What is the clinical evidence from this study?

Study design: Observational. Population: COVID-19 vaccination (n=2403307). Intervention: mRNA-1273 vs. BNT162b2. Primary outcome: Incidence of myocarditis and pericarditis 0-7 days post-vaccination (RR 1.61, 95% CI 1.02-2.54, p=0.041).

What does this research mean for the field?

The mRNA-1273 COVID-19 vaccine is associated with a moderately higher risk of myocarditis and pericarditis compared to the BNT162b2 vaccine in 18-39-year-olds during the 0-7 days post-vaccination. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

July 12, 2022Open Access

Risk of myocarditis and pericarditis following BNT162b2 and mRNA-1273 COVID-19 vaccination

Key Result

The mRNA-1273 vaccine was associated with a moderately higher risk of myocarditis and pericarditis compared to the BNT162b2 vaccine during the 0-7 days post-vaccination in 18-39-year-olds (RR 1.61).

Study Design

Type

Observational (n=2,403,307)

Multicenter

Yes

Structured PICO

Does the mRNA-1273 COVID-19 vaccine increase the risk of myocarditis and pericarditis compared to the BNT162b2 vaccine in adults aged 18-39 years?

Population

Members 18-39 years of age at eight integrated healthcare-delivery systems

Intervention

mRNA-1273 COVID-19 vaccine (dose 1 or 2)

Comparator

BNT162b2 COVID-19 vaccine (head-to-head comparison) and vaccinated concurrent comparators who received their most recent dose 22 to 42 days earlier

Outcome

Incidence of myocarditis and pericarditis events 0 to 7 days post-vaccinationsafety

In adults aged 18-39, the risk of myocarditis and pericarditis within 7 days of vaccination is modestly higher following the mRNA-1273 vaccine compared to the BNT162b2 vaccine.

Main Result

Effect estimate: RR 1.61 (95% CI 1.02-2.54)

Absolute Event Rate: 21.1% vs 14.2%

p-value: p=0.041

Limitations

Case identification was limited to ED or inpatient care with specific diagnosis codes, potentially missing outpatient or less-specific cases.
Small number of verified cases (79) resulted in wide confidence intervals for some analyses.
Potential detection or diagnosis bias due to increased awareness of myocarditis after mRNA vaccines.
Individual choice of vaccine product may be related to unmeasured risk factors for myocarditis.
Head-to-head comparisons were not possible in the 12-17-year age group as only BNT162b2 was authorized.

Abstract

BACKGROUND: Evidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population. METHODS: Members 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination. RESULTS: From December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7-64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54). CONCLUSIONS: Both vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.

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