Bivalent COVID-19 Targeting Vaccine Formula Approved as Booster for 5-11 Year Olds

On October 12, 2022, the US Food and Drug Administration (FDA) amended the previously issued emergency use authorizations (EUAs) for both the Moderna COVID-19 and Pfizer-BioNTech COVID-19 bivalent vaccine formulas, authorizing their use as a single booster dose for those 5-11 years old. Following FDA’s announcement, Centers for Disease Control (CDC) released a decision memo, signed by Director Rochelle Walensky, expanding the recommendations for the use of bivalent vaccines matching the EUA expansions. As such, the Moderna formulation is now available for use in children six and older, at least two months post-completion of a primary series or previous booster dose. The Pfizer formulation is now authorized for use in children five and older, at least two months post-completion of a primary series or booster dose.

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. Indian country has had highly successful vaccine rollouts and urban Indian organizations (UIOs) have been instrumental in the success of vaccinating AI/AN populations in urban areas. As of October 2022, AI/ANs have some of the highest vaccination administration rates in the US with 75.7% of AI/ANs having received at least one dose, and 62.9% having completed the primary series. However, just under half of AI/ANs (47.3%) have received their first booster, and even less have received the second booster dose (37.4%), per CDC data.

The National Council of Urban Indian Health (NCUIH) will continue to monitor and provide updates on any changes in COVID-19 vaccine guidance, or other COVID-19 updates. For more information on the changes to COVID-19 vaccine guidance or the success UIOs have had with the vaccine rollout, see below:

• Urban Indian Organizations: Key Partners for COVID-19 Vaccination Equity
• New Omicron Targeting Vaccine Formula Approved as Booster Dose for Individuals 12 years and Older
• CDC Endorses Fourth COVID-19 Vaccine for Adults
• NCUIH Endorses Bicameral Bill that Extends Grants to Urban Indian Organizations to Treat Long COVID