Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is now authorized and ACIP recommended
Now that Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has received FDA authorization for emergency use in the US for individuals aged 12 and older, it is also included in ACIP’s recommendation for use of authorized/approved 2023-2024 XBB COVID-19 vaccines. The vaccine was studied globally in approximately 45,000 participants.1
Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
When you discuss the Novavax COVID-19 vaccine to your patients, you’re helping them choose the only non-mRNA COVID-19 vaccine option built on a well-established protein subunit platform. This is similar to how some vaccines, such as hepatitis B or flu, are made.2
The Novavax COVID-19 vaccine is available through these distributors:
Cardinal Health, Inc.: 1-833-358-8326
FFF Enterprises, Inc.: 1-800-843-7477
Henry Schein, Inc.: 1-800-772-4346
McKesson Medical-Surgical, Inc.: 1-855-571-2100
McKesson Plasma & Biologics: 1-855-571-2100
AmeriSource Bergen or Cencora: 1-855-571-2100
LEARN MORE ABOUT THE NOVAVAX COVID-19 VACCINE HERE
Please see Important Safety Information below.
Emergency Use Authorization (EUA)
The Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA, under EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
To learn more about the robust efficacy of the Novavax COVID-19 Vaccine, please visit us.novavaxcovidvaccine.com/hcp.
IMPORTANT SAFETY INFORMATION
Authorized Use
Individuals previously vaccinated with any COVID-19 vaccine: A single dose is administered at least 2 months after receipt of the last previous dose of COVID-19 vaccine. Individuals not previously vaccinated with any COVID-19 vaccine: Two doses are administered 3 weeks apart. The safety data for Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) are based on studies of the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) [no longer authorized for use in the U.S.] and of the Novavax monovalent vaccine (Omicron BA.1); bivalent vaccine (Original and Omicron BA.1); bivalent vaccine (Original and Omicron BA.5); and monovalent vaccine (Omicron BA.5) [none of which has been authorized or approved in the U.S.].
Contraindications
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted, or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Novavax COVID-19 Vaccine, Adjuvanted.
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 Novavax COVID-19 Vaccine, Adjuvanted. Monitor Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines.
Myocarditis and Pericarditis: Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Fact Sheet). 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/interim-considerations-us.html#myocarditis-pericarditis
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 immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
Adverse Reactions
Adverse reactions reported in clinical trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted include injection site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.
Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider enrolled in the federal COVID-19 Vaccination providers must report the events listed below following administration of the Novavax COVID-19 Vaccine, Adjuvanted (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 results in hospitalization or death
Complete and submit reports to VAERS online: https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA” in the description section of the report.
To the extent feasible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
Please see the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and EUA Full Prescribing Information.
References: 1. Novavax COVID-19 Vaccine, Adjuvanted EUA Fact Sheet for Healthcare Providers. Novavax Inc. October 2023. 2. U.S. Department of Health & Human Services. Vaccine Types. https://www.hhs.gov/immunization/basics/types/index.html. Updated July 7, 2021. Accessed August 7, 2023.