The safety of a booster dose of Moderna COVID-19 Vaccine, Bivalent is based on:
- safety data from a clinical study which evaluated a booster dose of Moderna’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
- safety data from clinical trials which evaluated primary and booster vaccination with Moderna COVID-19 Vaccine,2 and
- postmarketing safety data with Moderna COVID-19 Vaccine
The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Moderna COVID-19 Vaccine are relevant to Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process. The bivalent vaccine (Original and Omicron BA.1) contained 25 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 25 mcg of mRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 50 mcg mRNA per dose. This is the same total quantity of mRNA per dose as a dose of Moderna COVID-19 Vaccine, Bivalent for individuals 12 years of age and older and as a booster dose of Moderna COVID-19 Vaccine (previously but no longer authorized for booster vaccination in individuals 18 years of age and older), and half the total quantity of mRNA as a primary series dose of Moderna COVID-19 Vaccine for individuals 12 years of age and older. The total quantity of mRNA contained in a booster dose of Moderna COVID-19 Vaccine, Bivalent for individuals 6 through 11 years is half the total quantity of mRNA contained in a booster dose for individuals 12 years of age and older.
Adverse Reactions in Clinical Trials
Adverse reactions reported in clinical trials following administration of bivalent vaccine (Original and Omicron BA.1) include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, nausea/vomiting, erythema at the injection site, swelling at the injection site, and fever. (See Full EUA Prescribing Information)
Adverse Reactions in Post-Authorization Experience of Moderna COVID-19 Vaccine
Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become apparent with post-authorization use of Moderna COVID-19 Vaccine, Bivalent.
- Moderna COVID-19 Vaccine is a monovalent vaccine that encodes the spike protein of only the Original SARS-CoV-2.
There is no information on the co-administration of Moderna COVID-19 Vaccine, Bivalent with other vaccines.
As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “VACCINE INFORMATION 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 Moderna COVID-19 Vaccine, Bivalent, including:
- FDA has authorized the emergency use of Moderna COVID-19 Vaccine, Bivalent, which is not an FDA-approved vaccine.
- The recipient or their caregiver has the option to accept or refuse Moderna COVID-19 Vaccine, Bivalent.
- The significant known and potential risks and benefits of Moderna COVID-19 Vaccine, Bivalent, 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 Moderna COVID-19 Vaccine, Bivalent to prevent COVID-19, please see www.clinicaltrials.gov.
Provide a vaccination card to the recipient or their caregiver.
Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a 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.
MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE, BIVALENT ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION
In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Moderna COVID-19 Vaccine, Bivalent, the following items are required. Use of unapproved Moderna COVID-19 Vaccine, Bivalent for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):
- Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 years of age and older.
- The vaccination provider must communicate to the individual receiving Moderna COVID-19 Vaccine, Bivalent or their caregiver information consistent with the “VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS” prior to the individual receiving the Moderna COVID-19 Vaccine, Bivalent.
- The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.
- The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
- vaccine administration errors whether or not associated with an adverse event,
- serious adverse events* (irrespective of attribution to vaccination),
- cases of myocarditis,
- cases of pericarditis,
- cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
- cases of COVID-19 that result in hospitalization or death.
- Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine, Bivalent EUA” in the description section of the report.
- The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of myocarditis, cases of pericarditis, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Moderna COVID-19 Vaccine, Bivalent to recipients.
- *Serious adverse events are defined as:
- A life-threatening adverse event;
- Inpatient hospitalization or prolongation of existing hospitalization;
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
- A congenital anomaly/birth defect;
- An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.
Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.
To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.
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For general questions, visit the website or call the telephone number provided below.
To access the most recent Moderna COVID-19 Vaccine, Bivalent Fact Sheets, please scan the QR code or visit the website provided below.
There may be clinical trials or availability under EUA of other COVID-19 vaccines for use as a booster dose, including bivalent vaccines that contain or encode the spike protein of the Omicron variant of SARS-CoV-2.
This vaccine is being made available for emergency use exclusively through the CDC COVID-19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.
Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.
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