Why Choose the updated Novavax
COVID-19 Vaccine?
Data to support this protein-based
COVID-19 vaccine option1
Sandra - Hypothetical patient case
95.2% of patients enrolled in the phase 3 pivotal
clinical trial, PREVENT-19, were high risk2,a
Efficacy outcomes among adult clinical trial participants
The effectiveness of the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is based on the effectiveness of the Novavax COVID-19 vaccine (original monovalent) and the immunogenicity of the monovalent vaccine (Omicron BA.1) and the monovalent vaccine (Omicron BA.5)1
Primary endpoint1
Secondary endpoints2
Vaccine efficacy against COVID-19
in adults aged 18 years or olderb
Protection against COVID-19
in high risk patientsa
Protection against
moderate-to-severe disease from
then-circulating strains of virusc
The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients1
a
Participants at overall high risk included those 65 years of age or older and those of any age with chronic health conditions or an increased risk for COVID-19 because of work or living conditions.1
b
In a phase 3 clinical trial, the vaccine met the primary endpoint of preventing symptomatic mild, moderate, or severe COVID-19 from 7 days after dose 2 of the primary vaccine series.1
c
Moderate COVID-19 was defined as high fever and objective evidence of lower respiratory tract infection. Severe disease was defined as clinically significant tachypnea, tachycardia, or hypoxia; receipt of intensive respiratory support; major dysfunction of one or more organ systems; admission to an intensive care unit; or death.2
Abbreviations & References
COVID-19, coronavirus disease 2019.
- Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA Fact Sheet for Healthcare Providers. Novavax, Inc.
- Dunkle LM, et al. N Engl J Med. 2022;386(6):531-543.
Please see Important Safety Information throughout and on the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) at https://novavax.widen.net/s/9tkdmzh9z6/us-eua-fact-sheet-hcp.
Authorized Use and Important Safety Information
COM-US-CVD-2400016 4/2024
Authorized Use
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 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. 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.
Important Safety information
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 (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
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.
Required Reporting for Adverse Events and Vaccine Administration Errors
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).