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Changes in incidence rates of outcomes of interest in vaccine safety studies during the COVID-19 pandemic.
Xu, Stanley; Hong, Vennis; Sy, Lina S; Glenn, Sungching C; Ryan, Denison S; Morrissette, Kerresa L; Nelson, Jennifer C; Hambidge, Simon J; Crane, Bradley; Zerbo, Ousseny; DeSilva, Malini B; Glanz, Jason M; Donahue, James G; Liles, Elizabeth; Duffy, Jonathan; Qian, Lei.
  • Xu S; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States. Electronic address: Stan.Xu@kp.org.
  • Hong V; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
  • Sy LS; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
  • Glenn SC; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
  • Ryan DS; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
  • Morrissette KL; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
  • Nelson JC; Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.
  • Hambidge SJ; Denver Health Ambulatory Care Services, Denver, CO, United States.
  • Crane B; Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
  • Zerbo O; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, United States.
  • DeSilva MB; HealthPartners Institute, Minneapolis, MN, United States.
  • Glanz JM; Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, United States.
  • Donahue JG; Marshfield Clinic Research Institute, Marshfield, WI, United States.
  • Liles E; Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
  • Duffy J; Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, United States.
  • Qian L; Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA, United States.
Vaccine ; 40(23): 3150-3158, 2022 05 20.
Article in English | MEDLINE | ID: covidwho-1796041
ABSTRACT

BACKGROUND:

The COVID-19 pandemic caused an abrupt drop in in-person health care (inpatient, Emergency Department, outpatient) and an increase in telehealth care, which poses challenges in vaccine safety studies that identify outcomes from in-person encounters. We examined the changes in incidence rates of selected encounter-based outcomes during the COVID-19 pandemic.

METHODS:

We assembled a cohort of members from 8 Vaccine Safety Datalink sites from January 1, 2017 through December 31, 2020. Using ICD-10 diagnosis codes or laboratory criteria, we identified 21 incident outcomes in traditional in-person settings and all settings. We defined 4 periods in 2020 January-February (pre-pandemic), April-June (early pandemic), July-September (middle pandemic), and October-December (late pandemic). We defined four corresponding periods in each year during 2017-2019. We calculated incidence rates, conducted difference in difference (DiD) analyses, and reported ratios of incidence rate ratios (RRR) to examine changes in rates from pre-pandemic to early, middle, and late pandemic in 2020, after adjusting for changes across similar periods in 2017-2019.

RESULTS:

Among > 10 million members, regardless of setting and after adjusting for changes during 2017-2019, we found that incidence rates of acute disseminated encephalomyelitis, encephalitis/myelitis/encephalomyelitis/meningoencephalitis, and thrombotic thrombocytopenic purpura did not significantly change from the pre-pandemic to early, middle or late pandemic periods (p-values ≥ 0.05). Incidence rates decreased from the pre-pandemic to early pandemic period during 2020 for acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, convulsions/seizures, Guillain-Barré syndrome, immune thrombocytopenia (ITP), narcolepsy/cataplexy, hemorrhagic stroke, ischemic stroke, and venous thromboembolism (p-values < 0.05). Incidence rates of Bell's palsy, ITP, and narcolepsy/cataplexy were higher in all settings than in traditional in-person settings during the three pandemic periods (p-values < 0.05).

CONCLUSION:

Rates of some clinical outcomes during the pandemic changed and should not be used as historical background rates in vaccine safety studies. Inclusion of telehealth visits should be considered for vaccine studies involving Bell's palsy, ITP, and narcolepsy/cataplexy.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Vaccines / Cataplexy / Bell Palsy / COVID-19 / Narcolepsy Type of study: Incidence study / Prognostic study / Risk factors Topics: Long Covid / Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thrombocytopenia / Vaccines / Cataplexy / Bell Palsy / COVID-19 / Narcolepsy Type of study: Incidence study / Prognostic study / Risk factors Topics: Long Covid / Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article