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New Omicron Targeting Vaccine Formula Approved as Booster Dose for Individuals 12 years and Older

On August 31, 2022, the US Food and Drug Administration (FDA) amended the previously issued emergency use authorizations (EUAs) for both the Moderna and the Pfizer-BioNTech (Pfizer) COVID-19 vaccines to authorize the use of bivalent formulations for boosters. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend both the Moderna and Pfizer bivalent formulation boosters on September 1, 2022. This new formulation, which can be administered at least two months following the completion of a primary series or a previous booster dose, targets both the original virus and the current Omicron variants.  During a monthly call with Tribal and urban Indian organization (UIO) leaders, the Indian Health Service (IHS) stated that it started shipping the bivalent formulation the week of Labor Day and that these boosters will replace all booster formulations once rolled out. Currently, Omicron variants make up more than 99% of COVID-19 cases within the US.

As it stands, the monovalent (original) COVID vaccine is no longer the recommended booster for people ages 12 and up. In order for an individual to be considered ‘up to date’ on their COVID vaccination, they must have received the bivalent booster, regardless of previous booster status. Individuals who have previously caught COVID-19 can be vaccinated up to three months after the infection.

Background

American Indians and Alaska Natives (AI/ANs) have been disproportionately affected by the COVID-19 pandemic. At the height of the pandemic, AI/ANs were 3.5 times more likely to test positive, 3.2 times more likely to be hospitalized, and 2.2 times more likely to die to due COIVD-19.

Indian Country has had highly successful vaccine rollouts and UIOs have been instrumental in the success of vaccinating AI/AN populations in urban Areas. As of August 2022, AI/ANs have the highest vaccination administration rates in the US with 74.5% of AI/ANs having received at least one dose of one of the three previously available COVID-19 vaccines, per CDC data.

CDC Endorses Fourth COVID-19 Vaccine for Adults

On Tuesday, July 19, 2022, the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation for Novavax’s COVID-19 vaccine as another primary series option for adults 18 and older. Novavax’s vaccine, Adjuvanted, was granted an emergency use authorization on July 13, 2022, by the US Food and Drug Administration.

The Novavax vaccine, Adjuvanted, is another two-dose vaccine that will be available to administer to adults 18 and older in the coming weeks. The Novavax vaccine is administered three weeks apart and uses a more traditional technology for vaccine delivery. In total, there are now four different COVID-19 vaccines for adults 18 and older to choose from; Moderna, Pfizer, Johnson & Johnson, and Novavax.

Background

American Indians and Alaska Natives (AI/ANs) have been disproportionately affected by the COVID-19 pandemic. At the height of the pandemic, AI/ANs were 3.5 times more likely to test positive, 3.2 times more likely to be hospitalized and 2.2 times more likely to due to du COIVD-19.

Indian Country has had highly successful vaccine rollouts and Urban Indian Organizations have been instrumental in the success of vaccinating AI/AN populations in urban Areas. As of July 2022, AI/ANs have the highest vaccination administration rates in the US with 73% of AI/ANs having received at least one dose of one of the three previously available COVID-19 vaccines, per CDC data.

CDC Expands Eligibility of COVID-19 Boosters for Youth

On Thursday, May 19th, the Centers for Disease Control and Prevention (CDC) expanded eligibility of COVID-19 vaccine boosters for everyone 5-years and older. This expansion follows a meeting of the Advisory Committee on Immunization Practices’ (ACIP) and its recommendations. With this expansion of eligibility, the CDC recommendations for children are the following:

  • Children 5-11 years old should receive a booster shot 5 months post initial series of the Pfizer-BioNTech vaccine
  • Children 12 and older, who are immunocompromised, should receive a second booster at least 4 months after their first booster.

If you are eligible for a booster, be it the first or second dose of such, and you have not had one since December 2021, now is the time to do so. To see if you are eligible for a booster, click here.

COVID-19 and Native Communities

American Indians and Alaska Natives (AI/ANs) have been disproportionately affected by the COVID-19 pandemic. At the height of it, AI/ANs were 3.5 times more likely to test positive, 3.2 times more likely to be hospitalized, and 2.2 times more likely to die due to COVID-19. Since the pandemic began, nearly 5 million kids, ages 5 to 11, have been diagnosed with COVID, 15,000 have been hospitalized, and over 180 have died.

Indian Country has had highly successful vaccine rollouts and Urban Indian Organizations (UIO) have been instrumental in the success of vaccinating AI/AN populations in urban areas. As of June 2022, AI/ANs have the highest vaccination administration rates in the U.S with 73% of AI/ANs having received at least one dose of the COVID-19 vaccine, according to CDC Vaccine Administration Data. As of June 2022, UIOs that use IHS vaccine distribution have administered over 174,105 doses of the COVID-19 vaccine and fully vaccinated 67,883 people.

NCUIH Endorses Bicameral Bill that Extends Grants to Urban Indian Organizations to Treat Long COVID

On April 7, 2022, Representative Ayanna Pressley (D-MA-07) and Senator Tammy Duckworth (D-IL) introduced the bicameral Targeting Resources for Equitable Access to Treatment for Long COVID (TREAT Long COVID) Act (H.R. 7482/S. 4015) to increase access to medical care and treatment for communities and individuals struggling with Long COVID. Specifically, this legislation would establish a grant program for eligible entities, including urban Indian organizations (UIOs), for the purpose of creating or enhancing capacity to treat patients with Long COVID through a multidisciplinary approach. The bill authorizes up to $2 million in grant funding to eligible entities and the period of a grant shall be up to three years, with an opportunity for renewal.

The TREAT Long COVID Act is co-sponsored by Rep. Donald Beyer (D-VA-8), Rep. Lisa Rochester (D-DE-1), Sen. Tim Kaine (D-VA), and Sen. Edward J. Markey (D-MA). The National Council of Urban Indian Health (NCUIH) endorses this bill that brings critical funding to UIOs to treat the lasting effects of COVID on the American Indian/Alaska Native (AI/AN) community.

“NCUIH is pleased to endorse Rep. Ayanna Pressley and Sen. Tammy Duckworth’s Targeting Resources for Equitable Access to Treatment for Long COVID Act. The COVID-19 pandemic has disproportionately impacted Native communities and we are left to deal with the devastating lasting impacts of this disease. We are grateful for the inclusion of urban Indian organizations to be eligible for these critical grants to address Long COVID conditions,” – Francys Crevier (Algonquin), CEO, NCUIH.

Next Steps

The bill was referred to the House Energy and Commerce and Senate Health, Education, Labor, and Pensions Committees. It currently awaits consideration. This bill has been added to the NCUIH legislative tracker and can be found here.

Background

Native communities face some of the harshest disparities in health outcomes of any population in the U.S. and are disproportionately impacted by the COVID-19 pandemic. American Indians and Alaska Natives have infection rates over 3.5 times higher than non-Hispanic whites, are over 3.2 times more likely to be hospitalized as a result of COVID-19 and have higher rates of mortality at younger ages than non-Hispanic whites.

The impact of COVID-19 on American Indian and Alaska Native health will continue beyond the pandemic. Lasting illness such as Long COVID need to be addressed.

NCUIH Resource: American Indian/Alaska Native Data on COVID-19

The TREAT Long COVID Act would expand treatment for Long COVID nationwide by:

  • Authorizing the Department of Health and Human Services to award grants up to $2,000,000 to health care providers, including community health centers;
  • Granting funding for the creation and expansion of multidisciplinary Long COVID clinics to address the physical and mental health needs of patients;
  • Prioritizing funding for health providers that plan to engage medically underserved populations and populations disproportionately impacted by COVID-19;
  • Ensuring that treatment is not denied based on insurance coverage, date or method of diagnosis, or previous hospitalization;
  • Encouraging ongoing medical training for physicians in Long COVID Clinics and other health care workers serving patients; and
  • Requiring grantees to submit an annual report on its activities that includes evaluations from patients.

Full Text of the House Bill

Full Text of the Senate Bill

Resource: American Indian/Alaska Native Data on COVID-19 Document Released on NCUIH Website

The National Council of Urban Indian Health (NCUIH) recently released an infographic about American Indian/Alaska Native (AI/AN) Data on COVID-19 on the NCUIH website. This document shows the disproportionate impacts of the COVID-19 pandemic on AI/ANs and Indian Country’s success with vaccinations for the virus. Native communities face some of the harshest disparities in health outcomes of any population in the U.S. and are disproportionately impacted by the COVID-19 pandemic. The impact of COVID-19 on American Indian and Alaska Native health will continue beyond the pandemic. Loss of American Indian and Alaska Native lives—especially the loss of elders—means loss of Native culture, including language, ceremonies, and more.

View the resource

Disproportionate Rates of COVID-19 Cases, Hospitalizations, and Mortality Among AI/ANs

American Indians and Alaska Natives have infection rates over 3.5 times higher than non-Hispanic whites, are over 3.2 times more likely to be hospitalized as a result of COVID-19 and have higher rates of mortality at younger ages than non-Hispanic whites.

AI/AN Children and Orphanhood Due to COVID-19

1 of every 168 AI/AN children experienced orphanhood or death of caregivers due to the pandemic, and AI/AN children were 4.5 times more likely than white children to lose a parent or grandparent caregiver.

Indian Country Lead on Vaccination Rates

As of February 2022, AI/ANs have the highest vaccination administration rates in the U.S with 70.6% of AI/ANs having received at least one dose of the COVID-19 vaccine, according to CDC Vaccine Administration Data. As of January 2022, UIOs that use IHS vaccine distribution have administered over 164,095 doses of the COVID-19 vaccine and fully vaccinated 65,957 people.

AI/AN Food Insecurity and COVID-19

NCUIH Endorses Bill to Understand and Address Long COVID, Including in Urban Indian Communities

On March 3, 2022, Senator Tim Kaine (D-VA) introduced the Comprehensive Access to Resources and Education (CARE) for Long COVID Act (S. 3726). This bill would improve research on long COVID as well as expand resources for those dealing with the long-term impacts of the virus. Specifically, the bill authorizes $50 million for each of fiscal years 2023 through 2027 to fund grants to eligible entities, including Tribes, Tribal organizations, and urban Indian organizations (UIOs), to support legal and social service assistance for individuals with long COVID or related post-viral illnesses. Additionally, UIOs are included in outreach and research activities of the long-term symptoms of COVID–19 by the Patient-Centered Outcomes Research Trust Fund.

“The National Council of Urban Indian Health (NCUIH) is pleased to endorse Senator Kaine’s Comprehensive Access to Resources and Education (CARE) for Long COVID Act. The pandemic has taken a disproportionate toll Indian Country and the public health crisis continues to affect Native communities experiencing symptoms of long COVID. This bill is a step in the right direction to better understand the long-term effects of the virus and provide support for those suffering.” – Francys Crevier (Algonquin), CEO, NCUIH.

The Comprehensive Access to Resources and Education (CARE) for Long COVID Act is co-sponsored by Senators Richard Blumenthal (D-CT), Tammy Duckworth (D-IL), Edward Markey (D-MA), and Tina Smith (D-MN). The bill was referred to the Senate Health, Education, Labor, and Pensions Committee. It currently awaits consideration.

This bill has been added to the NCUIH legislative tracker and can be found here.

Background

The COVID-19 pandemic has had devastating and disproportionate impacts on American Indians/Alaska Natives and continue to feel the lingering effects of the virus. This legislation aims to address this issue by:

  • Accelerating research by centralizing data regarding long COVID patient experiences;
  • Increasing understanding of treatment efficacy and disparities by expanding research to provide recommendations to improve the health care system’s responses to long COVID;
  • Educating long COVID patients and medical providers by working with the CDC to develop and provide the public with information on common symptoms, treatment, and other related illnesses;
  • Facilitating interagency coordination to educate employers and schools on the impact of long COVID and employment, disability, and education rights for people with long COVID; and
  • Developing partnerships between community-based organizations, social service providers, and legal assistance providers to help people with long COVID access needed services.

 

Senate Text of Bill

Senator Kaine’s Press Release

CDC and FDA Approve COVID-19 Boosters for Certain Individuals

On March 29, 2022, the Food and Drug Administration (FDA) authorized secondary booster doses of either Pfizer-BioNTech or Moderna COVID-19 vaccines for older adults and certain immunocompromised individuals. The Centers for Disease Control and Prevention (CDC) also updated its recommendations following the approval. The updated CDC recommendations acknowledge the increased risk of severe COVID-19 for the elderly, those over the age of 50 with underlying conditions, and are given based on available data on vaccine and booster effectiveness and FDA recommendations.

The FDA amended the emergency use authorizations with the following:

  • Individuals 50 years of age and older, who received their first booster of any authorized or approved COVID-19 vaccine at least 4 months prior, may receive a second booster dose of either the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 vaccine
  • Individuals 12 years of age and older with certain immunocompromises, who received their first booster dose of any authorized or approved COVID-19 vaccine at least 4 months prior, may receive a second booster dose of the Pfizer-BioNTech COVID-19 vaccine.
  • Individuals 18 years of age and older, who received their first booster dose of any authorized or approved COVID-19 vaccine at least 4 months prior, may receive a secondary booster dose of the Moderna COVID-19 vaccine.

Background

American Indians and Alaska Natives (AI/ANs) have been disproportionately affected by the COVID-19 pandemic. At the height of it, AI/ANs were 3.5 times more likely to test positive, 3.2 times more likely to be hospitalized and 2.2 times more likely to die due to COVID-19. Due to NCUIH advocacy, UIOs were included in initial vaccine rollout plans and efforts.  NCUIH also partnered with Native American Lifelines – Baltimore and the University of Maryland to create a vaccine clinic for urban AI/ANs in the DC area.