WELL-DEFINED Safety Profile in adolescents1,2
Data to support this protein-based
COVID-19 vaccine option1
Natalie - Hypothetical patient case
PREVENT-19 Safety Profile—Primary Series
(Ages 12-17 years)1
The safety data accrued with the Novavax COVID-19 Vaccine, Adjuvanted (original monovalent [no longer authorized for use in the US]) and from studies of Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.1), Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.5), Novavax’s adjuvanted bivalent vaccine (original and Omicron BA.1) and Novavax’s adjuvanted bivalent vaccine (original and Omicron BA.5), none of which have been authorized in the US, are relevant to the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) because those vaccines are manufactured using a similar process1
| Event (any grade) | Novavax COVID-19 Vaccine, Adjuvanted | Placebo | ||
|---|---|---|---|---|
| Dose 1 (n=1,448) | Dose 2 (n=1,394) | Dose 1 (n=726) | Dose 2 (n=686) | |
| Local adverse reactions, n (%) | ||||
| Pain/tenderness | 945 (65.3) | 1045 (75.0) | 204 (28.1) | 141 (20.6) |
| Redness | 15 (1.0) | 104 (7.5) | 5 (0.7) | 0 (0) |
| Swelling | 20 (1.4) | 111 (8.0) | 3 (0.4) | 1 (0.1) |
| Systemic adverse reactions, n (%) | ||||
| Fever | 11 (0.8) | 235 (16.9) | 5 (0.7) | 1 (0.1) |
| Headache | 440 (30.4) | 793 (56.9) | 181 (24.9) | 119 (17.3) |
| Fatigue/malaise | 418 (28.9) | 807 (57.9) | 142 (19.6) | 113 (16.5) |
| Muscle pain | 492 (34.0) | 683 (49.0) | 114 (15.7) | 82 (12.0) |
| Joint pain | 102 (7.0) | 226 (16.2) | 35 (4.8) | 21 (3.1) |
| Nausea or vomiting | 113 (7.8) | 277 (19.9) | 56 (7.7) | 33 (4.8) |
Data were collected from 2,232 participants aged 12 through 17 years receiving at least 1 dose of Novavax COVID-19 Vaccine, Adjuvanted (n=1,448) or placebo (n=726)1
Adverse reactions were usually mild to moderate in severity, with a median duration of 2 days or less for systemic and local events2
Solicited local and systemic adverse reactions were evaluated within 7 days after each dose of the Novavax COVID-19 Vaccine, Adjuvanted (original monovalent) or placebo for participants who completed the electronic diary1
Abbreviations & References
COVID-19, coronavirus disease 2019.
- Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA Fact Sheet for Healthcare Providers. Novavax, Inc.
- Áñez G, et al. JAMA Netw Open. 2023;6(4):e239135. doi:10.1001/jamanetworkopen.2023.9135
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).