Vaccine Information: Moderna COVID-19 Vaccine

MODERNA COVID-19 VACCINE- cx-024414 injection, suspension
Moderna US, Inc.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE , for active immunization to prevent COVID-19 in individuals 18 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Moderna COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine-eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

Storage and Handling

The information in this Fact Sheet supersedes the information on the vial and carton labels.

During storage, minimize exposure to room light.

The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.

Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2° to 8°C (35° to 46°F)

If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2° to 8°C (35° to 46°F) when shipped using shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to 8°C (35° to 46°F) until use.

Dosing and Schedule

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID-19 Vaccine to complete the vaccination series.

Dose Preparation

• The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.
• Remove the required number of vial(s) from storage and thaw each vial before use following the instructions below.

Vial	Thaw in Refrigerator	Thaw at Room Temperature
Maximum 11-Dose Vial (range: 10-11 doses)	Thaw in refrigerated conditions between 2° to 8°C for 2 hours and 30 minutes. Let each vial stand at room temperature for 15 minutes before administering.	Alternatively, thaw at room temperature between 15° to 25°C for 1 hour.
Maximum 15-Dose Vial (range: 13-15 doses)	Thaw in refrigerated conditions between 2° to 8°C for 3 hours. Let each vial stand at room temperature for 15 minutes before administering.	Alternatively, thaw at room temperature between 15° to 25°C for 1 hour and 30 minutes.

• After thawing, do not refreeze.
• Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
• The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Visually inspect the Moderna COVID-19 Vaccine vials for other particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
• The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations:
  • A multiple-dose vial containing a maximum of 11 doses: range 10-11 doses (0.5 mL each).
  • A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5 mL each).
• Depending on the syringes and needles used for each dose, there may not be sufficient volume to extract more than 10 doses from the maximum of 11 doses vial or more than 13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and needle:
  • Each dose must contain 0.5 mL of vaccine.
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
  • Pierce the stopper at a different site each time.
• After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial label. Discard vial after 12 hours. Do not refreeze.

Administration

Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to administration. The white to off-white suspension may contain white or translucent product-related particulates. During the visual inspection,

• verify the final dosing volume of 0.5 mL.
• confirm there are no other particulates and that no discoloration is observed.
• do not administer if vaccine is discolored or contains other particulate matter.

Administer the Moderna COVID-19 Vaccine intramuscularly.

CONTRAINDICATION

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine (see Full EUA Prescribing Information) .

WARNINGS

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines ( https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

ADVERSE REACTIONS

Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. (See Full EUA Prescribing Information)

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

USE WITH OTHER VACCINES

There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS

As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the Fact Sheet) prior to the individual receiving each dose of the Moderna COVID-19 Vaccine, including:

• FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not an FDA-approved vaccine.
• The recipient or their caregiver has the option to accept or refuse the Moderna COVID-19 Vaccine.
• The significant known and potential risks and benefits of the Moderna COVID-19 Vaccine, and the extent to which such risks and benefits are unknown.
• Information about available alternative vaccines and the risks and benefits of those alternatives

For information on clinical trials that are evaluating the use of the Moderna COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Moderna COVID-19 Vaccine.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information, visit: www.cdc.gov/vsafe.