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Waning of vaccine effectiveness against moderate and severe covid-19 among adults in the US from the VISION network: test negative, case-control study
Open accessAbstract
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.
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“Further, although boosting by BNT162b2 or CoronaVac restores strong protection against hospitalization and death33–35, the incremental effectiveness of BNT162b2 boosters against such outcomes waned over the course of 4–6 months34 for both adults and the elderly36.”
From Real-world COVID-19 vaccine effectiveness against the Omicron BA.2 variant in a SARS-CoV-2 infection-naive population (2023) · cites this paper as [36]
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“This led to a decline in vaccine effectiveness (VE) over time, as shown in several observational studies [2, 3].”
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Citations
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Risk factors of COVID-19 breakthrough infection: a case-control test-negative design study
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Dehnen, D., Botzenhardt, S., Giagkou, E., Enders, K., Hoeter, K., Simon, P. D., & Neuberger, E. W. I. (2025) · Virology Journal · doi:10.1186/s12985-025-03016-x
“Studies on vaccine effectiveness showed a lower effectiveness of mRNA vaccines against Omi-cron variants due to immune escape mechanisms [10– 12]; however, booster vaccinations improve protection against severe illness [13–15].”
Taus, E., Shino, M. Y., Ibarrondo, F. J., Hausner, M. A., Hofmann, C., & Yang, O. O. (2024) · Figshare · doi:10.6084/m9.figshare.26595695
Tsang, T. K., Sullivan, S. G., Meng, Y., Lai, F. T. T., Fan, M., Huang, X., Lin, Y., Peng, L., Zhang, C., Yang, B., et al. (2024) · Figshare · doi:10.6084/m9.figshare.27012277
Uemura, K., Ono, S., Michihata, N., Yamana, H., & Yasunaga, H. (2024) · Figshare · doi:10.6084/m9.figshare.26740445
Taus, E., Shino, M. Y., Ibarrondo, F. J., Hausner, M. A., Hofmann, C., & Yang, O. O. (2024) · Figshare · doi:10.6084/m9.figshare.26595698
Ess, G., Lew, A. S., Tippett, A., Salazar, L. W., Choi, C., Castro, K. D., Taylor, E. G., Reese, O., Momin, H., Ciric, C. R., et al. (2025) · Vaccines · doi:10.3390/vaccines14010045
“However, real-world VE decreased from the original estimates due to factors such as the emergence of SARS-CoV-2 variants, including Delta and Omicron with its subvariants [12–14].”
Wang, L., Swayze, S., Siddiqi, A., Baral, S., Sander, B., Sbihi, H., Kwong, J. C., & Mishra, S. (2026) · American Journal of Epidemiology · doi:10.1093/aje/kwag047 · Cited by 1
“…based on an individual’s vaccination status and prior COVID-19 diagnosis as of August 1, 2021, classified as either being immune (received ≥ 1 dose of the Johnson-Johnson vaccine or ≥ 2 doses of other vaccines or had a positive SARS-CoV-2 test, in the past 165 days 21 , 22 ) or non-immune.”
Holmes, A., Narayan, K. M., Yalcin, I., Hu, L., & Wingertzahn, M. A. (2026) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofag168
Dadabhai, S. S., Samandari, T., Zhang, B., Hudson, A., Mkhize, N. N., Tapley, A., Andriesen, J. G., Moore, P., Chirenje, Z. M., Elyanu, P., et al. (2026) · Research Square · doi:10.21203/rs.3.rs-10935317/v1
“However, as with all COVID-19 vaccine platforms, waning immunity and escape from prior immunity by new SARS-CoV-2 variants – particularly omicron and its sub-lineages – reduced vaccine efficacy, especially in the elderly and the immunocompromised 3,4 .”
Ivo Rakovac, A., Triantafyllou, C., Psiakis, V., Galinovic, A., Domingues, A. M., Myrianthefs, P. M., & Breda, J. (2026) · Epidemiologia · doi:10.3390/epidemiologia7050129
“As vaccine effectiveness wanes over time, especially among elderly people and people with comorbidities, booster vaccine doses are key tools in protecting the most vulnerable [31,32].”
Feikin, D. R., Higdon, M. M., Abu-Raddad, L. J., Andrews, N., & Araos, R. (2023) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(23)00015-6
“S, ChAdOx1, and mRNA-1273 Primary series Hospitalisations Delta El Adam (2022)51 Canada mRNA-1273 and BNT162b2 Primary series Infections Non-specific El Sahly (2021)52 USA mRNA-1273 Primary series Infections Non-specific Ferdinands (2022)53 USA mRNA-1273 and BNT162b2 Primary series Infections Omicron Florea (2021)54 U…”
BackgroundInfluential
Metadata
- Authors
- Ferdinands, J. M., Rao, S., Dixon, B. E., Mitchell, P. K., DeSilva, M. B., Irving, S. A., Lewis, N., Natarajan, K., Stenehjem, E., Grannis, S. J., Han, J., McEvoy, C., Ong, T. C., Naleway, A. L., Reese, S. E., Embi, P. J., Dascomb, K., Klein, N. P., Griggs, E. P., Liao, I.-C., Yang, D.-H., Fadel, W. F., Grisel, N., Goddard, K., Patel, P., Murthy, K., Birch, R., Valvi, N. R., Arndorfer, J., Zerbo, O., Dickerson, M., Raiyani, C., Williams, J., Bozio, C. H., Blanton, L., Link-Gelles, R., Barron, M. A., Gaglani, M., Thompson, M. G., & Fireman, B.
- Affiliations
- Centers for Disease Control and Prevention (US)
- University of Colorado Anschutz (US)
- Regenstrief Institute (US)
- Westat (United States) (US)
- HealthPartners (US)
- Kaiser Permanente (US)
- NewYork–Presbyterian Hospital (US)
- Intermountain Healthcare (US)
- Columbia University Irving Medical Center (US)
- Baylor Scott & White Medical Center - Temple (US)
- Corresponding author
- Ferdinands, Jill M
- ORCID
- Ferdinands, Jill M
- Rao, Suchitra
- Dixon, Brian E
- Mitchell, Patrick K
- DeSilva, Malini B
- Irving, Stephanie A
- Lewis, Ned
- Natarajan, Karthik
- Stenehjem, Edward
- Grannis, Shaun J
- McEvoy, Charlene
- Ong, Toan C
- Naleway, Allison L
- Reese, Sarah E
- Dascomb, Kristin
- Klein, Nicola P
- Griggs, Eric P
- Liao, I-Chia
- Yang, Duck-Hye
- Fadel, William F
- Goddard, Kristin
- Patel, Palak
- Murthy, Kempapura
- Valvi, Nimish R
- Zerbo, Ousseny
- Dickerson, Monica
- Raiyani, Chandni
- Bozio, Catherine H
- Blanton, Lenee
- Barron, Michelle A
- Gaglani, Manjusha
- Thompson, Mark G
- Fireman, Bruce
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2022-10-03
- Volume
- 379
- Pages
- e072141
- ISSN
- 1756-1833 (ISSN-L)
- PMC
- PMC9527398
- OpenAlex
- W4300863078
- Cited by
- 185
- References
- 30
- Citations by year
- 2026: 5 · 2025: 23 · 2024: 63 · 2023: 88 · 2022: 5
- FWCI
- 21.96
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion, cc-by-nc)
- Funders
- National Center for Immunization and Respiratory Diseases
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Keywords
- waning vaccine effectiveness, COVID-19 pandemic, SARS-CoV-2, mRNA vaccines, BNT162b2, mRNA-1273, booster vaccination, immunocompromised patients, hospitalization, emergency department visits, Omicron variant, Delta variant, adults, test-negative case-control, COVID-19 vaccination
- MeSH terms
- COVID-19, SARS-CoV-2, Vaccine Efficacy, BNT162 Vaccine, Humans, Case-Control Studies, Young Adult
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