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Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants.
JAMA. 2022 02 15; 327(7):639-651.JAMA

Abstract

Importance

Assessing COVID-19 vaccine performance against the rapidly spreading SARS-CoV-2 Omicron variant is critical to inform public health guidance.

Objective

To estimate the association between receipt of 3 doses of Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 vaccine and symptomatic SARS-CoV-2 infection, stratified by variant (Omicron and Delta).

Design, Setting, and Participants

A test-negative case-control analysis among adults 18 years or older with COVID-like illness tested December 10, 2021, through January 1, 2022, by a national pharmacy-based testing program (4666 COVID-19 testing sites across 49 US states).

Exposures

Three doses of mRNA COVID-19 vaccine (third dose ≥14 days before test and ≥6 months after second dose) vs unvaccinated and vs 2 doses 6 months or more before test (ie, eligible for a booster dose).

Main Outcomes and Measures

Association between symptomatic SARS-CoV-2 infection (stratified by Omicron or Delta variants defined using S-gene target failure) and vaccination (3 doses vs unvaccinated and 3 doses vs 2 doses). Associations were measured with multivariable multinomial regression. Among cases, a secondary outcome was median cycle threshold values (inversely proportional to the amount of target nucleic acid present) for 3 viral genes, stratified by variant and vaccination status.

Results

Overall, 23 391 cases (13 098 Omicron; 10 293 Delta) and 46 764 controls were included (mean age, 40.3 [SD, 15.6] years; 42 050 [60.1%] women). Prior receipt of 3 mRNA vaccine doses was reported for 18.6% (n = 2441) of Omicron cases, 6.6% (n = 679) of Delta cases, and 39.7% (n = 18 587) of controls; prior receipt of 2 mRNA vaccine doses was reported for 55.3% (n = 7245), 44.4% (n = 4570), and 41.6% (n = 19 456), respectively; and being unvaccinated was reported for 26.0% (n = 3412), 49.0% (n = 5044), and 18.6% (n = 8721), respectively. The adjusted odds ratio for 3 doses vs unvaccinated was 0.33 (95% CI, 0.31-0.35) for Omicron and 0.065 (95% CI, 0.059-0.071) for Delta; for 3 vaccine doses vs 2 doses the adjusted odds ratio was 0.34 (95% CI, 0.32-0.36) for Omicron and 0.16 (95% CI, 0.14-0.17) for Delta. Median cycle threshold values were significantly higher in cases with 3 doses vs 2 doses for both Omicron and Delta (Omicron N gene: 19.35 vs 18.52; Omicron ORF1ab gene: 19.25 vs 18.40; Delta N gene: 19.07 vs 17.52; Delta ORF1ab gene: 18.70 vs 17.28; Delta S gene: 23.62 vs 20.24).

Conclusions and Relevance

Among individuals seeking testing for COVID-like illness in the US in December 2021, receipt of 3 doses of mRNA COVID-19 vaccine (compared with unvaccinated and with receipt of 2 doses) was less likely among cases with symptomatic SARS-CoV-2 infection compared with test-negative controls. These findings suggest that receipt of 3 doses of mRNA vaccine, relative to being unvaccinated and to receipt of 2 doses, was associated with protection against both the Omicron and Delta variants, although the higher odds ratios for Omicron suggest less protection for Omicron than for Delta.

Authors+Show Affiliations

Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia. Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia. Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.Centers for Disease Control and Prevention COVID-19 Response, Atlanta, Georgia.

Pub Type(s)

Journal Article
Observational Study
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

35060999

Citation

Accorsi, Emma K., et al. "Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused By the SARS-CoV-2 Omicron and Delta Variants." JAMA, vol. 327, no. 7, 2022, pp. 639-651.
Accorsi EK, Britton A, Fleming-Dutra KE, et al. Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants. JAMA. 2022;327(7):639-651.
Accorsi, E. K., Britton, A., Fleming-Dutra, K. E., Smith, Z. R., Shang, N., Derado, G., Miller, J., Schrag, S. J., & Verani, J. R. (2022). Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants. JAMA, 327(7), 639-651. https://doi.org/10.1001/jama.2022.0470
Accorsi EK, et al. Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused By the SARS-CoV-2 Omicron and Delta Variants. JAMA. 2022 02 15;327(7):639-651. PubMed PMID: 35060999.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants. AU - Accorsi,Emma K, AU - Britton,Amadea, AU - Fleming-Dutra,Katherine E, AU - Smith,Zachary R, AU - Shang,Nong, AU - Derado,Gordana, AU - Miller,Joseph, AU - Schrag,Stephanie J, AU - Verani,Jennifer R, PY - 2022/1/22/pubmed PY - 2022/2/22/medline PY - 2022/1/21/entrez SP - 639 EP - 651 JF - JAMA JO - JAMA VL - 327 IS - 7 N2 - Importance: Assessing COVID-19 vaccine performance against the rapidly spreading SARS-CoV-2 Omicron variant is critical to inform public health guidance. Objective: To estimate the association between receipt of 3 doses of Pfizer-BioNTech BNT162b2 or Moderna mRNA-1273 vaccine and symptomatic SARS-CoV-2 infection, stratified by variant (Omicron and Delta). Design, Setting, and Participants: A test-negative case-control analysis among adults 18 years or older with COVID-like illness tested December 10, 2021, through January 1, 2022, by a national pharmacy-based testing program (4666 COVID-19 testing sites across 49 US states). Exposures: Three doses of mRNA COVID-19 vaccine (third dose ≥14 days before test and ≥6 months after second dose) vs unvaccinated and vs 2 doses 6 months or more before test (ie, eligible for a booster dose). Main Outcomes and Measures: Association between symptomatic SARS-CoV-2 infection (stratified by Omicron or Delta variants defined using S-gene target failure) and vaccination (3 doses vs unvaccinated and 3 doses vs 2 doses). Associations were measured with multivariable multinomial regression. Among cases, a secondary outcome was median cycle threshold values (inversely proportional to the amount of target nucleic acid present) for 3 viral genes, stratified by variant and vaccination status. Results: Overall, 23 391 cases (13 098 Omicron; 10 293 Delta) and 46 764 controls were included (mean age, 40.3 [SD, 15.6] years; 42 050 [60.1%] women). Prior receipt of 3 mRNA vaccine doses was reported for 18.6% (n = 2441) of Omicron cases, 6.6% (n = 679) of Delta cases, and 39.7% (n = 18 587) of controls; prior receipt of 2 mRNA vaccine doses was reported for 55.3% (n = 7245), 44.4% (n = 4570), and 41.6% (n = 19 456), respectively; and being unvaccinated was reported for 26.0% (n = 3412), 49.0% (n = 5044), and 18.6% (n = 8721), respectively. The adjusted odds ratio for 3 doses vs unvaccinated was 0.33 (95% CI, 0.31-0.35) for Omicron and 0.065 (95% CI, 0.059-0.071) for Delta; for 3 vaccine doses vs 2 doses the adjusted odds ratio was 0.34 (95% CI, 0.32-0.36) for Omicron and 0.16 (95% CI, 0.14-0.17) for Delta. Median cycle threshold values were significantly higher in cases with 3 doses vs 2 doses for both Omicron and Delta (Omicron N gene: 19.35 vs 18.52; Omicron ORF1ab gene: 19.25 vs 18.40; Delta N gene: 19.07 vs 17.52; Delta ORF1ab gene: 18.70 vs 17.28; Delta S gene: 23.62 vs 20.24). Conclusions and Relevance: Among individuals seeking testing for COVID-like illness in the US in December 2021, receipt of 3 doses of mRNA COVID-19 vaccine (compared with unvaccinated and with receipt of 2 doses) was less likely among cases with symptomatic SARS-CoV-2 infection compared with test-negative controls. These findings suggest that receipt of 3 doses of mRNA vaccine, relative to being unvaccinated and to receipt of 2 doses, was associated with protection against both the Omicron and Delta variants, although the higher odds ratios for Omicron suggest less protection for Omicron than for Delta. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/35060999/Association_Between_3_Doses_of_mRNA_COVID_19_Vaccine_and_Symptomatic_Infection_Caused_by_the_SARS_CoV_2_Omicron_and_Delta_Variants_ DB - PRIME DP - Unbound Medicine ER -