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New COVID-19 Boosters Against Subvariants Coming Soon

Image of Marine on right gets a COVID-19 booster vaccination from a nursing student on his left. Ian Sheer, Keller Army Community Hospital at West Point nursing student, administers a COVID-19 booster to Master Sgt. Jose Rivera, 1179th Transportation Surface Brigade, during a COVID-19 booster shot clinic at the Fitness Center, U.S. Army Garrison Fort Hamilton, New York, Feb. 24, 2022. The DOD remains committed to protecting our service members, civilian employees, and families around the globe; safeguarding our national security capabilities; and supporting the whole-of nation response to COVID-19.

Public health experts say COVID-19 cases are anticipated to spike again this fall, but new vaccine versions expected to be released soon will target subvariants that dominate cases in the United States.

These updated vaccines to be available as a single-dose booster sometime after Labor Day are termed “bivalent” vaccines, meaning they work by stimulating an immune response against two different antigens.

The Food and Drug Administration and the Centers for Disease Control and Prevention are anticipated to authorize and recommend the Pfizer bivalent vaccine as a booster for those age 12 and older and the Moderna version for those 18 years and older. However, per the FDA, the bivalent vaccines will not be able to be administered as a primary series.

The new COVID-19 bivalent booster combines the original strain with the Omicron subvariants BA.4 and BA.5 and will be distributed under FDA Emergency Use Authorization (EUA). Pfizer and Moderna applied for EUAs for their bivalent products on Aug. 22 and Aug. 23, respectively.

The BA.4 and BA.5 subvariants account for more than three-quarters of COVID-19 infections in the country. The subvariants also account for the majority of cases worldwide, according to the CDC.

The FDA and CDC decisions are expected to occur prior to or just after the Labor Day holiday, said Air Force Col. Tonya Rans, chief of the Defense Health Agency Immunization Health Division.

Pfizer and Moderna anticipate quickly shipping their messenger RNA (mRNA) bivalent vaccines in September pending authorization.

Since the bivalent vaccines will be issued under emergency use authorization, getting this booster shot is not required, but highly recommended.

For Military Health System beneficiaries, the Department of Defense does not currently mandate booster shots, but does require that service members and other beneficiaries must have first received a primary series from one of the available vaccines before getting the bivalent booster.

Will I Be Able to Find a Bivalent Shot?

Military medical treatment facilities are pre-ordering the new vaccines, and there is not a supply issue anticipated, Rans noted. The Department of Health and Human Services has secured more than 171 million doses of the bivalent boosters for distribution.

CDC has not yet decided what the minimum interval between your most recent COVID-19 vaccine shot and the new bivalent booster will be. “However, we expect a decision soon after a CDC meeting on September 1 or 2,” Rans said.

The CDC published a chart that shows the schedule for primary series and boosters and clinical considerations for four FDA authorized or approved vaccines, including the latest authorized from Novavax. That vaccine received EUA only as a two-shot primary series for those 12 and older.

Novavax cannot be administered as a booster dose at this time.

All current COVID-19 vaccine booster doses are available under an EUA. The primary doses of Pfizer and Moderna’s vaccines have full FDA approval, while Johnson & Johnson/Janssen and Novavax are available as an EUA.

The Johnson & Johnson/Janssen vaccine should only be used in “very limited situations for primary and booster vaccinations,” CDC said.

Authorized in December 2020, the original vaccines were designed to protect against serious consequences of the COVID-19 pandemic that began in March 2020. Those shots and then boosters also protect against the Delta variant that began circulating in June 2021 as well as the Omicron B.1 variant, which began showing up in November 2021.

The BA.4 and BA.5 subvariants evolved from the Omicron mutation in early 2022. They are more contagious and can bypass the immunity you may have developed from a past infection or vaccination, according to federal experts.

Bivalent Shots and Flu

The availability of the new bivalent boosters will coincide with the traditional influenza vaccination season. A COVID-19 booster and the flu vaccine can be given at the same time, Rans emphasized.

DOD will begin shipping the 2022-2023 influenza vaccines right after Labor Day, she said. DOD expects HHS to begin shipping the Pfizer and Moderna bivalent boosters around the same time, pending authorization.

The flu is expected to show a resurgence this year after two slower seasons, and the infection season is expected to start earlier, federal experts have predicted.

The FDA is not requiring new studies in humans for the bivalent vaccines to receive an EUA, but will use data already gathered from the Delta and Omicron BA.1 variant studies and public health vaccination data.

The agency has directed that there will be new clinical studies on the BA.4 and BA.5 boosters from manufacturers that will be reviewed at a later date to see if the results can support full FDA approval.

The FDA’s Dr. Peter Marks, who has vaccine oversight at the agency, said he expects “this coming year to be a transitional period” for COVID-19.

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Consolidated Department of Defense Coronavirus Disease 2019 Force Health Protection Guidance

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Consolidates and updates the Department’s guidance regarding vaccination verification, vaccination status, COVID-19 testing, surveillance and screening testing, personnel protection on-site mask requirements, (e.g., DHA military medical treatment facilities, meetings, travel), and the protection of personally identifiable information.

  • Identification #: 22-006
  • Date: 8/18/2022
  • Type: Memorandums
  • Topics: COVID-19

DHA-IPM 20-004: Department of Defense (DOD) Coronavirus Disease 2019 (COVID-19) Vaccination Program Implementation

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Establishes the Defense Health Agency’s procedures to implement instructions, assign responsibilities, and prescribe procedures for the DHA’s implementation of the DOD’s COVID-19 Vaccination Program.

  • Identification #: DHA-IPM 20-004
  • Date: 6/16/2022
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Coronavirus Disease 2019 Vaccination Attestation, Screening Testing, and Vaccination Verification

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This memorandum provides guidance on the implementation of vaccination, attestation, and testing requirements in accordance with the References listed in Attachment 1 to reduce the transmission of the virus that causes COVID-19.

  • Identification #: 21-004
  • Date: 11/3/2021
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Medical Logistics Guidance for the DoD Coronavirus Disease 2019 (COVID-19) Vaccination Program

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Establishes the DHA's procedures for ordering, receiving, and managing COVID-19 Vaccines inventory and ancillary kits for enduring COVID-19 support.

  • Identification #: 6025.01
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TAB A MEO COVID19 Medical Coding Policy

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Memorandum for DHA Staff - Military Medical Treatment Facilities to Implement Updated DHA COVID-19 Medical Coding Policy

  • Identification #: N/A
  • Date: 3/25/2021
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DHA COVID19 Medical Coding PolicyV5 1v

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Establishes the DHA procedures to standardize the coding for Coronavirus 2019 (COVID-19) within military medical treatment facilities (MTFs). This memorandum replaces DHA-Policy Memorandum 20-003 of July 1, 2020. Attachment 1 was updated to include the 2021 procedure and diagnosis codes for COVID-19, including the new vaccination and treatment codes.

  • Identification #: 20-003
  • Date: 3/25/2021
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Supplemental Guidance for Providing DOD Coronavirus Disease 2019 Vaccines to DOD Contractor Employees and Select Foreign Nationals

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This memorandum provides supplemental guidance on the provision of coronavirus disease 2019 (COVID-19) vaccines, in accordance with reference (a). The Defense Health Agency (DHA) is the lead coordinating DOD Component for executing this guidance, in coordination with the Military Departments and other DOD Components as appropriate.

  • Identification #: N/A
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HA Guidance for Coronavirus Disease 2019 (COVID-19) Laboratory Pre-Testing Questionnaire

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This memorandum provides guidance for a COVID-19 laboratory pre-testing questionnaire that will be mandatory for all Active Duty Service members and encouraged for all other DOD beneficiaries treated at military medical treatment facilities.

  • Identification #: N/A
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This EO outlines who should receive priority access to COVID-19 vaccines developed in the United States or procured by the United States Government (“United States Government COVID-19 Vaccines”).

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Coronavirus Disease 2019 Vaccine Guidance

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Establishes the DHA's plan to return to full operations and support the whole-of-government response, during the Coronavirus Disease 2019 (COVID-19) pandemic

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The Defense Health Agency (DHA) Memorandum, based on the authority of References (a) and (b), and in accordance with the guidance of References (c) and (d), establishes the DHA’s procedures to standardize the coding for Coronavirus 2019 (COVID-19) Military Medical Treatment Facilities (MTFs). This memorandum cancels and replaces DHA- Policy Memorandum 20-003 of (13 April 2020). A change was issued since the cancelled Memorandum 20-003 of (13 April 2020), the Attachment titles were updated to reflect that Attachments 1, 2, and 4 are considered Policies as opposed to Guidance.

  • Identification #: 20-003
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Last Updated: May 04, 2023
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