The Novavax COVID‑19 Vaccine, Adjuvanted (2023-2024 Formula) safety profile1
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 these vaccines are manufactured using a similar process.1
Primary series
Solicited local and systemic adverse reactions starting within 7 days* after each dose1†
| 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.
Booster
Solicited local and systemic adverse reactions starting within 7 days‡ after a booster dose1
| Event (any grade) | Novavax COVID‑19 vaccine§ | |
|---|---|---|
| n=238 | ||
| Local adverse reactions, % | ||
| Pain/tenderness | 81.1 | |
| Redness | 6.3 | |
| Swelling | 8.4 | |
| Systemic adverse reactions, % | ||
| Fever | 6.3 | |
| Headache | 52.9 | |
| Fatigue/malaise | 63.4 | |
| Muscle pain | 63.0 | |
| Joint pain | 30.3 | |
| Nausea or vomiting | 14.7 | |
‡Seven days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in an eDiary.
§The analysis included a total of 238 participants who received the booster dose and who completed their eDiary.
‖The analysis included a total of 190 participants who received the booster dose and who completed their eDiary.
| Event (any grade) | Novavax COVID‑19 vaccine‖ | |
|---|---|---|
| n=190 | ||
| Local adverse reactions, % | ||
| Pain/tenderness | 80.5 | |
| Redness | 10.5 | |
| Swelling | 10.0 | |
| Systemic adverse reactions, % | ||
| Fever | 23.2 | |
| Headache | 68.4 | |
| Fatigue/malaise | 69.5 | |
| Muscle pain | 61.6 | |
| Joint pain | 22.6 | |
| Nausea or vomiting | 26.3 | |
‡Seven days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in an eDiary.
§The analysis included a total of 238 participants who received the booster dose and who completed their eDiary.
‖The analysis included a total of 190 participants who received the booster dose and who completed their eDiary.
The safety of the Novavax COVID-19 Vaccine, Adjuvanted (original monovalent), monovalent vaccine (Omicron BA.1), the bivalent vaccine (original and Omicron BA.1), the monovalent vaccine (Omicron BA.5), and the bivalent vaccine (original and Omicron BA.5) booster dose in individuals who received 3 or more doses of mRNA vaccines was studied in a 2-part randomized, observer-blinded study conducted to evaluate the safety and immunogenicity of Novavax COVID-19 vaccines in adults previously vaccinated with other COVID-19 mRNA vaccines. The original monovalent, the monovalent vaccine (Omicron BA.1), and the bivalent vaccine (original and Omicron BA.1) groups included individuals 18 to 64 years of age. The monovalent vaccine (Omicron BA.5) and the bivalent vaccine (original and Omicron BA.5) groups included individuals 18 years of age and older.1
