Table 3 Analysis of COVID-19 incidence based on adjudication committee assessments starting 14 days after booster, by pre-booster SARS-CoV-2 status (Part C safety set)

From: Long-term safety and effectiveness of mRNA-1273 vaccine in adults: COVE trial open-label and booster phases

 

Part C booster mRNA-1273 50 µg

 

mRNA-1273

100 µg

Primary seriesa

Placebo-mRNA-1273

100 µg

Primary series

mRNA-1273

100 µg

Primary seriesa

Placebo-mRNA-1273

100 µg

Primary series

Negative

N = 8705

Negative

N = 8305

Positive

N = 941

Positive

N = 1647

≥14 days after booster

 Number at risk (N1)

8431

8031

120

119

 Participants with event, n (%)a

1802 (21.4)

1845 (23.0)

18 (15.0)

13 (10.9)

 Person-monthsb

70251.6

62537.2

1057.6

1079.1

 Incidence/1000 person-months (95% CI)c

25.65

(24.48–26.86)

29.50

(28.17–30.88)

17.02

(10.09–26.90)

12.05

(6.41–20.60)

September 1, 2021–November 30, 2021 (Delta predominant)

 Number at risk (N1)

7175

6497

92

98

 Participants with event, n (%)a

6 (<0.1)

5 (<0.1)

0

0

 Person-monthsb

6688.5

5840.7

78.8

78.7

 Incidence/1000 person-months (95% CI)c

0.90

(0.33–1.95)

0.86

(0.28–2.00)

0.00

(NE–46.80)

0.00

(NE–46.88)

December 1, 2021–March 31, 2022 (Omicron BA.1 predominant)

 Number at risk (N1)

8404

8005

115

119

 Participants with event, n (%)a

699 (8.3)

823 (10.3)

9 (7.8)

5 (4.2)

 Person-monthsb

30589.4

28103.2

399.6

424.0

 Incidence/1000 person-months (95% CI)c

22.85

(21.19–24.61)

29.29

(27.32–31.36)

22.52

(10.30–42.76)

11.79

(3.83–27.52)

April 1, 2022–June 30, 2022 (Omicron BA.2 predominant)

 Number at risk (N1)

7425

6595

106

106

 Participants with event, n (%)a

590 (7.9)

577 (8.7)

3 (2.8)

3 (2.8)

 Person-monthsb

18829.2

16582.4

302.8

293.9

 Incidence/1000 person-months (95% CI)c

31.33

(28.86–33.97)

34.80

(32.01–37.76)

9.91

(2.04–28.96)

10.21

(2.11–29.83)

July 1, 2022–November 30, 2022 (Omicron BA.4/5 predominant)

 Number at risk (N1)

5357

4617

95

92

 Participants with event, n (%)a

507 (9.5)

440 (9.5)

6 (6.3)

5 (5.4)

 Person-monthsb

14077.1

11968.3

273.9

280.8

 Incidence/1000 person-months (95% CI)c

36.02

(32.95–39.29)

36.76

(33.41–40.37)

21.90

(8.04–47.67)

17.80

(5.78–41.55)

After December 1, 2022 (Omicron BQ.1.1 predominant)

 Number at risk (N1)

135

95

3

2

 Participants with event, n (%)a

0

0

0

0

 Person-monthsb

67.5

42.6

2.5

1.6

 Incidence/1000 person-months (95% CI)c

0.00

(NE–54.66)

0.00

(NE–86.57)

0.00

(NE–1477.37)

0.00

(NE–2245.61)

  1. CI, confidence interval; COVID-19, coronavirus disease 2019; NE, not estimable.
  2. aOne participant from the mRNA-1273 group had a missing pre-booster SARS-CoV-2-status.
  3. bPercentages are based on N1.
  4. cPerson-months for each time period is defined as the total months from the start of each time period to the date of event, the end of each time period, last date of study participation, or effectiveness data-cutoff date, whichever is the earliest. 1 month = 30.4375 days.
  5. dIncidence for each time period is defined as the number of participants with an event during the time period divided by the number of participants at risk during the time period and adjusted by person-months (total time at risk) in each treatment group. The 95% CI is calculated using the exact method (Poisson distribution) and adjusted by person-months.
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