NCL testified before FDA committee meeting on Pfizer-BioNTech COVID-19 vaccine

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For immediate release: December 11, 2020

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) testified before the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) this week regarding the Pfizer-BioNTech COVID-19 Vaccine.

“As the nation’s oldest consumer advocacy organization, NCL has been encouraged by the honesty, transparency, and access afforded to the public during this critical time.” NCL commended the Food and Drug Administration, Centers for Disease Control and Prevention, and other public health entities for their commitment to fostering public trust throughout the COVID-19 vaccine development and approval process and thanked the committee for the opportunity to speak.

In its testimony, NCL noted that there has never been a more critical time for consumers to have confidence in the FDA.

Emergency Use Authorization (EUA):

The FDA has undergone scrutiny from the scientific community for prematurely issuing EUAs for COVID-19 therapeutics. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority and appreciates that the FDA recognizes that an EUA is not intended to replace long-term randomized clinical trials data associated with full FDA approval. We are encouraged by data reporting a consistent vaccine efficacy rate of 95 percent across age, gender, race, and ethnicity demographics and look forward to seeing more guidance around the vaccine, as the trial continues to collect safety and efficacy data.

Safety and Effectiveness:

NCL noted the public’s growing trust in the FDA’s rigorous vaccine approval process and called on the agency to perform ongoing post-market surveillance. Such surveillance performed in the United Kingdom found that the vaccine may be unsafe for individuals with severe allergies. Consumers will rely on ongoing guidance from public health agencies regarding any potential adverse events from the vaccine and expect that the FDA will be aware of these concerns.

Innovative Vaccine Delivery Systems:

Additionally, ensuring innovative vaccine delivery methods, such as including oral or nasal options, could address geographical access issues, diverse health needs, and increase uptake overall.

Diversity in Clinical Trials:

We applaud Pfizer’s efforts to ensure diversity in their COVID-19 vaccine clinical trials. NCL requests that the FDA continue to prioritize vaccine clinical trial data that reflects diversity, as people of color will need to have confidence in the vaccine’s efficacy. This will affect the overall uptake of the vaccine.

The development of a COVID-19 vaccine in such a short time frame is a huge scientific feat, made possible through robust collaboration between private and public entities. NCL will continue to support the FDA and CDC in efforts to release a COVID-19 vaccine safely and expeditiously.

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About the National Consumers League (NCL)

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.

NCL statement on vaccine for COVID-19

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For immediate release: November 12, 2020

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) welcomes the very hopeful news that a coronavirus vaccine with a reported efficacy rate of 90 percent may be approved and rolled out in the next few months. NCL has historically advocated for vaccines because they have overwhelming effectiveness and safety profiles, preventing billions of often debilitating and deadly diseases across the globe—from small pox to measles to polio. The clinical evidence on the coronavirus vaccine—developed by Pfizer Inc. and partner BioNTech SE—though incomplete at the moment, is very promising.

“We applaud the unprecedented cooperation by public and private entities, along with concerted coordination among scientists, doctors, and researchers that has gone into developing a vaccine to combat this terrible pandemic, which has killed over 237,000 Americans, struck 10 million people, and only shows signs of worsening over the winter months,” said NCL Executive Director Sally Greenberg. “As this vaccine moves closer to being cleared for widespread use and the safety data verified, we are grateful to the companies and government officials who urgently prioritized the development of an effective and safe vaccine to combat the scourge of COVID-19. We are also encouraged that other companies are in the later stages of reviewing their own COVID-19 vaccines, which use different technologies to fight the virus but hopefully will be effective and safe as well.”

The FDA will be reviewing the safety data in the next few weeks on the Pfizer vaccine and will then determine to whom the first doses will be directed. Pfizer has said the vaccine could become available before the end of the year and that the company can produce 50 million doses globally—equivalent to reaching 25 million people because two doses are required for maximum protection from the virus. The most vulnerable populations are likely to receive the first batch of vaccines.

NCL cautioned consumers that during this period, people should maintain all the safety practices for preventing spread of the virus—wearing masks and practicing social distancing and keeping social gatherings to a minimum.

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About the National Consumers League (NCL)

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.

Jeanette Contreras portrait

Low-income essential workers lack adequate COVID-19 testing

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By NCL Director of Health Policy Jeanette Contreras

As the United States enters the third wave of COVID-19, low-income and minority communities hit hardest by the virus continue to disproportionately lack access to testing. The pandemic is shining a spotlight on the underlying health disparities that have long persisted within these medically underserved communities. Racial and ethnic minorities experience more severe COVID-related illness requiring hospitalization and are at higher risk for death from COVID-19. This is due largely to the prevalence of chronic conditions such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease (COPD).

In addition, racial and ethnic minorities make up a significant portion of the low-wage essential workers on farms, in grocery stores and warehouses, and in truck shipping. The essential workforce is composed of  64 percent women and 41.2 percent people of color. This translates to a higher risk of exposure to the virus among minorities because their employment involves interacting with the general public or co-workers in an unsafe environment. According to an August 2020 report from the U.S. Department of Health and Human Services (HHS), Hispanic/Latino persons were the largest demographic living in counties identified as coronavirus hotspots (3.5 million persons), followed by Black/African American persons (2 million).

HHS released a comprehensive strategy to address the lack of access to COVID-19 testing in vulnerable communities, which included expanded testing at federally qualified health centers (FQHCs) and partnerships with retail pharmacies. However, the very social determinants of health that these communities face, such as lack of transportation, child care, and paid sick leave, create significant barriers to getting to a community health clinic or a drive-through testing site. Despite higher demand in minority communities, there are fewer testing sites available to them when compared to access in predominantly white, more affluent areas. Researchers of the COVID Tracking Project found that zip codes with white populations of 75 percent had significantly more testing sites per capita than zip codes that were 75 percent minority.

Though adequate testing is only one of the prongs in confronting the pandemic, followed by contact tracing and isolation, it provides critical data needed to provide resources in the communities hardest hit by this pandemic. The World Health Organization (WHO) recommends conducting around 10–30 tests per confirmed case as a general benchmark–less than 5 percent positivity rate suggests the pandemic is under control. The U.S. currently has a positivity rate of 6 percent, and many states are not testing at a rate needed to contain the spread. Further adding to the disproportionate burden, there is no federal guidance for routine testing of essential workers. To provide adequate testing in low-income and minority communities, we need to address the underlying social determinants of health that place them at greater risk.

CMS Proposed Rule Ignores Data & Bipartisan Support for the Value of Copay Assistance Programs

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By NCL Director of Health Policy Jeanette Contreras

Americans love getting a discount. As consumers, we like to shop to save without compromising the quality of the products we buy. But in healthcare, the stakes are higher at the checkout counter. Patients not only want a discount, they depend on it to afford necessary, sometimes lifesaving, medication to treat their health condition.

Despite what we know about the value and impact of copay assistance programs, a new policy from the Centers for Medicare & Medicaid Services (CMS) could put a barrier between these critical programs and the patients who need them most.

Manufacturer copay assistance programs include discounts, coupon cards, and vouchers which many of our friends, family members, and neighbors use to afford their prescriptions. Studies have shown that without these financial support systems, many patients couldn’t afford their medicines.

The CMS proposal, which has yet to be finalized, would require manufacturers to guarantee that this assistance goes directly to patients—and if manufacturers do not, they would be required to include the value of the copay assistance in Medicaid Best Price and Average Manufacturer Price (AMP) calculations. That would be fine but there’s a  problem.

CMS has a separate policy that was already finalized earlier this year: the Notice of Benefit and Payment Parameters (NBPP) Rule for 2021. In part, the NBPP allows health insurance companies and pharmacy benefit managers (PBMs) to use policies that stop copay assistance from counting towards a patient’s out-of-pocket burden—sometimes called copay accumulator adjustment programs.

NCL criticized HHS for permitting health plans to use these so-called copay accumulator adjustment programs.

“Removing this cost-sharing assistance will force those patients to pay thousands of dollars more in unexpected costs at the pharmacy. These new costs could push some to forego those medications, leading to worsened health outcomes. This could compromise medication adherence and will lead to increased health care costs over time.” – NCL Executive Director Sally Greenberg

Separate studies conducted by the Centers for Disease Control and Prevention (CDC) and IQVIA show that out-of-pocket costs can contribute substantially to reduced adherence or to patients not taking their medication altogether. This is counterproductive because if patients do not take their meds as directed, it means higher costs in other parts of the healthcare system stemming from increased hospitalizations, ER visits, and long-term health issues.

If the data doesn’t convince CMS, voters should. Weeks before the presidential election, we can clearly see widespread support for the value of copay assistance regardless of political affiliation. According to a new National Hemophilia Foundation national survey, more than 80 percent of registered voters believe the government should require copay assistance to be applied to patients’ out-of-pocket costs. Even lawmakers agree that CMS should stop this policy before it launches. A bipartisan group of 36 members of the U.S. House of Representatives sent a letter to CMS urging the agency to not finalize the “contentious line extension section or the Medicaid best price change as currently defined in the notice of proposed rulemaking.”

Clearly, copay assistance is critical to Americans. We hope CMS reevaluates the potentially harmful consequences of this new rule on patients and pulls back this counterproductive proposal.

NCL testified before FDA Vaccines and Related Biological Products Advisory Committee

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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) testified before the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (FDA). For over 120 years, NCL has advocated on behalf of consumers who depend on vaccines as lifesaving medical interventions. NCL extended its gratitude to the Vaccines and Related Biological Products Advisory Committee for all they do to protect public health and for the opportunity to speak before the Committee.

In its testimony, NCL highlighted the following priorities: the deployment of Emergency Use Authorizations; the safety and effectiveness of the vaccine; and the inclusion of diversity in clinical trials. These three concerns align directly with NCL’s efforts to enhance vaccine confidence and uptake, especially in the context of COVID-19.

Safety and Effectiveness:

NCL trusts that the FDA will release a vaccine only upon careful consideration of its safety and effectiveness. Post-market surveillance of the vaccine is imperative to determining the ongoing efficacy of the vaccine. Implementing the release of a vaccine on such a magnificent scale will involve precise coordination that traverses all levels of government and consumers will rely on public health agencies to communicate and respond to any potential adverse events regarding the COVID-19 vaccine.

Emergency Use Authorization (EUA):

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration. The FDA is entrusted with ensuring the safety, efficacy, and security of the treatments needed to treat and prevent the spread of the virus.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority, however, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs.

NCL appreciates that the FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a treatment. Through our education and outreach of consumers, we support the FDA in its efforts to develop a safe, effective, and expedited pathway towards a COVID-19 vaccine.

Diversity in Clinical Trials:

Finally, to mitigate the disproportionate disease burden experienced by people of color during the pandemic, NCL requests that clinical trials for the COVID-19 vaccine are inclusive and consist of diverse subjects. People of color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon will prove to be a challenge when encouraging vaccine uptake. Ensuring adequate representation in clinical trials would foster vaccine confidence across all demographics.

In closing, to stem the tide of deaths from these vaccine-preventable diseases, NCL submits these comments for review by the Committee to ensure that consumers are afforded with safe and effective vaccines to combat the pandemic.

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About the National Consumers League (NCL)

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.

Equitable allocation of a COVID-19 vaccine

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

As the world waits with bated breath for the release of a safe and effective COVID-19 vaccine, one concern that is paramount is the proper distribution of the vaccine. According to leaders of Operation Warp Speed (OWS)—a coordinated partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DoD)—detailed planning is ongoing to realize OWS’s lofty goal of delivering 300 million doses of a COVID-19 vaccine, with the initial doses available by January 2021.

Implementing a vaccine program of this magnitude is contingent upon precise coordination that traverses federal, state, local, tribal, and territorial governments. The prodigious task ahead is determining who would get the first initial doses of the vaccine upon release. The pandemic has further illustrated that communities most vulnerable to COVID-19 are often rife with systemic racism and socioeconomic factors conducive to higher infection rates. An initial limited supply of a vaccine will only intensify these inequities.

Multiple analyses conducted on the federal, state, and local levels confirm that people of color have experienced a disproportionate burden of COVID-19 cases and deaths. Hispanic or Latinx, and American Indian and Alaskan Native (AI/AN) communities have experienced three times the rate of infection, and Black communities two times the rate of infection, compared to White populations. The CDC warns that this imbalance in morbidity and mortality is begotten by deep-seated disparities that stem from generations of racism and unaddressed social determinants of health.

To mitigate these inequities, the National Academies of Science, Engineering, and Medicine (NASEM) have formed a committee to establish an overarching framework addressing key considerations for the equitable allocation of a COVID-19 vaccine, including at-risk communities, priority populations, geographic distribution, scalable measures, and vaccine hesitancy.

The framework proposes four phases of vaccine distribution and their corresponding priority populations, as follows:

[Source: NASEM]

The above proposal will inform CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendations in advance of a COVID-19 vaccine release; and it was developed through careful consideration of CDC’s Social Vulnerability Index (CDC SVI), and the apropos, COVID-19 Community Vulnerability Index (CCVI). To elucidate, these phases were designed with people of color in mind, as they experience heightened risk of exposure working in essential roles in society, and therefore succumb to higher rates of infection.

Another key component of the vaccine plan is addressing vaccine hesitancy. People of Color are significantly underrepresented in clinical trials and undertreated in medical settings. This phenomenon, compounded by a general mistrust of medical establishments by minorities, will prove to be a challenge when encouraging vaccine uptake. Community engagement will be essential in building trust among the vaccine hesitant and messaging should be delivered by community leaders, or healthcare providers that resemble the population they treat. Culturally competent care has proven to have favorable effects on health outcomes and it is critical in encouraging vaccine confidence.

Once a vaccine becomes available, health officials across the country will need to deploy resources and personnel to ensure access to the vaccine among our most vulnerable. As affirmed by U.S. Army Lt. Gen. Paul Ostrowski (OWS), “We have to be able to go beyond the pharmacies, the hospitals and so forth to get after nursing homes; to get after meatpacking facilities; to get after those that are sheltered [at home]. We have to get this out to all four corners of this nation.” Getting to a vaccine is a challenge in itself, but once its released, it’s all hands-on deck.

Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials

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Hispanic Heritage Month: Focus on the importance of participating in research through clinical trials
by Elena Rios, MD, MSPH, FACP
President & CEO, National Hispanic Medical Association

The COVID-19 pandemic has impacted the world and the United States with a double threat: decreasing health and function of many, especially older patients with underlying diseases (obesity, asthma, diabetes, hypertension, etc.) that decrease the body’s immune response to fight off the virus; and millions left jobless as businesses downsize or close. In the healthcare arena, scientists and physicians are learning about the disease and how to treat it: We now know to limit ventilators to avoid high air pressures that can hurt damaged lungs; to place infected patients on their stomachs to allow lungs to expand; to use dexamethasone to decrease inflammation; and to use new antiviral therapies like Remdesivir and monoclonal antibodies. While there is no vaccine to prevent COVID-19, vaccine developers, researchers, and manufacturers are expediting the development of one.

The National Institutes of Health (NIH) and several pharmaceutical companies are conducting research through clinical trials that have found potential vaccines to be safe. This summer they started to enroll people and closely follow them for any adverse effects. Historically, Hispanics, Blacks, and Native Americans have been underrepresented in clinical trial research for a variety of factors, chief among them, a distrust of research and the concept of fatalism (leaving life’s challenges in God’s hands). But it is crucially important to have diversity in clinical trials to have information on the vaccine impact for Hispanics, for example. I encourage all persons over the age of 18 to enroll in the important COVID-19 clinical trials — and recommend websites for two ongoing clinical trials: the CoronaVirusPreventionNetwork.org from the NIH and Moderna, and the CovidVaccineStudy1.com

from Pfizer Inc. Each site provides consumers with information on the locations and how to enroll.

The National Hispanic Medical Association (NHMA) was established in 1994 to represent trusted Hispanic physicians and to improve the health of Hispanics and underserved populations. Given that, by 2042, one out of four people living in our nation will be Latino, NHMA has joined as a partner to encourage the Latino community to join the NIH All of Us Research Program. In May 2018, the NIH opened national enrollment for the All of Us Research Program—a momentous effort to advance individualized prevention, treatment, and care for people of all backgrounds—in collaboration with NHMA and other national partners. People ages 18 and older who reside in the United States, regardless of health status, are eligible to enroll. The overall aim is to enroll 1 million or more volunteers and to oversample communities that have historically been underrepresented in research to make the program the largest, most diverse resource of its kind. Our participation will provide information on how to better develop health care prevention and treatment programs for generations to come.

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. By partnering with 1 million diverse people who share information about themselves over a 10-year period, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

Participants can access their own health information, including genetics information, summary data about the entire participant community, and information about studies and findings, that come from All of Us. Participants are asked to share different types of health and lifestyle information, through online surveys and electronic health records (EHRs), which will continue to be collected over the course of the program. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight, to ensure that the program gathers information fromall types of people. This program is especially focused on those who have been underrepresented in research, but not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research program will be a rich and open data resource for traditional academic researchers as well as citizen scientists—and everyone in between. To learn more about the program and how to join, please visit https://www.JoinAllofUs.org.

About NHMA

NHMA is a nonprofit association representing the interests of 50,000 Hispanic physicians with the mission to improve the health of Hispanics in the U.S. For more information, please visit www.NHMAmd.org

Jeanette Contreras portrait

FDA Emergency Use Authorizations and public trust for COVID-19 treatments

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By NCL Director of Health Policy Jeanette Contreras

There has never been a more critical time for consumers to have confidence in the Food and Drug Administration (FDA). The FDA is charged with ensuring the safety, efficacy, and security of the drugs, biologic products, and medical devices needed to treat and prevent the spread of COVID-19. The agency has undergone scrutiny from the scientific community for issuing Emergency Use Authorization (EUA) for COVID-19 treatments and diagnostics that appeared to be politically motivated.

On August 23, the FDA issued an EUA for the use of an investigational convalescent plasma to treat patients with COVID-19, touting it as yet another achievement in the Administration’s fight against the pandemic. After just two days of backlash from the scientific community, FDA Commissioner Dr. Stephen Hahn, took to Twitter to concede his mistake, admitting that the criticism was justified. Commissioner Hahn stated that the EUA is not the final FDA approval and that the agency would revoke authorization if needed. Criticism included former FDA Commissioners who stand by randomized clinical trial as the gold standard for evidence-based medicine.

This renowned round of criticism has come not long after the FDA provided EUA for hydroxychloroquine in March which it revoked in July after further review proved that it lacked efficacy.

The Federal Food, Drug, and Cosmetic Act provides the FDA Commissioner with the authority to issue EUAs for unapproved medical products or unapproved uses of medical products in response to a public health emergency, such as the current pandemic. An EUA can be revoked when new evidence emerges and the risk no longer outweighs the benefit of the unapproved use of a drug or product, yet the Trump Administration claimed that it was revoked due to political reasons.

Since February, when the Department of Health and Human Services (HHS) declared the pandemic a public health emergency, the FDA has exercised its authority to issue hundreds of EUAs for diagnostic tests, personal protective equipment, ventilators, and other medical devices to combat COVID-19. In August alone, the FDA revoked EUAs for over 100 diagnostic tests, including antibody and rapid tests. The FDA recognizes that EUA is not intended to replace randomized clinical trials and that clinical trials are critically important for the definitive demonstration of safety and efficacy of a drug, treatment, or product.

Throughout the pandemic, consumers have received conflicting information from the Administration on various COVID-19 treatments, testing products, and safety recommendations. After witnessing the media controversy over EUAs for hydroxychloroquine and convalescent plasma, we are concerned that consumers may believe that the FDA is hastily approving investigational tests and drugs for political gain. The FDA, now more than ever, needs to reestablish public trust as it proceeds to fast track the approval of a COVID-19 vaccine.

NCL leads advocates in urging FDA to protect patient access to critical therapy for preterm birth

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By Sally Greenberg, NCL Executive Director

The National Consumers League and 14 leading health organizations and individual providers have collaborated in sending a letter to the Food and Drug Administration (FDA) as the agency considers whether to withdraw the only FDA-approved therapy that reduces the risk of preterm birth in women with a history of preterm birth.

Why did we and our fellow advocates decide to send this letter in the midst of the COVID-19 pandemic? Several important reasons.

First, preventing preterm birth is always a vital cause—during or without a pandemic. The leading cause of infant death in the United States, premature birth has devastating effects on families and is very costly to our health care system. For babies who do survive, short and long-term complications can accompany preterm birth. For mothers, a history of spontaneous preterm birth is a leading risk factor for recurrent preterm birth, yet providers have only one therapeutic option – hydroxyprogesterone caproate or “17P,” in one branded and five generic forms – to prevent recurrent preterm birth for these at-risk mothers.

Taking away these options—especially in the midst of a pandemic—would be concerning for pregnant women who are at high-risk for preterm birth, including those that reduce their risk of being admitted to the hospital for early delivery.

Secondly, as recent events surrounding both COVID-19 and continued fundamental rights injustices have reminded us, a profound and systemic inequity exists in the United States where institutional racism contributes to health disparities—including preterm birth and infant mortality. COVID-19 has disproportionally impacted African American women, the same population that is most likely to experience preterm birth. The preterm birth rate among U.S. black women is 49 percent higher than the rate among all other women, according to the March of Dimes.

Thirdly, 17P is the only FDA-approved therapy that reduces the risk of preterm birth and has been used for nearly a decade. We are concerned that removing access to the only FDA-approved therapy may deepen maternal and infant health inequities that exist within the U.S.

It is also troubling that if providers cannot access FDA-approved forms of 17P, this may expose pregnant women to compounded medications, which have no labeling to provide guidance on administration, contraindications, or potential side effects.

Removing 17P products in the absence of suitable alternatives would leave patients and providers significantly disadvantaged in the fight against prematurity. While we recognize the FDA is encountering tremendous challenges in addressing the COVID-19 pandemic, it is important to underscore the public health need for continued access to approved treatment options, and we trust that the agency will consider the patient impact as they evaluate this issue.

To add your voice to the letter to FDA, urging the agency to preserve patient access to the only FDA-approved therapy to reduce the risk of preterm birth, you can sign on here.

Vaccine hesitancy and the unique challenge of COVID-19

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headshot of NCL Health Policy intern Talia

By NCL Health Policy intern Talia Zitner

Around the globe, researchers and scientists are racing to find a vaccine for the COVID-19 virus. Developing a safe, effective, and affordable vaccine is already a challenging feat, but vaccine hesitancy presents another unique challenge to scientists, government researchers, and community leaders.

“Vaccine hesitancy” refers to the reluctance or refusal to be vaccinated or have one’s children vaccinated against a disease, even if a vaccine is proven to be safe and effective. Vaccine hesitancy poses dangers to both the individual and their community, since exposure to a contagious disease puts the person at risk, and they are far more likely to spread the disease to others if they won’t get vaccinated. Ironically, these communities may be the most vulnerable to COVID-19, and a serious effort must be made to create a sense of comfort around the COVID-19 vaccine once it’s available to the public.

Not to be confused with the vaccine-hesitant, “anti-vaxxers” represent a movement of people who dispute the safety of vaccinations and challenge laws that mandate vaccinations. This is a more insidious movement funded by dubious sources (reportedly, one New York couple has donated millions of dollars to the movement) that deceptively politicize public health measures under the guise of protecting personal liberties.

Public health agencies are trying to get vaccination levels to 95 percent to guarantee herd immunity. Some concerns that are top of mind for consumers include knowing the timeframe for a vaccine, who will have access to it, what it will cost consumers, if anything, and how states will determine methods of enforcing vaccination. The possibility of a COVID-19 vaccine also begs the question of whether vaccination will be mandatory for public schools and government workers.

Perhaps one of the most important projects right now surrounding vaccine hesitancy is the Vaccine Confidence Project (VCP), which is dedicated to “conducting a global study to track public sentiment and emotions around current and potential measures to contain and treat COVID-19.” Using a mix of population surveys and social media tracking, VCP “will investigate perception and sentiment of COVID-19 social distancing measures and potential medical tools globally.” This project will be essential moving forward, as it will continue to inform understanding on how the global population perceives the eventual vaccine.

As of now, VCP reports that only 25 percent of African Americans—a population that has been disproportionately hit by the virus—plan to get the COVID-19 vaccine. Why is this the case? Due to lack of access to hospitals, pharmacies, doctors and clinics in Black communities, failure to expand Medicaid, and other root causes; the COVID-19 pandemic has laid bare the disparities in our health care system.

To ensure herd immunity—which is somewhere north of 90 percent immunity—much work needs to be done, especially with the Black community, to increase confidence when a COVID-19 vaccine is released. At this time, Black leaders such as former U.S. Surgeon General, Dr. Regina Benjamin, and current U.S. Surgeon General Dr. Jerome Adams, are among those leading the charge to encourage public health efforts such as advocating for face-mask usage and collaborating with the National Newspaper Publishers Association (NNPA) Coronavirus Task Force and Resource Center, which provides expertise on the virus and its impact on the Black community.

Another community that will be crucial to prioritize surrounding vaccine hesitancy is the older Americans. The New York Times reported that of the “241 interventional COVID-19 studies undertaken in the United States and listed on clinicaltrials.gov…37 of these trials—testing drugs, vaccines and devices—set specific age limits and would not enroll participants older than 75, 80 or 85 years old. A few even excluded those over 65.” Why would older Americans trust a vaccine not tested for their age groups? Clinical trials will need to include people across all ages, otherwise, this will only increase vaccine hesitation. The vaccine must be safe and effective, and ample outreach must be conducted to ensure vaccine confidence across all demographics.

There are many questions left to be addressed. As we continue to navigate preventive measures for COVID-19, independent researchers and organizations will become increasingly more important to guiding decision making before and after a vaccine is developed.

Vaccine hesitancy is a global problem that will only be compounded by the COVID-19 pandemic. Fostering vaccine confidence will be imperative when the second wave of the virus sweeps the globe, as it inevitably will.

Talia is a Washington, D.C. native, and a rising sophomore at Wesleyan University, where she majors in English. Beyond health, Talia’s interests are in journalism, law, and social justice.