Table 1 Analysis of COVID-19 and severe COVID-19 incidence based on adjudication committee assessments starting 14 days after injection 2 of mRNA-1273 100-µg primary series prior to the booster, by variant waves (PP-primary series set)

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

	COVID-19 cases		Severe COVID-19 cases
	mRNA-1273 100 µg Primary series	Placebo-mRNA-1273 100 µg Primary series	mRNA-1273 100 µg Primary series	Placebo-mRNA-1273 100 µg Primary series
	N = 14,291	N = 10,623	N = 14,291	N = 10,623
September 1, 2021–November 30, 2021 (Delta predominant)
Number at risk (N1)	11,436	10,020	1,1751	10,179
Participants with event, n (%)^a	159 (1.4)	113 (1.1)	27 (0.2)	15 (0.1)
Person-months^b	20,488.2	19,620.5	21,388.1	20,112.0
Incidence/1000 person-months (95% CI)^c	7.76 (6.60–9.07)	5.76 (4.75–6.92)	1.26 (0.83–1.84)	0.75 (0.42–1.23)
December 1, 2021–March 31, 2022 (Omicron BA.1 predominant)
Number at risk (N1)	1648	1610	1816	1714
Participants with event, n (%)^a	127 (7.7)	107 (6.6)	8 (0.4)	5 (0.3)
Person-months^b	2817.0	2230.5	3343.3	2614.6
Incidence/1000 person-months (95% CI)^c	45.08 (37.58–53.64)	47.97 (39.31–57.97)	2.39 (1.03–4.72)	1.91 (0.62–4.46)
April 1, 2022–June 30, 2022 (Omicron BA.2 predominant)
Number at risk (N1)	399	271	506	356
Participants with event, n (%)^a	14 (3.5)	5 (1.8)	1 (0.2)	0
Person-months^b	1120.3	719.8	1437.4	976.2
Incidence/1000 person-months (95% CI)^c	12.50 (6.83–20.97)	6.95 (2.26–16.21)	0.70 (0.02–3.88)	0.00 (NE–3.78)
July 1, 2022–November 30, 2022 (Omicron BA.4/5 predominant)
Number at risk (N1)	349	220	459	308
Participants with event, n (%)^a	8 (2.3)	12 (5.5)	0	0
Person-months^b	1081.6	672.1	1407.2	940.1
Incidence/1000 person-months (95% CI)^c	7.40 (3.19–14.57)	17.85 (9.23–31.19)	0.00 (NE–2.62)	0.00 (NE–3.92)
December 1, 2022–April 7, 2023 (Omicron BQ.1.1 predominant)
Number at risk (N1)	38	31	41	34
Participants with event, n (%)^a	0	0	0	0
Person-months^b	28.6	16.8	31.1	18.2
Incidence/1000 person-months (95% CI)^c	0.00 (NE–128.91)	0.00 (NE–220.16)	0.00 (NE–118.69)	0.00 (NE–203.04)

CI confidence interval, NE not estimable.
Incidence based on COVID-19 and severe COVID-19 cases adjudicated by an independent adjudication committee to determine if the criteria for the effectiveness endpoints were met. COVID-19 is based on adjudicated cases as assessed in the primary approach for COVID-19 throughout the study. Per-protocol primary series set includes participants in Part A per-protocol set who received two doses of mRNA-1273 primary series in either Part A or Part B per schedule without major protocol deviations.
^aPercentages are based on N1.
^bPerson-months for each time period is defined as the total months from the start of each time period or 14 days after the date of injection 2 of the mRNA-1273 primary series, whichever is later, to the date of event, one day before the date of booster if received, 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.
^cIncidence 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.

Back to article page

Table 1 Analysis of COVID-19 and severe COVID-19 incidence based on adjudication committee assessments starting 14 days after injection 2 of mRNA-1273 100-µg primary series prior to the booster, by variant waves (PP-primary series set)

Search

Quick links