Did Covid Vaccine Mandates Do More Harm Than Good?

By Dr. Rachel Gur-Arie, Arizona State University

Ending pandemics is a social decision, not scientific. Governments and organizations rely on social, cultural and political considerations to decide when to officially declare the end of a pandemic. Ideally, leaders try to minimize the social, economic and public health burden of removing emergency restrictions while maximizing potential benefits.

Vaccine policy is a particularly complicated part of pandemic decision-making, involving a variety of other complex and often contradicting interests and considerations. Although COVID-19 vaccines have saved millions of lives in the U.S., vaccine policymaking throughout the pandemic was often reactive and politicized.

A late November 2022 Kaiser Family Foundation poll found that one-third of U.S. parents believed they should be able to decide not to vaccinate their children at all. The World Health Organization and the United Nations Children’s Fund reported that between 2019 and 2021, global childhood vaccination experienced its largest drop in the past 30 years.

The Biden administration formally removed federal COVID-19 vaccination requirements for federal employees and international travelers in May 2023. Soon after, the U.S. government officially ended the COVID-19 public health emergency. But COVID-19’s burden on health systems continues globally.

I am a public health ethicist who has spent most of my academic career thinking about the ethics of vaccine policies. For as long as they’ve been around, vaccines have been a classic case study in public health and bioethics. Vaccines highlight the tensions between personal autonomy and public good, and they show how the decision of an individual can have populationwide consequences.

COVID-19 is here to stay. Reflecting on the ethical considerations surrounding the rise – and unfolding fall – of COVID-19 vaccine mandates can help society better prepare for future disease outbreaks and pandemics.

Types of Vaccine Mandates

Vaccine mandates are the most restrictive form of vaccine policy in terms of personal autonomy. Vaccine policies can be conceptualized as a spectrum, ranging from least restrictive, such as passive recommendations like informational advertisements, to most restrictive, such as a vaccine mandate that fines those who refuse to comply.

Each sort of vaccine policy also has different forms. Some recommendations offer incentives, perhaps in the form of a monetary benefit, while others are only a verbal recommendation. Some vaccine mandates are mandatory in name only, with no practical consequences, while others may trigger termination of employment upon noncompliance.

COVID-19 vaccine mandates took many forms throughout the pandemic, including but not limited to employer mandates, school mandates and vaccination certificates – often referred to as vaccine passports or immunity passports – required for travel and participation in public life.

Because of ethical considerations, vaccine mandates are typically not the first option policymakers use to maximize vaccine uptake. Vaccine mandates are paternalistic by nature because they limit freedom of choice and bodily autonomy. Additionally, because some people may see vaccine mandates as invasive, they could potentially create challenges in maintaining and garnering trust in public health. This is why mandates are usually the last resort.

However, vaccine mandates can be justified from a public health perspective on multiple grounds. They’re a powerful and effective public health intervention.

Mandates can provide lasting protection against infectious diseases in various communities, including schools and health care settings. They can provide a public good by ensuring widespread vaccination to reduce the chance of outbreaks and disease transmission overall. Subsequently, an increase in community vaccine uptake due to mandates can protect immunocompromised and vulnerable people who are at higher risk of infection.

Early in the pandemic, arguments in favor of mandating COVID-19 vaccines for adults rested primarily on evidence that COVID-19 vaccination prevented disease transmission. In 2020 and 2021, COVID-19 vaccines seemed to have a strong effect on reducing transmission, therefore justifying vaccine mandates.

COVID-19 also posed a disproportionate threat to vulnerable people, including the immunocompromised, older adults, people with chronic conditions and poorer communities. As a result, these groups would have significantly benefited from a reduction in COVID-19 outbreaks and hospitalization.

Many researchers found personal liberty and religious objections insufficient to prevent mandating COVID-19 vaccines. Additionally, decision-makers in favor of mandates appealed to the COVID-19 vaccine’s ability to reduce disease severity and therefore hospitalization rates, alleviating the pressure on overwhelmed health care facilities.

However, the emergence of even more transmissible variants of the virus dramatically changed the decision-making landscape surrounding COVID-19 vaccine mandates.

The public health intention (and ethicality) of original COVID-19 vaccine mandates became less relevant as the scientific community understood that achieving herd immunity against COVID-19 was probably impossible because of uneven vaccine uptake, and breakthrough infections among the vaccinated became more common. Many countries like England and various states in the U.S. started to roll back COVID-19 vaccine mandates.

With the rollback and removal of vaccine mandates, decision-makers are still left with important policy questions: Should vaccine mandates be dismissed, or is there still sufficient ethical and scientific justification to keep them in place?

Vaccines are lifesaving medicines that can help everyone eligible to receive them. But vaccine mandates are context-dependent tools that require considering the time, place and population they are deployed in.

Though COVID-19 vaccine mandates are less of a publicly pressing issue today, many other vaccine mandates, particularly in schools, are currently being challenged. I believe this is a reflection of decreased trust in public health authorities, institutions and researchers – resulting in part from tumultuous decision-making during the COVID-19 pandemic.

Engaging in transparent and honest conversations surrounding vaccine mandates and other health policies can help rebuild and foster trust in public health institutions and interventions.

Rachel Gur-Arie, PhD, is an assistant professor with Edson College of Nursing and Health Innovation at Arizona State University. Her expertise lies at the intersection of ethics, global health and policy. Prior to joining ASU, Rachel was a Hecht-Levi postdoctoral Fellow, focused on ethics and infectious disease, at Johns Hopkins University and the University of Oxford. She completed her doctorate in health systems management and served as a Fulbright Scholar at Ben-Gurion University of the Negev in Israel.

This article originally appeared in The Conversation and is republished with permission.

CDC Recommends New Covid Boosters

By Arthur Allen, KFF Health News

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who Should Get a Booster Shot?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When Should You Get It?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who Pays For It?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines.

For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will New Booster Work Against Current Variants?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why Are People Still Skeptical About Vaccines?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism.

Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

What About Getting Other Vaccines?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said.

Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year. Although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Experimental Vaccines Target Epstein-Barr Virus

By Liz Szabo, Kaiser Health News

Maybe you’ve never heard of the Epstein-Barr virus. But it knows all about you.

Chances are, it’s living inside you right now. About 95% of American adults are infected sometime in their lives. And once infected, the virus stays with you.

Most viruses, such as influenza, just come and go. A healthy immune system attacks them, kills them, and prevents them from sickening you again. Epstein-Barr and its cousins, including the viruses that cause chickenpox and herpes, can hibernate inside your cells for decades.

This viral family has “evolved with us for millions of years,” said Blossom Damania, a virologist at the University of North Carolina-Chapel Hill. “They know all your body’s secrets.”

Although childhood Epstein-Barr infections are typically mild, exposure in teens and young adults can lead to infectious mononucleosis, a weeks-long illness that sickens 125,000 Americans a year, causing sore throats, swollen glands, and extreme fatigue. And while Epstein-Barr spends most of its time sleeping, it can reawaken during times of stress or when the immune system is off its game. Those reactivations are linked to a long list of serious health conditions, including several types of cancer and autoimmune diseases.

Scientists have spent years trying to develop vaccines against Epstein-Barr, or EBV. But recently several leaps in medical research have provided more urgency to the quest — and more hope for success. In just the past year, two experimental vaccine efforts have made it to human clinical trials.

What’s changed?

First, the Epstein-Barr virus has been shown to present an even greater threat. New research firmly links it to multiple sclerosis, or MS, a potentially disabling chronic disease that afflicts more than 900,000 Americans and 2.8 million people worldwide.

The journal Science in January published results from a landmark 20-year study of 10 million military personnel that offers the strongest evidence yet that Epstein-Barr can trigger MS. The new study found that people infected with Epstein-Barr are 32 times as likely as people not infected to develop MS.

And shedding new light on the mechanisms that could explain that correlation, a separate group of scientists published a study in Nature describing how the virus can cause an autoimmune reaction that leads to MS.

The disease, which usually strikes between ages 20 and 40, disrupts communication between the brain and other parts of the body and is often marked by recurring episodes of extreme fatigue, blurred vision, muscle weakness, and difficulty with balance and coordination. At its worst, MS can lead to impaired speech and paralysis.

“Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now.”

— Blossom Damania, Virologist

Amplifying that newfound urgency, several new studies suggest that reactivation of the Epstein-Barr virus also is involved with some cases of long covid, a little-understood condition in which patients experience lingering symptoms that often resemble mononucleosis.

And just as crucial to the momentum: Advances in vaccine science spurred by the pandemic, including the mRNA technology used in some covid vaccines, could accelerate development of other vaccines, including ones against Epstein-Barr, said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. Hotez co-created a low-cost, patent-free covid vaccine called Corbevax.

Some researchers question the need for a vaccine that targets a disease like MS that, while debilitating, remains relatively rare.

Eliminating Epstein-Barr would require vaccinating all healthy children even though their risk of developing cancer or multiple sclerosis is small, said Dr. Ralph Horwitz, a professor at the Lewis Katz School of Medicine at Temple University.

Before exposing children to the potential risks of a new vaccine, he said, scientists need to answer basic questions about MS. For example, why does a virus that affects nearly everyone cause disease in a small fraction? And what roles do stress and other environmental conditions play in that equation?

The answer appears to be that Epstein-Barr is “necessary but not sufficient” to cause disease, said immunologist Bruce Bebo, executive vice president for research at the National MS Society, adding that the virus “may be the first in a string of dominoes.”

‘We Could Save a Lot of Lives’

Hotez said researchers could continue to probe the mysteries surrounding Epstein-Barr and MS even as the vaccine efforts proceed. Further study is required to understand which populations might benefit most from a vaccine, and once more is known, Hotez said, such a vaccine possibly could be used in patients found to be at highest risk, such as organ transplant recipients, rather than administered universally to all young people.

“Now that we know that Epstein-Barr is very tightly linked to MS, we could save a lot of lives if we develop the vaccine now,” Damania said, “rather than wait 10 years” until every question is answered.

Moderna and the National Institute of Allergy and Infectious Diseases launched separate clinical trials of Epstein-Barr vaccines over the past year. Epstein-Barr vaccines also are in early stages of testing at Opko Health, a Miami-based biotech company; Seattle’s Fred Hutchinson Cancer Center; and California’s City of Hope National Medical Center.

Scientists have sought to develop vaccines against Epstein-Barr for decades only to be thwarted by the complexities of the virus. Epstein-Barr “is a master of evading the immune system,” said Dr. Jessica Durkee-Shock, a clinical immunologist and principal investigator for NIAID’s trial.

Both MS and the cancers linked to Epstein-Barr develop many years after people are infected. So a trial designed to learn whether a vaccine can prevent these diseases would take decades and a lot of money.

Moderna researchers initially are focusing on a goal more easily measured: the prevention of mononucleosis, which doubles the risk of multiple sclerosis. Mono develops only a month or so after people are infected with Epstein-Barr, so scientists won’t have to wait as long for results.

Mono can be incredibly disruptive on its own, keeping students out of class and military recruits out of training for weeks. In about 10% of cases, the crippling fatigue lasts six months or more. In 1% of cases, patients develop complications, including hepatitis and neurological problems.

For now, the clinical trials for Epstein-Barr immunizations are enrolling only adults. “In the future, the perfect vaccine would be given to a small child,” Durkee-Shock said. “And it would protect them their whole life, and prevent them from getting mono or any other complication from the Epstein-Barr virus.”

The NIAID vaccine, being tested for safety in 40 volunteers, is built around ferritin, an iron-storage protein that can be manipulated to display a key viral protein to the immune system. Like a cartoon Transformer, the ferritin nanoparticle self-assembles into what looks like a “little iron soccer ball,” Durkee-Shock said. “This approach, in which many copies of the EBV protein are displayed on a single particle, has proved successful for other vaccines, including the HPV and hepatitis B vaccine.”

Moderna’s experimental vaccine, being tested in about 270 people, works more like the company’s covid shot. Both deliver snippets of a virus’s genetic information in molecules called mRNA inside a lipid nanoparticle, or tiny bubble of fat. Moderna, which has dozens of mRNA vaccines in development, hopes to learn from each and apply those lessons to Epstein-Barr, said Sumana Chandramouli, senior director and research program leader for infectious diseases at Moderna.

“What the covid vaccine has shown us is that the mRNA technology is well tolerated, very safe, and highly efficacious,” Chandramouli said.

But mRNA vaccines have limitations.

Although they have saved millions of lives during the covid pandemic, the antibody levels generated in response to the mRNA vaccines wane after a few months. It’s possible this rapid loss of antibodies is related specifically to the coronavirus and its rapidly evolving new strains, Hotez said. But if waning immunity is inherent in the mRNA technology, that could seriously limit future vaccines.

Designing vaccines against Epstein-Barr is also more complicated than for covid. The Epstein-Barr virus and other herpesviruses are comparatively huge, four to five times as large as SARS-CoV-2, the coronavirus that causes covid. And while the coronavirus uses just one protein to infect human cells, the Epstein-Barr virus uses many, four of which are included in the Moderna vaccine.

Earlier experimental Epstein-Barr vaccines targeting one viral protein lowered the rate of infectious mononucleosis but failed to prevent viral infection. Targeting multiple viral proteins may be more effective at preventing infection, said Damania, the UNC virologist.

“If you close one door, the other door is still open,” Damania said. “You have to block infection in all cell types to have a successful vaccine that prevents future infections.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Covid’s New Wave: Get Another Booster Shot or Wait?

By Sam Whitehead and Arthur Allen, Kaiser Health News

Gwyneth Paige didn’t want to get vaccinated against covid-19 at first. With her health issues — hypertension, fibromyalgia, asthma — she wanted to see how other people fared after the shots. Then her mother got colon cancer.

“At that point, I didn’t care if the vaccine killed me,” she said. “To be with my mother throughout her journey, I had to have the vaccination.”

Paige, who is 56 and lives in Detroit, has received three doses. That leaves her one booster short of federal health recommendations.

Like Paige, who said she doesn’t currently plan to get another booster, some Americans seem comfortable with the protection of three shots. But others may wonder what to do: Boost again now with one of the original vaccines, or wait months for promised new formulations tailored to the latest, highly contagious omicron subvariants, BA.4 and BA.5?

The rapidly mutating virus has created a conundrum for the public and a communications challenge for health officials.

“What we’re seeing now is a little bit of an information void that is not helping people make the right decision,” said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University School of Medicine.

Del Rio said the public isn’t hearing enough about the vaccines’ value in preventing severe disease, even if they don’t stop all infections. Each new covid variant also forces health officials to tweak their messaging, del Rio said, which can add to public mistrust.

About 70% of Americans age 50 and older who got a first booster shot — and nearly as many of those 65 and older — haven’t received their second covid booster dose, according to data from the Centers for Disease Control and Prevention. The agency currently recommends two booster shots after a primary vaccine series for adults 50 and older and for younger people with compromised immune systems. Last week, multiple news outlets reported that the Biden administration was working on a plan to allow all adults to get second covid boosters.

Officials are worried about the surge of BA.4 and BA.5, which spread easily and can escape immune protection from vaccination or prior infection. A recent study published in Nature found BA.5 was four times as resistant to the currently available mRNA vaccines as earlier omicron subvariants.

Mixed Messages

Consistent messaging has been complicated by the different views of leading vaccine scientists. Although physicians like del Rio and Dr. Peter Hotez of Baylor College of Medicine see the value in getting a second booster, Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, is skeptical it’s needed by anyone but seniors and people who are immunocompromised.

“When experts have different views based on the same science, why are we surprised that getting the message right is confusing?” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation and Offit’s colleague on the FDA panel.

Janet Perrin, 70, of Houston hasn’t gotten her second booster for scheduling and convenience reasons and said she’ll look for information about a variant-targeted dose from sources she trusts on social media. “I haven’t found a consistent guiding voice from the CDC,” she said, and the agency’s statements sound like “a political word salad.”

On July 12, the Biden administration released its plan to manage the BA.5 subvariant, which it warned would have the greatest impact in the parts of the country with lower vaccine coverage. The strategy includes making it easier for people to access testing, vaccines and boosters, and covid antiviral treatments.

During the first White House covid briefing in nearly three weeks, the message from top federal health officials was clear: Don’t wait for an omicron-tailored shot. “There are many people who are at high risk right now, and waiting until October, November for their boost — when in fact their risk is in the moment — is not a good plan,” said Dr. Rochelle Walensky, head of the CDC.

With worries about the BA.5 subvariant growing, the FDA on June 30 recommended that drugmakers Pfizer-BioNTech and Moderna get to work producing a new, bivalent vaccine that combines the current version with a formulation that targets the new strains.

The companies both say they can make available for the U.S. millions of doses of the reformulated shots in October. Experts think that deadline could slip by a few months given the unexpected hitches that plague vaccine manufacturing.

“I think that we have all been asking that same question,” said Dr. Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program. “What’s the benefit of getting another booster now when what will be coming out in the fall is a bivalent vaccine and you will be getting BA.4/5, which is currently circulating?”

“There are many people who are at high risk right now, and waiting until October, November for their boost — when in fact their risk is in the moment — is not a good plan. ”

— Dr. Rochelle Walensky, CDC.Director

The FDA on July 13 authorized a fourth covid vaccine, made by Novavax, but only for people who haven’t been vaccinated yet. Many scientists thought the Novavax shot could be an effective booster for people previously vaccinated with mRNA shots from Pfizer-BioNTech and Moderna because its unique design could broaden the immune response to coronaviruses. Unfortunately, few studies have assessed mix-and-match vaccination approaches, said Gellin, of the Rockefeller Foundation.

Edwards and her husband got covid in January. She received a second booster last month, but only because she thought it might be required for a Canadian business trip. Otherwise, she said, she felt a fourth shot was kind of a waste, though not particularly risky. She told her husband — a healthy septuagenarian — to wait for the BA.4/5 version.

People at very high risk for covid complications might want to go ahead and get a fourth dose, Edwards said, with the hope that it will temporarily prevent severe disease “while you wait for BA.4/5.”

The omicron vaccines will contain components that target the original strain of the virus because the first vaccine formulations are known to prevent serious illness and death even in people infected with omicron.

Those components will also help keep the earlier strains of the virus in check, said Dr. David Brett-Major, an infectious disease specialist at the University of Nebraska Medical Center. That’s important, he said, because too much tailoring of vaccines to fight emerging variants could allow older strains of the coronavirus to resurface.

Brett-Major said messages about the value of the tailored shots will need to come from trusted, local sources — not just top federal health officials.

“Access happens locally,” he said. “If your local systems are not messaging and promoting and enabling access, it’s really problematic.”

Although some Americans are pondering when, or whether, to get their second boosters, many people tuned out the pandemic long ago, putting them at risk during the current wave, experts said.

Dr. Georges Benjamin, executive director of the American Public Health Association, said he doesn’t expect to see the public’s level of interest in the vaccine change much even as new boosters are released and eligibility expands. Parts of the country with high vaccine coverage will remain relatively insulated from new variants that emerge, he said, while regions with low vaccine acceptance could be set for a “rude awakening.”

Even scientists are at a bit of a loss for how to effectively adapt to an ever-changing virus.

“Nothing is simple with covid, is it? It’s just whack-a-mole,” said Edwards. “This morning I read about a new variant in India. Maybe it’ll be a nothingburger, but — who knows? — maybe something big, and then we’ll wonder, ‘Why did we change the vaccine strain to BA.4/5?’”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

HIPAA-critical Vaccine Exemptions

By Mia Maysack, PNN Columnist

A friend recently invited me to a concert that demanded proof of full vaccination against covid or at least a medical exemption from getting one. 

I want to make it clear that I'm not an "anti-vaxxer." But I personally do not feel that I can tell another person what to do with their own body. I exist as a chronically ill person due to circumstances that were entirely out of my control as a child. Through the years, managing these ailments has been daunting, and mainstream treatment options inflicted even more complications that I still live with to this day. 

For credibility’s sake, you should know that I received an average of 30 injections every three months for about 15 years as a method for pain control. The last time I went in, my world was flipped upside down by such a bad reaction to the shots that I haven't returned for that treatment or any other mainstream approaches to medicine.  

Although I'm aware it could've been an allergic reaction (they've been producing cheap medication overseas), I have no reason to expect such a thing won’t occur again. The words “rare” and “unlikely” don’t mean much when bacterial meningitis threatened my young life through an untreated ear infection. That wasn’t a foreseeable circumstance either. So the fact remains: no one can be sure what they are getting. Due to how difficult it has been to survive in this body up to now, I'm not content on taking any more unnecessary risks. 

I requested and was denied a vaccine exemption, the desire for which did not stem from any place of entitlement, but because I cannot gamble with my quality of life. The fact that I'm expected to is an illustration of the deeply rooted problems within our healthcare system and proves that, despite what they claim, it is not operating from a place of patient-centeredness.  

I don't find contentment with the reassurance that few adverse reactions have been reported from covid vaccines, because I personally know people who have experienced them and there simply hasn't been enough time passed for anyone to even begin to know what things could happen down the line. 

I was told that an exemption isn’t something my clinic can do, not even for religious reasons, because they consider it a “personal choice.” The only way to have it granted is to literally attempt an injection and experience adverse effects. But that’s something I’ve already – and barely -- lived through. 

Suffice to say, this is not a one-size-fits-all situation. They encourage everyone to get vaccinated, but why does that encouragement feel more like I’m being forced? I know what's best for my body and if/when I do take the jab, it’ll be on my terms and not because I was bullied into it. 

The job of medical professionals is to honor and be a partner in care. I know this because I was once one of them, but had to step off my beloved hospital floor for good after a setback in my health. Back then, under the Health Insurance Portability and Accountability Act (HIPAA), we could’ve lost our jobs for peeking into our own medical charts. Yet now we’re suddenly expected to carry personal health information on us at all times and surrender it to everyone who demands it.  How is that not a HIPAA violation? 

Regardless of your stance on the science, it’s undeniable that this conduct is questionable at best. Why are we continuing to allow it? The intention here is not to shame anyone for their choices, but to draw attention to our freedom of choice essentially being eliminated. 

There are many different forms of “justice” but our systems have been designed in ways that evade them, along with any responsibility for their lack of equity.  It’s undoubtedly a hindrance, not only for patients, but our constitutional rights. If this is how our institutions are operating, we should be holding them to public accountability.  

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

Pharmacies Turning Away Patients Seeking 4th Covid Shot

By Liz Szabo, Kaiser Health News

Patients with weakened immune systems — who are at high risk from covid-19 — say pharmacies are turning them away when they seek additional vaccine doses recommended by federal health officials.

Alyson Smith became eligible this month for a fourth vaccine dose because her medications leave her immunocompromised.

Although the Centers for Disease Control and Prevention encourages most adults to receive a total of three mRNA vaccines — two “primary” vaccinations and a booster — the agency now advises people with weak immune systems to receive three primary shots plus a booster, for a total of four doses.

Many people are confused about the difference between a primary vaccine series and a booster. A primary vaccine series helps people build antibodies to a new pathogen, while a booster combats waning immunity.

As Smith learned, many pharmacists are unaware that the CDC’s vaccine guidance has changed.

Smith booked her vaccine appointment online. But when she showed up at a Chicago-area Walgreens for the appointment Jan. 19, an employee told her the pharmacy chain wasn’t administering fourth doses to anyone.

Smith said she’s frustrated that vulnerable people are being forced to make multiple visits to crowded pharmacies and supermarkets, where many customers are unmasked.

“I feel for the pharmacists, because they’re overwhelmed like everyone else,” said Smith, 52. “But two years into the pandemic, there is a corporate responsibility to take action when the guidance comes down.”

In a written statement, Walgreens said it has administered thousands of fourth doses to immunocompromised people. “As vaccination guidelines continue to evolve, we make every effort to continuously update our pharmacy teams.”

(Update: In a conference call on January 26, the CDC told pharmacists that people with moderate to severe immune suppression are eligible for a 4th covid shot. About 7 million Americans can get the extra shot.)

Confusing Vaccine Guidance

The confusion stems from recent updates in vaccine advice for immunocompromised people, as well as a change in the interval between the end of a primary vaccine series and a booster.

• In August, the CDC began allowing immunocompromised people to receive a third dose of mRNA vaccine as part of their primary vaccination.

• In October, the CDC quietly updated its website to allow people with suppressed immune systems to receive a fourth shot as a booster.

• In January, the agency shortened the time that anyone must wait for a booster from six months to five.

People who received the one-dose Johnson & Johnson vaccine are eligible for a single booster, for a total of two shots, according to the CDC.

Given how often vaccine guidelines have been revised in recent months, some pharmacists have had a hard time keeping pace, said Mitchel Rothholz, chief of governance and state affiliates at the American Pharmacists Association. Pharmacy employees have coped with an ever-expanding workload but a deepening shortage of employees during the pandemic, he said.

“I don’t know any provider who wants to turn away a patient,” Rothholz said. “The CDC continues to make updates, and it’s becoming very difficult for providers at the grassroots level to keep up. I can understand why a pharmacist would say, ‘Corporate hasn’t given us the green light.’”

Confusion about who is eligible for a fourth shot “was inevitable, although I’m not saying it’s right or wrong,” he said.

Yet many patients and their doctors are frustrated.

If patients keep up with the latest guidelines, they ask, why can’t their pharmacy?

“It’s ridiculous,” said Dr. Dorry Segev, a transplant surgeon and researcher at Johns Hopkins University. “CDC makes it very clear that it’s allowed, and even people who print out the CDC guidance and take it to their pharmacies are being turned away.”

Charis Hill, 34, joined a chorus of immune-suppressed people venting their concerns on social media in recent days. When Hill tweeted Jan. 21 that Rite Aid should better educate its staff, the retailer tweeted back that day, saying, “We’re very sorry you didn’t have a great experience, Charis. Please check back with us early next month for more information regarding the fourth dose.”

In a written statement, Rite Aid said it continually educates its staff as CDC advice changes, and “is looking into the response that was provided to the customer on social media.”

Dr. Shikha Jain, an assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said patients in rural areas often drive long distances to look for vaccines. One of her patients was “almost in tears” after being turned away. Jain tried to help by calling the pharmacy but was on hold so long that she had to hang up to see patients.

Jain said the CDC needs to do a better job educating doctors, pharmacists, and patients.

The CDC did not respond to a request for comment before publication.

Teresa Strahlman, 61, said she’s immunocompromised due to medications she takes for lupus, an autoimmune disease. But the Maryland woman said she didn’t realize she was eligible for a fourth dose until reading a KHN post on Facebook. “I had no idea, and I have a million doctors,” Strahlman said. “No one has said anything to me.”

The CDC estimates that 2.7% of adults — or 7 million people — are immunocompromised, a group that includes people with medical conditions that dampen their immune response, as well as those taking immune-suppressing drugs because of organ transplants, cancer, or autoimmune diseases.

Some immunocompromised people say that being turned away from a pharmacy is especially frustrating, given all that they have sacrificed during the pandemic.

Linda Rushing, 74, has given up attending church services in person, although she’s deeply religious, because of a weakened immune system that leaves her prone to a variety of infections.

Rushing made three visits to local pharmacies before finding someone to administer her fourth shot.

“It’s a tragedy to need help and not be able to get it,” said Rushing, of Rowlett, Texas, whose daughter and granddaughter are also immunocompromised. “I don’t want covid. I don’t want to give it to anybody, and I’m trying to do everything I can not to die from it.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

Surprise Discovery Could Lead to Vaccine for Rheumatoid Arthritis

By Pat Anson, Editor

A surprise discovery at a university laboratory could lead to a vaccine that can prevent rheumatoid arthritis, a chronic and incurable disease in which the body’s own immune system attacks joint tissues.

Researchers at The University of Toledo years were studying a protein called 14-3-3 zeta and its role in immune system pathologies. Previous studies have suggested the protein could be a possible trigger for rheumatoid arthritis (RA) and other autoimmune conditions that cause pain, inflammation and bone erosion.

But researchers found just the opposite. The team discovered that 14-3-3 zeta proteins may actually help prevent arthritis. When they removed the proteins through gene-editing technology, it caused severe early onset arthritis in laboratory animals.

Realizing that the proteins may be beneficial, the team developed an experimental vaccine using purified 14-3-3 zeta protein grown in a bacterial cell. They found the vaccine promoted a strong, immediate and long-lasting response in rodents that protected them from RA.

"Much to our happy surprise, the rheumatoid arthritis totally disappeared in animals that received a vaccine," said Ritu Chakravarti, PhD, an assistant professor at UToledo College of Medicine and lead author of research published in the journal Proceedings of the National Academy of Sciences. "Sometimes there is no better way than serendipity. We happened to hit a wrong result, but it turned out to be the best result. Those kinds of scientific discoveries are very important in this field."

In addition to suppressing the immune system response, the vaccine also significantly improved collagen content and bone quality — findings that suggests there could be long-term benefits following immunization.

Currently, rheumatoid arthritis is treated with steroids or medications that suppress the immune system, such as biologics and biosimilar drugs. While those therapies can alleviate pain and reduce inflammation, they can also make patients more vulnerable to infection and, in the case of biologics, are expensive. Biologic drugs can cost $25,000 a year.

“We have not made any really big discoveries toward treating or preventing rheumatoid arthritis in many years,” Chakravarti said. “Our approach is completely different. This is a vaccine-based strategy based on a novel target that we hope can treat or prevent rheumatoid arthritis. The potential here is huge.”

RA affects about 1.5 million Americans and about one percent of the global population. Women experience RA at a rate three times greater than men, have more severe symptoms and increased disability.

“In spite of its high prevalence, there is no cure and we don’t entirely know what brings it on. This is true of nearly all autoimmune diseases, which makes treating or preventing them so difficult,” said Chakravarti. “If we can successfully get this vaccine into the clinic, it would be revolutionary.”

Chakravarti and her colleagues have filed for a patent on their discovery and are seeking pharmaceutical industry partners to fund more research and preclinical trials.

COVID Vaccine Anxiety: What If You Are Immunocompromised?

By Cynthia Toussaint, PNN Columnist

In the midst of our once-in-a-century pandemic, it’s my deep belief that we all have a responsibility to get the COVID vaccine in hopes of extracting ourselves and each other from this crisis. We’re in this together, and if we do our part, we’ll get out of these dire straits faster and with fewer deaths.

That being said, there’s no doubt that getting a full dose is a rockier, less certain road for those of us who are immunocompromised, whether by current treatment (organ transplant, chemotherapy, etc.), wrangling with years of severe chronic illness, or both.

It disturbs and angers me that we were left out of the vaccine trials, but we can’t fight or fix that familiar marginalization now. We also can’t use that as an excuse to sit on the sidelines.

Courage remains our best ally.

Before my first vaccine, I was facing surgery for cancer and was frantic to get dosed as older folk at my swimming hole were already going mask-less. I couldn’t afford to be left behind because my upcoming treatment was dangerous and I was labeled “highest risk” for severe COVID – this due to being immunocompromised from four decades of high-impact pain and five months of chemotherapy.

With that first poke, I was relieved to initially go relatively unscathed, side-effect wise, with only a headache and “COVID arm.” But that arm soon went to hell. For four days I couldn’t move it without shrieking. I imagined this would be the feeling of a bullet piercing my skin, something I’ve heard from other immunocompromised sisters. More bizarre, after my COVID arm eased, it returned a week later with the damp weather.

When my second vaccine date approached, I was anxious, feeling like a guinea pig because even healthy people were getting pretty darn sick with this bookend dose. It spooked me to see the fear in the eyes of my 40-year partner and caregiver after he got his. John rarely gets sick, but his two-day bout with crippling fatigue reduced him to someone struggling to take care of himself, let alone being there fulltime for me.

But I persisted.

Just after receiving that dose, I posted my concern on Facebook, and someone was kind enough to share a National Public Radio article about immunocompromised people and the vaccine. The article supported my firm belief that everyone needs to be vaccinated, while pointing out that as a result of not being part of the study group, its efficacy was not entirely known.

Additionally, researchers urged us to work with our doctors to time treatment with the vaccine for safety and effectiveness – as immune deficiency can compromise potency. I was troubled that my doctor hadn’t weighed these considerations when urging me to get the vaccine pronto.

I had one bone to pick with the article. It mentioned that enough immunocompromised folk had been vaccinated to gain assurance that it would not ignite a flare, stating that side-effects often resembled auto-immune symptoms. I was dubious as most everyone I know with pain had flared significantly.

Still, I’d made my decision. I threw caution to the wind and gingerly decided that I’d respond like a healthy person. I was only going to be sick for a couple of days.

Side Effects From Second Dose

At first I was on track with just a few symptoms, including that familiar headache and low-grade COVID arm. But by the first night, I was quite ill. High fever, chills, fatigue and muscle aches. While those symptoms can be part of a bad reaction for a healthy person, my illness lasted longer than what would be expected. In fact, I was sick for almost a week.

And oddly, mid-week after my fever broke, I woke in the night super-hot, sweaty and chilled again. I suspect I was having a vaccine relapse, something I’ve not heard from others. It didn’t come as a surprise that my CRPS flared badly that week too.  

What threw me for a loop was having many of my long-gone, chemo side-effects return. I had severe spatial difficulties, causing me to run into walls and spill glasses of juice. More unpleasant reminders of those wretched days included distorted eyesight and hearing, a bladder infection, my heart beating too hard, neuropathy, anemia and painful joints and muscles. In fact, one day my hamstring (the original site of my CRPS injury) sprung out of place and I screamed bloody murder until it popped back, allowing me to move.

While those troubles have mostly resolved, my worst two chemo redux symptoms are hanging on a bit longer. Today, five weeks after that shot, I’m still having a hard time holding my back up straight without pain, something unsettling for this former ballerina who prides herself on proper posture.

Perhaps worse, my food tastes a bit like there’s chemo in it. I can get through meals without needing a barf bag, but recently gagged on my water for the first time, post-chemo. At times it’s difficult to touch my tongue to my teeth and to breathe in, due to the rancid taste. 

Despite it all, I’m on the mend and ecstatic that I’m fully vaccinated. It feels damn awesome to know that I made the best self-care decision and the best one for the world. When I get news of friends dying from COVID or see photos of people in the ICU, intubated and at the edge, this is a no brainer. The vaccine is far less dangerous than the virus, and everyone has to pull their weight.

Before rolling up your sleeve though, I advise that, if you are immunocompromised, be prepared to have a longer, more severe adverse reaction. Many of my sisters in pain did, and I had a much tougher road due to chemo. So, stock up your pantry, prep some meals, make accommodations for work and kids and be prepared to bunker down for a spell. Also, I think you’d be wise to have a discussion with your doctor to determine best timing to minimize suffering and optimize efficacy. 

Let’s keep this in mind. We, the mighty immunocompromised, are tougher than the rest. We’re independent, having learned through the most rugged of knocks how to care for ourselves. We also tend to think of others – as we know going it alone is a one-way ticket to malady.  As such, we know the importance of keeping our loved ones and communities healthy.

We can do this. The decision to get the vaccine is about being kind to ourselves and to each other. And in my book, that’s what life is only and all about.              

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has had Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for nearly four decades. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

Vaccines Help Some Covid Long Haulers

By Will Stone, Kaiser Health News

An estimated 10% to 30% of people who get covid-19 suffer from lingering symptoms of the disease, or what’s known as “long covid.”

Judy Dodd, who lives in New York City, is one of them. She spent nearly a year plagued by headaches, shortness of breath, extreme fatigue and problems with her sense of smell, among other symptoms.

Dodd worried that this “slog through life” was going to be her new normal. But everything changed after she got her covid vaccine.

“I was like a new person. It was the craziest thing ever,” said Dodd, referring to how many of her health problems subsided significantly after her second shot.

As the U.S. pushes to get people vaccinated, a curious benefit is emerging for those with this post-illness syndrome: Their symptoms are easing and, in some cases, fully resolving after vaccination.

It’s the latest clue in the immunological puzzle of long covid, a still poorly understood condition that leaves some who get infected with wide-ranging symptoms months after the initial illness.

The notion that a vaccine aimed at preventing the disease may also treat it has sparked optimism among patients, and scientists who study the post-illness syndrome are taking a close look at these stories.

“I didn’t expect the vaccine to make people feel better,” said Akiko Iwasaki, an immunologist at the Yale School of Medicine who’s researching long covid.

“More and more, I started hearing from people with long covid having their symptoms reduced or completely recovering, and that’s when I started to get excited because this might be a potential cure for some people.”

While promising, it’s still too early to know just how many people with long covid feel better as a result of being vaccinated and whether that amounts to a statistically meaningful difference.

In the meantime, Iwasaki and other researchers are beginning to incorporate this question into ongoing studies of long haulers by monitoring their symptoms pre- and post-vaccination and collecting blood samples to study their immune response.

There are several leading theories for why vaccines could alleviate the symptoms of long covid: It’s possible the vaccines clear up leftover virus or fragments, interrupt a damaging autoimmune response or in some other way “reset” the immune system.

“It’s all biologically plausible and, importantly, should be easy to test,” said Dr. Steven Deeks of the University of California-San Francisco, who is also studying the long-term impacts of the coronavirus on patients.

Patient Stories Offer Hope

Before getting the vaccine, Dodd, who’s in her early 50s, said she felt as if she had aged 20 years. She had trouble returning to work, and even simple tasks left her with a crushing headache and exhaustion.

“I’d climb the subway stairs and I’d have to stop at the top, take my mask off just to get air,” Dodd said.

After she got her first dose of the Pfizer vaccine in January, many of Dodd’s symptoms flared up, so much so that she almost didn’t get her second dose.

But she did — and a few days later, she noticed her energy was back, breathing was easier and soon even her problems with smell were resolving.

“It was like the sky had opened up. The sun was out,” she said. “It’s the closest I’ve felt to pre-covid.”

In the absence of large studies, researchers are culling what information they can from patient stories, informal surveys and clinicians’ experiences. For instance, about 40% of the 577 long-covid patients contacted by the group Survivor Corps said they felt better after getting vaccinated.

Among the patients of Dr. Daniel Griffin at Columbia University Medical Center in New York, “brain fog” and gastrointestinal problems are two of the most common symptoms that seem to resolve post-vaccination.

Griffin, who is running a long-term study of post-covid illness, initially estimated that about 30% to 40% of his patients felt better. Now, he believes the number may be higher, as more patients receive their second dose and see further improvements.

“We’ve been sort of chipping away at this [long covid] by treating each symptom,” he said. “If it’s really true that at least 40% of people have significant recovery with a therapeutic vaccination, then, to date, this is the most effective intervention we have for long covid.”

A small U.K. study, not yet peer-reviewed, found about 23% of long-covid patients had an “increase in symptom resolution” post-vaccination, compared with about 15% of those who were unvaccinated.

But not all clinicians are seeing the same level of improvement.

Clinicians at post-covid clinics at the University of Washington in Seattle, Oregon Health & Science University in Portland, National Jewish Health in Denver and the University of Pittsburgh Medical Center say only a small number of patients — or none at all — have reported feeling better after vaccination.

“I’ve heard anecdotes of people feeling worse, and you can scientifically come up with an explanation for it going in either direction,” said UCSF’s Deeks.

Why Are Patients Feeling Better?

There are several theories for why vaccines could help some patients — each relying on different physiological understandings of long covid, which manifests in a variety of ways.

“The clear story is that long covid isn’t just one issue,” said Dr. Eric Topol, director of the Scripps Research Translational Institute, which is also studying long covid and the possible therapeutic effects of vaccination.

Some people have fast resting heart rates and can’t tolerate exercise. Others suffer primarily from cognitive problems, or some combination of symptoms like exhaustion, trouble sleeping and issues with smell and taste, he said.

As a result, it’s likely that different therapies will work better for some versions of long covid than others, said Deeks.

One theory is that people who are infected never fully clear the coronavirus, and a viral “reservoir,” or fragments of the virus, persist in parts of the body and cause inflammation and long-term symptoms, said Iwasaki, the Yale immunologist.

According to that explanation, the vaccine might induce an immune response that gives the body extra firepower to beat back the residual infection.

“That would actually be the most straightforward way of getting rid of the disease, because you’re getting rid of the source of inflammation,” Iwasaki said.

Griffin at Columbia Medical Center said this “viral persistence” idea is supported by what he’s seeing in his patients and hearing from other researchers and clinicians. He said patients seem to be improving after receiving any of the covid vaccines, generally about “two weeks later, when it looks like they’re having what would be an effective, protective response.”

Another possible reason that some patients improve comes from the understanding of long covid as an autoimmune condition, in which the body’s immune cells end up damaging its own tissues.

A vaccine could hypothetically kick into gear the “innate immune system” and “dampen the symptoms,” but only temporarily, said Iwasaki, who has studied the role of harmful proteins, called autoantibodies, in covid.

This self-destructive immune response happens in a subset of covid patients while they are ill, and the autoantibodies produced can circulate for months later. But it’s not yet clear how that may contribute to long covid, said John Wherry, director of the Institute for Immunology at the University of Pennsylvania.

Another theory is that the infection has “miswired” the immune system in some other way and caused chronic inflammation, perhaps like chronic fatigue syndrome, Wherry said. In that scenario, the vaccination might somehow “reset” the immune system.

With more than 77 million people fully vaccinated in the U.S., teasing apart how many of those with long covid would have improved even without any intervention is difficult.

“Right now, we have anecdotes; we’d love it to be true. Let’s wait for some real data,” said Wherry.

This story is part of a partnership that includes NPR and Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues.

Don't Get Picky: All Three Covid Vaccines Highly Effective

By Arthur Allen and Liz Szabo, Kaiser Health News

When getting vaccinated against Covid-19, there’s no sense being picky. You should take the first authorized vaccine that’s offered, experts say.

The newest Covid vaccine on the horizon, from Johnson & Johnson, is probably a little less effective at preventing sickness than the two shots already being administered around the U.S., from Pfizer-BioNTech and Moderna.

The Food and Drug Administration authorized the Johnson & Johnson vaccine after reporting it showed about 66% effectiveness at preventing Covid illness in a 45,000-person trial. No one who received the vaccine was hospitalized with or died of the disease, according to the data released by the company and FDA. As many as 4 million doses could be shipped out of J&J’s warehouses beginning this week.

The J&J vaccine is similar to the shots from Moderna and Pfizer-BioNTech, but uses a different strategy for transporting genetic code into human cells to stimulate immunity to the disease. The Moderna and Pfizer-BioNTech vaccines were found in trials last fall to be 94% effective in preventing illness caused by Covid. They also prevented nearly all severe cases.

But the difference in those efficacy numbers may be deceptive. The vaccines were tested in different locations and at different phases of the pandemic. And J&J gave subjects in its trial only one dose of the vaccine, while Moderna and Pfizer have two-dose schedules, separated by 28 and 21 days, respectively. The bottom line, however, is that all three do a good job at preventing serious Covid.

“It’s a bit like, do you want a Lamborghini or a Chevy to get to work?” said Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group, who was a paid consultant in the J&J study. “Ultimately, I just need to get to work. If a Chevy is available, sign me up.”

“From a personal and public health perspective, the best advice for now is to get whatever you can as soon as you can get it, because the sooner we all get vaccinated the better off we all are,” said Dr. Norman Hearst, a family doctor and epidemiologist at the University of California-San Francisco.

Of the 10 people who got severe disease in the Pfizer trial, nine had received a placebo, or fake vaccine; none of the 30 severe cases in the Moderna trial occurred in people who got the true vaccine. A month after receiving the Johnson & Johnson shot there were no deaths or hospitalizations in those who had been vaccinated.

“The real goal is to keep people out of the hospital and the ICU and the morgue,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “This vaccine will do that well.”

J&J Vaccine Tested Against Variants

The data that Moderna and Pfizer-BioNTech presented to the FDA for their vaccines came from large clinical trials that took place over the summer and early fall in the United States. At the time, none of the new variants of Covid — some of which may be better at evading the immune responses produced by vaccines — were circulating here.

In contrast, the J&J trial began in September and was put into the arms of people in South America, South Africa and the United States. The J&J vaccine was 72% effective against moderate to severe Covid in the U.S. part of the trial, compared with 57% in South Africa, where a more contagious mutant virus is the dominant strain.

The Moderna and Pfizer-BioNTech vaccines might not have gotten the same sparkling results had they been tested more recently — or in South Africa.

“This vaccine was tested in the pandemic here and now,” said Dr. Dan Barouch, a Harvard Medical School professor whose lab at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston developed the J&J vaccine. “The pandemic is a much more complex pandemic than it was several months ago.”

The J&J vaccine appears to have some other advantages. First, it seems to cause fewer serious side effects like the fever and malaise suffered by some Pfizer-BioNTech and Moderna vaccine recipients. High fever and dehydration are particular concerns in fragile elderly people who “have one foot on the banana peel,” said Dr. Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program. The J&J vaccine “may be a better vaccine for the infirm.”

Many people may prefer the J&J shot because “it’s one and done.” It’s easier for administrators too: just one appointment to schedule.

The J&J vaccine can also be stored in regular refrigerators, while the Pfizer and Moderna vaccines have to be stored in freezers and must be used or discarded within six hours after the vial is opened. Vials of the J&J vaccine can be restored in a refrigerator for later use if doses remain.

“Right now we have mass immunization clinics that are open but have no vaccine,” said Offit. “Here you have a single-dose regime with easy storage and handling.”

Ultimately, a person’s address — not their personal preference — may determine which vaccine they receive, said E. John Wherry, director of the Institute for Immunology at the University of Pennsylvania’s Perelman School of Medicine. He pointed out that the Johnson & Johnson vaccine is a simpler choice for rural areas.

“A vaccine doesn’t have to be 95% effective to be an incredible leap forward,” said Wherry. “When we get to the point where we have choices about which vaccine to give, it will be a luxury to have to struggle with that question.”

Kaiser Health News is a nonprofit news service covering health issues. It is not affiliated with Kaiser Permanente.

Online Race for Vaccines Leaves Many Seniors Behind

By Will Stone, Kaiser Health News

With millions of older Americans eligible for covid-19 vaccines and limited supplies, many continue to describe a frantic and frustrating search to secure a shot, beset by uncertainty and difficulty. 

The efforts to vaccinate people 65 and older have strained under the enormous demand that has overwhelmed cumbersome, inconsistent scheduling systems.

The struggle represents a shift from the first wave of vaccinations — health care workers in health care settings — which went comparatively smoothly. Now, in most places, elderly people are pitted against one another, competing on an unstable technological playing field for limited shots.

“You can’t have the vaccine distribution be a race between elderly people typing and younger people typing,” said Jeremy Novich, a clinical psychologist in New York City who has begun a group to help people navigate the technology to get appointments. “That’s not a race. That’s just cruel.”

While the demand is an encouraging sign of public trust in the vaccines, the challenges facing seniors also speak to the country’s fragmented approach, which has left many confused and enlisting family members to hunt down appointments. 

“It’s just maddening,” said Bill Walsh, with AARP. “It should be a smooth pathway from signing up to getting the vaccine, and that’s just not what we’re seeing so far.” 

Glitchy websites, jammed phone lines and long lines outside clinics have become commonplace as states expand who’s eligible — sometimes triggering a mad dash for shots that can sound more like trying to score a ticket for a music festival than obtaining a lifesaving vaccine. 

“You can’t have the vaccine distribution be a race between elderly people typing and younger people typing. That’s not a race. That’s just cruel.”

— Jeremy Novich, Psychologist

After being inundated, some public health departments are trying to hire more staff members to handle their vaccination hotlines and specifically target seniors who may not be able to navigate a complicated online sign-up process.  

“Just posting a website and urging people to go there is not a recipe for success,” said Walsh. 

‘Terribly Competitive’ 

Like many other seniors, Colleen Brooks, 85, had trouble sorting through the myriad online resources about how to find the vaccine where she lives, on Vashon Island in the Puget Sound near Seattle.

“It was an overwhelming amount of information,” she said. “I knew it was here someplace, but it wasn’t easy to find out how to get it.”

After making calls, Brooks eventually got a tip from a friend who had spotted the vaccines being unloaded at their town pharmacy. When she dropped by her health clinic to inquire about how to sign up, it happened they were giving out shots that same day.  

“That was totally serendipitous for me, but I actually personally know several seniors who just kind of gave up,” said Brooks. 

Finding out how to get a vaccine appointment was more straightforward for Gerald Kahn, 76, who lives in Madison, Connecticut. 

Kahn got an email notice from the state’s vaccine registration system telling him to make an appointment, but he ran into problems at the very end of the sign-up process. 

“As much as I would pound my finger on the face of my iPad, it didn’t do me any good,” he said.

So Kahn did what many have and called a younger family member, who was able to help him finish signing up. 

“I think there are a lot of people my age, maybe the preponderance, who can only go so far into the internet, and then we’re not only stymied but also frustrated,” he said. 

When Helen Francke, 92, logged on for a vaccine at the designated time, she discovered the spots available in Washington, D.C., filled up almost instantaneously. 

“It was evident that I was much too slow,” she said. “It’s terribly competitive and clearly favors those with advanced computer skills.” 

The next week, Francke tried calling and going online — this time with the help of her neighbors — without success.

“If I had had to depend on the D.C. vaccination website and telephone, I’d still be anxious and unsuccessful,” said Francke, who got a shot only after finding information on a neighborhood discussion group that directed her to a hospital. 

In Arizona, Karen Davis, 80, ended up on a roundabout quest through state and hospital websites with no clear sense of how to actually book an appointment. 

“I kept trying to do it and kind of banged my head against the wall too many times,” she said. 

Davis, a retired nurse, called her doctor and the pharmacy and then eventually turned to a younger relative, who managed to book a 5 a.m. appointment at a mass vaccination site. 

“I’m sure they did not expect older people to be able to do this,” she said. 

Miguel Lerma, who lives in Phoenix, said his 69-year-old mother has been unsuccessful in finding a shot. 

“She’s not an English speaker and doesn’t know technology well, and that’s how everything is being done,” said Lerma, 31. 

Lerma said it’s especially painful to watch his mother struggle to get the vaccine — because he lost his father to covid last year. 

“She’s mourning not only for my dad, but she’s also suffering as an adult now because she depended on him for certain tasks,” Lerma said. “He would’ve handled all this.” 

‘Desperate’ Seniors Look for Help  

Philip Bretsky, a primary care doctor in Southern California, said his older patients would typically call him or visit a pharmacy for vaccines like the annual flu shot, rather than rely on novel online scheduling systems. 

“That’s not how 85-year-olds have interacted with the health care system, so it’s a complete disconnect,” he said. “These folks are basically just investing a lot of time and not getting anything out of it.” 

California’s recent decision to change its vaccination plan and open it up to those over 65 only adds to the confusion. 

Bretsky said his patients are being told to call their doctor for information, but he isn’t even sure when his office, which is authorized to give the vaccines, will receive any. 

“Patients in this age group want to know that they’re at least being heard or somebody is thinking about the challenges they have,” he said. 

There are some local efforts to make that happen.  

In the village of Los Lunas, New Mexico, public health workers held an in-person sign-up event for seniors who needed assistance or simply a device connected to the internet. 

A Florida senior center recently held a vaccination registration event and a clinic specifically for people over 80 who might not have a computer. 

Novich, the clinical psychologist in New York, teamed up with a few other people to create an informal help service for older adults. It began as a small endeavor, advertised through a few synagogues and his Facebook page. They’ve now helped more than 100 people get shots.  

“We have a huge number of requests that are just piling up,” said Novich. 

“People are really desperate and they’re also confused because nobody has actually explained to them when they are expected to get vaccinated. … It’s a big mess.” 

The ongoing shortage of vaccines has led Novich to halt the service for now. 

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

If I Have MS or an Autoimmune Condition, Should I Get the Covid Vaccine?

By Judith Graham, Kaiser Health News

As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses, including those with cancer, multiple sclerosis or autoimmune conditions.

Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.

Q: My 80-year-old mother has chronic lymphocytic leukemia. Should she get vaccinated?

First, some basics. Older adults, in general, have responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drug makers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.

But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.

Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19?

Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.

Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. “We are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.

The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.

In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception:  Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.

The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.”

Q: Should my 97-year-old mom, in a nursing home with dementia, get the covid vaccine?

The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.

The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.

Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine.

“Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said. “My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in.”

Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?

There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?

Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.

“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.

The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.

Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.

So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.

Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.

“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

What to Expect When COVID Vaccines Roll Out

By Judith Graham, Kaiser Health News

Vaccines that protect against COVID-19 are on the way. What should older adults and people with chronic illness expect? Will there be enough doses for everyone who wants to be vaccinated?

The first vaccine candidates, from Pfizer and Moderna, could arrive before Christmas, according to Alex Azar, who heads the Department of Health and Human Services.

Both vaccines are notably effective in preventing illness due to the coronavirus, according to information released by the companies, although much of the data from clinical trials is still to come. Both have been tested in adults age 65 and older, who mounted a strong immune response.

Seniors in nursing homes and assisted living centers will be among the first Americans vaccinated, following recommendations last week by a federal advisory panel. Older adults living at home will need to wait a while longer.

Many uncertainties remain. Among them: What side effects can older adults anticipate and how often will these occur? Will the vaccines offer meaningful protection to seniors who are frail or have multiple chronic illnesses?

Here’s a look at what’s known, what’s not and what lies ahead.

Timetable for Vaccines

Pfizer’s vaccine will be evaluated by a 15-member Food and Drug Administration advisory panel on Thursday. Moderna’s vaccine is expected to go before the panel Dec. 17.

At least two days before each meeting, an analysis by FDA staff will be made public. This will be the first opportunity to see extensive data about the vaccines’ performance in large phase 3 clinical trials, including more details about their impact on older adults.

So far, summary results disclosed in news releases indicate that Pfizer’s vaccine, produced in partnership with BioNTech, has an overall efficacy rate of 95% and efficacy of 94% in people 65 and older. Moderna’s overall efficacy is 94%, with 87% efficacy in preventing moderate disease in older adults, according to Moncef Slaoui, chief science adviser to Operation Warp Speed, the government’s COVID-19 vaccine development program.

If the advisory panel gives a green light, the FDA will decide within days or weeks whether to authorize the Pfizer and Moderna vaccines for emergency use. Distribution of the vaccine has already begun, and health care providers are expected to begin administering it immediately after the FDA acts.

Who Gets Vaccinated First?

At a Dec. 1 meeting of the Advisory Commission on Immunization Practices (ACIP), which guides the Centers for Disease Control and Prevention on vaccines, experts recommended that people living in long-term care (primarily nursing homes and assisted living facilities) and health care workers be the first groups to get COVID-19 vaccines.

This recognizes the extraordinary burden of COVID-19 in long-term care facilities. Although their residents represent fewer than 1% of the U.S. population, they account for 40% of COVID deaths — more than 100,000 deaths to date.

The commission’s decision comes despite a lack of evidence that Pfizer’s and Moderna’s vaccines are effective and safe for frail, vulnerable seniors in long-term care. Vaccines were not tested in this population. Federal officials insist side effects will be carefully monitored.

Next in line likely would be essential workers who cannot work from home, such as police, firefighters, teachers and people employed in food processing and transportation, according to commission deliberations Nov. 23 that have not come to a formal vote.

Then would be adults with high-risk medical conditions such as diabetes, cancer, kidney disease, obesity, heart disease and autoimmune diseases and all adults age 65 and older.

Although states typically follow ACIP guidelines, some states may choose, for instance, to vaccinate high-risk older adults before some categories of essential workers.

Left off the list are family caregivers, who provide essential support to vulnerable older adults living in the community — an unpaid workforce of tens of millions of people. “If someone is providing day-to-day care, it makes sense they should have access to the vaccine, too, to keep everyone safe,” said Beth Kallmyer, vice president of care and support for the Alzheimer’s Association.

Priority Groups

The priority groups constitute nearly half of the U.S. population — 21 million health care workers, 3 million long-term care residents, 66 million essential workers, more than 100 million adults with high-risk conditions and 53 million adults age 65 and older.

With initial supplies of vaccines limited, setting priorities will be inevitable. Practically, this means that hospitals and physicians may try to identify older adults who are at the highest risk of becoming seriously ill from COVID-19 and offer them vaccines before other seniors.

A study of more than 500,000 Medicare beneficiaries age 65 and older provides new evidence that could influence these assessments. It found the conditions that most increase older adults’ chances of dying from COVID-19 are sickle cell disease, chronic kidney disease, leukemias and lymphomas, heart failure, diabetes, cerebral palsy, obesity, lung cancer and heart attacks, in that order.

“Out of all Medicare beneficiaries, we identified just under 2,500 who had no medical problems and died of COVID-19,” said Dr. Martin Makary, co-author of the study and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We knew risk was skewed toward comorbidity [multiple underlying medical conditions], but we didn’t realize it skewed this much.”

Supplies Available

Both the Pfizer and Moderna vaccines require two doses, administered three to four weeks apart. The companies have said about 40 million doses of their vaccines should be available this year, enough to fully vaccinate about 20 million people.

After that, 50 million doses might become available in January, followed by 60 million doses in both February and March, according to Dr. Larry Corey, a virologist who heads the COVID-19 Prevention Trials Network.

That translates into enough vaccine for another 85 million people and should be sufficient to vaccinate older adults in addition to medical personnel on the front lines and many other at-risk individuals, Corey suggested at a recent panel on COVID-19 sponsored by the National Academy of Medicine and American Public Health Association.

He acknowledged these were estimates, based on information he has been given. Pfizer and Moderna have not yet specified how much vaccine will be delivered and when. Nor is it clear when other vaccines under investigation will become available — 13 are in phase 3 clinical trials — or what their monthly production capacity might be.

Distribution Issues

As Pfizer’s and Moderna’s vaccines are rolled out, a very vulnerable group may have difficulty getting them: 2 million seniors who are homebound and another 5.3 million with physical impairments who have problems getting around.

The reason: handling and cold storage requirements.

Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius, calling for special equipment not available in small hospitals, clinics or doctors’ offices. Moderna’s vaccine needs long-term storage at minus 20 degrees Celsius.

Landmark Health provides in-home medical care to more than 120,000 frail, chronically ill homebound seniors in 15 states. “We don’t have the capabilities to store and distribute these vaccines to our population,” said Dr. Michael Le, the company’s co-founder and chief medical officer.

Instead, he said, Landmark is working to arrange transportation for its patients to centers where COVID-19 vaccines will be administered and educating them about the benefits of the vaccines. “Given the trust, the bond we have with our patients, we can play a big role as advocates,” Le said.

Addressing Mistrust

Advocates have a big job ahead of them. According to a recent poll from the University of Michigan, only 58% of older adults (ages 50 to 80) said they were very or somewhat likely to get a COVID-19 vaccine. A significant number of older adults, 46%, thought they’d get the vaccine eventually but wanted others to go first. Only 20% wanted to get it as soon as possible.

Most important in making decisions is knowing how well the vaccine works, according to 80% of the 1,556 older adults surveyed. Just over half (52%) said a recommendation from their doctor would be influential.

Dr. Sharon Inouye, a geriatrician at Hebrew Senior Life in Boston and a professor of medicine at Harvard Medical School, is among the physicians impatiently awaiting the publication of data from Pfizer’s and Moderna’s phase 3 clinical trials.

Among the things she wants to know: How many older adults with chronic health conditions participated? How many participants were 75 and older? Did side effects differ for older adults?

“What I worry about most is the side effects,” she said. “We may not be able to know about serious but rare side effects until millions of people take them.”

But that’s a gamble she’s willing to take. Not only will Inouye get a vaccine, she just told her 91-year-old mother, who lives in assisted living, to say “yes” when one is offered.

“My whole family lives in fear that something will happen to her every day,” Inouye said. “Even though there’s a lot we still don’t know about these vaccines, it’s compelling that we protect people from this overwhelming illness.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

COVID-19 Vaccines May Be Risky for People with Chronic Illness

By Roger Chriss, PNN Columnist

Covid-19 vaccine researchers reported good news this week. Pfizer and Moderna both announced encouraging efficacy data and will soon submit applications to the Food and Drug Administration for emergency use authorizations.

Moderna reported that its vaccine was 94.5% effective in a Phase 3 trial of more than 30,000 participants. Similarly, Pfizer’s vaccine had an efficacy rate of over 90 percent, with only 94 confirmed cases of COVID-19 in a study that included over 43,000 volunteers.

Both of these vaccines are based on mRNA technology, a genetic approach to vaccines that directs protein production throughout the body. AstraZeneca took a more conventional approach with its vaccine and just reported promising Phase 2 trial results.

There are of course important questions to sort out, including long-term efficacy and safety. This latter point is particularly important for people with chronic illness.

The vaccine trials have been run with volunteers, who may be more health conscious and healthier than the population at large, and people with specific disorders are excluded. As a result, safety issues for people in treatment for active cancer, people with autoimmune diseases, and people with rare genetic disorders are unclear.

“We also don't know for sure whether this vaccine is safe and effective in different types of people, such as pregnant women, the elderly, or those with a chronic illness,” MedicalXpress reported. “Once a vaccine is deployed ‘in the real world,’ we'll start to understand its true effectiveness. In practice, this is likely to be different to its efficacy in highly controlled clinical trials.”

Specific disorders sometimes require avoiding certain vaccines. The CDC maintains a comprehensive list of vaccine contraindications and precautions, including a recommendation that live virus vaccines “should not be administered to severely immunocompromised persons.”

The CDC cautions that anyone with a “weakened immune system, or has a parent, brother, or sister with a history of hereditary or congenital immune system problems” should talk to their doctor before being vaccinated. People who have had any other vaccines in the past 4 weeks should also consult with a provider first.  

The American Cancer Society recommends against live vaccines for patients getting chemotherapy or radiation treatment.

“In general, anyone with a weak immune system should not get any vaccines that contain live virus. There are a few vaccines that contain live viruses, which can sometimes cause infections in people with weak immune systems that can become life-threatening,” the Society warns.

Autoimmune disorders are also complex. The Hospital for Special Surgery warns that live vaccines “are not recommended for lupus patients, due to the increased risk of infection from the vaccine.”

Most vaccines are very safe for most people. But vaccine safety presents a big question for a small group of people with specific risk factors like cancer or chronic illness. At this point there is simply no safety data on COVID-19 vaccines in such people. Hopefully there will soon be clear answers.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

6 Reasons to Participate in Clinical Trials

By Dr. Lynn Webster, PNN Columnist

The COVID-19 pandemic has left many people feeling helpless -- yet you can help defeat the virus. You may not be a medical researcher, but you can still be part of developing a vaccine. There are three COVID-19 late-phase vaccine trials currently underway in the United States, and they will involve more than 100,000 individuals. 

All stages of research  require volunteer subjects. Early-phase trials require healthy volunteers, who may not directly benefit from a vaccine or medication but participate for other reasons. The current COVID-19 vaccine trials, for example, involve people who do not have the infection. Some will receive the new vaccine and others will get a placebo.

Only after volunteers are exposed to the virus can scientists determine if the vaccine is safe and effective when compared to a placebo. If a participant becomes ill because of exposure during the trial, the sponsor of the study generally pays for their medical expenses.

Not all clinical trials involve a placebo, but most do. Later-phase trials may offer benefits to the volunteers who have the disease or condition that the drug targets.

There are various ways to get involved in a trial. You may be invited to join one of these trials. Your physician may be part of network of providers participating in a study. If so, they can offer you an opportunity for enrollment. Or, if you are looking for a specific treatment, you can go online to find a study that may be of interest to you.

Here are six reasons to consider participating in a clinical trial:

1) Clinical trials provide safer and more effective therapies

Without clinical trials, development of new and more effective treatments would not be possible. Medical advances depend upon people who are willing to participate in trials. Every drug, from vaccines to pain treatments, approved by the FDA has been studied in clinical trials.

2) Clinical trials provide you with free access to a new treatment

When I started to treat people in pain, I conducted clinical trials to provide my patients with cutting-edge technology that was not yet publicly available. I wanted my patients to have access to the best and newest therapies in the pipeline.

Of course, there was no guarantee that the experimental therapies would be effective. However, the treatments were free to participants in the trial. If the risks were perceived as acceptable, it could be worth it for patients to take the chance.

3) Clinical trials can save your life

Late-phase clinical trials, such as the three currently underway for COVID-19, may provide immunization that could save the life of the participant. Through other clinical trials, we have provided lifesaving therapies to subjects who otherwise could not have obtained them because they couldn’t afford the treatments, or the treatments simply were not available to consumers.

4) Clinical trials can save a loved one’s life

Clinical trials provide researchers with more knowledge and potential therapeutic options. Participating in vaccine trials can lead to the approval of a treatment. This could save the life of a family member who may one day need a vaccination or drug treatment.

5) Clinical trials are regulated by FDA

Clinical trials are highly regulated and generally regarded as safe. Most clinical trials sponsored by industry are required to have their protocols reviewed and accepted by the U.S. Food and Drug Administration, which assesses the safety of every trial. The agency will not allow a company to begin a trial that has not been fully vetted by several FDA departments.

In addition, all protocols must be submitted to an institutional review board (IRB) for approval. This is an independent body charged by the FDA to evaluate and monitor trials. The IRBs and principal investigators contract with the FDA to follow guidance from the Federal Office for Human Research Protections. Both IRBs and principal investigators can be criminally charged if they fail to adequately monitor and accurately report results of a trial.

When the FDA grants permission to fast-track a particular therapy because of an emergency situation, protocols may be loosened. The potential benefits, in that case, have been determined to outweigh the risks. We have to hope that the accelerated approval process for a COVID-19 vaccine will not cause adverse events.

Prior to enrolling in a trial, participants are provided with an informed consent form that describes the trial in layman's terms and explicitly states all of the potential risks. Participation in clinical trials is always voluntary, and a person can withdraw from a trial at any time.

6) Clinical trials may compensate participants

Some trials compensate participants for their time and travel. This occurs more often in early-phase trials for which there is no clear clinical benefit to the individuals. Most trials requiring participants to stay overnight in a research facility compensate volunteers. Participants' compensation depends on the amount of time the testing takes and the types of tests that are performed.

Compensation must be reasonable, yet not excessive. Compensation ranges from $50 or less for a simple saliva sample to $10,000 or more for studies that require staying in a facility for 30 days or so. 

You can learn more about clinical trials at the National Institutes of Health website or by visiting the Clinical Trials website. The National Institute of Allergy and Infectious Diseases also has a website to connect volunteers to coronavirus vaccine trials. And COVID Dash has a portal where people can volunteer for dozens of coronavirus studies around the world.

One clinical trial may create the breakthrough that helps us get the pandemic under control. But that can only happen if enough people from a variety of demographics are willing to volunteer to be a part of the effort.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD.