Effectiveness of mRNA vaccine boosters against infection with the SARS-CoV-2 omicron (B.1.1.529) variant in Spain: a nationwide cohort study
Open accessAbstract
Background The omicron (B.1.1.529) variant of SARS-CoV-2 has increased capacity to elude immunity and cause breakthrough infections. The aim of this study was to estimate the effectiveness of mRNA-based vaccine boosters (third dose) against infection with the omicron variant by age, sex, time since complete vaccination, type of primary vaccine, and type of booster. Methods In this nationwide cohort study, we linked data from three nationwide population registries in Spain (Vaccination Registry, Laboratory Results Registry, and National Health System registry) to select community-dwelling individuals aged 40 years or older, who completed their primary vaccine schedule at least 3 months before the start of follow-up, and had not tested positive for SARS-CoV-2 since the start of the pandemic. On each day between Jan 3, and Feb 6, 2022, we matched individuals who received a booster mRNA vaccine and controls of the same sex, age group, postal code, type of vaccine, time since primary vaccination, and number of previous tests. We estimated risk of laboratory-confirmed SARS-CoV-2 infection using the Kaplan-Meier method and compared groups using risk ratios (RR) and risk differences. Vaccine effectiveness was calculated as one minus RR. Findings Between Jan 3, and Feb 6, 2022, 3 111 159 matched pairs were included in our study. Overall, the estimated effectiveness from day 7 to 34 after a booster was 51·3% (95% CI 50·2-52·4). Estimated effectiveness was 52·5% (51·3-53·7) for an mRNA-1273 booster and 46·2% (43·5-48·7) for a BNT162b2 booster. Effectiveness was 58·6% (55·5-61·6) if primary vaccination had been with ChAdOx1 nCoV-19 (Oxford-AstraZeneca), 55·3% (52·3-58·2) with mRNA-1273 (Moderna), 49·7% (48·3-51·1) with BNT162b2 (Pfizer-BioNTech), and 48·0% (42·5-53·7) with Ad26.COV2.S (Janssen). Estimated effectiveness was 43·6% (40·0-47·1) when the booster was administered between 151 days and 180 days after complete vaccination and 52·2% (51·0-53·3) if administered more than 180 days after primary scheduled completion. Interpretation Booster mRNA vaccine-doses were moderately effective in preventing infection with the omicron variant of SARS-CoV-2 for over a month after administration, which indicates their suitability as a strategy to limit the health effects of COVID-19 in periods of omicron variant domination. Estimated effectiveness was higher for mRNA-1273 compared with BNT162b2 and increased with time between completed primary vaccination and booster. Funding None.
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A booster dose administered at least 5 months after the primary series of mRNA vaccines restores protection against SARS-CoV-2 infection and severe COVID-19 outcomes.
“a booster dose administered at least 5 months after the primary series of mRNA vaccines restores protection against SARS-CoV-2 infection and severe COVID-19 outcomes,12–14”
From Protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant: a systematic review and meta-analysis (2023) · cites this paper as [12]
The Results report that boosters given 151–180 days after primary vaccination were moderately effective against omicron infection. The Discussion explicitly says the study could not estimate effectiveness against severe disease or death; it only predicts protection against severe disease based on other studies. Thus, this paper does not establish the claimed restoration of protection against severe outcomes. (LLM, conf=0.90)
Experimental — accuracy not yet measuredNumerous studies conducted during the Omicron BA.1 period have reported an increase in VE against infection caused by this variant following a booster dose.
“Still, numerous studies conducted during the Omicron BA.1 period have reported an increase in VE against infection caused by this variant following a booster dose [19,26,32-35].”
From Vaccine effectiveness and duration of protection of COVID-19 mRNA vaccines against Delta and Omicron BA.1 symptomatic and severe COVID-19 outcomes in adults aged 50 years and over in France (2023) · cites this paper as [35]
The Results report 51.3% booster effectiveness against laboratory-confirmed infection compared with no booster, and the Procedures say the study took place when Omicron accounted for more than 90% to 99% of detected variants in Spain. Our copy does not identify BA.1 specifically or establish that each recorded infection was caused by that subvariant, so it supports the booster-effectiveness finding during Omicron predominance but not the BA.1-specific wording. (LLM, conf=0.82)
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“Still, numerous studies conducted during the Omicron BA.1 period have reported an increase in VE against infection caused by this variant following a booster dose [19,26,32–35].”
- Authors
- Monge, S., Rojas-Benedicto, A., Olmedo, C., Mazagatos, C., José Sierra, M., Limia, A., Martín-Merino, E., Larrauri, A., Hernán, M. A., Moreno, D., Méndez Díaz, M., Huerta González, I., Galmés Truyols, A., Barreno Estévez, A., García Velasco, V., Rodríguez Recio, M. J., Sacristán, J., Martínez Marcos, M., Pastor Villalba, E., Macías Ortiz, M. J., García Vallejo, A., Sánchez Gómez, A., García Pina, R., Barricarte Gurea, A., Sancho Martínez, R., Ochoa, E. M., Vázquez Cantero, M., Gómez Anés, A., Pareja Megía, M. J., Castán, Y., Fonseca Álvarez, M. R., Salvà Fiol, A., Sánchez Janáriz, H., López Arce, L., Cisneros Martín, M. Á., Gibernau, F. J., Fernandez Buey, C., Villatoro Bongiorno, K., Rubio García, F. J., Santos Guerra, F., Astray Mochales, J., Francisco Verdu, F. J., García Romero, I., Oriza Bernal, R., Gómez Pérez, T., Hijano Villegas, S., Román Soto, S., Gómez-Barroso, D., Lapeña, M. F., Yagüe Galaup, V., Alfaro Latorre, M., Aguilera Guzmán, M., Crespo Sánchez-Eznarriaga, B., Neira León, M., & Cívicos Villa, N.
- Affiliations
- Instituto de Salud Carlos III (ES)
- Ministry of Health (ES)
- Corresponding author
- Monge, Susana
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2022-09
- Volume
- 22
- Issue
- 9
- Pages
- 1313-1320
- ISSN
- 1473-3099 (ISSN-L)
- PMC
- PMC9162477
- OpenAlex
- W4281955002
- Cited by
- 81
- References
- 18
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 14 · 2023: 39 · 2022: 17
- FWCI
- 9.41
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- The Lancet Infectious Diseases (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- 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
- Omicron variant, mRNA vaccine booster, third dose, vaccine effectiveness, breakthrough infection, mRNA-1273, BNT162b2, ChAdOx1 nCoV-19 vaccine, age and sex differences, Spain, COVID-19 vaccination
- MeSH terms
- COVID-19, SARS-CoV-2, mRNA Vaccines, BNT162 Vaccine, Ad26COVS1, ChAdOx1 nCoV-19, Humans, Immunization Schedule, Spain, Vaccines, Synthetic, Cohort Studies
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