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Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States.
Schrag, Stephanie J; Verani, Jennifer R; Dixon, Brian E; Page, Jessica M; Butterfield, Kristen A; Gaglani, Manjusha; Vazquez-Benitez, Gabriela; Zerbo, Ousseny; Natarajan, Karthik; Ong, Toan C; Lazariu, Victoria; Rao, Suchitra; Beaver, Ryan; Ellington, Sascha R; Klein, Nicola P; Irving, Stephanie A; Grannis, Shaun J; Kiduko, Salome; Barron, Michelle A; Midturi, John; Dickerson, Monica; Lewis, Ned; Stockwell, Melissa S; Stenehjem, Edward; Fadel, William F; Link-Gelles, Ruth; Murthy, Kempapura; Goddard, Kristin; Grisel, Nancy; Valvi, Nimish R; Fireman, Bruce; Arndorfer, Julie; Konatham, Deepika; Ball, Sarah; Thompson, Mark G; Naleway, Allison L.
  • Schrag SJ; CDC COVID-19 Emergency Response Team, Atlanta, Georgia.
  • Verani JR; CDC COVID-19 Emergency Response Team, Atlanta, Georgia.
  • Dixon BE; Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana.
  • Page JM; Fairbanks School of Public Health, Indiana University, Indianapolis.
  • Butterfield KA; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah, Salt Lake City.
  • Gaglani M; Westat, Rockville, Maryland.
  • Vazquez-Benitez G; Baylor Scott & White Health Temple, Texas.
  • Zerbo O; Texas A&M University College of Medicine, Temple.
  • Natarajan K; HealthPartners Institute, Minneapolis, Minnesota.
  • Ong TC; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland.
  • Lazariu V; Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, New York.
  • Rao S; NewYork-Presbyterian Hospital, New York.
  • Beaver R; School of Medicine, University of Colorado Anschutz Medical Campus, Aurora.
  • Ellington SR; Westat, Rockville, Maryland.
  • Klein NP; School of Medicine, University of Colorado Anschutz Medical Campus, Aurora.
  • Irving SA; Baylor Scott & White Health Temple, Texas.
  • Grannis SJ; CDC COVID-19 Emergency Response Team, Atlanta, Georgia.
  • Kiduko S; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland.
  • Barron MA; Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.
  • Midturi J; Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana.
  • Dickerson M; Indiana University School of Medicine, Indianapolis.
  • Lewis N; Westat, Rockville, Maryland.
  • Stockwell MS; School of Medicine, University of Colorado Anschutz Medical Campus, Aurora.
  • Stenehjem E; Baylor Scott & White Health Temple, Texas.
  • Fadel WF; CDC COVID-19 Emergency Response Team, Atlanta, Georgia.
  • Link-Gelles R; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland.
  • Murthy K; NewYork-Presbyterian Hospital, New York.
  • Goddard K; Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, New York, New York.
  • Grisel N; Department of Population and Family Health, Columbia University Mailman School of Public Health, New York, New York.
  • Valvi NR; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah, Salt Lake City.
  • Fireman B; Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana.
  • Arndorfer J; Fairbanks School of Public Health, Indiana University, Indianapolis.
  • Konatham D; CDC COVID-19 Emergency Response Team, Atlanta, Georgia.
  • Ball S; Baylor Scott & White Health Temple, Texas.
  • Thompson MG; Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland.
  • Naleway AL; Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah, Salt Lake City.
JAMA Netw Open ; 5(9): e2233273, 2022 09 01.
Article in English | MEDLINE | ID: covidwho-2047371
ABSTRACT
Importance Pregnant people are at high risk for severe COVID-19 but were excluded from mRNA vaccine trials; data on COVID-19 vaccine effectiveness (VE) are needed.

Objective:

To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during Delta and Omicron predominance. Design, Setting, and

Participants:

This test-negative, case-control study was conducted from June 2021 to June 2022 in a network of 306 hospitals and 164 emergency department and urgent care (ED/UC) facilities across 10 US states, including 4517 ED/UC encounters and 975 hospitalizations among pregnant people with COVID-19-like illness (CLI) who underwent SARS-CoV-2 molecular testing. Exposures Two doses (14-149 and ≥150 days prior) and 3 doses (7-119 and ≥120 days prior) of COVID-19 mRNA vaccine (≥1 dose received during pregnancy) vs unvaccinated. Main Outcomes and

Measures:

Estimated VE against laboratory-confirmed COVID-19-associated ED/UC encounter or hospitalization, based on the adjusted odds ratio (aOR) for prior vaccination; VE was calculated as (1 - aOR) × 100%.

Results:

Among 4517 eligible CLI-associated ED/UC encounters and 975 hospitalizations, 885 (19.6%) and 334 (34.3%) were SARS-CoV-2 positive, respectively; the median (IQR) patient age was 28 (24-32) years and 31 (26-35) years, 537 (12.0%) and 118 (12.0%) were non-Hispanic Black and 1189 (26.0%) and 240 (25.0%) were Hispanic. During Delta predominance, the estimated VE against COVID-19-associated ED/UC encounters was 84% (95% CI, 69% to 92%) for 2 doses within 14 to 149 days, 75% (95% CI, 5% to 93%) for 2 doses 150 or more days prior, and 81% (95% CI, 30% to 95%) for 3 doses 7 to 119 days prior; estimated VE against COVID-19-associated hospitalization was 99% (95% CI, 96% to 100%), 96% (95% CI, 86% to 99%), and 97% (95% CI, 79% to 100%), respectively. During Omicron predominance, for ED/UC encounters, the estimated VE of 2 doses within 14 to 149 days, 2 doses 150 or more days, 3 doses within 7 to 119 days, and 3 doses 120 or more days prior was 3% (95% CI, -49% to 37%), 42% (95% CI, -16% to 72%), 79% (95% CI, 59% to 89%), and -124% (95% CI, -414% to 2%), respectively; for hospitalization, estimated VE was 86% (95% CI, 41% to 97%), 64% (95% CI, -102% to 93%), 86% (95% CI, 28% to 97%), and -53% (95% CI, -1254% to 83%), respectively. Conclusions and Relevance In this study, maternal mRNA COVID-19 vaccination, including booster dose, was associated with protection against medically attended COVID-19. VE estimates were higher against COVID-19-associated hospitalization than ED/UC visits and lower against the Omicron variant than the Delta variant. Protection waned over time, particularly during Omicron predominance.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pregnancy Complications, Infectious / Influenza Vaccines / Influenza, Human / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Adult / Female / Humans / Pregnancy Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article Affiliation country: Jamanetworkopen.2022.33273

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pregnancy Complications, Infectious / Influenza Vaccines / Influenza, Human / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Adult / Female / Humans / Pregnancy Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article Affiliation country: Jamanetworkopen.2022.33273