Vaccine hesitancy lower in poorer countries

 New research published in Nature Medicine reveals willingness to get a COVID-19 vaccine was considerably higher in developing countries (80% of respondents) than in the United States (65%) and Russia (30%).

The study provides one of the first insights into vaccine acceptance and hesitancy in a broad selection of low- and-middle income countries (LMIC), covering over 20,000 survey respondents and bringing together researchers from over 30 institutions including the International Growth Centre (IGC), Innovations for Poverty Action (IPA), WZB Berlin Social Science Center, the Yale Institute for Global Health, the Yale Research Initiative on Innovation and Scale (Y-RISE), and HSE University (Moscow, Russia).

Personal protection against COVID-19 was the main reason given for vaccine acceptance among LMIC respondents (91%), and concern about side effects (44%) was the most common reason for vaccine hesitancy. Health workers were considered the most trusted sources of information about COVID-19 vaccines.

The study comes at a critical juncture when vaccine shipments are still slow to arrive to the majority of the world's population, and COVID-19 cases are surging in many parts of Africa, Asia, and Latin America. The findings suggest that prioritizing vaccine distribution to low- and middle -income countries should yield high returns in expanding global immunization coverage.

"As COVID-19 vaccine supplies trickle into developing countries, the next few months will be key for governments and international organizations to focus on designing and implementing effective vaccine uptake programs," said Niccoló Meriggi, Country Economist for IGC Sierra Leone and study co-author. "Governments can use this evidence to develop communications campaigns and systems to ensure that those who intend to get a vaccine actually follow through."

The researchers, who conducted the surveys between June 2020 and January 2021, point out that vaccine acceptance may vary with time and with the information that people have available to them. While the evidence on the safety and efficacy of available COVID-19 vaccines has become more clear in the last six months, severe, but rare, side effects may have undermined public confidence.

Saad Omer, Director of the Yale Institute of Global Health and study co-author, said: "What we've seen in Europe, the US, and other countries suggests that vaccine hesitancy can complicate policy decisions, thereby hindering rapid and widespread vaccine uptake. Governments in developing countries can start engaging trusted people like health workers now to deliver vaccine messaging about side effects that is accurate, balanced, and easily available to the public."

"Across countries, we observe that acceptance of COVID-19 vaccines is generally somewhat lower than for other vaccines, perhaps because of their novelty. However, the consistently pro-vaccine attitudes we see in low and middle income countries give us reason to be optimistic about uptake," said Alexandra Scacco, Senior Research Fellow at the WZB and study co-author. "We hope that evidence from our study can help inform strategies to expand global COVID-19 vaccination."

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Globally, most pregnant women and mothers would get COVID-19 vaccine, vaccinate their children

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More information: Shingai Machingaidze et al, Understanding COVID-19 vaccine hesitancy, Nature Medicine (2021). DOI: 10.1038/s41591-021-01459-7

https://medicalxpress.com/news/2021-07-vaccine-hesitancy-poorer-countries.html

Will we finally get another human Lyme disease vaccine?

T hey look like fever-dream sesame seeds, tipped with ugly fangs and eight tiny legs, perched on blades of grass. And they’re spreading. Deer ticks — the carriers of Lyme disease — are expanding their ranges and bringing their pathogenic passengers with them. Cases of Lyme have been growing for two decades, mostly in the northeast, but also spreading to new regions.

Despite the burden and growing danger, however, there is no human Lyme disease vaccine currently available. That may be about to change, though.

French vaccine company Valneva has a candidate that began its second phase 2 trial in March. With backing from Pfizer, the company hopes it will be the last hurdle before phase 3 efficacy trials, which could finally put a Lyme disease vaccine back on the market.

“The work on a vaccine — we have to,” says Eva Sapi, a Lyme disease expert at the University of New Haven in Connecticut. With ticks spreading unabated, we “have no choice but to work on a vaccine.”

A debilitating disease: Lyme disease is the most common animal-borne infection in the United States, causing up to 476,000 cases per year, according to analysis of insurance data by the CDC.

It can have an extremely long course. Fever, chills, fatigue, head and joint aches can arise days to a month after the initial bite, as well as Lyme’s most famous pathology, a large rash that sometimes takes the shape of a bull’s eye.

Left untreated, however, more serious symptoms can include inflammation of the brain and spinal cord, irregular beating of the heart, and severe head, neck, and joint pain — called Lyme arthritis.

If caught early, most patients respond well to a course of antibiotics. For some patients, however, the impacts of Lyme infection can linger. 

Death of a Lyme disease vaccine: As Time’s Mandy Oaklander reported, we used to have an effective Lyme disease vaccine. 

Approved in 1998, LYMErix was developed by GlaxoSmithKline (GSK), then known as SmithKline Beecham (SKB).

So what happened? The jab became a casualty of the anti-vaccine movement. Fears of a potential autoimmune reaction that would cruelly cause some of Lyme disease’s very symptoms — including arthritis and chronic fatigue — were seized upon by anti-vaccine groups, despite a lack of evidence that the vaccine caused arthritis.

A year after the Lyme disease vaccine’s approval, a class-action lawsuit was brought against SKB, and the image problem decimated sales. Dropping from over a million sales in 1999 to 10,000 in 2002, SKB eventually dropped the vaccine. 

Birth of a Lyme disease vaccine: Valneva and Pfizer’s new candidate, VLA15, is the only active Lyme disease vaccine in clinical development. 

The vaccine targets six different serotypes of Lyme disease. “They looked at different species of Borrelia, including the European species and some other species,” Sapi says. “So this vaccine is a little bit more complex” to cover numerous species.

Taking aim at a protein Borrelia expresses inside ticks, called outer surface protein A, the Lyme disease vaccine sparks antibodies that aim to prevent the nasty spirals from migrating from the tick.

VLA15 has thus far been through multiple phase 2 trials. In October 2020, the companies announced the results of their second phase 2 trial. According to Valneva, the vaccine was “generally safe across all doses and age groups tested,” and sparked an encouraging immune response, including in older adults. 

The Lyme disease vaccine’s antibodies worked against all of the serotypes targeted.

Phase 2, round 3: The latest phase 2 study, announced in March of this year, will include 600 healthy participants, Yahoo! Finance reported. The study will include pediatric patients starting from age 5. Participants will be split evenly into a placebo group and two groups that will receive the vaccine on two different dosing schedules, according to BioPharma-Reporter.

Included in the subject population will be people who have previously cleared a Lyme infection, as well as those who have never been exposed to Borrelia.

“I like the idea,” Sapi says, as a way to investigate whether previous infection causes a different reaction to the vaccine. Previous infection with SARS-CoV-2, for example, changes a patient’s reaction to the vaccine, Sapi points out. 

“This trial initiation marks an important step in the development of VLA15 toward a potential licensure,” Juan Carlos Jaramillo, Valneva’s chief medical officer, said in a statement. 

Including children at this stage could pave the way towards their inclusion in a phase 3 trial, which tests for efficacy in the real world, allowing the companies to “potentially offer a vaccine for Lyme disease that may help prevent disease in both adults and children, if approved.”

https://www.freethink.com/health/lyme-disease-vaccine

Anyone can now make mouse-human chimeras

I n 2020, University at Buffalo scientists announced that they’d found a way to grow millions of human cells in mouse embryos.

Now, they’ve published a how-to guide so that others can make their own mouse-human chimeras, a move that could lead to treatment breakthroughs for countless diseases — and maybe even growing human organs in animals.

The challenge: Lab mice play a huge role in medical research, giving scientists a way to study disease progression and test new treatments in living organisms without experimenting on people.

However, while mice and humans have similar DNA, they’re still very different animals, and much of what we see in mouse models doesn’t translate to people.

Why it matters: UB’s mouse-human chimeras offer the best of both worlds, giving researchers a way to study the impact of diseases or treatments on human cells in vivo (that is, in a live animal), without putting any people in harm’s way.

“These mice contain critical human cells, tissues, or even organs so that they more accurately reflect the human condition,” senior author Jian Feng said in a press release. “With our method, the human cells are made along with the mouse during the development of the mouse embryo.”

DIY mouse-human chimeras: The newly published protocol guides researchers through the three-step process UB developed to create the chimeras. 

That starts with coaxing “primed” stem cells, derived from people, into their less-developed “naïve” state. Next comes getting those naïve stem cells to grow within a mouse embryo, and finally, the protocol explains how to quantify the number of human cells that develop in the mouse-human chimeras.

Looking ahead: UB was encouraged to publish the guide following significant interest from the scientific community. 

Now that the protocol is out there, Feng is confident that researchers will run with it, using the mouse-human chimeras to study diseases, develop potentially life-saving treatments, and maybe even figure out how to grow transplantable human organs in animals.

“It will stimulate unforeseen discoveries and applications that may fundamentally change our understanding of human biology and medicine,” he said. 

https://www.freethink.com/science/mouse-human-chimeras

Hair-thin spine stimulator could relieve severe back pain

A Cambridge University-led team of scientists has developed an ultra-tiny implant that can deliver pain-relieving spinal cord stimulation — and patients won’t even need invasive surgery to use it.

Spinal cord stimulation: As many as 1 in 12 Americans lives with back pain that can’t be treated effectively with normal medication, according to the CDC.

Implantable devices that deliver electrical impulses right to the spinal cord — spinal cord stimulators — can sometimes provide long-term pain relief to people with intractable back pain.

The challenge: While potentially millions of people could benefit from spinal cord stimulation, doctors only implant about 50,000 of the devices every year. One explanation for their rarity is the fact that all of the available implants have shortcomings.

The most effective stimulator covers a large area of the spinal cord, but because the device itself is large, it must be implanted through an invasive surgery while patients are under general anesthesia.

There’s also a smaller stimulator that can be implanted via a needle with just local anesthesia, but it covers a smaller area of the spinal cord and is less effective.

“Our goal was to make something that’s the best of both worlds — a device that’s clinically effective but that doesn’t require complex and risky surgery,” Christopher Proctor, co-senior author of the study, said in a press release.

Stimulation with inflation: The spinal cord stimulator they developed is only about the width of a human hair. It’s also flexible, which means it can be rolled into a cylinder and inserted into the spinal column via a needle — no invasive procedure required.

Once in place, air or water is pumped into tiny channels in the device, which causes it to unfurl like an air mattress to cover a larger area of the spinal cord.

“Thin-film electronics aren’t new, but incorporating fluid chambers is what makes our device unique,” Proctor explained.

Looking ahead: So far, the spinal cord stimulation device has only been tested in human cadavers and models of spinal columns, so we don’t know for sure yet how its efficacy compares to existing devices.

However, the stimulator could be ready for clinical trials within two or three years — and it may have more uses than just pain management.

“The way we make the device means that we can also incorporate additional components — we could add more electrodes or make it bigger in order to cover larger areas of the spine with increased accuracy,” Damiano Barone, the study’s other co-senior author, said.

“This adaptability could make our SCS device a potential treatment for paralysis following spinal cord injury or stroke or movement disorders such as Parkinson’s disease,” he continued. “An effective device that doesn’t require invasive surgery could bring relief to so many people.”

https://www.freethink.com/health/spinal-cord-stimulation

CRISPR halts coronavirus transmission in human cells

 Using CRISPR, Australian researchers have prevented a coronavirus infection from spreading in human cells in the lab. They’re now looking for a way to develop the treatment into an oral drug that could halt coronavirus transmission in people — and potentially stop other viruses as well.

The challenge: While we do have effective COVID-19 vaccines, we’re still in need of better treatments. Right now, our best options are monoclonal antibodies, but those must be delivered intravenously, limiting their use to hospitals, and they are already becoming less effective against new variants.

This lack of treatments is a problem because, while restrictions have been eased or outright lifted in much of the United States, the pandemic is far from over — cases and deaths are on an upward trend in many parts of the nation.

The need: An oral medication that could be taken as soon as someone was diagnosed with COVID-19 could mark a turning point in the pandemic, and the Australian researchers think their CRISPR treatment could lead to the development of such a drug.

“This approach — test and treat — would only be feasible if we have a cheap, oral, and non-toxic antiviral,” lead author Sharon Lewin told Agence France-Presse (AFP).“That’s what we hope to achieve one day with this gene scissors approach.”

Blocking coronavirus transmission: CRISPR is a gene editing tool that originally evolved in bacteria as an antivirus system, for searching out viral genes and destroying them. 

In a newly published study, Australian scientists demonstrate how they programmed a CRISPR system to bind to and degrade specific parts of the coronavirus’ genome, blocking transmission between human cells.

“Once the virus is recognized, the CRISPR enzyme is activated and chops up the virus,” Lewin said. “We targeted several parts of the virus — parts that are very stable and don’t change and parts that are highly changeable — and all worked very well in chopping up the virus.”

“The power of this tool lies in its design-flexibility and adaptability.”

MOHAMED FAREH

When they tested the system on infected human cells in the lab, it prevented coronavirus transmission between the cells, meaning the virus couldn’t spread from infected cells to non-infected cells.

The CRISPR treatment even worked on several troubling variants, including the one that emerged in the U.K., and could be easily tweaked to address the Delta variant or other strains, according to Lewin.

“The flexibility of CRISPR-Cas13 — which only needs the viral sequence — means we can look to rapidly design antivirals for COVID-19 and any new emerging viruses,” she said in a press release.

Looking ahead: Animal studies are next on the researchers’ agenda, and if those go well, clinical trials to see if the CRISPR treatment can prevent coronavirus transmission in humans could follow.

While Lewin said it’ll likely be “years, not months” before a medication is widely available, the coronavirus shows no signs of disappearing, so the treatment is still well worth pursuing — especially since it could potentially be adapted to treat diseases beyond COVID-19.

“Unlike conventional antiviral drugs, the power of this tool lies in its design-flexibility and adaptability, which make it a suitable drug against a multitude of pathogenic viruses, including influenza, Ebola, and possibly HIV,” co-author Mohamed Fareh told AFP.

https://www.freethink.com/health/coronavirus-transmission-2

Washington setting drug prices would be a disaster for American health care

 Through the near-miraculous success of vaccines at ending the coronavirus pandemic, it’s clear that medical innovation both saves and improves lives. Yet many leading congressional Democrats are pushing a deeply flawed bill that will harm patients by undermining the very innovation that delivered multiple safe and effective vaccines in record time. 

This bill, H.R. 3, would give the federal bureaucracy unprecedented power to set prices for prescription drugs. Rather than pursuing this measure, Congress should work toward common-sense reforms that have broad support and will ensure continued access to life-saving and life-enhancing medications. 

To understand the problems with H.R. 3, look to the experience of countries where the government sets drug prices. While price controls might reduce the sticker price of a drug, patients in these countries suffer from drug shortages and restricted access to treatments. 

For example, in Canada, where a government board determines drug prices, patients only have access to half of new drugs. In contrast, US patients have access to 89 percent of new drugs.

Similarly, European Union countries with price controls have experienced worsening drug shortages. The low prices limit production of the drug and what is available for patients. According to a 2019 report, in France, “The number of drugs reported as scarce in the country increased 20-fold between 2008 and 2018, according to the country’s drugs regulator — and is predicted to rise by a further 60 percent this year.” In Italy, some cancer patients struggle to access medications. In Poland, the shortage of neurological drugs rose to an “unprecedented scale.”

Price controls will slash the number of new medications by limiting the returns on innovation. A 2019 report from the White House Council of Economic Advisors (CEA) estimated that H.R. 3 would reduce the number of new treatments by one-third over 10 years. According to the CEA, H.R. 3 would reduce average American life expectancy by about four months and have total economic costs that far exceed the benefits from lower prices.

Democrats are pushing a flawed bill that will harm patients by undermining the very innovation that delivered multiple safe and effective COVID-19 vaccines in record time.

Matthew McDermott

Over the past few decades, pharmaceutical innovation has produced breakthrough drugs in the treatment of many diseases, like heart disease, HIV and hepatitis C. These treatments significantly improved and extended life. Medical researchers are currently making strides in the treatment of other diseases, like cancer. The last thing policymakers should do is smother medical innovation and limit new discoveries with bigger government.

Fortunately, Congress can take steps to expand patient access to more affordable medications in ways that won’t have such severe side effects. 

First, Congress should make it easier for the Food and Drug Administration (FDA) to quickly approve safe generics and also make it more difficult for pharmaceutical companies to game the patent system to limit competition from generics. Increasing the availability of generics would be especially helpful for fixed-income seniors, people with low incomes, and individuals with preexisting conditions who need medication. 

Congress should also reform the FDA approval process to grant automatic approval to medications authorized in other countries with regulatory processes we trust. In some cases, Americans waited years for drugs already benefiting patients in Japan and other countries with robust screens for safety. 

Furthermore, Congress should allow all Americans to open tax-free health savings accounts (HSAs). HSAs would let patients use some of their pre-tax income to cover prescription drug costs, such as copays. 

Aduhelm, the FDA-approved drug that could slow the progression of Alzheimer’s, is expensive — but market competition will lower the price of such treatment over time.

Reuters

Understandably, there is concern about the launch price of Aduhelm, the recently FDA-approved drug that may be beneficial to slow the progression of Alzheimer’s. As a result of Medicare’s design, which needs significant reform, the federal government simply reimburses the price set by the manufacturer. For Aduhelm, this price is $56,000 per year. Of course, the ravages of this disease are extremely high and over time, market competition will lower the price of such treatment. Already, a second drugmaker has filed for accelerated approval of its Alzheimer’s treatment. 

Pharmaceutical innovation is one of the best features of America’s health-care system. Nearly 60 percent of new drugs are produced in the United States, and Americans typically enjoy the world’s best access to new medications. Congress should not take action that would imperil this innovation and the life-enhancing and life-saving products that result. Fortunately, there are many actions that Congress can take to bring down the prices of drugs by reducing regulatory barriers and promoting market competition. And unlike H.R. 3, these reforms will have bipartisan support. 

Brian Blase served as a special assistant to President Trump at the National Economic Council, 2017-19. He is president of Blase Policy Strategies LLC. 

https://nypost.com/2021/07/10/drug-prices-set-by-washington-would-be-a-disaster-for-health-care/

Instead of Tightening Government Grip on Healthcare, Give Americans a Personal Option

 As America begins to put the COVID-19 pandemic in the rearview, the lesson from this once-in-a-generation crisis couldn’t be clearer: We need less, not more, central planning in our lives.

For example, a study earlier this year by health economist Casey Mulligan revealed that economic lockdowns mandated by government were counterproductive, given the significant steps workplaces took to prevent the virus from spreading.

The same is true with health care. By now, most folks know the story of how Operation Warp Speed — the previous administration’s unprecedented plan to trim bureaucracy from the vaccine development process — resulted in the creation of multiple safe and effective vaccines in record time. But an equally important storyline is how states took a sledgehammer to their own bureaucracies to expand access to care for those in need.

Thirty-eight states increased the availably of telehealth in response to the pandemic. Another 24 states waived certificate-of-need laws, which require hospitals to receive a permission slip from the government before they can open or add new facilities.

COVID-19 is forcing a long-overdue transformation of how health care is delivered in our country. As University of Michigan professor Rashid Bashur recently put it, “the genie’s out of the bottle.”

And yet, President Joe Biden, House Speaker Nancy Pelosi, and others in Congress are remarkably missing this point. Even though their big government approach to health care hasn’t increased access to affordable care, they claim the solution is to double down on this failed path. The far left is pushing Biden to adopt even more radical ideas, like putting government in complete control of health care.

Instead of an even more centralized system, let’s give voters what they deserve — a personal option that keeps what they like about their health care, fixes what they don’t like, and puts people, not bureaucrats, in control of their care.

More affordability

One important improvement would be to expand tax-free health savings accounts. HSAs save people at least 15 percent each time they make a health care purchase. Yet, given the current constraints, only one in 10 Americans are eligible for an HSA at any given time. By expanding eligibility, more Americans would be able to save for health care costs. For those with less income, Congress could directly fund their accounts.

Increased access

There is strong bipartisan support for expanding the use of telehealth, which has the ability to level the playing field in terms of location and access. While it has seen an uptick during the COVID-19 pandemic, this technology is still not available to all, especially in underserved rural and urban communities. There is bipartisan support for giving more Americans access to virtual care. Lawmakers should waste no time getting it done.

Greater control

While short-term coverage is, by definition, not a long-term solution, it is a viable option for people and families, especially when the policy holder is between jobs. In some states, short-term plans cost up to 80 percent less than traditional health insurance plans. While opponents feared short-term plans would drive up prices on the ACA exchanges, the only states where premiums have gone up are in the five that prohibit short-term plans.

More choices

For far too long, the Food and Drug Administration has taken its time in approving drugs and medical devices that were approved in other advanced countries, such as Japan and in the EU. In addition, the FDA won’t allow the sharing of valid scientific information about promising experimental or “off-label” uses of already approved drugs and devices. Changing these processes could save many lives and result in cost savings.

All of this builds on reforms proposed last year in Healthcare For You, and these ideas resonate strongly with Americans. A recent poll by Public Option Strategies shows that voters prefer a personal option to the “public option” or “Medicare for All” by nearly 40 points. Among independents, the poll found that a personal option outperformed “Medicare for All” by 60 points and the “public option” by more than 35 points

The point is, there are smarter, more effective, and more popular ways to reduce costs and give people more options than simply expanding government’s grip over the system.

For years, opponents of government-run health care have made this argument but haven’t sold the public on a compelling enough alternative. That alternative has arrived. 

It’s time to deliver a health care system that works for everyone. It’s time for a personal option. 

Tom Price is a physician who served as Health and Human Services secretary in 2017 and is a former U.S. congressman from Georgia. 

https://www.realclearhealth.com/articles/2021/07/12/instead_of_tightening_governments_grip_on_healthcare_give_americans_a_personal_option__111228.html