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Research

Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study

BMJ 2022; 379 doi: https://doi.org/10.1136/bmj-2022-072141 (Published 03 October 2022) Cite this as: BMJ 2022;379:e072141
  1. Jill M Ferdinands, research epidemiologist1,
  2. Suchitra Rao, associate professor of pediatrics2,
  3. Brian E Dixon, director of public health informatics3 4,
  4. Patrick K Mitchell, senior epidemiologist5,
  5. Malini B DeSilva, internal medicine specialist6,
  6. Stephanie A Irving, project director7,
  7. Ned Lewis, data manager8,
  8. Karthik Natarajan, assistant professor of biomedical informatics9 10,
  9. Edward Stenehjem, infectious disease specialist11,
  10. Shaun J Grannis, vice president of data analytics3 12,
  11. Jungmi Han, research analyst9,
  12. Charlene McEvoy, internal medicine specialist6,
  13. Toan C Ong, research instructor2,
  14. Allison L Naleway, senior epidemiologist7,
  15. Sarah E Reese, senior biostatistician5,
  16. Peter J Embi, professor of medicine,
  17. Kristin Dascomb, medical director infection prevention11,
  18. Nicola P Klein, senior research scientist8,
  19. Eric P Griggs, epidemiologist1,
  20. I-Chia Liao, analytics developer13,
  21. Duck-Hye Yang, senior epidemiologist5,
  22. William F Fadel, clinical assistant professor3 4,
  23. Nancy Grisel, analyst11,
  24. Kristin Goddard, senior research manager8,
  25. Palak Patel, epidemiologist1,
  26. Kempapura Murthy, SAS programmer13,
  27. Rebecca Birch, senior epidemiologist5,
  28. Nimish R Valvi, postdoctoral fellow3,
  29. Julie Arndorfer, analyst11,
  30. Ousseny Zerbo, research scientist8,
  31. Monica Dickerson, epidemiologist1,
  32. Chandni Raiyani, biostatistician13,
  33. Jeremiah Williams, surveillance coordinator1,
  34. Catherine H Bozio, epidemiologist1,
  35. Lenee Blanton, research epidemiologist1,
  36. Ruth Link-Gelles, epidemiologist1,
  37. Michelle A Barron, senior medical director2,
  38. Manjusha Gaglani, chief of pediatric infectious diseases13,
  39. Mark G Thompson, epidemiologist1,
  40. Bruce Fireman, biostatistician8
  1. 1Centers for Disease Control and Prevention COVID-19 Response Team, Atlanta, GA, USA
  2. 2Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO, USA
  3. 3Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, USA
  4. 4Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA
  5. 5Westat, Rockville, MD, USA
  6. 6HealthPartners Institute, Minneapolis, MN, USA
  7. 7Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA
  8. 8Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research, Oakland, CA, USA
  9. 9Department of Biomedical Informatics, Columbia University Irving Medical Center, New York, NY, USA
  10. 10New York Presbyterian Hospital, New York, NY, USA
  11. 11Division of Infectious Diseases and Clinical Epidemiology, Intermountain Healthcare, Salt Lake City, UT, USA
  12. 12Indiana University School of Medicine, Indianapolis, IN, USA
  13. 13Baylor Scott &White Health, Temple, TX, USA
  1. Correspondence to: J M Ferdinands zdn5{at}cdc.gov

  1. † Patients aged <50 years were excluded from estimates of fourth dose effectiveness; thus, column sum might not equal 100% of encounters.

  • Accepted 9 September 2022

Abstract

Objective To estimate the effectiveness of mRNA vaccines against moderate and severe covid-19 in adults by time since second, third, or fourth doses, and by age and immunocompromised status.

Design Test negative case-control study.

Setting Hospitals, emergency departments, and urgent care clinics in 10 US states, 17 January 2021 to 12 July 2022.

Participants 893 461 adults (≥18 years) admitted to one of 261 hospitals or to one of 272 emergency department or 119 urgent care centers for covid-like illness tested for SARS-CoV-2.

Main outcome measures The main outcome was waning of vaccine effectiveness with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine during the omicron and delta periods, and the period before delta was dominant using logistic regression conditioned on calendar week and geographic area while adjusting for age, race, ethnicity, local virus circulation, immunocompromised status, and likelihood of being vaccinated.

Results 45 903 people admitted to hospital with covid-19 (cases) were compared with 213 103 people with covid-like illness who tested negative for SARS-CoV-2 (controls), and 103 287 people admitted to emergency department or urgent care with covid-19 (cases) were compared with 531 168 people with covid-like illness who tested negative for SARS-CoV-2. In the omicron period, vaccine effectiveness against covid-19 requiring admission to hospital was 89% (95% confidence interval 88% to 90%) within two months after dose 3 but waned to 66% (63% to 68%) by four to five months. Vaccine effectiveness of three doses against emergency department or urgent care visits was 83% (82% to 84%) initially but waned to 46% (44% to 49%) by four to five months. Waning was evident in all subgroups, including young adults and individuals who were not immunocompromised; although waning was morein people who were immunocompromised. Vaccine effectiveness increased among most groups after a fourth dose in whom this booster was recommended.

Conclusions Effectiveness of mRNA vaccines against moderate and severe covid-19 waned with time after vaccination. The findings support recommendations for a booster dose after a primary series and consideration of additional booster doses.

Footnotes

  • Contributors: All authors contributed to the design of the study. PKM, SER, RB, and DY performed the statistical analysis. SR, BD, MBD, SAI, NL, KN, ED, SJG, JH, CM, TCO, ALN, PJE, KD, NPK, IL, WFF, NG, KG, KP, NRV, JA, OZ, CR, MB, MG, and BF were involved in data collection and study coordination at partner sites. EPG, PP, MD, JW, CHB, LB, and RL provided data collection and central study coordination at US Centers for Disease Control and Prevention, supervised by MT. JMF and BF produced the first draft of this manuscript and all authors reviewed, edited, and approved the final version. JMF is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding: This study was funded by the Centers for Disease Control and Prevention through contract 75D30120C07986 to Westat and contract 75D30120C07765 to Kaiser Foundation Hospitals.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: NPK reports institutional support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, and Protein Sciences (now Sanofi Pasteur) for unrelated studies and institutional support from Pfizer for a covid-19 vaccine trial. CM received institutional support from AstraZeneca for a covid-19 vaccine trial. ALN received institutional support from Pfizer for an unrelated study of meningococcal B vaccine safety during pregnancy. SR received grant funding from GlaxoSmithKline and Biofire Diagnostics. Authors declare no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.

  • The lead author (JMF) affirms that this manuscript is an accurate and transparent account of the study being reported and that no important aspects of the study have been omitted.

  • Dissemination to participants and related patient and public communities: The individual level dataset from this study is held securely in limited deidentified form at the US Centers for Disease Control and Prevention. Data sharing agreements between CDC and data providers prohibit CDC from making this dataset publicly available. CDC will share aggregate study data once study objectives are complete, consistent with data use agreements with partner institutions.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

Data availability statement

No additional data available.

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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