Monthly Musings On American Healthcare

A compendium about healthcare

Thought ideas to improve healthcare

July 2023 What do the best healthcare leaders have in common?

June 2023 Best summer reading for healthcare professionals?

May 2023 Will our nation make time to mourn 1.1 million Covid-19 deaths?

April 2023 Where are the healthcare regulators?

March 2023 What is the promise (and peril) of AI-enabled healthcare?

February 2023 Will ChatGPT change medical practice?

January 2023 How did healthcare become a “conglomerate of monopolies”?

2022

2021

2020

2019

2018

2017

Monthly Musings On American Healthcare by Dr. Robert Pearl

What's New for Treatment of Alzheimer's Disease

Overview

Alzheimer's disease is a brain disorder that gets worse over time. It's characterized by changes in the brain that lead to deposits of certain proteins. Alzheimer's disease causes the brain to shrink and brain cells to eventually die. Alzheimer's disease is the most common cause of dementia — a gradual decline in memory, thinking, behavior and social skills. These changes affect a person's ability to function.

About 6.5 million people in the United States age 65 and older live with Alzheimer's disease. Among them, more than 70% are 75 years old and older. Of the about 55 million people worldwide with dementia, 60% to 70% are estimated to have Alzheimer's disease.

The early signs of the disease include forgetting recent events or conversations. Over time, it progresses to serious memory problems and loss of the ability to perform everyday tasks.

Medicines may improve or slow the progression of symptoms. Programs and services can help support people with the disease and their caregivers.

There is no treatment that cures Alzheimer's disease. In advanced stages, severe loss of brain function can cause dehydration, malnutrition or infection. These complications can result in death.

Broader Medicare coverage is now available for Biogen and Eisai’s Leqembi (the brand name for lecanemab) following the Food and Drug Administration’s (FDA) move to grant traditional approval to the drug that treats individuals with Alzheimer’s disease. The Centers for Medicare & Medicaid Services had previously announced this would be the case and released more details on coverage today.

Now that the FDA has granted traditional approval, a CMS-facilitated registry is open for clinicians to access here. Additional background information is available for providers here and for patients here and at medicare.gov.

Under the Medicare National Coverage Determination, if FDA grants traditional approval to other drugs in this class, Medicare will cover them using this same coverage framework.

Thanks to the Mayo Clinic a book is available to explain what is known about Alzheimer's Disease.

It can be purchased here

A guide for people with dementia and those who care for them

Dementia is a serious health challenge. By some estimates, the number of people living with dementia could triple by 2050.

While Alzheimer's disease is the most common cause of dementia, many related types of dementia also affect adults worldwide.

Although the diseases that cause dementia have long been considered unrelenting and incurable, there is hope.

Lecanemab for Alzheimer's disease: An option for you?

The drug lecanemab appears to slow mental decline in people with early Alzheimer's disease. Learn whether it might be right for you.

By Mayo Clinic Staff

Lecanemab is a drug given to slow the progression of mild Alzheimer's disease (AD). This drug reduces clumps of proteins that play a key role in AD. Reducing brain amyloid-beta proteins modestly slows memory and thinking decline from AD.

Lecanemab is for people who have early symptomatic AD. In a recent drug trial, taking lecanemab over 18 months slowed the rate of cognitive decline. It's not yet known whether the drug helps in other ways such as slowing the development of AD in people without symptoms of memory loss.

Lecanemab is given by IV infusion every two weeks. Your care team likely will watch for side effects and ask you or your caregiver how your body reacts to the drug.

Because lecanemab is a new drug, there is still much to learn about it. Some people who take lecanemab have side effects such as:

Dizziness.

Headache.

Visual changes.

Worsening confusion.

Swelling or bleeding in the brain.

Rarely, death.

Brain shrinkage.

Not for everyone

Lecanemab is not helpful for people with full cognitive function or later stages of AD. The drug does not prevent or cure AD. Your health care team will help you decide if lecanemab is an option for you.

The medicines you take for other conditions and your health history may affect whether you can take lecanemab. A history of cancer or bleeding in your brain or use of anticoagulant drugs, such as warfarin or apixaban, may prevent you from taking lecanemab.

If you take lecanemab, you likely will have regular MRI scans to check for brain bleeds. If your side effects are severe, you may need anti-seizure drugs or care in a hospital. You also may have to stop taking the drug.

What is Lecanemab and how does it work?  Lecanemab is a monoclonal antibody drug.

What is the pathophysiology of Alzheimer disease?

 Alzheimer's disease is characterized by an accumulation of abnormal neuritic plaques and neurofibrillary tangles. Plaques are spherical microscopic lesions that have a core of extracellular amyloid beta-peptide surrounded by enlarged axonal endings.

Lecanemab is a monoclonal antibody consisting of the humanized version of a mouse antibody, mAb158, that recognizes protofibrils and prevents amyloid beta deposition in animal models of Alzheimer's disease.

Three drugs used to treat AD are all in one family, called cholinesterase inhibitors, which boost brain levels of acetylcholine: Galantamine (Razadyne®) Rivastigmine (Exelon®) Donepezil (Aricept®)

None of these drugs offer a cure for AD. These drugs appear to slow down the process of AD. Research into new treatments is ongoing. Promising drug therapies under investigation include medications to target the formation of abnormal neuritic plaques, reduce inflammation in affected brain areas, and prevent cell death. Vaccines that prompt the body’s immune system to attack amyloid beta are also being researched.

In addition to medical treatment, certain lifestyle changes may help individuals with AD. This includes physical exercise, social interaction, mental stimulation, and a healthy diet rich in antioxidants and omega-3 fatty acids. Caregivers should also help ensure the individual is getting enough sleep. Additionally, individuals with AD should avoid alcohol, smoking, and caffeine as these can worsen symptoms. Finally, participation in clinical trials may provide access to experimental treatments for AD.

Biblio:

Clin Med (Lond). 2016 Jun;16(3):247-53. doi: 10.7861/clinmedicine.16-3-247.

Australas Psychiatry. 2018 Aug;26(4):347-357. doi: 10.1177/1039856218762308. Epub 2018 Apr 3.

PMID: 29614878 Review.

Curr Neuropharmacol. 2020;18(11):1106-1125. doi: 10.2174/1570159X18666200528142429.

PMID: 32484110 Free PMC article. Review.

 Comprehensive Review on Alzheimer's Disease: Causes and Treatment.

Breijyeh Z, Karaman R.

Molecules. 2020 Dec 8;25(24):5789. doi: 10.3390/molecules25245789.

PMID: 33302541 Free PMC article. Review.

 

A review on advances of treatment modalities for Alzheimer's disease.

Se Thoe E, Fauzi A, Tang YQ, Chamyuang S, Chia AYY.

Life Sci. 2021 Jul 1;276:119129. doi: 10.1016/j.lfs.2021.119129. Epub 2021 Jan 27.

PMID: 33515559 Review.

Physician Turnover in the United States

Medical groups, health systems, and professional associations are concerned about potential increases in physician turnover, which may affect patient access and quality of care. 

To address this concern, they are working together to develop innovative strategies to retain physicians. These include providing financial incentives, such as loan repayment programs and signing bonuses; offering flexible work schedules; increasing administrative support staff; creating career development opportunities for physicians; and improving the overall work environment. Additionally, physician organizations are exploring how technology can be leveraged to help retain doctors, such as through telemedicine and remote patient monitoring. 

The hope is that these measures will enable physicians to better manage their workloads, allowing them to spend more time providing quality care and less time dealing with administrative tasks. A strong emphasis on physician retention could help ensure the continued availability of reliable medical care for patients across the country.

A study from the Annals of Internal Medicine by Amelia M. Bond, PhD, Lawrence P. Casalino, MD, PhD, Ming Tai-Seale, PhD indicates there was little change in physician turnover.  The study, however, was based upon billing practices for Medicare patients. 

To examine whether turnover has changed over time and whether it is higher for certain types of physicians or practice settings.

Design:

The authors developed a novel method using 100% of traditional Medicare billing to create national estimates of turnover. Standardized turnover rates were compared by physician, practice, and patient characteristics.

Setting:  Traditional Medicare, 2010 to 2020.

Participants: Physicians billing traditional Medicare.

Measurements:  Indicators of physician turnover—physicians who stopped practicing and those who moved from one practice to another—and their sum.

Results:

The annual rate of turnover increased from 5.3% to 7.2% between 2010 and 2014, was stable through 2017, and increased modestly in 2018 to 7.6%. Most of the increase from 2010 to 2014 came from physicians who stopped practicing increasing from 1.6% to 3.1%; physicians moving increased modestly from 3.7% to 4.2%. Modest but statistically significant (P < 0.001) differences existed across rurality, physician sex, specialty, and patient characteristics. In the second and third quarters of 2020, quarterly turnover was slightly lower than in the corresponding quarters of 2019.

Implications:

The data suggest that physician turnover is an ongoing challenge for healthcare organizations, particularly in rural areas. It also suggests that healthcare organizations may be more successful in recruiting and retaining physicians if they can identify the factors associated with increased turnover, anticipate changes in the local or larger healthcare market, and design strategies to retain existing staff. The findings from this study add

Conclusion:

Over the past decade, physician turnover rates have had periods of increase and stability. These early data, covering the first 3 quarters of 2020, give no indication yet of the COVID-19 pandemic increasing turnover, although continued tracking of turnover is warranted. This novel method will enable future monitoring and further investigations into turnover. It also indicates that healthcare organizations should remain engaged in identifying the factors associated with increased turnover and developing strategies to retain existing staff. With this information, healthcare organizations can create better working environments and more efficient health service delivery for their patients. ~~~~~~~~~END~~~~~~~~~~~

This study flies in the face of frequent statements and beliefs about physician burnout, depression, suicide, and career change.

There are no national estimates of physician turnover, so it is not known whether turnover has increased, as is sometimes assumed (2). If changes in turnover over time exist, they could be driven by the large shift in the composition of physicians and their practices as the number of female physicians and the size of practices have grown in recent years. Even if turnover rates have not changed, they may vary by physician and practice characteristics, geographic location, or the composition of a practice’s patient population. The degree to which turnover merits additional or targeted organizational and policy intervention and investment requires information on these questions.1. Shanafelt T, Goh J, Sinsky C. The business case for investing in physician well-being. JAMA Intern Med. 2017;177:1826-1832. [PMID: 28973070] doi:10.1001/jamainternmed.2017.4340

Measuring Physician Turnover

We defined 2 types of physician turnover, physicians who moved from one practice to another and those who stopped practicing (that is, left practice), henceforth “movers” and “leavers.”

When identifying movers, our goal was to determine whether a physician who was working with one practice ended the relationship and joined a second practice. In billing data, it is possible to identify the month a physician begins billing a new practice or TIN. However, billing a new practice does not necessarily indicate movement; it could, for example, indicate that a medical group is using more than 1 TIN, that a medical group was acquired by another practice, or that a physician worked part-time in 2 practices. We developed 3 preconditions to determine whether the billing of a new practice constituted a physician moving: A physician had to have a relationship with both the first and new practices through sufficient months of billing—we used 4 months as the primary specification, with 3 and 6 months in sensitivity analyses; the relationships with the first and second practices had to be temporally independent (that is, a physician must bill at least 4 months with their old practice and new practice in different months); and the potential move should not represent a medical group reorganizing its financial structure. Specifically, the old practice had to continue to exist after a physician moved, and a physician could not continue to bill with many of their former peers. Section II of the Supplement provides full details on methods and sample flow charts

The goal in identifying physician leavers was to identify physicians who fully retired from practice or stopped practicing for an extended period. This method considered an extended period to be 2 years and identified physician leavers as those who stopped billing for 2 years (Section II of the Supplement). In sensitivity analyses, we applied periods of 3 months, 1 year, and 3 years.

Primary measures of moving and leaving were reported on a July-to-June basis because measurement of moving required up to 6 months of billing data before and after a potential month of moving. Rates of moving were reported for years 2010 to 2020. Rates of leaving were reported for years 2010 to 2018 because measurement of leaving required 2 years of billing data after a potential month of leaving.

In a supplementary analysis examining turnover during the beginning of the COVID-19 pandemic, we used modified quarterly measures that could be constructed through the third quarter of 2020. Moving required a physician to have a 3-month rather than a 4-month relationship with both the first and new practices. Leaving required a physician to stop billing for 3 months rather than 2 years.

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What is 'long vax'? Symptoms linked to COVID-19 shot baffle docs

You’ve heard of “long COVID,” the cases of people who can’t shake the lingering symptoms of COVID-19.

Now comes “long vax” — a rare, but baffling set of symptoms that follow a small number of people for months after receiving the COVID-19 vaccine.

“You see one or two patients and you wonder if it’s a coincidence,” Dr. Anne Louise Oaklander, a neurologist and researcher at Harvard Medical School, told Science Magazine. “But then you see 10 or 20, and you think, ‘Oh my gosh, this could be real.'”

Dr. Oaklander is one of a handful of researchers trying to figure out what’s happening with these patients. While most reported side effects from the COVID-19 vaccines are temporary and mild – such as sore arms, fatigue, and fever – some people are experiencing an array of symptoms that last for weeks or months. These include exhaustion, joint pain, nerve pain, headaches, cognitive problems, and heart palpitations.

It’s still unclear exactly how common long vax is in the general population and whether it’s directly linked to the vaccines. Scientists believe it may be related to the body’s immune response to the virus or to inflammation caused by the vaccine. While a few studies have looked at people who received the mRNA vaccines, there is still much that remains unknown.

The question of how long these symptoms will last and whether they can be treated with existing medications has been on many people’s minds since the beginning of the pandemic. In some cases, symptoms may improve over time as the body recovers from its immune response. Doctors are also looking at ways to treat long vax with medications and therapies that target inflammation or other underlying causes. 

Ultimately, more research is needed to fully understand this condition and provide treatments for those who experience it. 

Long Covid or Long Vax may be attributed to spike proteins remaining in the circulation causing inflammation in the heart, central nervous system, and immune system.  This can lead to symptoms such as fatigue, difficulty breathing, and other physical limitations. In some cases, long Covid sufferers may experience mental health issues such as depression or anxiety. 

Medical professionals are currently working on ways to diagnose Long Covid/Long Vax through tests that measure biomarkers of inflammation and oxidative stress in the body. Additionally, doctors are researching treatments to help mitigate the symptoms of this condition. So far, these have included various forms of physical therapy and lifestyle modifications such as yoga or meditation to reduce stress levels. More research is still needed in order to develop effective treatment strategies for those with Long Covid/Long Vax. 

With more knowledge about Long Covid/Long Vax, healthcare professionals are also looking into providing care for those suffering from mental health issues such as depression and anxiety related to the condition. This could involve therapies like cognitive-behavioral therapy or mindfulness-based interventions that help people better understand their experiences, cope with their thoughts and emotions, and manage their daily lives in a healthy way. 

The Covid vaccine was manufactured using a new process.. By introducing mRNA spike proteins are manufactured. Spike proteins reside on the viral capsid and are immunogenic, as well as providing entrance to the cell. 

The concern with these vaccines is that they appear to be causing some adverse effects, but it is too early to tell if Long Covid/Long Vax will become a persistent medical issue. There have been reports of side effects such as headaches, fatigue, muscle aches, and fever that can last for weeks after receiving the vaccine. 

To help manage these long-term effects, mental health professionals recommend a number of interventions. Cognitive behavioral therapy (CBT) can help people better understand their experiences and cope with their thoughts and emotions. Stress management techniques such as mindfulness practice, breathing exercises, and journaling can also be beneficial for those dealing with the after-effects of Covid vaccinations. Additionally, exercise and activity can help to improve overall well-being and boost energy levels. Finally, connecting with family, friends, and peers is a great way to stay grounded and share your experiences. 

Although it may be difficult to manage these lingering effects, understanding the cause of them is key in helping people recover from Long Covid/Long Vax. As vaccine research continues and more people are vaccinated, it is important to recognize the emotional and physical tolls that may come with this process. With proper self-care techniques and support from loved ones, it is possible to manage these post-vaccination effects. 

Myocardial inflammation caused by spike proteins in the Covid-19 vaccine has also been identified as a potential long-term effect. Studies have found that this inflammation can lead to an increased risk of heart disease and other cardiovascular issues for some individuals. Although more research is needed, it is important to be aware of the potential risks of receiving the vaccine and speak with your doctor if you experience any cardiac symptoms such as chest

It’s also important to seek medical help if symptoms persist for an extended period of time or become unmanageable.

Neurologic symptoms may also occur after receiving the vaccine, including headaches, dizziness, confusion, and difficulty sleeping. Many individuals have also reported feeling weak or tired for a period of time after vaccination. While these symptoms usually decline over time, it is important to seek medical help if they persist or become severe.

It can be difficult to determine whether post-vaccination effects are related to the vaccine itself.

In addition to the symptoms outlined above, individuals may experience fever, chills, joint pain, and rash. These are usually mild and go away after a few days. If they persist or become severe it is essential to receive medical attention.  The length of long covid is yet to be determined, however, it is important to seek medical help if any symptoms persist for more than a few days.

I 

 

What is 'long vax'? Symptoms linked to COVID-19 shot baffle docs

5 Simple Ways to Get Healthy and Fit on a Budget

Are you looking for ways to get fit and healthy without breaking the bank? Health Train Express is here to show you how! With a few simple tips and tricks, you can learn how to take control of your health and fitness goals on a budget. So don't let financial constraints hold you back - set yourself up for success with these 5 cost-effective methods to stay healthy and fit.

1. Shop Smarter - Eating healthy doesn't have to cost you a fortune. Take the time to research which stores offer discounts on organic and natural foods, and try shopping at local farmer's markets for fresh produce that won't leave your wallet feeling empty. Additionally, look for deals like BOGO (Buy One Get One) or bulk buying options at grocery stores to help you save money.

2. Get Moving - Exercise doesn't have to involve expensive gym memberships or fancy equipment. You can get just as much benefit from activities like walking, jogging, biking, and swimming that don't require any extra costs after the initial investment of a pair of shoes or swimsuit. Plus, these activities are free and easily accessible, so you can get your workouts in without having to worry about the price tag.

3. Try At-Home Workouts - If you prefer more structured workout sessions, there are plenty of free and affordable options available online. From yoga and Pilates to HIIT and strength training programs, the internet is full of resources that will help keep your fitness goals on track.

4. Get Creative with Meal Prep - It's easy to get into a meal prep rut but don't let that deter you from eating healthy on a budget. Instead of buying pre-packaged meals or ingredients, create your own recipes using pantry staples like dry beans and grains. This way, you'll save money while still enjoying nutritious meals.

5. Find Support - Having a support system is crucial when it comes to staying motivated and on track with your fitness goals. Ask friends or family members to join you in healthy activities like walks, hikes, cooking classes, or even just meal prepping together. Not only will this help keep you accountable and motivated, but it can also be a great way to bond and have fun. With a few simple changes, staying fit on a budget is easy!

By taking advantage of the free and low-cost options available, you can still achieve your fitness goals without breaking the bank. Remember to plan ahead, get creative with your meals and workouts, and don’t forget to find a support system that will help keep you on track. With these tips in mind, you’ll have no problem staying fit without spending too much. Good luck!

Happy fitness journey! :-)

Moving Away From the Medical Control Grid | Childrens Health Defense

Moving Away From the Medical Control Grid | Childrens Health Defense

References:

Citizens' Council For Health Freedom

CCHF Coalition Letter To Stop The National Patient ID

Navigating Healthcare: Like A Mom | Jennifer Walters BSN-RN, PHN, MFA

Association Of American Physicians And Surgeons | A Voice For Private Physicians

Chiropractic - Mission Of The World Chiropractic Alliance

The Impact Of Technology On The Future Of Healthcare

CDC Panel Recommends Pfizer Pneumococcal Vaccines For Infants, RSV Vaccines For Adults

Merck Knew Its Popular Asthma Drug Could Lead Kids To Commit Suicide, Lawsuits Allege

Join The Wedge

American Association Of Naturopathic Physicians

Surgery Center Of Oklahoma

Scriptco Pharmacy

My Med Lab

Protocolkills | Home

American Frontline Nurses

IPAK-EDU

Dr. Sherri Tenpenny's Educational Site | Learning4You

Congress Must Reject PFAS Polluter Holiday | EWG

The Solari Report

How To Make Your Own Perfect First Aid Kit | Dr. Sam Bailey

Military Guide To Building A First Aid Kit

Homeopathy For Mommies

Getting Started With Oxygen In Metal Tanks

Importance Of A Fever - Dr. Sherri Tenpenny

The HIPAA Deception - Why HIPAA Is Not A Privacy Law

Patient Tools | Association Of American Physicians And Surgeons

Holistic Dental Association | Find A Holistic Dentist

What Is Concierge Medicine And Is It Worth The Price Tag?

"Nursing Drug Handbook"

The Best Family Homeopathy Acute Care Manual: A Pictorial Guide To First Aid And Acute Therapeutics

The School Of Natural Healing | Dr. Christopher

Dr. Tenpenny’s “The Importance Of Fever” Digital Book

"A Holistic Approach To Viruses "By Dr. Brownstein

"Iodine: Why You Need It. Why You Can't Live Without It. 5th Edition" By Dr. Brownstein

"The Grow System" By Marjory Wildcraft

Moving Away From the Medical Control Grid | Childrens Health Defense

New forms of Oral Polio Virus

“We’ve designed these new vaccines using lessons learned from many years of fighting polio and believe they will help eliminate the disease once and for all,” Andino says. “If there’s polio anywhere, it will come back where there are gaps in vaccination. The perception that polio is gone is a dangerous one.”

‘Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants • Children's Health Defense Fund

Treatment options continue to expand

To create the new vaccines, the researchers used the molecular backbone of their earlier vaccine for the type 2 virus. They retained the genetic components that help keep the weakened virus from becoming pathogenic. But they replaced coding regions for the virus capsid (shell) unique to the type 2 virus with sequences from the other two polio types.

Time has shown critics were wrong.  This is only the beginning of a tug of war as others pursue gains from Pfizer-Moderna.

The oral polio vaccine is often used in resource-poor regions, due to its lower cost and easy delivery. The oral vaccine is also more effective in many ways, but it has a significant drawback: It is based on a live weakened poliovirus that can mutate and evolve. In rare cases, it can become infectious. This can lead to a vaccine-derived outbreak in communities with many unvaccinated people. There are three poliovirus types, with only type one still spreading in the wild. But episodes of all three types can still occur because of the vaccines.

Studies in mice showed that both novel vaccines triggered strong immune responses similar to those seen with the current oral vaccines. Each effectively prevented infection after exposure to the poliovirus. 

Since then, more than 600 million doses of the vaccine have been used to treat polio outbreaks in 28 countries. In their latest study, the researchers created modified oral vaccines that target the other two polioviruses, types 1 and 3. Research to develop the vaccines was supported in part by NIH. Results appeared in Nature on June 14, 2023.

Polio – a disease many have prematurely consigned to history – made headlines around the world in recent months when the virus was detected in relatively high-income country settings from New York, London, Montreal, and Jerusalem. This apparent comeback in polio-free countries has left many questioning the feasibility of eradication. On the contrary, we have never been closer to achieving our goal of a polio-free world: this resurgence only underscores the urgent need for eradication.

When the Global Polio Eradication Initiative (GPEI) was launched in 1988, nearly 1,000 children were being paralyzed with wild poliovirus (WPV) infection across 125 countries every single day. Since then, a concerted effort of health workers, communities, local governments, and global partners such as Rotary International has helped eradicate two of the three serotypes of wild poliovirus (WPV2 and WPV3) and cornered the remaining strain of WPV – type 1 (WPV1) – to small areas of Pakistan and Afghanistan – the last wild polio-endemic countries. The genetic diversity of the remaining chains of WPV1 is also on the decline, indicating the virus might very well be on the verge of being wiped out.  

However, this incredible progress is in jeopardy. Due in part to the COVID-19 pandemic, the world has seen a worrying drop in immunization rates over the past few years, creating pockets of under-immunized communities at heightened risk of polio infection and paralysis. Children missing polio vaccinations create opportunities for polio to re-emerge and spread – as seen in 2022 when WPV1 originating in Pakistan was detected in paralyzed children in Malawi and Mozambique. This episode served as a poignant reminder that as long as polio exists anywhere in the world, it remains a threat to people everywhere.

Persistently under-vaccinated communities are also at risk of outbreaks of vaccine-derived poliovirus (VDPVs). These polio variants evolve from oral polio vaccines (OPVs), which use a weakened form of the virus to protect children from infection and act as a key tool for many countries to stop the spread of polio. When a vaccinated child sheds that weakened virus into the environment, it can help provide indirect protection for the entire community. However, in areas with persistently low immunization coverage, the weakened vaccine virus can circulate over a prolonged period, ultimately regaining the ability to cause paralytic outbreaks that can spread across geographies. 

What do we do about it?

One technological solution to the VDPV situation is the development of OPV strains that are more genetically stable and therefore less likely to evolve into VDPVs. In 2011, a scientific consortium was formed to explore the development of a next-generation vaccine while still maintaining the advantages of existing OPV, such as ease of delivery and intestinal mucosal immunogenicity. As poliovirus serotype 2 strain has been associated with most of the paralytic polio outbreaks of cVDPVs, a new, type 2 OPV was selected as the initial focus of the consortium.

In November 2020, the novel oral polio vaccine type 2 (nOPV2) was authorized under the Emergency Use Listing (EUL) pathway by the World Health Organization (WHO) following positive findings from phase I and phase II studies of safety, reactogenicity, immunogenicity, and the desired genetic stability. The rollout of nOPV2 for outbreak response began in March 2021 and since then, more than 580 million doses of nOPV2 have been delivered in 28 countries, with surveillance data from initial field use indicating a high likelihood of success at closing outbreaks with a lower risk of seeding the emergence of new ones.

Regardless of which polio vaccine is used to stop an outbreak, there must be high immunization coverage for all children to be protected against paralysis. Following the detection of an environmental sample or confirmation of a case of paralytic polio, outbreak response campaigns must be launched in a timely manner to reach all at-risk communities with vaccines. Coordination transcending geographic borders is also key, which is why countries currently at a high risk of polio spread – such as Pakistan and Afghanistan as well as Malawi, Mozambique, Tanzania, Zambia, and Zimbabwe – are synchronizing campaigns to help ensure that underserved and migrant communities are not missed. Readiness on the regulatory front to use a vaccine under EUL provisions as in the case of nOPV2 and maintaining adequate global supplies of such vaccines will be important in minimizing the risk of the spread of polio.

https://pubmed.ncbi.nlm.nih.gov/25824845/

https://pubmed.ncbi.nlm.nih.gov/32330425/

https://pubmed.ncbi.nlm.nih.gov/37317297/

https://pubmed.ncbi.nlm.nih.gov/24175215/

Novel vaccines may help quell polio outbreaks | National Institutes of Health (NIH)

In the mid-1900s, the highly contagious disease poliomyelitis, or polio, was responsible for about a half-million cases of paralysis or death worldwide each year. Polio outbreaks began to drop dramatically beginning in the 1950s, after the development of two effective vaccines—one given orally, the other by injection. But despite worldwide efforts to eliminate polio, a few pockets of infection still remain, especially in developing countries.

The oral polio vaccine is often used in resource-poor regions, due to its lower cost and easy delivery. The oral vaccine is also more effective in many ways, but it has a significant drawback: It is based on a live weakened poliovirus that can mutate and evolve. In rare cases, it can become infectious. This can lead to a vaccine-derived outbreak in communities with many unvaccinated people. There are three types of poliovirus, with only type one still spreading in the wild. But outbreaks of all three types can still occur because of the vaccines.

An international research team has been seeking ways to improve the safety of the oral polio vaccine. The team is led by Drs. Raul Andino of the University of California, San Francisco, and Andrew Macadam of the U.K.’s National Institute for Biological Standards and Control. In 2020, they reported on modifications to the oral vaccine for type 2 poliovirus that made it genetically more stable. That means it was less likely to mutate, evolve, and become infectious. That same year, the World Health Organization approved the vaccine for emergency use.

Since then, more than 600 million doses of the vaccine have been used to treat polio outbreaks in 28 countries. In their latest study, the researchers created modified oral vaccines that target the other two polioviruses, types 1 and 3. Research to develop the vaccines was supported in part by NIH. Results appeared in Nature on June 14, 2023.

To create the new vaccines, the researchers used the molecular backbone of their earlier vaccine for the type 2 virus. They retained the genetic components that help keep the weakened virus from becoming pathogenic. But they replaced coding regions for the virus capsid (shell) that are unique to the type 2 virus with sequences from the other two polio types.

Studies in mice showed that both novel vaccines triggered strong immune responses similar to those seen with the current oral vaccines. Each effectively prevented infection after exposure to the poliovirus.

Further study showed that the new vaccines were genetically stable and so unlikely to evolve. The vaccines prevented infection even when packaged together to target two or all three types of poliovirus at once. The finding suggests that a combination vaccine could target all three strains and enable broad protection from poliovirus via an oral vaccine.

“We’ve designed these new vaccines using lessons learned from many years of fighting polio and believe they will help eliminate the disease once and for all,” Andino says. “If there’s polio anywhere, it will come back where there are gaps in vaccination. The perception that polio is gone is a dangerous one.”

Novel vaccines may help quell polio outbreaks | National Institutes of Health (NIH)