About this event
Please join our event on December 14 hosted by Moderna’s Medical Affairs Diversity Panel to discuss the importance of staying up to date with COVID-19 vaccines within communities of color this holiday season.
In this session, we will discuss how COVID-19 has affected Black and Hispanic communities, review the most recent ACIP recommendations and updates, and address common myths and misconceptions about COVID-19 vaccines that may impact vaccine confidence.
Please note that in order to receive a webinar replay link, you must be registered for that event.
AUTHORIZED USE
- Moderna COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by the FDA, but has been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months through 11 years of age.
- The EUA for this product is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
- For more information on the EUA authorized uses of the vaccine, refer to the Fact Sheet for Healthcare Providers Administering Vaccine.
IMPORTANT SAFETY INFORMATION
Contraindications
- Do not administer the vaccine 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.
Warnings and Precautions
- 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 vaccine. 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 with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 years 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 Moderna COVID-19 Vaccine.
- Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Solicited adverse reactions included:
- 6 months through 36 months of age: Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness
- 37 months of age and older: Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, nausea/vomiting, and rash
Reporting Adverse Events and Vaccine Administration Errors
Vaccination providers must report the listed events following administration of the Moderna COVID-19 Vaccine (2023-2024 Formula) 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 (2023-2024 Formula) EUA” in the description section of the report.
In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762) or by visiting https://report.moderna.convergehealthsafety.com/.
Please see the accompanying Moderna COVID-19 Vaccine (2023-2024 Formula) Fact Sheet for Healthcare Providers Administering Vaccine and Letter of Authorization for more information.
SPIKEVAX (COVID-19 Vaccine, mRNA)
INDICATION
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX.
Warnings and Precautions
- 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 SPIKEVAX.
- Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 through 24 years of age.
- Syncope (fainting): May occur in association with administration of injectable vaccines, including SPIKEVAX. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to SPIKEVAX.
- Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, swelling at the injection site, erythema at the injection site, and fever.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov or by calling 1-800-822-7967.
Please click for SPIKEVAX Full Prescribing Information.
MED-US-mRNA1273.815-2300064 12/2023
