Vaccines to protect all

 

By Sally Greenberg, NCL Executive Director
With co-author Marla Dalton, Executive Director and CEO, National Foundation for Infectious Diseases

COVID-19 has had profound implications on individual health and well-being and the U.S. healthcare system at-large. During the pandemic, we have seen routine vaccination rates decline significantly across all populations, putting individuals at risk of contracting vaccine-preventable diseases. The pandemic has also brought significant public attention to vaccines and now, perhaps more than ever before, many see the value of life-saving vaccines as one of the most effective public health prevention tools available to keep us safe and help end the pandemic.

The National Foundation for Infectious Diseases (NFID) and the National Consumers League (NCL) are committed to educating people about how to live healthier, safer lives. NFID is focused on educating the public and healthcare professionals about the burden, causes, prevention, diagnosis, and treatment of infectious diseases across the lifespan, and the mission of NCL is to protect and promote social and economic justice for consumers and workers in the United States and abroad.

NFID's Marla receiving her vaccine

NFID’s Marla Dalton receiving her flu vaccine.

Both organizations recognize the tremendous benefits that vaccination provides for both individuals and entire communities. While fall and winter raise the need for annual vaccination against influenza (flu), and the current pandemic has led to the need for COVID-19 vaccines and boosters, we must not overlook the importance of routine vaccines that may have been missed during the pandemic. Vaccines are for people of all ages and there are specific vaccines recommended for children, adolescents, adults, and older adults 65+ to protect against serious and potentially deadly diseases.

NCL and nearly 150 other partner organizations are proud to participate in the NFID Keep Up The Rates campaign, to share messages to encourage all individuals to receive recommended vaccines that may have been delayed during the pandemic. Since the campaign launched in 2020, Keep Up The Rates has engaged national experts and leading public health organizations to reach populations most at risk of delaying vaccinations or experiencing complications from vaccine-preventable diseases.

Sally Greenberg getting vaccinated.

Keep Up The Rates recently released resources to educate healthcare professionals and consumers about vaccine coadministration—receiving multiple vaccines at the same time. When you bring your car in for an oil change, a good mechanic takes care of other routine maintenance to make sure your car runs safely. Protecting your health is not much different, so when you receive a COVID-19 vaccine or a flu vaccine, we encourage you to make sure that you are protected against other serious but preventable diseases. A new PSA and infographics are available to help share that messaging with all relevant audiences.

The COVID-19 pandemic has demonstrated that protecting public health is more important than ever. Just as we must always protect the rights of consumers and workers, we must also encourage measures that promote better health and a safe environment for all.

NCL supports the Helping Adults Protect Immunity (HAPI) Act

September 30, 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org, (412) 945-3242

Washington, DC—The National Consumers League (NCL) is pleased to support the Helping Adults Protect Immunity (HAPI) Act (HR 2170), introduced by Representative Darren Soto (D-FL) in the House and by Senator Sherrod Brown (D-OH) in the Senate. The bill would expand access to immunizations for adults by eliminating cost-sharing for vaccines recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).

“Throughout its rich history, NCL has advocated for increased access to vaccines as life-saving medical interventions. The HAPI Act is common sense legislation that would help to eliminate out-of-pocket costs for all vaccines recommended by the ACIP,” said NCL Director of Health Policy Jeanette Contreras. This legislation would apply to crucial immunizations such as Shingles and tetanus, diphtheria, and pertussis vaccines, along with future vaccines.

NCL is grateful for the important role of the ACIP to make recommendations using evidence-based research methods, examining the harm-benefit ratio, and understanding the values of the affected populations. Currently, all ACIP and CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicare Part B, and ACA Medicaid Expansion. Unfortunately, traditional Medicaid beneficiaries must often pay varying out-of-pocket costs for recommended vaccines depending on the state.

More than 50,000 adults in the United States die annually from vaccine preventable deaths. The HAPI Act would help to lower that number significantly by providing more vaccine access to Medicaid beneficiaries, our most vulnerable low-income populations. “No one should be unable to obtain a vaccine due to cost barriers. We can ensure that all Americans are protected against preventable diseases regardless of their state of residence or their ability to pay,” said Contreras.

NCL urges Congress to pass the HAPI Act to ensure Medicaid beneficiaries across the country have  equitable access to recommended vaccines across lifespan.

About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
Intern Spencer Cramer

Redesigning our communities to fight health disparities

Intern Spencer CramerBy Spencer Cramer, NCL Health Policy Intern

Spencer is a student at Brandeis University, where he is studying Politics and Health: Science, Society & Policy.

The COVID-19 pandemic has fostered a better understanding of how a public health emergency can devastate different groups of Americans already negatively impacted by health problems. These health disparities, which are differences in health outcomes based on factors such as race, ethnicity, or socioeconomic status, are deeply influenced by “social determinants of health.” Social determinants of health are factors in our environments and societies that have a large impact on someone’s health status, independent of their personal choices or lifestyle.

These social factors are the main contributors to health disparities, which represent one of the ugliest faces of inequality in America today. An example of how social determinants of health and health disparities are inextricably linked can be seen in the maternal mortality crisis, where Black women are more than three times more likely to experience a pregnancy-related death than white women. This disparity can be attributed to institutional racism, lack of access to maternal health services, and the aggregate stress of dealing with discrimination on a daily basis.

Even more illuminating, one of the best predictors of health outcomes is a person’s zip code. In many major U.S. cities, the gap in life expectancy between the highest and lowest zip codes is 20+ years. Similar gaps can be seen between different cities and states. Additionally, it is clear that locations with predominantly low-income populations and many people from racial or ethnic minority groups generally experience worse health outcomes than wealthier, white areas. Geographic location is an excellent predictor of health status for a couple of reasons. Our society still has a tremendous amount of segregation, as people of the same race, ethnicity, and socioeconomic background tend to live near each other. This means that the health inequities facing these groups become disproportionately concentrated in certain neighborhoods.

Another reason for these geographic health disparities is how under-resourced the physical neighborhoods are. Poorer and heavily minority neighborhoods are less likely to have parks, green spaces, quality grocers, and health services, and they are more likely to be afflicted by environmental pollution and other societal abuses. Urban planning has a huge impact on public health. Ensuring that we build our cities to equitably distribute public services and amenities will be a critical strategy in addressing social determinants of health and eliminating health disparities.

One way to create healthier communities for all would be to increase the amount and quality of green spaces like parks or urban forests. A large body of research suggests that urban green spaces provide a wide variety of health benefits to residents ranging from increased opportunities for exercise, cleaner air, and improved mental well-being. Urban trees are proven to be particularly important for removing pollutants and addressing other environmental risks, while improving many different health outcomes. Unfortunately, green spaces, parks, and urban trees are concentrated in whiter, richer, and healthier neighborhoods. Investing in parks and green urban spaces in disadvantaged communities can go a long way towards boosting health outcomes and increasing economic opportunities for those residents.

Perhaps nothing is more important for a community’s health than access to quality, nutritious, and affordable food. Unfortunately, millions of Americans live in food deserts, areas where there is little supply of nutritious, whole foods. Again, food deserts predominate poorer neighborhoods and racial and ethnic minority communities. Living in a food desert means that people cannot access healthy or substantial food at an affordable price, inadvertently resorting to more expensive, lower nutrition food from places like convenience stores. Poor diets driven by this lack of food access cause tons of health problems and are a key driver of health disparities. As a society we often associate diet with personal choice. However, people living in food deserts usually have no option other than to eat low-quality food, and subsequently suffer from the health consequences. Ensuring that all neighborhoods and communities can easily access healthy food at affordable prices will surely help to reduce disparities in areas such as obesity, diabetes, heart disease, and others. What we eat everyday has an astronomical impact on our health, so we must make equitable access to good food a priority when creating healthier communities.

Similarly, many of the same neighborhoods plagued by food deserts also suffer from a stunning lack of access to health and medical services. Many healthcare resources are concentrated in areas with higher insurance rates, especially places with high rates of private insurance, leaving neighborhoods with many uninsured or Medicaid-eligible residents without needed health providers. The health consequences caused by the uneven distribution of health services can be devastating and can result in the delay in crucial preventive health screenings. To address this, we can provide incentives, like additional funding or student loan forgiveness to health care providers who practice in underserved communities, and implement public policies to achieve an equitable geographic distribution of medical resources.

A final factor that leads to these health inequalities between zip codes is pollution. It is certainly no secret that environmental pollutants are often horribly damaging to human health. They can cause diseases ranging from asthma to cancer, and are devastating for any community that they afflict. And of course, pollution has a disparate impact on lower-income and predominately minority communities. Developers frequently choose to build factories and other waste-producing sites in these communities because their residents have fewer resources and less political and social capital to advocate against them. Nobody should be subjected to residing in the midst of toxins and waste.

This will require a massive shift to clean energy, responsible development, and safer waste disposal. We can create more health equity by eliminating the health costs brought upon poor and minority communities by pollutants. Designing our neighborhoods and cities with a focus on public health and health equity will help to close the gaps in health outcomes between different zip codes, and should be one of our top priorities as we battle health disparities and social inequities.

Diverse research for a diverse America: The value of equitable, real-world research

By Sally Greenberg, NCL Executive Director

While the COVID-19 pandemic has led to hardship for all Americans, it is clear that people of color have been disproportionately burdened. Across the health care continuum, addressing this disparity has become part of the broader conversation about the history of systemic racism and the underlying social determinants of health that negatively affect the mental, physical, and economic health of individuals and entire communities.

The pandemic has underscored persistent health disparities, and there is growing recognition that representation in research and clinical trials can have a profound impact on health outcomes. A lack of representation from racially and ethnically diverse groups in research and clinical trials have typically led to gaps in data, missing the opportunity to assess the full impact of various treatments and drugs across a range of populations. The collection and use of real-world research and data to inform the potential use, risks, and benefits of medical products and treatments can ultimately lead to better health outcomes, particularly for those who have been underrepresented in the past.

Existing efforts to improve inclusion

Efforts to expand diversity and representation in medical research are underway in Congress. Policymakers are encouraging the incorporation of Real World Evidence (RWE) in drug development through the recent Cures 2.0 draft legislation released by Reps. Diana Degette (D-CO-1) and Fred Upton (D-MI-6). While the status quo limits us from effectively reaching underserved populations, the proposed legislation would allow studies that include RWE for some drugs after they have been approved. At the heart of this issue is a growing appreciation that the same therapy can affect different populations in different ways, which is why Cures 2.0 supports collecting data that more accurately reflects the unique experiences and needs of patients across diverse populations.

Recognizing the potential for RWE in maternal health

The lack of representative research in the field of maternal health is undeniable, and its implications are staggering. The dismal state of maternal care in the United States reflects how our health care system has failed women of color, including by not adequately studying treatment options to prevent maternal morbidity and mortality. The need for RWE is clear when you consider the persistent disparities in health outcomes that plague minority communities.

Preterm birth and its disproportionate impact on women of color is a stark illustration of the need to make progress on representative research in maternal health. Preterm birth is the second-largest contributor to infant death in America today. Despite the tremendous physical, emotional, and financial toll that preterm birth continues to take on our country — disproportionately so on women and families of color — not enough therapeutic tools currently exist to prevent it.

Today, “17P,” the only FDA-approved treatment to help reduce the likelihood of spontaneous, recurrent preterm birth in the United States is at-risk of being withdrawn from the market in all its forms, including the branded product and five generic versions. Unfortunately there is conflicting evidence from two different clinical trials, one representative of a diverse U.S. population and another studied in a largely white population in Europe. It’s not a straightforward comparison. If 17P is withdrawn, the women most affected by preterm birth, predominantly women of color, would be left without an FDA-approved treatment option.

The FDA is considering the path forward, including additional data collection through leveraging RWE from past patient use. The success of the first (approval) trial for 17P in the impacted communities signals the importance of RWE. Continued access to 17P is, at its core, a matter of health equity. Black women must not yet again be left vulnerable to a system that historically has overlooked them.

Intern Spencer Cramer

Gun violence is a public health crisis—We must treat it like one

Intern Spencer CramerBy Spencer Cramer, NCL Health Policy Intern

Spencer is a student at Brandeis University, where he is studying Politics and Health: Science, Society & Policy.

Most Americans are all too familiar with our country’s gun violence epidemic. In a typical year, around 40,000 Americans are killed by a firearm, including deaths from homicides, suicides, and accidents. Gun related fatalities in other high-income countries pale in comparison to those of the U.S. Based on 2010 data from the Organization for Economic Co-operation and Development (OECD), Americans were over 10 times more likely to be killed by a gun than people in Australia, a country that once dealt with a similar gun violence problem. This crisis comes in the form of street crime, domestic violence, accidents involving children, and the mass shootings that seem to occur on a multi weekly basis.

Of particular concern has been the rise in gun violence during the COVID-19 pandemic. Last year, 2020, saw a 10 percent increase in gun deaths over the previous year, fueled primarily by a 25 percent rise in homicides and accidental gun deaths. Experts say the recent spike is due to the economic and social stresses of the pandemic, and the numbers are showing no signs of abating as we open back up post-COVID.

What can we do to address this terrible situation? Sadly, the typical debate pits stricter gun control measures against Second Amendment absolutists who believe any gun reform measure to be a threat to their freedom. But those absolutists have outsized power. According to a recent poll, approximately 2 in 3 Americans support stricter gun control measures, with certain policies like enhanced background checks gaining even higher support. Yet attention to the spike in gun violence perversely spikes sales of firearms.

For many years, thoughtful experts have argued that America’s gun violence problem must be viewed as a public health crisis. That approach allows researchers and policymakers to tackle the problem from multiple angles, like understanding why people commit violence, creating safer environments, and implementing common-sense gun violence prevention measures.

The first step to a public health effort should be far-ranging research on gun violence so we can have the proper knowledge to inform policy solutions. Unfortunately, until very recently the federal government was barred from researching gun violence. The Dickey Amendment has been attached to federal spending bills since 1996 and had banned the Centers for Disease Control and Prevention (CDC) from researching gun violence. For the first time, in 2018, the Dickey Amendment was reinterpreted, allowing research to be conducted as long as it does not specifically advocate for gun control policies. After this reinterpretation, Congress proceeded to provide $25 million in funding for gun violence research.

Unfortunately, this funding is a pittance compared with the scope of the crisis. For reference, the National Institutes of Health (NIH) provided $170 million in funding for back pain research in 2019. To meet the scale of the gun violence epidemic, we must dramatically increase funding for research so we can properly direct resources to fight the problem.

We often view gun violence as an issue of criminal justice that narrowly focuses on prosecuting homicides and gun crimes. Many policy solutions therefore involve traditional gun control methods: assault weapons bans, enhanced background checks, and stronger law enforcement tactics to target gun crimes. But by treating gun violence as a public health issue, researchers can undertake a wide-ranging holistic approach that accounts for the numerous societal factors that contribute to gun violence.

A public health approach to the gun violence epidemic—if done well—could be as successful as the campaigns to reduce smoking and automobile accidents. To combat cigarette smoking, we engaged in a multi-pronged strategy involving tobacco taxes, age restrictions, public awareness campaigns, and bans on smoking in many public spaces. These measures have resulted in the adult smoking rate to fall by nearly 70 percent since the 1960’s. Similarly, to deal with vehicular accidents and deaths, we instituted new safety measures in cars and on roads, improved licensing restrictions, enacted tough DUI laws, and better traffic enforcement. As a result of these solutions, deaths from car crashes have fallen dramatically over the last few decades.

Similarly, strategies to combat gun violence can include better mental health services, doctors consulting their patients on gun safety, better firearm safety training, or improved designs of guns that reduce the risk of accidents. It may also involve creating a safer society overall, where lower poverty rates and better economic prospects will naturally lead to less violence. Of course, better gun control policies are needed, but we should think of them as one important part of a larger public health strategy for fighting the gun violence epidemic.

Firearm deaths have shown no signs of letting up—in fact they are exploding. Gun violence has reached horrific levels in the U.S. and tragically destroys many lives. By recognizing this epidemic as a public health crisis, we can address the issue from many different societal perspectives. We need gun control, but we also need stronger mental healthcare, community interventions, poverty reduction, even safer firearms. Any successful public health effort must embrace an all-of-the-above approach. America’s campaigns against cigarettes and automobile deaths should serve as examples to lead our struggle against gun violence. By finally investing in robust research and multiple solutions for gun violence, we can start to eliminate the scourge of gun violence in our society.

NCL comments on pediatric COVID-19 vaccines before CDC’s Advisory Committee on Immunization Practices

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242

Washington, DC—Today, June 24, 2021, NCL Director of Health Policy Jeanette Contreras, submitted written testimony to the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices in support of pediatric COVID-19 vaccines. Her comments appear below.

José R. Romero, MD, FAAP, Chair
Advisory Committee on Immunization Practices
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mailstop A27
Atlanta, GA 30329-4027

RE: Docket No. CDC- 2021-0060; rescheduled from June 18; new docket no. CDC-2021-0034

Good afternoon. My name is Jeanette Contreras, and today I am representing the National Consumers League (NCL), which for over 120 years has championed the overwhelming safety and efficacy of vaccines and promoted vaccine education. Consumer access to these lifesaving medical interventions is critical. I am also speaking today as a mother of two boys, ages 8 and 9. I appreciate the opportunity to provide public comment before this advisory committee.

The U.S. has reached a tragic 600,000 deaths as a result of COVID-19. The virus continues to spread and mutate around the world. Sadly, 330 children and adolescents are among the 600,000 deaths. Although preexisting medical conditions clearly predispose children to severe disease, healthy children are also at risk for severe COVID-19 and multisystem inflammatory syndrome (MIS-C). Though MIS-C is a rare condition associated with COVID-19, Black and Hispanic children are disproportionately affected, making up 64% of the cases observed in children 1-14 years of age.

Though there is reason to be concerned about the increase in cases of myocarditis or pericarditis following the second shot of the Pfizer and Moderna vaccines, consumers should be reassured that the safety monitoring system, Vaccine Adverse Event Reporting System (VAERS), is working as intended. Federal health officials are investigating the rare cases of which the most common symptoms reported were chest pain, elevated cardiac enzymes, ST or T wave changes, dyspnea and abnormal echocardiography or imaging. We applaud the Centers for Disease Control and Prevention (CDC) for releasing clinical guidance to providers alerting them to consider myocarditis and pericarditis in adolescents or young adults with acute chest pain, shortness of breath, or palpitations. So far, 80 percent of patients reported have made a full recovery.

We commend the coordinated efforts of the U.S. Food and Drug Administration and CDC to monitor the safety and efficacy of the vaccine. The COVID-19 vaccine has been administered safely to over 150 million Americans, and we are on target to reach herd immunity by October, with at least 70% of Americans vaccinated. Given the remarkable evidence of safety and efficacy of the COVID-19 in adults, parents should be assured that the vaccine will keep their children safe.

Our children are vaccinated for measles, rubella, polio, diphtheria, typhoid, and other routine childhood vaccines that have for decades prevented deadly illnesses that historically killed millions of children. Today, thanks to vaccine adherence, these illnesses have virtually been eradicated and far rarer than COVID-19. Unfortunately, uptake for routine pediatric immunizations have declined during the pandemic. It is essential we ensure that children are up to date with their vaccines. We are excited that data show the COVID-19 vaccine can safely be co-administered along with routine pediatric vaccinations. As we consider future educational outreach campaigns to increase vaccine confidence, we should encourage families to seek recommended immunizations for their children along with the COVID-19 vaccine.

As states lift public health emergency protocols across the country, too many of our children remain unnecessarily unprotected. According to the American Academy of Pediatrics, as of June 10, over 4 million children have tested positive for COVID-19 since the onset of the pandemic. About 14,500 new child cases were reported last week. We are only beginning to understand the long-term health effects associated with COVID-19, which include extreme fatigue, rapid heart rate, memory loss, gastrointestinal problems and other symptoms that are lasting months after infection. There is a need to collect more data on the long-haul effects on children, and to provide assistance to families who are struggling to find care for their children. We urge the CDC to provide guidance to providers and patients on what to look for when treating children who were previously infected with COVID-19.

As I dropped my 8-year-old at camp yesterday, I was telling him how beginning July 1 we won’t need to wear masks. He asked me “is that because everybody will be vaccinated- except me?” My husband and I are vaccinated, but our family is still at risk of being infected by any of the emerging variants. And when school-aged children return to the classroom in the fall, we may face a spike in pediatric cases.

Through our education and outreach efforts, the National Consumers League will continue to support efforts to vaccinate the nation across lifespan. The absence of a COVID-19 vaccine for pediatric populations will lead to continued transmission and leave children at risk for infection. To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

Thank you to the Committee for your consideration of our views on this important public health issue.

Sincerely,

Jeanette Contreras, MPP
Director of Health Policy
National Consumers League

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

Maternal vaccines: Safe for mom and baby

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

In the last few weeks, I’ve noticed an old friend from high school, a mother of an infant, consistently posting anti-vaccine content to her social media. Her posts, which were initially mere reflections, have transformed into full-on conspiracy theories about the safety of the COVID-19 vaccines and cast doubts about to the speed of their approval.

At first, I bypassed these posts, not wanting to create tension with an old friend. However, as they became more inflammatory, I realized that she was essentially spreading falsehoods about vaccines. As a public health advocate, I decided to reach out and offer my perspective. I assured my friend that vaccines have gone through rigorous testing and approval by multiple regulatory bodies in order to be deemed safe for widespread use.

She argued that she went through her entire pregnancy without being vaccinated and that she felt mask-wearing and proper hygiene would offer sufficient protection, ending her thoughts with, “maybe I’m crazy, because I think with this big push, that maybe there’s something else in it that the public doesn’t know about.” While my friend may need more and better information to convince her of the benefits of getting vaccinated, it’s important to know what the science says about vaccine safety for expectant or new mothers.

Per the  Centers for Disease Control and Prevention (CDC) guidance, vaccines are an extremely safe and effective method of avoiding communicable diseases. Certain vaccines for pregnant people not only help the mother stay healthy, but the antibodies developed in response to the vaccine penetrate the placenta and offer protection to the unborn child as well. If you are pregnant or planning on becoming pregnant, the specific vaccines you should receive depend on your age, lifestyle, medical conditions, and other factors. You should consult your doctor for the most up to date information.

The CDC recommends that pregnant women receive two vaccines during the gestational period, the inactivated flu (injection) vaccine, and the tetanus, diphtheria, and pertussis or Tdap vaccine. Vaccines that are not recommended during pregnancy include the nasal influenza vaccine, the human papillomavirus (HPV), measles, mumps, and rubella (MMR), and Varicella (chickenpox) vaccines. Some travel vaccines, such as yellow fever, typhoid fever, and Japanese encephalitis are not recommended during pregnancy, but can be administered based on a health provider’s advice.

Vaccines also offer immense protections via lactation. With exception to live virus vaccines like smallpox and yellow fever, most vaccines provide safety to new moms and babies during pregnancy and postpartum via lactation. There is also evidence that breastfed babies respond better to routine pediatric immunizations than those on formula. The CDC has provided a chart of vaccines that are safe for use in lactation.

An even more convincing case for maternal vaccines are the protections offered against COVID-19.  Data  shows that pregnant people are more vulnerable to severe illness with COVID-19. COVID-19 complications during pregnancy include hospitalization, intensive care, or the use of a ventilator or special equipment to breathe, or illness that results in death. Additionally, pregnant people with COVID-19 are at increased risk of adverse pregnancy outcomes, such as preterm birth.

The CDC has found the COVID-19 vaccine to be safe for pregnant and lactating people. The CDC and Food and Drug Administration (FDA) have safety monitoring systems in place to gather data regarding adverse reactions to vaccines. Currently, neither the mRNA (Pfizer and Moderna) nor the viral vector (Johnson & Johnson) COVID-19 vaccines have demonstrated adverse outcomes and have been deemed safe for use in pregnant populations. While more data are needed to assess potential adverse reactions in pregnant individuals before or early in pregnancy, the agencies have vowed to closely monitor that information.

Expectant and new mothers are often faced with a host of difficult decisions about their own health and the health of their babies. Adding to the uncertainty brought on by COVID-19, it’s understandable that people are apprehensive. Through compassionate and non-judgmental conversations, we can help encourage vaccine confidence. Even though my friend seems adamant in her stance, I still see an opportunity to turn the tide. There are so many great resources to help address these concerns, like these ones by the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians. It’s up to everyday immunization advocates like you and me to quell concerns related to vaccine safety to ensure our friends and loved ones are safe.

June 10 testimony before FDA’s Vaccines and Related Biological Products Advisory Committee

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—Today, June 10, 2021, NCL’s Associate Director of Health Policy Nissa Shaffi, testified before the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, about the ongoing rollout of COVID-19 vaccines for pediatric populations. Her testimony appears below:

Arnold Monto, M.D., Acting Chair
Vaccines and Related Biological Products Advisory Committee
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993

RE: Docket No. FDA- 2021-N-0458; for Vaccines and Related Biological Products Advisory Committee

Good afternoon. My name is Nissa Shaffi, and I am representing the National Consumers League (NCL). I have no conflicts of interests regarding today’s remarks.

The National Consumers League was founded in 1899, by the renowned social reformer Florence Kelley. General Secretary Kelley’s support of vaccinations played a key part in mitigating a critical smallpox outbreak towards the end of the 19th century, and her stalwart advocacy for immunizations has informed NCL’s bedrock principles for vaccine education, confidence, and safety.

122 years later, we are honored to persist in our pursuit to advance vaccines as vital public health interventions, and we extend our gratitude to the Vaccines and Related Biological Products Advisory Committee for the opportunity to present comment during this public hearing session.

Emergency Use Authorization (EUA)

NCL appreciates that the FDA recognizes that Emergency Use Authorization is not intended to replace the rigor of full approval, and that randomized clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment.

The diligent review and public engagement that went into the EUA process for the COVID-19 vaccines currently available have helped our nation reach key milestones in immunizations.

As our adult populations have benefitted from these critical public health efforts, we are energized to extend that momentum towards our youngest citizens. Through our education and outreach of consumers, we support FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine via an EUA to help prevent the spread of the virus in pediatric populations.

Safety and Effectiveness

We have great trust in the FDA’s safety monitoring systems and call on the Agency to perform ongoing post-market surveillance to ensure the vaccine’s continued safety and efficacy.

As we’ve observed with recent vaccine safety concerns, consumers rely heavily on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine. We call on the FDA to continue to sustain its robust interagency collaboration as we endeavor to vaccinate the nation.

Pediatric Population Vaccine Uptake

Although children are at a lower risk of COVID-19 compared to adults, and tend to experience milder symptoms, pediatric populations now account for 22% of new COVID cases, compared to 3% last year. As with adults, children and adolescents with underlying chronic health conditions are at higher risk for COVID-19-related hospitalization and death.

The absence of a vaccine for pediatric populations will lead to continuing transmission that will consistently put children at risk for infection.

Furthermore, vaccine uptake for routine pediatric immunizations have declined dramatically during the pandemic. It is essential for public health officials, advocates, and parents to ensure that children are up to date with their vaccines, and that children eligible for the COVID-19 vaccine receive their shots. Data shows that the COVID-19 vaccine currently available for children ages 12-15 is safe and effective, and has been recommended to be co-administered along with routine pediatric vaccinations.

Health Disparities

While COVID-19 has impacted the entire country, it has largely devastated communities of color. Children of color, specifically Black and Hispanic youth, have been especially vulnerable. This has been even more apparent with the prevalence of Multisystem inflammatory syndrome in children, a rare but serious COVID-19-associated condition, that has been observed in children 1- 14 years of age, 64% of which were reported to be Black or Hispanic.

To achieve meaningful herd immunity, we will need to ensure that children have access to a safe and effective COVID-19 vaccine, and also consider the unique disparities that children of color experience in the face of the pandemic.

Thank you to the Committee for your consideration of our views on this important public health issue. 

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

AAPI Heritage Month: The ‘Model Minority Myth’ and its negative impact on health disparities

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

The month of May marks Asian American Pacific Islander (AAPI) Heritage Month, a time where we celebrate, honor, and reflect upon the vast contributions members of the AAPI community have made to our collective society. The AAPI community comprises more than 23 million individuals with origins from 20+ countries, who speak more than 200 languages or dialects, and it is the fastest growing subset of the population.

The AAPI community is one that harbors complex cultural and historical narratives, and varied generational traumas, such as colonialism, war, and the trials of immigration. The AAPI community’s resilience against these factors, while commendable, has contributed to the myth of the “Model Minority,” and has led to a host of social and health inequities. The model minority myth is one rooted in “positive” stereotypes. It is the assumption that deems AAPI individuals as docile, over-achieving, high-earning, and well-educated—denoting AAPI individuals as exemplars to other communities of color. While at face value these qualities are considered desirable, they tend to relegate an astoundingly diverse community to a monolith, resulting in a detrimental impact on their overall wellbeing.

Due to these unrealistic cultural standards, AAPI consumers face a host of internal and external barriers when interacting with the healthcare system, and are often deterred from seeking necessary care. According to a 2019 Substance Abuse and Mental Health Services Administration (SAMHSA) study, AAPIs have the lowest help-seeking rate for mental health services than any racial or ethnic group. Cultural identity, faith, stigma, and fear contribute to lower utilization of mental health services. Other systemic barriers such as disparities in access to culturally competent care also influence underutilization.

AAPIs are also the only racial or ethnic group for whom cancer is the leading cause of death. Despite facing a confluence of cancer risks, due to unique exposures and environmental factors, AAPIs are screened significantly less for cancers compared to other Americans. Because the model minority myth implies that AAPIs are “better off,” screening, public health, and cultural needs are often masked.

This is best demonstrated by the case of Susan Shinagawa, a leading Asian American breast cancer activist and cancer survivor, whose multiple attempts to obtain screening for a suspected lump in her breast was denied, due to the belief that “Asian women don’t get breast cancer.”

The pandemic has illuminated disparities experienced by AAPIs, such as being overrepresented among frontline healthcare workers, increasing risk of exposure to COVID-19. As a result, case fatality among AAPI healthcare workers is three times greater than their white counterparts. AAPIs also tend to live in multigenerational households, more than other minorities, where 29 percent of AAPI households consist of two or more generational families, further increasing risk of household transmission. Approximately 30 percent of AAPIs have limited English proficiency, augmenting overall barriers to care and government relief resources. This disparity has been especially cumbersome for AAPI consumers seeking telehealth, an integral part of our lives throughout the pandemic, where 50 percent of AAPIs with limited English proficiency were less likely to utilize telehealth than individuals with English proficiency.

One way to dispel the model minority myth and encourage greater health equity for AAPI consumers, is to disaggregate racial and ethnicity data in research studies. Disaggregation of data simply means breaking data into smaller, more precise segments. For example, recent United States census data reveal that AAPIs were less likely overall to live in poverty. However, when that data is disaggregated, it shows that Hmong, Bhutanese, and Burmese Americans experience higher incidence of poverty, in contrast to the greater AAPI community. Disaggregating data not only paints a more accurate picture regarding the different social and demographic characteristics that impact varied health statuses within the community, it influences proper allocation of community resources.

Disaggregation of data can only also happen when there is a prioritization of AAPI participants in research. The most illuminating example of this is highlighted by a 2019 study, which revealed that in the past 26 years, only 0.17 percent of the National Institute of Health’s (NIH) budget was allocated to research focused on the AAPI community. These gaps in funding have led to a paucity in data necessary for public health officials and policy makers to meaningfully address AAPI-specific health disparities. A lack of representation in research impacts how AAPI consumers seek, access, and utilize healthcare. It also impacts the greater community public health goals, impacting health equity for everyone.

Greater investments in culturally competent care, AAPI-focused research, and preventive services, such as screening and early intervention, can help improve overall health outcomes for AAPI consumers. The National Consumers League commends the Biden-Harris Administration’s efforts, such as the COVID-19 Hate Crimes Act and the establishment of a subcommittee on Structural Drivers of Health Inequity and Xenophobia, which aim to ensure the federal government’s response to COVID-19 mitigates anti-Asian xenophobia and bias. These measures are critical in addressing structural inequities experienced by the AAPI community, enhancing community health outcomes as a whole.

NCL supports the Protecting Seniors through Immunizations Act of 2021

Media contact: National Consumers League – Carol McKay, carolm@nclnet.org(412) 945-3242 or Taun Sterling, tauns@nclnet.org(202) 207-2832

Washington, DC—The National Consumers League (NCL) is delighted to support the Protecting Seniors through Immunizations Act of 2021 (H.R. 1978/S. 912), introduced by Senators Mazie Hirono (D-HI), Tim Scott (R-SC), Sheldon Whitehouse (D-RI), and Shelley Moore Capito (R-WV), and Representatives Ann Kuster (D-NH) and Larry Bucshon (R-IN). The bill would expand access to immunizations for seniors by eliminating cost sharing for vaccines covered under Medicare Part D.

The legislation would eliminate out-of-pocket costs for all vaccines recommended by Centers for Disease Control and Prevention (CDC) and covered under Medicare Part D. This would apply to crucial immunizations such as the Shingles and tetanus, diphtheria, and pertussis, or Tdap, vaccines, along with future vaccinations. Currently all CDC recommended vaccines are covered with no out-of-pocket costs under private insurance, Medicaid, and Medicare Part B. Unfortunately, Medicare beneficiaries must often pay out-of-pocket costs of up to $160 for vaccines covered under Part D.

“As healthcare costs continue to skyrocket, policymakers should support legislation that eliminates financial barriers for Medicare beneficiaries to get their CDC recommended vaccines,” said NCL Director of Health Policy Jeanette Contreras. “Research shows that higher cost-sharing means fewer seniors will elect to receive their vaccines. By eliminating out-of-pocket costs for immunizations, older Americans will be better protected from vaccine preventable illnesses.”

More than 50,000 American adults die from vaccine-preventable diseases every year. Among other provisions, this bill would increase education about vaccines for Medicare beneficiaries and would authorize a study to find ways to boost adult vaccination rates. These steps are important at a time when misinformation regarding vaccine safety is spreading rampantly throughout society. Improving access to and utilization of vaccinations will enhance overall health outcomes and help to address existing racial and socioeconomic health disparities.

“Vaccines are amongst the most effective public health measures at our disposal. Routine immunizations can prevent diseases that have the potential to cause severe disease and wreak havoc on our most vulnerable communities,” said Contreras. “We urge Congress to pass the Protecting Seniors Through Immunization Act, to ensure greater equity in access to vaccines, in turn protecting the most vulnerable members in society from unnecessary and easily preventable illness and death.”

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About the National Consumers League

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.