Table 10.6-3. Pooled adverse events with administration of the NVX-CoV2373 vaccine versus placebo, stratified by age of clinical trial participants

Adverse events within 7 days of administration from studies 2019n-501, -301, and -302; study participants aged 18-64 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local tenderness

50.7

69.3

Local erythema

1.0

6.3

Local swelling

0.9

5.8

Pain at injection site

35.2

57.7

Fatigue

24.9

46.8

Headache

25.3

43.4

Nausea or vomiting

6.7

11.3

Fever

0.6

5.7

Myalgia

22.7

46.0

Adverse events within 7 days of administration from studies 2019n-501, -301, and -302; study participants aged ≥65 years

Adverse event reported

Dose 1 (%)

Dose 2 (%)

Local tenderness

33.0

54.9

Local erythema

0.8

5.2

Local swelling

0.7

5.7

Pain at injection site

19.3

40.5

Fatigue

16.3

28.6

Headache

15.3

23.6

Nausea or vomiting

3.7

5.1

Fever

0.5

1.9

Myalgia

12.3

26.4

Adapted from Product Monograph including Patient Medication Information: Nuvaxovid COVID-19 Vaccine: SARS-CoV-2 Vaccine (Recombinant protein, Adjuvanted).