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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; [...]

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

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  • Media type: E-Article
  • Title: 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
  • Contributor: 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; [...]
  • imprint: American Medical Association (AMA), 2022
  • Published in: JAMA Network Open
  • Language: English
  • DOI: 10.1001/jamanetworkopen.2022.33273
  • ISSN: 2574-3805
  • Origination:
  • Footnote:
  • Description: <jats:sec id="ab-zoi220946-4"><jats:title>Importance</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="ab-zoi220946-5"><jats:title>Objective</jats:title><jats:p>To evaluate the estimated effectiveness of mRNA vaccination against medically attended COVID-19 among pregnant people during Delta and Omicron predominance.</jats:p></jats:sec><jats:sec id="ab-zoi220946-6"><jats:title>Design, Setting, and Participants</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="ab-zoi220946-7"><jats:title>Exposures</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="ab-zoi220946-8"><jats:title>Main Outcomes and Measures</jats:title><jats:p>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%.</jats:p></jats:sec><jats:sec id="ab-zoi220946-9"><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec id="ab-zoi220946-10"><jats:title>Conclusions and Relevance</jats:title><jats:p>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.</jats:p></jats:sec>
  • Access State: Open Access