Effectiveness of mRNA vaccine boosters against infection with the SARS-CoV-2 omicron (B.1.1.529) variant in Spain: a nationwide cohort study

Monge, Susana; Rojas-Benedicto, Ayelén; Olmedo, C.; Mazagatos, Clara; Sierra, María José; Limia, Aurora; Martín‐Merino, Elisa; Larrauri, Amparo; Hernán, Miguel A.; Moreno‐Ramírez, D.; Díaz, Manuel Méndez; González, Ismael Huerta; Truyols, Antònia Galmés; Estévez, Ana Barreno; Velasco, Valvanuz García; Recio, Ma Jesús Rodríguez; Sacristán, José Gimeno; Marcos, Montserrat Martínez; Villalba, Eliseo Pastor; Ortiz, María José Macías; Vallejo, Ana García; Gómez, Amaya Sánchez; Pina, Rocío García; Gurea, Aurelio Barricarte; Martínez, Rosa Sancho; Ochoa, Eva María; Cantero, Mauricio Vázquez; Anés, Atanasio Gómez; Megía, María Jesús Pareja; Castán, Yolanda; Álvarez, Manuel Roberto Fonseca; Fiol, Antonia Salvà; Janáriz, Hilda Sánchez; Arce, Luz López; Martín, Maria Ángeles; Gibernau, Frederic Jose; Buey, Cesar Fernandez; Bongiorno, Katja Villatoro; García, Francisco Javier Rubio; Guerra, Fernando Santos; Mochales, Jenaro Astray; Verdu, Francisco Javier Francisco; Romero, Isabel García; Bernal, Rosa Oriza; Pérez, Tomás Gómez; Villegas, Salomé Hijano; Soto, Sergio Román; Gómez-Barroso, Diana; Lapeña, María Fé; Galaup, Virgilio Yagüe; Latorre, Mercedes Alfaro; Guzmán, Marta Aguilera; Sánchez-Eznarriaga, Belén Crespo; León, Montserrat Neira; Villa, Noemí Cívicos

doi:10.1016/s1473-3099(22)00292-4

Cited by 68 publications

(80 citation statements)

References 26 publications

(33 reference statements)

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“…As in prior studies 13, 14 , we found that booster VE against infection and hospitalization was significantly higher as more time accrued since primary vaccination (>9 vs. 5-9 months). This is most likely related to the waning protection of primary vaccination over time in the comparator, no-booster group.…”

Section: Discussionsupporting

confidence: 84%

“…Some studies reported that mRNA-1273 booster VE against infection was slightly higher than BNT162b2 booster VE 14 but others did not 13 . We found that booster VE against infection, hospitalization and death was not significantly different between mRNA-1273 and BNT162b2.…”

Section: Discussionmentioning

confidence: 99%

“…Unlike the population we studied, only 9% of the population of Qatar are over age 50, few were reported to have serious coexisting conditions and no individual-level comorbid conditions were available for matching, adjustment or subgroup analysis. A target trial emulation using matched cohorts derived from nationwide population registries in Spain estimated that mRNA booster VE against infection in the omicron era was 51.3% (50.2-52.4) with follow-up extending only up to 34 days 14 – comorbid conditions were unavailable for matching, adjustment or sub-group analyses. A test-negative, case-control study from England reported that booster VE against infection was 67.2% (66.5-67.8) at 2-4 weeks after receipt of a BNT162b2 booster before declining to 45.7% (44.7-46.7) at 10 or more weeks 15 .…”

Section: Discussionmentioning

confidence: 99%

“…The omicron variant is thought to be more likely to evade immunity or cause breakthrough infection after vaccination than the delta variant 12 . Indeed, emerging evidence suggests that booster VE against infection and hospitalization caused by the omicron variant is much lower 9,[13][14][15] . Booster VE against the omicron variant requires further investigation especially in older, racially/ethnically diverse populations with high prevalence of comorbid conditions, who have the highest risk of morbidity and mortality from COVID-19.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of mRNA COVID-19 vaccine boosters against infection, hospitalization and death: a target trial emulation in the omicron (B.1.1.529) variant era

Ioannou

Bohnert

O’Hare

et al. 2022

Preprint

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Background: The effectiveness of a 3rd mRNA COVID-19 vaccine (booster) dose against the omicron (B.1.1.529) variant is uncertain especially in older, high-risk populations. Objective: To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization and death in the omicron era by type of booster, type of primary vaccine, time since primary vaccine, age and comorbidity burden. Design: Target trial emulation study comparing booster vaccination versus no booster. Setting: U.S. Department of Veterans Affairs (VA) healthcare system Participants and Intervention: Among persons who had received two mRNA COVID-19 vaccine doses at least 5 months earlier, we designed this retrospective matched cohort study to emulate a target trial of booster mRNA vaccination (BNT162b2 or mRNA-1273) versus no booster, conducted from 12/01/2021 to 03/31/2022. Measurements: Booster VE. Results: Each group included 490,838 well-matched persons, predominantly male (88%), mean age 63.0 years, followed for up to 121 days (mean 79.8 days). Booster VE >10 days after booster was 42.3% (95% CI 40.6-43.9) against SARS-CoV-2 infection, 53.3% (48.1-58.0) against SARS-CoV-2-related hospitalization and 79.1% (71.2-84.9) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups or primary vaccination regimens, but was significantly higher with longer time since primary vaccination and with higher comorbidity burden. Limitations: Predominantly male population. Conclusions: Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden. Primary Funding Source: Department of Veterans Affairs

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Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Effectiveness of mRNA COVID-19 vaccine boosters against infection, hospitalization and death: a target trial emulation in the omicron (B.1.1.529) variant era

Ioannou

Bohnert

O’Hare

et al. 2022

Preprint

View full text Add to dashboard Cite

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“…A study in Spanish registry data of people aged 40 years or over with no previous positive test for SARS-CoV-2 examined effectiveness of mRNA vaccine boosting, including a comparison of BNT162b2 with mRNA-1273 (9). For positive SARS-CoV-2 tests, it estimated a 34-day risk difference comparing mRNA-1273 with BNT162b2 of − 2.2 (− 2.7 to − 1.6) per 1,000 people (risk ratio 0.87 (0.84, 0.90)).…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness of BNT162b2 versus mRNA-1273 boosting in England: a cohort study in OpenSAFELY-TPP

Hulme

Horne

Parker

et al. 2022

Preprint

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Introduction The COVID-19 booster vaccination programme in England used both BNT162b2 and mRNA-1273 vaccines. Direct comparisons of the effectiveness against severe COVID-19 of these two vaccines for boosting have not been made in trials or observational data. Methods On behalf of NHS England, we used the OpenSAFELY-TPP database to match adult recipients of each vaccine type on date of vaccination, primary vaccine course, age, and other characteristics. Recipients were eligible if boosted between 29 October 2021 and 31 January 2022, and followed up for 12 weeks. Outcomes were positive SARS-CoV-2 test, COVID-19 hospitalisation, and COVID-19 death. We estimated the cumulative incidence of each outcome, and quantified comparative effectiveness using risk differences (RD) and hazard ratios (HRs). Results 1,528,431 people were matched in each group, contributing a total 23,150,504 person-weeks of follow-up. The 12-week risks per 1,000 people of positive SARS-CoV-2 test were 103.2 (95%CI 102.4 to 104.0) for BNT162b2 and 96.0 (95.2 to 96.8) for mRNA-1273: the HR comparing mRNA-1273 with BNT162b2 was 0.92 (95%CI 0.91 to 0.92). For COVID-19 hospitalisations the 12-week risks per 1,000 were 0.65 (95%CI 0.56 to 0.75) and 0.44 (0.36 to 0.54): HR 0.67 (95%CI 0.58 to 0.78). COVID-19 deaths were rare: the 12-week risks per 1,000 were 0.03 (95%CI 0.02 to 0.06) and 0.01 (0.01 to 0.02): HR 1.23 (95%CI 0.59 to 2.56). Comparative effectiveness was generally similar within subgroups. Conclusion Booster vaccination with mRNA-1273 COVID-19 vaccine was more effective than BNT162b2 in preventing SARS-CoV-2 infection and COVID-19 hospitalisation during the first 12 weeks after vaccination.

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Infections, Hospitalizations, and Deaths Among US Nursing Home Residents With vs Without a SARS-CoV-2 Vaccine Booster

et al. 2022

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ImportanceA SARS-CoV-2 vaccine booster dose has been recommended for all nursing home residents. However, data on the effectiveness of an mRNA vaccine booster in preventing infection, hospitalization, and death in this vulnerable population are lacking.ObjectiveTo evaluate the association between receipt of a SARS-CoV-2 mRNA vaccine booster and prevention of infection, hospitalization, or death among nursing home residents.Design, Setting, and ParticipantsThis cohort study emulated sequentially nested target trials for vaccination using data from 2 large multistate US nursing home systems: Genesis HealthCare, a community nursing home operator (system 1) and Veterans Health Administration community living centers (VHA CLCs; system 2). The cohort included long-term (≥100 days) nursing home residents (10 949 residents from 202 community nursing homes and 4321 residents from 128 VHA CLCs) who completed a 2-dose series of an mRNA vaccine (either BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna]) and were eligible for a booster dose between September 22 and November 30, 2021. Residents were followed up until March 8, 2022.ExposuresReceipt of a third mRNA vaccine dose, defined as a booster dose (boosted group), or nonreceipt of a booster dose (unboosted group) on an eligible target trial date. If participants in the unboosted group received a booster dose on a later target trial date, they were included in the booster group for that target trial; thus, participants could be included in both the boosted and unboosted groups.Main Outcomes and MeasuresTest-confirmed SARS-CoV-2 infection, hospitalization, or death was followed up to 12 weeks after booster vaccination. The primary measure of estimated vaccine effectiveness was the ratio of cumulative incidences in the boosted group vs the unboosted group at week 12, adjusted with inverse probability weights for treatment and censoring.ResultsSystem 1 included 202 community nursing homes; among 8332 boosted residents (5325 [63.9%] female; 6685 [80.2%] White) vs 10 886 unboosted residents (6865 [63.1%] female; 8651 [79.5%] White), the median age was 78 (IQR, 68-87) years vs 78 (IQR, 68-86) years. System 2 included 128 VHA CLCs; among 3289 boosted residents (3157 [96.0%] male; 1950 [59.3%] White) vs 4317 unboosted residents (4151 [96.2%] male; 2434 [56.4%] White), the median age was 74 (IQR, 70-80) vs 74 (IQR, 69-80) years. Booster vaccination was associated with reductions in SARS-CoV-2 infections of 37.7% (95% CI, 25.4%-44.2%) in system 1 and 57.7% (95% CI, 43.5%-67.8%) in system 2. For hospitalization, reductions of 74.4% (95% CI, 44.6%-86.2%) in system 1 and 64.1% (95% CI, 41.3%-76.0%) in system 2 were observed. Estimated vaccine effectiveness for death associated with SARS-CoV-2 was 87.9% (95% CI, 75.9%-93.9%) in system 1; however, although a reduction in death was observed in system 2 (46.6%; 95% CI, −34.6% to 94.8%), this reduction was not statistically significant. A total of 45 SARS-CoV-2–associated deaths occurred in system 1 and 18 deaths occurred in system 2. For the combined end point of SARS-CoV-2–associated hospitalization or death, boosted residents in system 1 had an 80.3% (95% CI, 65.7%-88.5%) reduction, and boosted residents in system 2 had a 63.8% (95% CI, 41.4%-76.1%) reduction.Conclusions and RelevanceIn this study, during a period in which both the Delta and Omicron variants were circulating, SARS-CoV-2 booster vaccination was associated with significant reductions in SARS-CoV-2 infections, hospitalizations, and the combined end point of hospitalization or death among residents of 2 US nursing home systems. These findings suggest that administration of vaccine boosters to nursing home residents may have an important role in preventing COVID-19–associated morbidity and mortality.

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Effectiveness of mRNA vaccine boosters against infection with the SARS-CoV-2 omicron (B.1.1.529) variant in Spain: a nationwide cohort study

Cited by 68 publications

References 26 publications

Effectiveness of mRNA COVID-19 vaccine boosters against infection, hospitalization and death: a target trial emulation in the omicron (B.1.1.529) variant era

Effectiveness of mRNA COVID-19 vaccine boosters against infection, hospitalization and death: a target trial emulation in the omicron (B.1.1.529) variant era

Comparative effectiveness of BNT162b2 versus mRNA-1273 boosting in England: a cohort study in OpenSAFELY-TPP

Infections, Hospitalizations, and Deaths Among US Nursing Home Residents With vs Without a SARS-CoV-2 Vaccine Booster

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