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.

The decline in COVID-19 testing nationwide could derail pandemic response wins

Nissa Shaffi

By Nissa Shaffi, NCL Associate Director of Health Policy

COVID-19 testing has been a critical component of the nation’s pandemic response, as health officials monitored the virus’s progression and set policies that supported back-to-school and return-to-work initiatives. Increased testing capacity has enabled our most essential industry sectors to resume activities that continue to carry us through the pandemic. However, as vaccines become more accessible and we surpass initial goals for population-wide immunizations, testing has declined by 35 percent daily since mid-January.

Testing provides a reliable snapshot into the virus’s trajectory that allows for proper allocation of vital resources (e.g., supplies, personal protective equipment (PPE), and medical equipment) and essential personnel. Data from testing rates are also critical for vaccine manufacturers, as they evaluate how the virus is mutating and further efficacy of the vaccine. The uptick in vaccinations, while incredibly promising, may have induced an inflated sense of security and diminished caution towards the virus. However, in the midst of rising variants, the decline in testing may very well be the Trojan horse that derails national efforts to combat the virus.

Testing has also declined in part due to a shift in focus to getting vaccinated. While vaccines are equally important, we need adequate COVID-19 testing for public health surveillance purposes. There needs to be sufficient capacity and public health messaging in place to encourage individuals who have potentially been exposed to SARS-CoV-2, or coronavirus, to get tested immediately.

Dr. Nasia Safdar, Medical Director for Infection Prevention at UW Health, states “we are seeing a decline in testing,” she said. “If we see the numbers continue to decline sharply, at some point then it may not be worthwhile to do widespread testing, but we’re certainly not there yet.” Without these measures, our healthcare system will be rendered unequipped to deal with dormant and emerging threats, like potential outbreaks and continuous mutations of the virus.

There are a couple of strategies that could help us get a hold on precipitous testing rates. It is estimated that a national program for universal mass testing for unvaccinated people would cost a few billion dollars a week—an amount that still presents a cost-benefit when considering potential shutdowns. The American Rescue Plan has appropriated $50 billion for expanded testing, which could help the situation significantly.

Another aspect of the problem is a lack of testing sites. With so many resources currently devoted to expanding vaccination sites at pharmacies and hospitals, people need places to get tested. Greater corporate involvement in the response could be a potential avenue for increasing capacity.

Finally, the Food and Drug Administration (FDA) is working to advance development and approval for over-the-counter (OTC) and point-of-care (POC) tests. Obtaining a greater number of FDA-approved OTC and POC COVID-19 tests could help address issues with logistics and access, and would give schools, workplaces, and communities more options for reliable and accurate screening.

The pandemic is far from over and experts predict that COVID-19 will likely be endemic, meaning it will be detected regularly, even if within small pockets of the population. We need all possible public health interventions at our disposal to ensure that we can effectively limit the spread of the virus and preserve ongoing plans to reopen the economy so that we can start the process to sustainably reintegrate back into society.

Dr. Safdar further emphasized, “the vaccines are great as they are, they’re not 100 percent. There will be a certain number of people that will…contract the illness despite having been vaccinated. It might be a milder condition which is very welcome news, but nonetheless, to make a diagnosis and figure out what treatment is required, you have to get a test.” Testing continues to be a simple, yet powerfully effective measure to prevent the massive spread of COVID-19 and we must persist in our efforts towards early detection.

NCL statement regarding efforts to ban menthol tobacco products

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) commends the Food and Drug Administration (FDA) for its efforts to ban menthol cigarettes and flavored cigars. The FDA states it will work to keep menthol flavored tobacco products off the market by enforcing a potential ban against manufacturers, distributors, wholesalers, importers, and retailers. The ban on menthol-flavored tobacco products is a historic measure to address health disparities present in vulnerable communities as a result of unfair marketing practices.

Menthol cigarettes continue to be heavily advertised, widely available, and priced cheaper in Black communities. Tobacco manufacturers have long deployed tactics that lure and entice young people with their menthol-flavored tobacco products, consequently contributing to a gateway for children to initiate cigarette smoking.

“For generations, tobacco companies have disproportionately targeted communities of color with advertisements of highly addictive menthol flavored tobacco products”, said NCL Executive Director, Sally Greenberg. The sales resulting from these predatory marketing practices have ravaged vulnerable communities, particularly African American youth. We applaud this Administration’s effort to protect consumers, particularly from the most marginalized areas of society, from the adverse effects of menthol-flavored tobacco products.

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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.

Giving a voice to women facing preterm birth

By Sally Greenberg, NCL Executive Director

Born out of our historical focus on reducing health inequities in the United States, and a nearly year-long movement to preserve access to approved therapies that fight premature birth, NCL supported the launch of the Preterm Birth Prevention Alliance (PBPA), which brings together a coalition of 15 patient advocacy organizations who share concerns about the grave state of preterm birth in the United States and its disproportionate impact on Black, Indigenous, and women of color.

For the past decade, hydroxyprogesterone caproate, commonly called “17P,” has been the only available FDA-approved treatment option to reduce the risk of recurrent preterm birth. Patients and the healthcare providers who serve them currently have access to one branded and five generic versions of the prescription product. However, in 2020, the FDA proposed withdrawing all forms of 17P, based on conflicting efficacy data from two studies composed of vastly different populations — one inclusive of women in the U.S. most vulnerable to preterm birth and one not. Both studies showed that this class of treatment is safe for both mother and baby.

Despite multiple formal requests to consider additional data and alternate ways to study the efficacy of this class of drugs before effectively depriving women of access, FDA made its recommendation without engaging the most important stakeholders—patients who are at the highest risk and their providers. And even after a recently published meta-analysis showed that 17P injections reduced the risk of preterm birth before 34 weeks in high-risk women with singleton pregnancies, FDA persisted in its recommendation.

The Alliance was formed to stand up for the needs of moms and babies of every race and ethnicity and urge regulators to hear directly from women facing prematurity and their providers about their real-world experiences — in a public hearing — before making a decision on withdrawal.

We believe that evidence of efficacy for Black, Indigenous, and women of color in the United States — who are at highest risk of adverse outcomes — should be more determinative than a lack of demonstrated treatment efficacy on primarily white women from other countries. And we believe that more inclusive studies and data are needed, across more racially and ethnically diverse patient populations, to better understand the causes and impact of disparate outcomes in preterm birth.

Alliance partners currently include:

  • 1,000 Days
  • 2020 Mom
  • American Association of Birth Centers
  • Black Mamas Matter Alliance
  • Black Women’s Health Imperative
  • Expecting Health
  • Healthy Mothers, Healthy Babies Montana
  • HealthyWomen
  • Miracle Babies
  • National Birth Equity Collaborative
  • National Black Midwives Alliance
  • National Consumers League
  • National Partnership for Women & Families
  • Sidelines High-Risk Pregnancy Support
  • SisterReach

Organizations or advocates concerned about the needs of women facing prematurity — whether you are a healthcare professional, maternal and infant health advocate or a health equity champion — are invited to join us and add your voice to this effort.

Learn more and join the Alliance: https://nclnet.org/pbp/

Leading patient advocates launch preterm birth prevention alliance to protect critical access to the sole fda-approved class of therapies to reduce recurrent preterm birth

April 20, 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—Today, the National Consumers League (NCL), along with a coalition of patient advocacy organizations dedicated to advancing the health of mothers and infants, announced the launch of the Preterm Birth Prevention Alliance.

Members of the Alliance are joining forces in an effort to preserve patient access to the only Food & Drug Administration-approved class of treatments for pregnant women who have previously had an unexpected, or spontaneous, preterm birth. Together, Alliance members seek to ensure that the Food & Drug Administration (FDA) hears concerns from the full range of stakeholders about the potential risks and impact of withdrawal for at-risk pregnant women and their providers.

For the fifth year in a row, the U.S. preterm birth rate has increased (to 10.2 percent of births), and preterm birth and its complications were the second largest contributor to infant death across the country. Preterm birth also represents a significant racial health disparity, with Black women in the U.S. experiencing premature delivery at a rate 50 percent higher than other racial groups throughout the country.

However, in 2020, the FDA proposed withdrawing hydroxyprogesterone caproate, commonly called “17P” or “17-OHPC”, the only FDA-approved class of branded and generic treatments to help prevent the risk of preterm birth in women with a history of spontaneous preterm birth. The FDA is currently determining whether to hold a hearing on the status of 17P, based on conflicting efficacy data from two studies composed of vastly different patient populations, one inclusive of women in the U.S. most vulnerable to preterm birth and one not.

“We’re fighting for a more inclusive healthcare system that gives everyone an equal chance to have the best outcomes possible,” said Sally Greenberg, executive director of the National Consumers League. “We don’t believe that removing 17P from the market without gaining a better understanding of who could benefit the most from its use is in the best interests of patients, nor their healthcare providers, particularly as there are no other approved treatment options available.”

To date, 14 organizations have joined NCL to advocate for the health interests of at-risk pregnant women and infants, including: 1,000 Days; 2020 Mom; American Association of Birth Centers; Black Mamas Matter Alliance; Black Women’s Health Imperative; Expecting Health; Healthy Mothers, Healthy Babies Montana; HealthyWomen; Miracle Babies; National Birth Equity Collaborative; National Black Midwives Alliance; National Partnership for Women & Families; Sidelines High-Risk National Support Network; and SisterReach.

“As a trained obstetrician and gynecologist, I know firsthand the impact of preterm birth on Black women and birthing people. I also know that racism – not race – is the driving factor leading the disproportionate impact of preterm birth on Black women and birthing people thereby exacerbating systemic inequities in maternal and infant health. To achieve birth equity, which is the assurance of the conditions of optimal births for all people with a willingness to address racial and social inequities in a sustained effort, we must work to protect and uphold a standard of care for spontaneous, recurrent preterm births and ensure it remains accessible and affordable for all who stand in need,” added Dr. Joia Crear Perry, founder and president of the National Birth Equity Collaborative.

The Preterm Birth Prevention Alliance is calling for the FDA to grant a public hearing to fully consider all of the data, additional research methods, and stakeholder perspectives before deciding whether to withdraw approval of this critical class of therapies. The health of America’s moms and babies warrants the utmost care and consideration.

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About the Preterm Birth Prevention Alliance

The Preterm Birth Prevention Alliance is a coalition of maternal and women’s health advocates who share a common concern about the state of preterm birth in the United States and the proposed market withdrawal of 17P, the only FDA-approved class of treatments to help prevent spontaneous, recurrent preterm birth. Formed in 2021 by the National Consumers League, we seek to improve preterm birth outcomes in the United States by maintaining access to safe, FDA-approved treatment options and advocating for more diverse medical research that adequately represents the experiences of women and newborns of color. Women of color need a seat at the table. To learn more, visit www.pretermbirthalliance.org.

Initial support for the Preterm Birth Prevention Alliance is provided by Covis Pharma.

Recognizing 2021 Black Maternal Health Week

April 12, 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) applauds the resolution introduced by Representative Alma Adams, (NC-12), Representative Lauren Underwood (IL- 14), and Senator Cory Booker (D-NJ) designating April 11-17, 2021 as national Black Maternal Health Week.

The dismal state of maternal and infant health disparities in the United States continues to disproportionately impact black women and babies. In 2020, the rate of pre-term births—the second largest contributor to infant death in the United States—increased to 10.2 percent of births. Black women experience premature delivery at a rate 50 percent higher than all other American women. To address this disparity, in June 2020 NCL led a coalition of organizations in advocating for the FDA to protect patient access to a critical therapy for pregnant mothers at risk of recurrent preterm birth—lack of access to this therapy could disproportionately and negatively impact women of color.

NCL has long advocated for policies to improve maternal health outcomes and sought to address the persistent racial and ethnic health disparities that lead to adverse birth outcomes for black women. NCL is proud to support the Black Maternal Health Momnibus, a package of 12 bills intended to comprehensively address the maternal health crisis that disproportionately impacts Black, Indigenous, and women of color in this country. NCL also applauded a provision within the American Rescue Plan that allows states to extend Medicaid coverage to women for up to one year after childbirth. This provision to expand postpartum care is vital to improving maternal health outcomes for our most vulnerable moms.

“In order to address the maternal mortality crisis in this country, we need to recognize the link between structural racism and the social determinants of health that contribute to the disproportionately high rate of maternal mortality among Black women. This resolution designating Black Maternal Health Week is an important step in supporting policies to improve maternal health outcomes for Black Mamas,” said NCL Health Policy Director Jeanette Contreras.

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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

La tercera vacuna trae esperanza

By NCL Director of Health Policy Jeanette Contreras

La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) acaba de aprobar una autorización de uso de emergencia para la vacuna de Johnson & Johnson, la tercera vacuna para combatir el coronavirus en EEUU. Aunque parece que no es tan efectiva como las otras dos, la vacuna de Johnson & Johnson ofrece una protección de 85 por ciento contra casos severos de COVID-19 y 100 por ciento de eficacia para evitar hospitalización y mortalidad, a causa del COVID-19. Con solo una dosis, esta vacuna ofrece protección de 72 por ciento contra el COVID-19 que ultimadamente ayuda controlar la pandemia en la población y alcanzar un nivel de inmunidad necesaria para regresar a la vida normal.

Una ventaja enorme de esta vacuna en términos de administración, es que se puede mantener en refrigeración normal por meses. Las otras vacunas requieren mantenimiento de temperatura súper baja en refrigeradores industriales que solo se encuentran en hospitales grandes. La vacuna de Johnson & Johnson es ideal para distribuir a comunidades rurales y en clínicas comunitarias. La aprobación de esta tercera vacuna, aumenta la disponibilidad y nos da esperanza de poder vacunar a más personas, más rápido con solo una dosis.

Sabemos que la comunidad Latina sufre de una taza de contagio más alta que otros grupos. Latinos constituyen una gran cantidad de empleados en trabajos esenciales con alto riesgo de contagio, como en la producción de comida y en puestos de trabajo de pequeños negocios. Mientras muchos esperan vacunarse, otros tendrán dudas o miedo de vacunarse. La campaña De Ti Depende nos asegura que es normal tener preguntas y ofrece información y respuestas en español para educar a la comunidad latina.

Campañas educativas como esta son necesaria para combatir información falsa y mitos que circulan en las redes sociales. Se escuchan mitos que las vacunas en general hacen daño o que alteran o cambian el ADN. Sin embargo, está comprobado científicamente por siglos que las vacunas han salvado vidas y nos han protegido. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) tiene una página dedicada a información para derribar los mitos más frecuentes acerca de estas vacunas.

Para alentar a la población a vacunarse, muchas empresas grandes están ofreciendo tiempo pagado o incentivos financieros a los empleados que se vacunan. Por ejemplo, supermercados como Publix les da $125 y Kroger les da $100 a empleados cuando reciben la vacuna completa. Dollar General les aumenta cuatro horas de pago normal a los que se vacunan.

Gracias a la autorización de la nueva vacuna, presidente Biden afirma que para el fin de mayo habrá vacunas para todos los adultos en EEUU. Las personas que deciden vacunarse, pueden buscar información confiable en el recurso de Telemundo – PlanificaTuVacuna.com para verificar la elegibilidad de acuerdo a las órdenes de cada estado.

Getting more vaccines in arms: Trust and efficiencies

Guest blog by Farah Towfic, PharmD, MBA, director of the U.S. Pharmacopeia COVID-19 Vaccine Handling Toolkit

In the United States, nearly 200 million doses of influenza vaccines are administered annually. Clearly, pharmacists, nurses, physicians, and other healthcare practitioners have demonstrated a successful track record of delivering robust immunization programs for many years. However, the unprecedented scale and speed at which the COVID-19 vaccinations must be delivered to curb the devastating impact of this pandemic has surfaced enormous challenges—which have been further compounded by significant vaccine supply demand.​ Never before have we had to distribute multiple doses to more than 15 billion individuals around the world, with more than 300 million in the U.S. alone.

The pandemic has also recharged the focus on vaccine hesitancy, a challenging and complex issue which, at its core, is about trust based on a person’s experience and perspective. According to the KFF COVID-19 Vaccine Monitor, a growing share of the public is open to getting vaccinated, but many of the same groups that were hesitant in December 2020, when the first COVID-19 vaccines were released, remain hesitant now. When deciding whether to get vaccinated, most people say they will likely turn to pharmacists, doctors, nurses, and healthcare providers as the source for information. The KFF COVID-19 Vaccine Monitor also notes that 85 percent of people trust their own doctor or healthcare provider at least a fair amount for reliable vaccine information.

If we are going to mitigate the impact of this pandemic, we need to help build and maintain trust in COVID-19 vaccines. As an independent, nonprofit, scientific organization, U.S. Pharmacopeia (USP) has been dedicated—for more than 200 years—to improving global health and building trust in medicine through public standards and related programs that help ensure the quality, safety, and benefit of our drugs. With our shared goals to provide patient access to quality medicines, USP is proud to be a founding member of the National Consumers League (NCL) Health Advisory Council. The Council’s informative communication and opportunities for engagement provide critical perspectives that help shape and inform USP’s strategic focus and initiatives. The Health Advisory Council also demonstrates the power of collaboration—which is a cornerstone of USP’s work.

By working together with stakeholders, partners in industry and the U.S. government, we are able to identify the COVID-19 vaccine operational challenges and also provide solutions. One of these solutions is the recently released USP COVID-19 Vaccine Handling Toolkit, which addresses gaps that slow getting shots in arms and helps healthcare practitioners safely deliver vaccines in a variety of settings.

As millions of additional doses of COVID-19 vaccines are released, the USP COVID-19 Vaccine Handling Toolkit is helping doctors, nurses, pharmacists, and other healthcare practitioners create operational efficiencies to vaccinate more people in their communities quickly and safely, all the while maintaining quality. It includes strategies in three key areas:

  • Preparation and labeling to support different practitioners preparing and administering vaccines including how to maximize the number of doses per vial and enabling pre-drawing of vaccines in advance of large immunization events.
  • Storing, handling, and transporting the vaccine to mass vaccination clinics, nursing and long-term care facilities, and more.
  • Waste prevention and disposal to support settings in preventing vaccine waste and addressing gaps for vaccine administrators in proper disposal of ancillary supplies, such as syringes.

“Using the strategies from the USP Vaccine Handling Toolkit for pre-drawing syringes and streamlining our processes and workflow we increased shots in arms by 50% per day,” says Patricia W. Slattum, Pharm.D., Ph.D., BCGP, a vaccine administrator with the Virginia Medical Reserve Corp and Virginia Commonwealth University.

More than 40 independent expert volunteers along with U.S. government representatives developed this toolkit that enables healthcare practitioners to benefit from consistent, scientific-based strategies developed by independent experts that close efficiency gaps across states and territories.

The USP COVID-19 Vaccine Handling Toolkit is one of several initiatives USP is undertaking to support quality and build trust in COVID-19 vaccines, treatments, and preventatives. For example, our Hand Sanitizer Toolkit, launched in spring 2020, is being used by many around the world to ensure quality preparation of this essential COVID-19 preventative.

As the nation’s pioneer consumer organization, that leads the charge on the importance of adherence to live-savings medicines, NCL plays a pivotal role in helping to build trust in vaccines. USP values the opportunity to share the COVID-19 Vaccine Handling Toolkit with NCL and looks ahead to future opportunities to partner with NCL and other stakeholders in the patient advocacy community.

As more is learned about COVID-19 vaccines, additional information will be shared in the future. We encourage NCL’s readers to sign-up for updates at https://www.usp.org/covid-19/vaccine-handling-toolkit.

About USP
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide.