Dataset Information

MRNA COVID-19 vaccine effectiveness against SARS-CoV-2 infection in a prospective community cohort, rural Wisconsin, November 2020 to December 2021.

ABSTRACT: Reduced COVID-19 vaccine effectiveness (VE) has been observed with increasing predominance of SARS-CoV-2 Delta (B.1.617.2) variant. Two-dose VE against laboratory-confirmed SARS-CoV-2 infection (symptomatic and asymptomatic) was estimated using Cox proportional hazards models with time-varying vaccination status in a prospective rural community cohort of 1266 participants aged ≥12 years. Between November 3, 2020 and December 7, 2021, VE was 56% for mRNA COVID-19 vaccines overall, 65% for Moderna, and 50% for Pfizer-BioNTech. VE when Delta predominated (June to December 2021) was 54% for mRNA COVID-19 vaccines overall, 59% for Moderna, and 52% for Pfizer-BioNTech.

SUBMITTER: McLean HQ

PROVIDER: S-EPMC9111813 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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mRNA COVID-19 vaccine effectiveness against SARS-CoV-2 infection in a prospective community cohort, rural Wisconsin, November 2020 to December 2021.

McLean Huong Q HQ McClure David L DL King Jennifer P JP Meece Jennifer K JK Pattinson David D Neumann Gabriele G Kawaoka Yoshihiro Y Rolfes Melissa A MA Belongia Edward A EA

Influenza and other respiratory viruses 20220218 4

Reduced COVID-19 vaccine effectiveness (VE) has been observed with increasing predominance of SARS-CoV-2 Delta (B.1.617.2) variant. Two-dose VE against laboratory-confirmed SARS-CoV-2 infection (symptomatic and asymptomatic) was estimated using Cox proportional hazards models with time-varying vaccination status in a prospective rural community cohort of 1266 participants aged ≥12 years. Between November 3, 2020 and December 7, 2021, VE was 56% for mRNA COVID-19 vaccines overall, 65% for Moderna ...[more]

PMID: 35178857

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Project description:ImportanceLimited data have been presented to examine breakthrough SARS-CoV-2 infections, hospitalizations, and mortality in vaccinated patients with cancer in the US.ObjectivesTo examine the risk of breakthrough SARS-CoV-2 infection, hospitalizations, and mortality in vaccinated patients with cancer between December 2020 and November 2021.Design, setting, and participantsRetrospective cohort study of electronic health records (EHRs) of vaccinated patients from a multicenter and nationwide database in the US during the period of December 2020 through November 2021. The study population comprised patients who had documented evidence of vaccination (2 doses of Moderna or Pfizer-BioNTech or single dose of Janssen/Johnson & Johnson vaccines) in their EHRs from December 2020 to November 2021 and had no SARS-CoV-2 infection prior to vaccination.ExposuresThe 12 most common cancers combined and separately; recent vs no recent encounter for cancer; and breakthrough SARS-CoV-2 infection.Main outcomes and measuresTime trends of incidence proportions of breakthrough SARS-CoV-2 infections from December 2020 to November 2021 in vaccinated patients with all cancer; cumulative risks of breakthrough infections in vaccinated patients for all cancer and 12 common cancer types; hazard ratios (HRs) and 95% CIs of breakthrough infections between propensity score-matched patients with vs without cancer and between propensity score-matched patients with cancer who had a recent medical encounter for cancer vs those who did not; overall risks, HRs, and 95% CIs of hospitalizations and mortality in patients with cancer who had breakthrough infections vs those who did not.ResultsAmong 45 253 vaccinated patients with cancer (mean [SD] age, 68.7 [12.4] years), 53.5% were female, 3.8% were Asian individuals, 15.4% were Black individuals, 4.9% were Hispanic individuals, and 74.1% were White individuals. Breakthrough SARS-CoV-2 infections in patients with cancer increased from December 2020 to November 2021 and reached 52.1 new cases per 1000 persons in November 2021. The cumulative risk of breakthrough infections in patients with all cancer was 13.6%, with highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers, and lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, vs 4.9% in the noncancer population (P < .001). Patients with cancer had significantly increased risk for breakthrough infections vs patients without cancer (HR, 1.24; 95% CI, 1.19-1.29), with greatest risk for liver (HR, 1.78; 95% CI, 1.38-2.29), lung (HR, 1.73; 95% CI, 1.50-1.99), pancreatic (HR, 1.64; 95% CI, 1.24-2.18), and colorectal (HR, 1.53; 95% CI, 1.32-1.77) cancers and lowest risk for thyroid (HR, 1.07; 95% CI, 0.88-1.30) and skin (HR, 1.17; 95% CI, 0.99-1.38) cancers. Patients who had medical encounters for cancer within the past year had higher risk for breakthrough infections than those who did not (HR, 1.24; 95% CI, 1.18-1.31). Among patients with cancer, the overall risk for hospitalizations and mortality was 31.6% and 3.9%, respectively, in patients with breakthrough infections, vs 6.7% and 1.3% in those without breakthrough infections (HR for hospitalization: 13.48; 95% CI, 11.42-15.91; HR for mortality: 6.76; 95% CI, 4.97-9.20).Conclusions and relevanceThis cohort study showed significantly increased risks for breakthrough infection in vaccinated patients with cancer, especially those undergoing active cancer care, with marked heterogeneity among specific cancer types. Breakthrough infections in patients with cancer were associated with significant and substantial risks for hospitalizations and mortality.

Project description:ImportanceVaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear.ObjectiveTo describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US.Design, setting, and participantsDescriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021.ExposuresVaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).Main outcomes and measuresReports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes.ResultsAmong 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%).Conclusions and relevanceBased on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be considered in the context of the benefits of COVID-19 vaccination.

Dataset Information

MRNA COVID-19 vaccine effectiveness against SARS-CoV-2 infection in a prospective community cohort, rural Wisconsin, November 2020 to December 2021.

Publications

mRNA COVID-19 vaccine effectiveness against SARS-CoV-2 infection in a prospective community cohort, rural Wisconsin, November 2020 to December 2021.

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