A simple call to your insurer can help you understand where your prescriptions are covered at the lowest cost. And if you take a medication that’s not covered by insurance, or if you’re uninsured, you should ask if the pharmacy can help you by offering member pricing or manufacturer coupons and discounts.
• What are your accessibility needs? Pharmacies often offer services to make your care more accessible and convenient. These may include medication packaging services, drive-thru windows and home delivery. And if you’re considering switching to a mail-order pharmacy, you should ask if it has a pharmacist to answer questions by phone or during telehealth visits.
Remember that it’s best to have all your prescriptions filled at the same pharmacy chain or location so that your pharmacist can perform a safety check with your complete medication list. Drug interactions can be dangerous.
Community pharmacies have been staples of neighborhoods for more than a century. Unfortunately, current trends in pharmacy closures pose real threats to public health. We hope lawmakers address the underlying systemic issues so more Americans don’t lose access to their medications, health services and pharmacists.
Lucas A. Berenbrok, Associate Professor of Pharmacy and Therapeutics, University of Pittsburgh; Michael Murphy, Assistant Professor of Pharmacy Practice and Science, The Ohio State University, and Sophia Herbert, Assistant Professor of Pharmacy, University of Pittsburgh
This article is republished from The Conversation under a Creative Commons license. Read the original article.
(Family Features) Clinical trials help researchers studying chronic conditions answer important questions about the diseases and their treatment options. However, uncertainty about what to expect and a lack of knowledge about how to get started can prevent patients from joining a clinical trial.
Choosing to take part in a clinical trial means helping a study team figure out if a new method of diagnosis, treatment or prevention is effective. If you live with a chronic condition, such as Crohn’s disease or ulcerative colitis, and want to help find answers for others who share your experience, a clinical trial is an option to consider.
Once you identify a study that interests you, you’ll want to talk with the professionals involved in your ongoing treatment, a clinical research coordinator and your family to gather information necessary to determine whether the clinical trial is a good fit.
To find additional information about clinical trials and begin exploring trials in your area, visit crohnscolitisfoundation.org, and consider these steps for participating in a trial.
1. Talking with Your Doctor
Your gastroenterologist and other care providers can help determine whether a clinical trial is right for you and may be able to help point you toward recommended trials. It’s important to ask if or how your doctor will continue to be involved in your care if you participate in a trial.
2. Finding a Study
If you need help beyond your care team in identifying clinical trial opportunities in your area, organizations dedicated to your condition can be a good resource. For example, the Crohn’s & Colitis Foundation offers an online Clinical Trial Finder for individuals with inflammatory bowel disease.
3. Talking with the Research Coordinator
A clinical trial research coordinator can provide details specific to your circumstances and needs. You can discuss potential benefits and risks, why the trial is being conducted and who is involved in the health care team. You can talk about past treatments and how this study may differ from your previous experiences. Other questions you might ask include what your options are if the trial doesn’t work, any costs you might expect and what your personal commitment will be.
4. Evaluating the Fit for You
Once you have the necessary information, you’ll be able to consider whether you’re ready to move forward with registering for the trial. You’ll want to weigh factors like your time commitment, travel distance and whether the trial will affect your personal or professional obligations.
Photos courtesy of Shutterstock
SOURCE:
Crohn’s & Colitis Foundation
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