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.

Throwing COVID-19-related cautions to the wind

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

Over the past nine months, we’ve lived in a state of hypervigilance. The meticulous precautions we’ve observed throughout the pandemic have taken a toll on us. At worse, we’ve lost a loved one, friend, or coworker to this incessant virus. At best, we’ve been forced to recalibrate our routines and our lives. This collective weariness, to which experts have coined “COVID-19 Caution Fatigue“ is a prevailing factor in the current spike in cases.

When we are subjected to high levels of stress (e.g., high alert related to COVID-19), it can activate the stress hormone, cortisol. High levels of this hormone can cause us to become desensitized to the stimuli that triggered the stress hormone in the first place. Meaning, we start to ease up on our vigilance because the threat feels less real. These factors compounded—by feelings of isolation due to limited social contact‑—may have caused us to lose the motivation to maintain safe practices.

We see evidence of this as people are increasingly dining indoors, gathering for weddings, going to rallies, and are boarding flights nationwide. These behaviors are considered responsible for “superspreader events,” where COVID positive people expose multiple others. On average, every person with COVID-19 can potentially transmit the virus to two to three additional people. This has a multiplier effect with people spreading it, in turn, to another two to three people, and, well, you get the picture.

Dr. Fauci has warned that large gatherings during the holiday season could lead to “a surge superimposed upon that surge that we’re already in.” The pandemic demands personal sacrifices—which in turn leads to COVID induced malaise. I’ve personally RSVP’d “No” to a couple of family weddings—because the health and safety of my family matters more than joining them for a round of the “Cha Cha Slide.”

We must listen to public health experts. As I write this, the United States has more than 14.2 million COVID-19 cases and 275,000 deaths. These sad statistics will increase throughout the holiday season. Here are some ways you can combat COVID-19 Caution Fatigue:

  • Build a new routine. Find new and safe ways to move, interact with people, and entertain.
  • Healthy behaviors: focus on nutrient dense food, get adequate sleep, and limit alcohol use.
  • Journal: reflect on all that you’ve endured this year. A lot of us have been pushed to grow, expand, and adjust in unexpected ways. Focus on how far you’ve come, how resilient you are, and keep pushing.
  • Limit sreen time: For those of us working from home, it’s become increasingly tricky to maintain a work-life balance. Try to log off at a set time every day and take a break from screens in general (phone, TV, computer) and find ways to decompress from your day.
  • Personal improvement: Use time that would’ve been spent socializing on cultivating a new hobby. Take a free online course to learn a new concept. I personally like Coursera. Or learn a new language through mobile apps like Duolingo.
  • Prioritize self-care. Practice guided meditations via mobile apps like Headspace, read, or even start virtual therapy to process your emotions, through services like Talkspace.

In recognition of the emotional toll of social distancing, the CDC has issued guidelines on how to cope during the holidays. There’s light at the end of the tunnel. Perhaps several COVID-19 vaccines will be available in the coming months. That said, we have a long way to go, as the demand for the vaccine will far exceed its supply for many months. Remain vigilant and continue to adhere to pandemic-related safety guidelines. Our collective efforts will keep us safe while the vaccines become available across many demographics. Let’s continue to keep ourselves, our loved ones, and our communities safe through care and precautions against COVID-19. Mask up, stay 6 feet apart, wash your hands frequently, and avoid large gatherings. Happy and safe holidays to all!

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.

For patients’ safety, it’s time Congress updated rules governing the $10 billion contact lens industry

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Contact lenses have come a long way since they were first introduced around 70 years ago.  Today, roughly 45 million Americans rely on them for safe, affordable vision correction each year.  But along the way, federal regulation of the contact lens market has not kept pace with the changing way Americans purchase and rely on these medical devices.  The result is that thousands of American consumers are at risk each year of adverse eye health outcomes including keratitis, corneal scarring, corneal ulcers, and infection.

Under federal law, online contact lens retailers do not require patients to provide their prescriptions before ordering contact lenses.  Patients can simply tell the retailer the lenses the doctor prescribed for them and the retailer then must verify the prescription with the prescribing doctor.  As required by the Federal Trade Commission’s Contact Lens Rule (“Rule”), contact lens-prescribing doctors have eight hours to respond to an online sellers’ verification communication before the contact lenses are sent to patients. If they don’t respond, the online contact lens seller can ship the products, regardless of the fact that prescription accuracy hasn’t yet been verified. Since the Rule was implemented in the mid-1990s, before the adoption of email, many sellers used automated telephone calls, or so-called “robocalls,” to fulfill the verification requirement of the Rule.

These automated robocalls use computer-generated voices.  They are often inaudible.  They frequently contain incomplete patient information, and, in practice, these robocalls are sent via computer at all hours of the day and night without noting any call back number to correct errors. This cumbersome process makes it nearly impossible for eye doctors to properly verify contact lens prescriptions.  In fact, this prescription verification system can lead to the shipment of incorrect contact lenses to patients with potentially dangerous consequences for patient vision health and safety.

As many consumers can attest from being bombarded with marketing robocalls, making sense of them is a nightmare. Using robocalls to verify important patient information, for the reasons previously outlined, is unsafe.

Current technology is capable of far better than this robocall system, especially due to the various forms of electronic communication we use today. These technologies can produce receipts, notify consumers of product shipments, and share product alerts and updates. Electronic communication is far more reliable and effective because it’s inexpensive, easy to understand, accessible.  It also creates a verifiable paper trail.  Therefore, we believe sellers of contact lenses should be required to use email or other forms of electronic communication, not automated robocalls, to keep consumers safe.

The FTC’s revised Contact Lens Rule also adds a cumbersome paperwork requirement that consumers and eye doctors need to complete at the end of a contact lens exam and fitting. Under this rule, prescribers must collect and store a so-called signed acknowledgment form in which a patient verifies that they received a copy of their prescription, as is already required under federal law.

That’s all well and good, but we believe a far better system to inform contact lens patients of their rights would be to require prescribers to post a sign in their offices, which is clear and conspicuous, noting that patients have a right to a copy of their contact lens prescription at the completion of their contact lens fitting. This type of posted signage is already mandatory in California, seems to be working well there, and we think it should be emulated on the federal level.

That’s a better solution because like many other forms consumers and patients are asked to sign, consumers probably won’t take time to read the form and thus won’t understand what they are signing; this is an ineffective exercise, in our view, and will result in more paperwork without necessarily ensuring patients have access to their prescriptions as the law intends.

In short, it’s time for Congress to update the rules governing this important, $10 billion industry.  It should start by requiring the use of the latest technologies—not robocalls—to get consumers the information they need about their eye prescriptions and that those prescriptions are verified as accurate by their eye professionals.

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.

What you should know about the Healthcare.gov Open Enrollment

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Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

From November 1, 2020 to December 15, 2020, consumers will be able to enroll in health coverage through the health insurance marketplace, Healthcare.gov. Choosing the right health plan involves thoughtful decision-making, with careful consideration of your needs and your budget. COVID-19 testing and treatment, telehealth, and mental health services have been vital pandemic necessities, and consumers are advised to pay attention to any changes in their current health plans to account for any adjustments in health needs.

It is estimated that annually consumers typically spend 17 minutes when selecting plan options during open enrollment, most simply sticking with their plans from the previous year. If you need assistance navigating the health insurance marketplace, you can consult a healthcare navigator to help in comparing the coverage options that make sense for you. Healthcare navigators provide free, unbiased advice and offer services in a number of languages. To find a navigator in your area, please click here.

Even with the election and looming challenge to the ACA coming before the Supreme Court, California v. Texas, consumers should know that the federal health insurance marketplace, also known as Obamacare, is still available. The Supreme Court will hear oral arguments on November 10, but the ultimate decision can come as late as June 2021. We’ve written more about the implications of California v. Texas here. Despite multiple attempts by opponents to repeal the ACA, over 20 million people have gained coverage through the marketplace in the past decade.

The Centers for Medicare & Medicaid Services (CMS) recently announced that marketplace premiums have dropped by 2 percent nationally. Additionally, as a result of the pandemic, the marketplace has seen greater insurer participation – in turn, offering consumers with more robust options for coverage. Plans offered via Healthcare.gov are required to cover a set of essential health benefits mandated by the ACA, ensuring that you have access to comprehensive care – a provision that is of chief importance during this time. The ACA has afforded consumers with a host of health protections and prohibits insurance plans from discriminating against enrollees based on health status, including pre-existing conditions. To learn more about the marketplace, click here.

The National Consumers League encourages consumers to seek coverage via ACA compliant plans offered on the marketplace. If you miss the deadline to apply for coverage within the open enrollment period, you may be able to qualify for a Special Enrollment Period (SEP). Applying during a SEP is contingent upon meeting certain criteria, such as life events like having a child or losing health coverage. If you qualify for Medicaid or the Children’s Health Insurance Program (CHIP), you can apply at any time. Most importantly, in order to have coverage that is effective by January 1, 2021, you must sign up by December 15, 2020.

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.

National Consumers League Expresses Concern Over Amy Coney Barrett Confirmation

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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 next three weeks will be critical for the American people. Amid a global pandemic, a historic presidential election, and the attempt to fill an equally historic Supreme Court vacancy, there’s a lot at stake for health care. On October 26, the Senate will vote on Judge Amy Coney Barrett’s nomination to succeed the late Justice Ruth Bader Ginsburg on the US Supreme Court. On November 10, merely a week following the presidential election, the Supreme Court of the United States (SCOTUS) hear arguments in the case of California v. Texas, the latest challenge to Patient Protection and Affordable Care Act (ACA), more commonly called Obamacare.

The rush to fill Justice Ginsburg’s seat on the Court on the eve of this election has worried health advocates and consumers alike, as a conservative majority court could potentially overturn the ACA. Conservatives have been hostile to the law, and Coney Barrett, herself an arch-conservative, seems to share that very hostility toward the ACA. This is illustrated by her disapproval of Justice John Roberts Jr.’s support of the ACA in a 2017 essay. In it, Coney Barrett wrote that Justice Roberts had “pushed the Affordable Care Act beyond its plausible meaning to save the statute.”

In 2017, the strife between Democrats and conservatives worsened when the individual mandate provision of the ACA was found unconstitutional. Following that ruling, conservatives have tried to grasp at opportunities to repeal the entire law, including arguing for severability. Severability of the individual mandate provision, as explained by Justice Roberts, would allow the Court to excise the provision with “a scalpel rather than a bulldozer.” Severability would still maintain the ACA as the law of the land and would save access to healthcare for over 20 million Americans. But the plaintiffs, all Republican Attorneys General from across the country, have argued that the individual mandate cannot be severed and if it goes down, the whole law falls.

Although Coney Barrett was reticent during the Senate Judiciary Committee hearings, her record serves as a warning about how she will come down on a host of consumer health issues. These include reproductive decisions granting women agency over their bodies and the freedom to choose how they form families. Based on her prior endorsement of the anti-choice organization Right to Life and her public support of overturning Roe v Wade, there is cause for concern that medical interventions like contraception, abortion, and even in-vitro fertilization (IVF), could all be at risk following Judge Barrett’s appointment to the high court.

Aside from reproductive issues, there are countless health care protections on the chopping block pursuant to the ACA deliberation. Below are a few at risk if the ACA is overturned:

The stakes are high. If the ACA is overturned, COVID-19 could be considered to be a pre-existing condition. The pandemic has laid bare deep structural inequities; stripping away coverage during such dire times would be unconscionable.

There are a few ways the Supreme Court could rule on the case come November 10.

  • If Coney Barrett is not sworn in before the oral argument, the Court could vote on the case with an 8-member court, leading to a potential tie. If tied, the case would be returned to the original trial judge for further analysis – meaning that in the interim, the ACA would remain the law of the land, ensuring protections for millions.
  • The Court may still rule in favor of salvaging the ACA. Many scholars deem the plaintiffs’ arguments to be legally weak. This is where the argument of severability comes in.
  • Finally, if a new justice is appointed to the Court and there is a majority vote to overturn the ACA, it may be overturned. The ACA is an extraordinarily complex and comprehensive law, and this result would wreak havoc across virtually every area of health policy.

Over the next few weeks, the health and civil liberties of millions of Americans will hang in the balance. NCL does not support Judge Amy Coney Barrett’s nomination. Justice Ginsburg was a champion of rights and protections for consumers and women and a strong defender of the ACA. Confirming a justice for the Supreme Court with Coney Barrett’s record before the election has the potential to endanger lives already vulnerable during this pandemic. We simply cannot afford to throw consumers’ health care into such chaos and uncertainly during this COVID-19 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.

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.