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Item Effectiveness of a Third Dose of mRNA Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance — VISION Network, 10 States, August 2021–January 2022(U.S. Department of Health & Human Services, 2022-01-28) Thompson, Mark G.; Natarajan, Karthik; Irving, Stephanie A.; Rowley, Elizabeth A.; Griggs, Eric P.; Gaglani, Manjusha; Klein, Nicola P.; Grannis, Shaun J.; DeSilva, Malini B.; Stenehjem, Edward; Reese, Sarah E.; Dickerson, Monica; Naleway, Allison L.; Han, Jungmi; Konatham, Deepika; McEvoy, Charlene; Rao, Suchitra; Dixon, Brian E.; Dascomb, Kristin; Lewis, Ned; Levy, Matthew E.; Patel, Palak; Liao, I-Chia; Kharbanda, Anupam B.; Barron, Michelle A.; Fadel, William F.; Grisel, Nancy; Goddard, Kristin; Yang, Duck-Hye; Wondimu, Mehiret H.; Murthy, Kempapura; Valvi, Nimish R.; Arndorfer, Julie; Fireman, Bruce; Dunne, Margaret M.; Embi, Peter; Azziz-Baumgartner, Eduardo; Zerbo, Ousseny; Bozio, Catherine H.; Reynolds, Sue; Ferdinands, Jill; Williams, Jeremiah; Link-Gelles, Ruth; Schrag, Stephanie J.; Verani, Jennifer R.; Ball, Sarah; Ong, Toan C.; Family Medicine, School of MedicineItem Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults - VISION Network, 10 States, December 2021-March 2022(Center for Disease Control, 2022-04-01) Natarajan, Karthik; Prasad, Namrata; Dascomb, Kristin; Irving, Stephanie A.; Yang, Duck-Hye; Gaglani, Manjusha; Klein, Nicola P.; DeSilva, Malini B.; Ong, Toan C.; Grannis, Shaun J.; Stenehjem, Edward; Link-Gelles, Ruth; Rowley, Elizabeth A.; Naleway, Allison L.; Han, Jungmi; Raiyani, Chandni; Vazquez Benitez, Gabriela; Rao, Suchitra; Lewis, Ned; Fadel, William F.; Grisel, Nancy; Griggs, Eric P.; Dunne, Margaret M.; Stockwell, Melissa S.; Mamawala, Mufaddal; McEvoy, Charlene; Barron, Michelle A.; Goddard, Kristin; Valvi, Nimish R.; Arndorfer, Julie; Patel, Palak; Mitchell, Patrick K.; Smith, Michael; Kharbanda, Anupam B.; Fireman, Bruce; Embi, Peter J.; Dickerson, Monica; Davis, Jonathan M.; Zerbo, Ousseny; Dalton, Alexandra F.; Wondimu, Mehiret H.; Azziz-Baumgartner, Eduardo; Bozio, Catherine H.; Reynolds, Sue; Ferdinands, Jill; Williams, Jeremiah; Schrag, Stephanie J.; Verani, Jennifer R.; Ball, Sarah; Thompson, Mark G.; Dixon, Brian E.; Community and Global Health, Richard M. Fairbanks School of Public HealthCDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted.Item 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(American Medical Association, 2022-09-01) 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.; Epidemiology, School of Public HealthImportance: 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.