Clinical Guidance for COVID-19 Booster Doses

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In this issue: COVID-19 Vaccines Authorized for Use as a Single Booster Dose | Booster Recommendations | Heterologous (mix-match) Booster Dose | Who is Fully Vaccinated? | Documentation | Moderna Guidance for 0.25 mL Dose | COVID-19 Vaccine Data

COVID-19 Vaccines Authorized for Use as a Single Booster Dose

The Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for COVID-19 vaccines to allow for expanded use of a single booster dose in eligible populations. Providers may begin administration of COVID-19 vaccine booster doses for the populations covered under the EUA. Providers should confirm with individuals that they received a primary COVID-19 vaccine series; review the COVID-19 vaccine record and look in MCIR. 

The three COVID-19 vaccines are currently approved under a Biologics License Application (BLA) or authorized under an EUA by the FDA are:

• Pfizer-BioNTech COVID-19 vaccine (COMIRNATY)
• Moderna COVID-19 vaccine
• Janssen (J&J) COVID-19 vaccine

COVID-19 Vaccine Booster Recommendations

Any of the COVID-19 vaccines can be used for booster vaccination, regardless of the vaccine product used for primary vaccination.

mRNA (Pfizer or Moderna) COVID-19 vaccines

Individuals who have received an mRNA primary vaccine series should receive a single COVID-19 booster dose (Pfizer, Moderna or J&J) at least 6 months after completion of the primary series:

• People aged 65 years and older
• Residents aged 18 years and older in long term care settings
• People aged 50–64 years with certain underlying medical conditions

Individuals who received an mRNA primary vaccine series may receive a single COVID-19 booster dose (Pfizer, Moderna or J&J) at least 6 months after completing their primary series based on their individual benefits and risks:

• People aged 18–49 years with certain underlying medical conditions
• People aged 18–64 years at increased risk for SARS-CoV-2 exposure and transmission because of occupational or institutional setting

Janssen/Johnson & Johnson COVID-19 vaccine

Individuals 18 years and older who received a single dose Janssen primary COVID-19 vaccine should receive a single COVID-19 booster dose (Pfizer, Moderna or J&J) at least 2 months (8 weeks) after completing their Janssen primary series.

Moderately to severely immunocompromised individuals and COVID-19 vaccine booster dose

Immunocompromised persons who received their 2-dose mRNA primary series and the additional (3rd) mRNA vaccine are recommended to receive ANY COVID-19 vaccine booster (Pfizer, Moderna, J&J) dose 6 months or more after the additional (3rd) mRNA vaccine dose.

• See COVID-19 Vaccine Dose Volume below. Note that for this booster dose Moderna is 0.25 mL.

• Immunocompromised individuals who received J&J are not recommended for an additional (3rd) dose. They are recommended to receive a booster dose.
  • Give any COVID-19 vaccine (Pfizer, Moderna, J&J) booster dose, 2 or more months after the primary J&J dose.
  • If Moderna is used for the booster dose see COVID-19 Vaccine Dose Volume below. Moderna will be 0.25 mL.

COVID-19 Vaccine Dose Volume

* This is half the amount used for the primary series and additional dose.

Resources 

CDC Vaccine Specific Product Information Updated
CDC is updating several of their vaccine specific clinical guidance documents. The standing orders have recently been updated for each COVID-19 vaccine and can be found under the specific vaccine tab on the website.

Flowchart: Who is eligible for an extra dose of COVID-19 vaccine? (pdf)

Infographic: Who is eligible for an extra dose of COVID-19 vaccine? (png)

Heterologous (mix-match) Booster Dose

A heterologous booster dose may be considered. People have the option to receive any of the FDA-approved or FDA-authorized COVID-19 booster products (Pfizer, Moderna [half dose] or J&J).

• Discuss the benefits and risks of each vaccine with your patients.

• When using Moderna vaccine for the booster, the dose is 0.25mL regardless of what vaccine was used for the primary vaccination.

Who is Fully Vaccinated?

Everyone is still considered fully vaccinated two weeks after their second dose in a two-dose series mRNA (Pfizer or Moderna) vaccine series, or two weeks after a single-dose Janssen COVID-19 vaccine.

• Administration of an additional dose or a booster dose is not required to be considered fully vaccinated for public health purposes at this time.
• People who have received an additional dose or a booster dose should continue to follow guidance for fully vaccinated persons to minimize spread of COVID-19 to others at this time.

Documentation

CDC requires COVID-19 Immunizing Providers to report doses to the MCIR within 24 hours of administration for all ages receiving COVID-19 vaccines. Be sure to document in the patient’s paper or electronic medical record.

• Special note for Moderna 0.25 mL booster dosage: The MCIR will accept Moderna 0.25 mL booster doses. However, this may not be reflected as a 0.25 mL dose in the MCIR as we have not been provided updated codes (CVX or NDC) specific to this dosage. It will be reflected as a 0.5 mL dose in the MCIR when you report it as a booster dose. MCIR enhancements are in progress regarding dosage.

Moderna Specific Guidance Related to the 0.25 mL Dose

The current Moderna product is used for both primary and booster dose vaccination, overall storage and handling guidance remains the same except for the following key points:

A maximum of 20 doses (booster and/or primary doses) may be withdrawn from the vial.

• When 20 doses have been withdrawn, the vial and any residual vaccine should be discarded appropriately.
• Do not pool excess vaccine from multiple vials.
• Do not puncture the vial stopper more than 20 times.
• As a reminder, once punctured, a vial may be stored between 2° to 25°C (36° to 77°F) for up to 12 hours. Record the date and time of first use on the Moderna vaccine vial label.

For questions regarding Moderna terminology, outbreak inventory reporting, and waste reporting, refer to the Moderna COVID-19 Vaccine Key Points document.

COVID-19 Vaccine Data

According to the Michigan First-Dose Tracker*, 69% of Michiganders 16 and over have received at least one dose of the COVID-19 vaccine as of October 28. A total of 10,183,359 vaccines have been administered in Michigan as of October 25.

* Progress is based on the CDC data tracker, which includes MI residents vaccinated by providers not currently reporting to the state dashboard: Veterans Affairs, Department of Defense, Bureau of Prisons, and most out-of-state providers.

For the most current information, please visit Michigan.gov/Coronavirus.