Cited by 83SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesCOVID-19 epidemiological studies

Assessing vaccine effectiveness against severe COVID-19 disease caused by omicron variant. Report from a meeting of the World Health Organization

Open access
Feikin, Daniel R., Abu-Raddad, Laith J., Andrews, Nick, Davies, Mary-Ann, Higdon, Melissa M., Orenstein, Walter A., Patel, Minal K.·2022·Vaccine

Abstract

Vaccine effectiveness is lower and wanes faster against infection and symptomatic disease caused by the omicron variant of SARS-CoV-2 than was observed with previous variants. Vaccine effectiveness against severe omicron disease, on average, is higher, but has shown variability, including rapid apparent waning, in some studies. Assessing vaccine effectiveness against omicron severe disease using hospital admission as a measure of severe disease has become more challenging because of omicron's attenuated intrinsic severity and its high prevalence of infection. Many hospital admissions likely occur among people with incidental omicron infection or among those with infection-induced exacerbation of chronic medical conditions. To address this challenge, the World Health Organization held a virtual meeting on March 15, 2022, to review evidence from several studies that assessed Covid-19 vaccine effectiveness against severe omicron disease using several outcome definitions. Data was shown from studies in South Africa, the United States, the United Kingdom and Qatar. Several approaches were proposed that better characterize vaccine protection against severe Covid-19 disease caused by the omicron variant than using hospitalization of omicron-infected persons to define severe disease. Using more specific definitions for severe respiratory Covid-19 disease, such as indicators of respiratory distress (e.g. oxygen requirement, mechanical ventilation, and ICU admission), showed higher vaccine effectiveness than against hospital admission. Second, vaccine effectiveness against progression from omicron infection to hospitalization, or severe disease, also showed higher vaccine protection. These approaches might better characterize vaccine performance against severe Covid-19 disease caused by omicron, as well as future variants that evade humoral immunity, than using hospitalization with omicron infection as an indicator of severe disease.

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Crossref · 10.1016/j.vaccine.2022.04.069

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  • Including incidental infections or exacerbations in hospitalization-based severe disease definitions would result in a lower vaccine effectiveness against hospitalization if vaccine effectiveness is truly lower against BA.4/5 infection.

    “both of which would result in a lower VE against hospitalization if VE is truly lower against BA.4/5 infection [37].”

    From Assessing COVID-19 vaccine effectiveness against Omicron subvariants: Report from a meeting of the World Health Organization (2023) · cites this paper as [37]

    The sections “Hospitalization with omicron infection rather than for omicron disease” and “Summary and conclusions” explain that incidental infections and exacerbations can make hospitalization-based estimates lower than estimates for severe COVID-19 disease. “Approaches to evaluating vaccine effectiveness” also states that lower effectiveness against omicron infection can lower apparent effectiveness against hospitalization. The paper does not specifically address BA.4/5, so it supports the conditional reasoning but not its application to that subvariant. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • A larger percentage of hospitalizations during the Omicron period likely had incidental, rather than causal, infections with SARS-CoV-2.

    “Additionally, a larger percentage of hospitalizations during the Omicron period likely had incidental, rather than causal, infections with SARS-CoV-2”
  • Infections would be more affected by true waning of vaccine effectiveness than hospitalizations.

    “and infections would be more affected by true waning of VE [37,41].”
  • Definitions of severe disease that rely solely on hospitalization might include persons hospitalized with incidental Omicron infection or exacerbations of underlying illness triggered by SARS-CoV-2 infection.

    “Alternatively, definitions of severe disease that rely solely on hospitalization might in fact include persons hospitalized with incidental Omicron infection or exacerbations of underlying illness triggered by SARS-CoV2 infection”

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Research works printed but not linked: 9

  1. [3]International Vaccine Access Center. Results of COVID-19 vaccine effectiveness & impact studies: an ongoing systematic review, methods. https://view-hub.org/sites/default/files/2022-04/COVID19_VE_and_Impact_Lit_Review_Methods.pdf (accessed April 19, 2022).
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  3. [8]Tartof SY, Slezak JM, Puzniak L, et al. BNT162b2 (Pfizer–Biontech) mRNA COVID-19 Vaccine Against omicron-Related Hospital and Emergency Department Admission in a Large US Health System: A Test-Negative Design. Rochester, NY. SSRN 2022; published online Jan 18. https://ssrn.com/abstract=4011905 https://ssrn.com/abstract=4011905 (preprint).
  4. [10]Gray GE, Collie S, Garrett N, et al. Vaccine effectiveness against hospital admission in South African health care workers who received a homologous booster of Ad26.COV2 during an omicron COVID19 wave: Preliminary Results of the Sisonke 2 Study. medRxiv 2021; published online Dec 29. https://www.medrxiv.org/content/10.1101/2021.12.28.21268436v1 (preprint). · DOI
  5. [13]Araos R, Jara A, Undurraga E, et al. Effectiveness of CoronaVac in children 3 to 5 years during the omicron SARS-CoV-2 outbreak. Research Square 2022; published online Apr 14. https://doi.org/10.21203/rs.3.rs-1440357/v1 (preprint). · DOI
  6. [16]Lauring A.S. Tenforde M.W. Chappell J.D. Clinical severity of, and effectiveness of mRNA vaccines against, covid-19 from omicron, delta, and alpha SARS-CoV-2 variants in the United States: prospective observational study BMJ 376 2022 e069761 PMC8905308 35264324
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Authors
Feikin, D. R., Abu-Raddad, L. J., Andrews, N., Davies, M.-A., Higdon, M. M., Orenstein, W. A., & Patel, M. K.
Affiliations
  • World Health Organization (CH)
  • Cornell University (US)
  • UK Health Security Agency (GB)
  • Western Cape Department of Health (ZA)
  • Johns Hopkins University (US)
  • Emory University (US)
Corresponding author
Feikin, Daniel R.
Venue
Vaccine
Publisher
Elsevier BV
Published
2022-06
Volume
40
Issue
26
Pages
3516-3527
ISSN
0264-410X (ISSN-L)
OpenAlex
W4225285640
Cited by
83
References
26
Citations by year
2026: 4 · 2025: 5 · 2024: 15 · 2023: 40 · 2022: 19
FWCI
9.66
Type
journal article
Language
en
Open access
Locations
  • Vaccine (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • World Health Organization
  • Centers for Disease Control and Prevention
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
Keywords
COVID-19 vaccine effectiveness, Omicron variant, severe COVID-19, hospitalization, respiratory distress, mechanical ventilation, intensive care unit admission, vaccine waning, immune evasion
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Vaccines, Vaccine Efficacy, Humans, United States, World Health Organization

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