Jeanette Contreras portrait

Como detectar el COVID-19 en casa

/in , , /by

By NCL Director of Health Policy Jeanette Contreras

Tras la efectiva campaña de vacunación, las pruebas de detección serán claves para seguir evitando contagios del coronavirus y resumir a la normalidad. Reconociendo que estamos en buen camino para controlar la pandemia del coronavirus, los estados están eliminando las restricciones de la cuarentena. Pero el 11 de mayo, el director de la Organización Mundial de la Salud (WHO, por sus siglas en inglés) nos alerta que seguimos en una situación peligrosa porque los estudios de la variante que se ha propagado en la India indican que esta se transmite más fácilmente y provoca una enfermedad más grave.

Expertos de salud siguen cuantificando y analizando los casos positivos para vigilar las variantes. Una recomendación importante es seguir administrando las pruebas de detección de COVID-19 aunque las personas sean asintomáticas. En abril, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) autorizó varias pruebas de uso personal que detectan el COVID-19 y que se pueden comprar en las tiendas y farmacias como CVS, Walgreens y Walmart sin receta médica .

Para los fines de mayo esperamos ver estas pruebas caseras disponibles en todo el país. Los Centros para el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés) ofrecen consejos sobre cómo usar un kit de recolección y realizarse la prueba en casa. Todas funcionan igual: toma el espécimen de tu nariz o de saliva, envíala al laboratorio por correo, y recibirás los resultados por el internet en un par de días.

Como todavía falta vacunar a los niños menores de 12 años, a las personas que por su religión no han sido vacunados, y personas con enfermedades graves que no se les permite vacunarse, los expertos de salud pública temen no poder eliminar el coronavirus por completo. Una de cada tres personas en el EE. UU. no confía en la vacuna. Y si la mayoría de la población no se vacuna, el COVID-19 será endémica en nuestro país. Solo el país de Israel ha logrado llegar a la inmunidad de grupo- incluso jóvenes de 16 años de edad se han vacunado.

Con acceso a estas pruebas personales, organizaciones y empleadores pueden comprar cantidades de kits de recolección para uso en sus comunidades. Las escuelas y lugares de trabajo ya están estableciendo programas de pruebas para detectar el COVID-19 rápidamente. Para proteger los más vulnerables en nuestras comunidades, todos los casos positivos se deben reportar al departamento de salud del condado en donde vives y al estado para iniciar un rastreo de contactos. Es importante saber dónde se inició el contagiado y con quien ha tenido contacto cercano las personas infectadas.

Aunque el CDC afirma que las personas con la vacuna completa que no presentan síntomas del COVID-19 no necesitan hacerse la prueba de detección después de haber estado expuestas a una persona contagiada con el COVID-19, es muy posible que personas que quieran viajar tengan que mostrar una prueba de detección negativa para entrar a otro estado o país. Mientras que no haya un pasaporte de vacunas, muchos países requirieran que los visitantes demuestren una prueba de COVID-19 negativa para ingresar a su territorio. El CDC tiene un planificador de viajes que las personas pueden utilizar para buscar información sobre el COVID-19 en las comunidades estatales, locales, territoriales y tribales que atraviesen en ruta a sus destinos.

La facilidad de obtener pruebas caseras nos ayudar a detener la propagación del COVID-19 e identificar los orígenes de contagio. Poder hacer un seguimiento de contactos en las comunidades afectadas no solo puede prevenir enfermedad, pero también controlar la evolución de nuevas variantes del COVID-19. La conveniencia de poder hacerse la prueba del coronavirus desde la comodidad de la casa y sin receta de un doctor significa tener un mejor control del bienestar de cada persona en nuestras comunidades.

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

/in , , , , , /by

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.

Consumer group urges FDA and CDC to remain vigilant in enforcing hand sanitizer standards

/in , , , /by

April 27, 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—This week, the National Consumers League (NCL) wrote a letter to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), urging them to remain vigilant on the enforcement of proper manufacturing and distribution of hand sanitizers as we continue to fight the COVID-19 pandemic.

During the initial surge in demand for hand sanitizers, the federal government relaxed certain regulations in order to get over-the-counter products into consumers’ hands. The combination of a need for an immediate ramp-up of hand sanitizer distribution and reduced oversight led to a concerning trend of what NCL believes is a case of mislabeling — and unfortunately misleading — information regarding hand hygiene products.

While local and small businesses stepping up to produce products for their communities is admirable, hastily manufactured hand sanitizer operations have resulted in lower efficacy rates, with even some reports of products being made with dangerous ingredients. As a result, the FDA has currently identified 230 hand sanitizer products marketed in 2020 as unsafe or ineffective.

NCL commends the FDA and the CDC for their ongoing efforts to keep the American people safe. But the fight against this virus is far from over, and under-regulated hand sanitizer production and distribution will only prolong this public health crisis.

The following statement is attributable to NCL Executive Director Sally Greenberg:

“For more than a century, the National Consumers League has fought for access to quality products, honest labeling, and safe, effective medicines for American consumers and workers. And leaving this growing issue alone would be a disservice to the many people NCL has worked so hard to protect.”

NCL urges the FDA and the CDC to enforce the law and hold accountable those businesses engaged in the production and distribution of poorly manufactured and dangerous hand sanitizer products.

###

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.

NCL testimony at CDC emergency meeting on J&J vaccine safety

/in , , , /by

April 23, 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) testified before the emergency meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to discuss updates on the recommendations to pause the Janssen COVID-19 vaccine. The full testimony appears below:

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

RE: Docket No. CDC-2021-0044; Advisory Committee on Immunization Practices (ACIP)

For over 120 years, the National Consumers League (NCL) has championed vaccine education and access for consumers to these lifesaving medical interventions. We extend our gratitude to the Advisory Committee on Immunization Practices for the opportunity to serve as a voice for consumers.

NCL commends the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) for their concerted efforts to promptly address the recent adverse events observed by the Johnson & Johnson COVID-19 vaccine. The decision for a momentary pause in the distribution of the vaccine enacted out of “an abundance of caution” illustrates how swiftly the agencies acted on vaccine surveillance data.

Consumers should be comforted to know that the vaccine safety monitoring system in place to protect them is working effectively, and further encourages transparency, following the reports of severe cases of a rare form of blood clots observed in young women. The pause allowed the agencies to gather and review additional evidence to ensure the safety of the American people.

Over 560,000 Americans have already died from COVID-19. The risk Americans face for dying from COVID-19 is one in 600 persons. While the risk of dying from COVID clearly outweighs the risk of forming blood clots from the vaccine, we commend the efforts of public health officials to evaluate the specific effects of the vaccine on women, to help ensure further safety and efficacy.

Due to its ease of transport and one-shot delivery, the Johnson & Johnson COVID-19 vaccine is the most accessible and convenient vaccine presently available. The vaccine has been administered to over 7 million Americans, with overwhelming success. Further delay of administering this vaccine only delays our ability to end the pandemic that much sooner.

The reports of adverse events experienced by patients who received the Johnson & Johnson COVID-19 vaccine are concerning and we appreciate the transparency afforded to the public during this time to identify and resolve the situation. NCL has long advocated for vaccine safety and for consumers to feel confident that they are safe, especially in the midst of a mass vaccination campaign.

In closing, we encourage the CDC to maintain effective public messaging to instill vaccine confidence. Consumers should rest assured that vaccines are effective measures to protect public health and vital to national efforts in ending the pandemic.

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

Sincerely,

Jeanette Contreras, MPP
Director of Health Policy
National Consumers League

###

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.

NCL statement on pause on J&J vaccine distribution

/in , , , /by

April 14, 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) commends the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) for their concerted efforts to promptly address recent adverse events observed by the Johnson & Johnson COVID-19 vaccine.

The decision for a momentary pause in distribution for the vaccine was enacted out of “an abundance of caution” on part of the CDC and FDA, following reports of 6 severe cases of a rare form of blood clots observed in young women, ranging from ages 18 to 48, roughly one to three weeks after receiving the shot.

Due to its ease of transport and one-shot delivery, the Johnson & Johnson COVID-19 vaccine is the most accessible and convenient vaccine presently on the market. The vaccine has been administered to more than 7 million Americans, with tremendous success. The measure to pause distribution to gather additional evidence is demonstrative of proper coordination between our most essential public health agencies.

The reports of adverse events experienced by patients who received the Johnson & Johnson COVID-19 vaccine are concerning, and NCL appreciates the efforts by public and industry partnerships to identify and resolve the situation. NCL has long advocated for vaccine safety and consumers need to feel confident that they are safe, especially in the midst of a mass vaccination campaign.

All three COVID-19 vaccines on the market have been shown to be effective against preventing severe symptoms and hospitalization from COVID-19. The incidence of adverse outcomes is very rare and should be put into context with the overwhelming benefits of the vaccine to prevent very serious effects of COVID transmission. Consumers should rest assured that vaccines are effective measures to protect public health and are vital to national efforts in ending the pandemic.

###

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.

National Consumers League applauds House passage of American Rescue Plan

/in , , /by

March 10, 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 House of Representatives’ action to approve President Joe Biden’s relief package, known as the American Rescue Plan.

“The American Rescue Plan is a monumental relief package and critical antipoverty measure that will give desperately needed support to average Americans who have been devastated by COVID-19, including sending out $1,400 checks and funding states’ efforts to streamline and speed up vaccine distribution. This is a much-needed measure, and we are grateful to the Administration and Congress for their round-the-clock work in getting this essential support into the pockets of hard working Americans,” said NCL Executive Director Sally Greenberg.

With the 220-211 House vote, the bill will go to the President’s desk for signature. NCL applauded specific measures included in the legislation:

  • $300 federal boost to weekly jobless payments and extension of two key pandemic unemployment benefits programs through September 6.
  • Expansion of the child tax credit to up to $3,600 per child and $3,000 for each child under age 18 . Currently, families can receive a credit of up to $2,000 per child under age 17.
  • The first $10,200 worth of benefits payments are tax-free for households with annual incomes less than $150,000.
  • The Pandemic Unemployment Assistance program, which provides benefits to freelancers, gig workers, and independent contractors.
  • The Pandemic Emergency Unemployment Compensation program, which increases the duration of payments for those in the traditional state unemployment system.
  • $350 billion in relief to states, local governments, territories. and tribes.
  • $10 billion Coronavirus Capital Projects Fund.
  • 15 percent increase in food stamp benefits through September (it was previously set to expire at the end of June).
  • $880 million for the Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC, to help increase participation and temporarily improve benefits, among other measures.
  • $30 billion to help renters and landlords weather economic losses.

“It’s a great relief that passage of the bill comes ahead of a Sunday deadline, when a federal boost to unemployment benefits was set to expire,” said Greenberg.

###

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.
[/av_textblock]

Jeanette Contreras portrait

La tercera vacuna trae esperanza

/in , , , , , /by

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

/in , , /by

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.

NCL testimony before FDA on Janssen Biotech COVID-19 vaccine

/in , , , /by

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

February 26, 2021

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.

Hana El Sahly, M.D., 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-0173; for Vaccines and Related Biological Products Advisory Committee

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.

Emergency Use Authorization (EUA)

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation’s pandemic strategy. NCL appreciates the FDA’s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.

Safety and Effectiveness

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.

Health Equity

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.

Sincerely,

Nissa Shaffi
Associate Director of Health Policy
National Consumers League

 

###

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.
[/av_textblock]

Preventing the spread of COVID-19: Testing & genetic sequencing efforts in response to emerging variants

/in , , /by

With growing concerns regarding the impact of emerging COVID-19 variants, testing and genetic sequencing are critical components of broader return-to-work, return-to-school, and public health surveillance efforts.

Read more