Helps protect patients against circulating variants with manageable common side effects1,2
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The safety data accrued with the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) [no longer authorized for use in the US] and from Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.1) [not authorized or approved in the US], Novavax’s adjuvanted monovalent COVID-19 vaccine (Omicron BA.5) [not authorized or approved in the US], Novavax’s adjuvanted bivalent vaccine (Original and Omicron BA.1) [not authorized or approved in the US], and Novavax’s adjuvanted bivalent vaccine (Original and Omicron BA.5) [not authorized or approved in the US], are relevant to Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) because these vaccines are manufactured using a similar process.1
| Event (any grade) | Novavax COVID‑19 vaccine | Placebo | ||
|---|---|---|---|---|
| Dose 1 n=15,884 | Dose 2 n=15,148 | Dose 1 n=7,868 | Dose 2 n=7,361 | |
| Local adverse reactions, % | ||||
| Pain/tenderness | 60.5 | 80.8 | 21.7 | 22.0 |
| Redness | 1.0 | 6.9 | 0.3 | 0.4 |
| Swelling | 0.9 | 6.2 | 0.3 | 0.3 |
| Systemic adverse reactions, % | ||||
| Fever | 0.4 | 6.2 | 0.4 | 0.2 |
| Headache | 26.2 | 47.1 | 23.7 | 20.3 |
| Fatigue/malaise | 30.8 | 58.3 | 26.6 | 25.7 |
| Muscle pain | 24.1 | 50.7 | 13.6 | 12.2 |
| Joint pain | 7.9 | 23.4 | 6.6 | 6.8 |
| Nausea or vomiting | 6.7 | 12.0 | 5.9 | 5.7 |
*Seven days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in an electronic diary (eDiary).
†Solicited safety set includes participants who received at least 1 dose of study vaccine and who completed their eDiary.
| Event (any grade) | Novavax COVID‑19 vaccine | Placebo | ||
|---|---|---|---|---|
| Dose 1 n=2,251 | Dose 2 n=2,048 | Dose 1 n=1,114 | Dose 2 n=978 | |
| Local adverse reactions, % | ||||
| Pain/tenderness | 37.9 | 61.4 | 15.7 | 16.5 |
| Redness | 0.7 | 4.8 | 0.4 | 0.4 |
| Swelling | 0.8 | 5.4 | 0.09 | 0.4 |
| Systemic adverse reactions, % | ||||
| Fever | 0.4 | 2.0 | 0.3 | 0.7 |
| Headache | 15.3 | 24.5 | 16.5 | 14.7 |
| Fatigue/malaise | 19.7 | 34.9 | 18.1 | 18.6 |
| Muscle pain | 12.6 | 27.4 | 11.2 | 10.4 |
| Joint pain | 6.2 | 13.2 | 6.4 | 6.4 |
| Nausea or vomiting | 3.6 | 5.3 | 2.9 | 3.6 |
*Seven days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in an electronic diary (eDiary).
†Solicited safety set includes participants who received at least 1 dose of study vaccine and who completed their eDiary.
| Event (any grade) | Novavax COVID‑19 vaccine | Placebo | ||
|---|---|---|---|---|
| Dose 1 n=1,448 | Dose 2 n=1,394 | Dose 1 n=726 | Dose 2 n=686 | |
| Local adverse reactions, % | ||||
| Pain/tenderness | 65.3 | 75.0 | 28.1 | 20.6 |
| Redness | 1.0 | 7.5 | 0.7 | 0.0 |
| Swelling | 1.4 | 8.0 | 0.4 | 0.1 |
| Systemic adverse reactions, % | ||||
| Fever | 0.8 | 16.9 | 0.7 | 0.1 |
| Headache | 30.4 | 56.9 | 24.9 | 17.3 |
| Fatigue/malaise | 28.9 | 57.9 | 19.6 | 16.5 |
| Muscle pain | 34.0 | 49.0 | 15.7 | 12.0 |
| Joint pain | 7.0 | 16.2 | 4.8 | 3.1 |
| Nausea or vomiting | 7.8 | 19.9 | 7.7 | 4.8 |
*Seven days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in an electronic diary (eDiary).
†Solicited safety set includes participants who received at least 1 dose of study vaccine and who completed their eDiary.
References: 1. Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) EUA Fact Sheet for Healthcare Providers. Novavax Inc.; September 2024. 2. Smith K, Hegazy K, et al. Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Vaccine. 2023;41(26):3930-3936. 3. Centers for Disease Control and Prevention. COVID-19 vaccine basics. https://www.cdc.gov/covid/vaccines/how-they-work.html. Updated July 12, 2024. Accessed July 18, 2024.