Moderna COVID-19 Vaccine

Updates on 2/22/2022

• Moderna materials have been updated to include the updated Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States posted on February 22, 2022.

Updates on 2/22/2022

• The following have been updated to reference the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States posted on February 22, 2022.

Updates on 10/26/2021

• The following have been updated to reference the Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States:
• Moderna COVID-19 Vaccine Storage and Handling Summary

Primary Series
Multidose vial: maximum of 15 doses per vial
Dosage: 0.5 mL

Booster Dose
Multidose vial: maximum of 20 doses per vial
Dosage: 0.25 mL

Do NOT mix with a diluent.

Discard vial when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.

18 years of age and older

mRNA COVID-19 vaccines are preferred over Janssen COVID-19 Vaccine for primary series and booster doses.

Primary Series:

2-dose series separated by at least 4-8 weeks*
A series started with Moderna COVID-19 vaccine should be completed with this product.

*An 8-week interval may be optimal for some people ages 12 years and older, especially for males ages 12 to 39 years. A shorter interval (3 weeks for Pfizer-BioNTech; 4 weeks for Moderna) between the first and second doses remains the recommended interval for:

• people who are moderately or severely immunocompromised;
• adults ages 65 years and older; and
• others who need rapid protection due to increased concern about community transmission or risk of severe disease.

Additional Primary Dose:

Moderately and severely immunocompromised people: Administer an additional primary dose at least 4 weeks after the initial 2-dose primary series.

Booster Dose:

• Persons who ARE NOT moderately or severely immunocompromised : Administer a booster dose at least 5 calendar months after the last dose of COVID-19 mRNA vaccine primary series (i.e., 2nd dose)
• Persons who ARE moderately or severely immunocompromised: Administer a booster dose at least 3 months (12 weeks) after the additional primary dose of COVID-19 mRNA vaccine series (i.e., 3rd dose).
• A Moderna booster dose is 0.25 mL.
• The booster dose may be a different product than the primary series. However, mRNA COVID-19 vaccines are preferred.
• Some people may be able to receive a second booster dose. Learn more about considerations for COVID-19 vaccine booster doses.
• For detailed information see Interim COVID-19 Immunization Schedule for Ages 5+pdf icon

Intramuscular (IM) injection in the deltoid muscle

• Contraindications:
  • History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
  • Known diagnosed allergy to a component of the vaccine
  • History of thrombosis with thrombocytopenia syndrome (TTS) following receipt of a previous Janssen COVID-19 Vaccine (or other COVID-19 vaccines not currently authorized in the United States that are based on adenovirus vectors)
    • Additionally, people with a history of an episode of immune-mediated syndrome characterized by thrombosis and thrombocytopenia, such as spontaneous or classic HIT, should not receive Janssen COVID-19 Vaccine. These people should receive an mRNA COVID-19 vaccine.
• Precautions:
  • History of an immediate allergic reaction to any non-COVID-19 vaccine or injectable therapy (i.e., intramuscular, intravenous, or subcutaneous vaccines or therapies [excluding subcutaneous immunotherapy for allergies, i.e., “allergy shots”])
    • This includes non-COVID-19 vaccines or therapies with multiple components, and the component(s) that elicited the reaction is unknown.
  • History of an immediate (within 4 hours after vaccination) non-severe, allergic reaction after a dose of one type of COVID-19 vaccine (i.e., mRNA or Janssen) have a precaution to the same type of COVID-19 vaccine
  • Contraindication to one type of COVID-19 vaccines (mRNA) is a precaution to the other types of COVID-19 vaccines (Janssen).^±
  • Moderate to severe acute illness, with or without fever
  • For mRNA COVID-19 vaccines, history of myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine
  • For Janssen COVID-19 Vaccine, a history of GBS
    • People who develop GBS within 6 weeks after receipt of Janssen COVID-19 Vaccine should not receive another dose of Janssen COVID-19 vaccine. These people should receive an mRNA COVID-19 vaccine.

†An immediate allergic reaction is defined as any hypersensitivity-related signs or symptoms, such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within 4 hours following exposure to a vaccine or medication.

^± Consider consultation with an allergist-immunologist to help determine if the patient can safely receive vaccination. Healthcare providers and health departments may also request a consultation from the Clinical Immunization Safety Assessment COVID vax Project. Vaccination of these individuals should only be done in an appropriate setting under the supervision of a healthcare provider experienced in the management of severe allergic reactions.

• Vaccine may be thawed in the refrigerator or at room temperature.
  • Refrigerator: Between 2°C and 8°C (36°F and 46°F). Unpunctured vials may be stored in the refrigerator for up to 30 days.
• Room temperature: Between 8°C and 25°C (46°F and 77°F).
  • Unpunctured vials may be held at room temperature for up to 24 hours
• Do NOT refreeze thawed vaccine.
• Use vials in the refrigerator before removing vials from the freezer.
• Use CDC’s beyond-use date labels for this vaccine to track storage time at refrigerated temperatures.

1. Assess recipient status:
   • Screen for contraindications and precautions.
   • Review vaccination history.
   • Review medical considerations.
2. Follow aseptic technique. Perform hand hygiene before vaccine preparation, between patients, when changing gloves (if worn), and any time hands become soiled.*
3. Vaccine must be thawed before using. If removing the vial from the refrigerator, let it stand at room temperature for 15 minutes.
4. Unpunctured vials: Check the expiration date.
   • Scan the QR code on the outer carton, or
   • Go to modernatx.com/covid19vaccine-euaexternal iconexternal icon
   • Use CDC’s expiration date tracker to document expiration date changes.
   • Do not discard vaccine until ensuring the expiration date has passed.
     As the expiration date approaches, check the expiration date again using the same process.
     Never use expired vaccine.
     Punctured vials: Check the beyond-use time and ensure the vial stopper has not been punctured more than 20 times. Never use vaccine after the beyond-use time or puncture limit.
5. With the vial upright, gently swirl the vaccine. Do NOT shake. If the vial is shaken, contact the manufacturer.
   Note: Gently swirl the vaccine before withdrawing subsequent doses.
6. Examine the vaccine. It should be white to off-white in color and may contain white particles. Do not use if liquid contains other particulate matter or is discolored.
7. Using a new, sterile alcohol prep pad, cleanse the stopper of the multidose vaccine vial.
8. Choose the correct equipment, including the correct needle size. Use a new, sterile needle and syringe for each injection. Ensure the needle and syringe are secured tightly together.
9. Withdraw the correct dosage of vaccine into the syringe (0.5 mL for primary and additional primary doses; 0.25 mL for booster dose).⁺Ensure the prepared syringe is not cold to the touch.
   • Discard vial when there is not enough vaccine to obtain a complete dose.
   • Do NOT combine residual vaccine from multiple vials to obtain a dose.
   • Regardless of the type of syringe used, ensure the amount of vaccine in the syringe is correct.
10. Note the date and time the vial was first punctured. Keep the vaccine between 2°C and 25°C (36°F and 77°F) for up to 12 hours. Discard any unused vaccine after 12 hours.
    • Do NOT puncture vial stopper more than 20 times.

*Gloves are not required unless the person administering the vaccine is likely to come in contact with potentially infectious body fluids or has open lesions on the hands. If worn, perform hand hygiene and change gloves between patients.

⁺Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

1. Bring the dose of vaccine from the designated preparation area immediately to the patient treatment area for administration.
2. Ensure staff has the correct PPE before administering vaccines and implement policies for the use of face coverings for vaccine recipients (if tolerated).
3. Administer the vaccine immediately by intramuscular (IM) injection in the deltoid muscle.
4. Observe recipients after vaccination for an immediate adverse reaction:
   • 30 minutes: Persons with a history of

1. • •  A contraindication to another type of COVID-19 vaccine product
     • Immediate (within 4 hours of exposure) non-severe allergic reaction to a non-COVID-19 vaccine or injectable therapies
     • Immediate allergic reaction of any severity to a non-COVID-19 vaccine or injectable therapies
     • Anaphylaxis due to any cause.

• 15 minutes: All other persons

⁺Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

• Persons age 18 years and older should receive 2 doses at least 4-8 weeks apart.
  • Second doses should be administered as close to the recommended interval as possible.
  • An 8-week interval may be optimal for some people ages 12 years and older, especially for males ages 12 to 39 years.
    • Doses inadvertently given before the 4-day grace period (i.e., less than 24 days apart) should be repeated
• Both doses should be Moderna COVID-19 Vaccine.
  • Every effort should be made to determine which vaccine product was received as the first dose.
  • In exceptional situations, if the vaccine product given as the first dose cannot be determined or is no longer available, any mRNA COVID-19 vaccine product may be administered at least 28 days after the first dose.
• Moderately to severely immunocompromised people: Administer an additional dose at least 4 weeks after the initial 2-dose primary series.
  • For more information, please see Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States
• Administer booster dose:
  •  5 months after of the last dose of a COVID-19 mRNA primary series (i.e., 2^nd dose) for those who ARE NOT moderately or severely immunocompromised
  • 3 months after of the last dose of a COVID-19 mRNA primary series (i.e., 3^rd dose) for those who ARE moderately or severely immunocompromised
  • The booster dose may be a different product than the primary series; however, mRNA COVID-19 vaccines are preferred.
• COVID-19 vaccines may be coadministered with other vaccines, including simultaneous administration.

Unpunctured Vials

• Vaccine may be stored in a freezer between -50°C and -15°C (-58°F and 5°F). Do not store with dry ice or below -50°C (-58°F).

• Unpunctured Vials
  • Vaccine vials may be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) for up to 30 days.
  • Thawed vaccine cannot be refrozen.
  • Use beyond-use date labels to track how long the vaccine has been in the refrigerator.
    • Remove the box from frozen storage.
    • Complete the information on the storage label and attach it to the box holding the vaccine vials.
    • Once labeled, store vaccine in the refrigerator.

  Punctured Vials

  • Vaccine vials may be stored between 2°C and 25°C (36°F and 77°F) for up to 12 hours.
  • After a vial is punctured 20 times it should be discarded even if the 12-hour time limit has not been met.

Storage unit temperatures must be monitored regularly and checked and recorded at the beginning of each workday to determine if any excursions have occurred since the last temperature check. For accurate temperature monitoring, use a digital data logger (DDL) with a detachable probe that best reflects vaccine temperatures (e.g., probe buffered with glycol, glass beads, sand, or Teflon®). Check and record the temperature daily using a temperature log and one of the options below:

• Option 1 (preferred): Minimum/Maximum Temperatures Most DDLs display minimum and maximum (min/max) temperatures. Check and record the min/max temperatures at the start of each workday.

• Option 2: Current Temperature If the DDL does not display min/max temperatures, check and record the current temperature at the start and end of the workday. Review the continuous DDL temperature data daily.

For CDC temperatures logs, see Storage and Handling Resources below.

Temperature excursions or inappropriate storage conditions for any vaccine require immediate action. Any temperature reading outside the recommended ranges is considered a temperature excursion. Responses to temperature excursion reports are dependent on information given by the provider to the manufacturer. Completing the Vaccine Troubleshooting Record for temperature excursions can help provide needed information for manufacturers to determine the viability of the vaccine.