See the dosing and data that led to the authorization of Moderna COVID-19 Vaccine, Bivalent for patients 6 months through 11 years of age.
See the dosing and data that led to the authorization of Moderna COVID-19 Vaccine, Bivalent for patients 12 through 17 years of age.
Find the answers to questions about Bivalent booster dosing and more.
An unpredictable virus
While millions of patients have received the Moderna COVID-19 Vaccine, the SARS-CoV-2 virus remains unpredictable. Additional variants have emerged, so Moderna is still working to help protect you and your patients.
Our Bivalent vaccine
Moderna COVID-19 Vaccine, Bivalent was created from original and Omicron strains of COVID-19, based on the data provided by the study of original and Omicron BA.1, to offer broader protection than the original vaccine against Omicron subvariants BA.4 and BA.5.
Authorized as a booster
Now authorized for emergency use in eligible individuals 6 months through 5 years of age, our updated vaccine can be administered to these patients at least 2 months following the completion of the Moderna COVID-19 Vaccine primary series. The vaccine can be administered to individuals 6 years of age and older at least 2 months following the completion of primary series vaccination or another booster dose.
Do not administer the vaccines to individuals with a known history of a severe allergic reaction (e.g. anaphylaxis) to any component of the Moderna COVID-19 Vaccine or Moderna COVID-19 Vaccine, Bivalent.
Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccines. Monitor 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).
Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following receipt of the second primary series dose or first booster dose. The observed risk is highest in males 18 through 24 years of age. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccines.
Limitations of Vaccine Effectiveness: The vaccines may not protect all vaccine recipients.
Adverse reactions reported in clinical trials for individuals 6 years of age and older following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, erythema at the injection site, swelling at the injection site, and arthralgia.
Adverse reactions in children 6 months through 5 years of age following administration of Moderna COVID-19 Vaccine include pain at the injection site, irritability/crying, fatigue, sleepiness, loss of appetite, headache, fever, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, erythema at the injection site, and swelling at the injection site.
Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, syncope, and urticaria 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 vaccines.
Reporting Adverse Events and Vaccine Administration Errors
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)
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. Reports should include the words “Moderna COVID-19 Vaccine EUA” or “Moderna COVID-19 Vaccine, Bivalent EUA” in the description section of the report.
Report to ModernaTX, Inc. by calling 1-866-MODERNA (1-866-663-3762) or provide a copy of the VAERS form by faxing 1-866-599-1342 or emailing ModernaPV@modernatx.com.
Please see the Vaccine Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information for: