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Peer reviewedOpen accessCOVID-19SARS

Relative effectiveness of monovalent and bivalent mRNA boosters in preventing severe COVID-19 due to omicron BA.5 infection up to 4 months post-administration in people aged 60 years or older in Italy: a retrospective matched cohort study

The Lancet Infectious Diseases·

Alberto Mateo-Urdiales, Chiara Sacco, Emmanouil Alexandros Fotakis, Martina Del Manso, Antonino Bella, Flavia Riccardo, Marco Bressi, Maria Cristina Rota, Daniele Petrone, Andrea Siddu, Giorgio Fedele, Paola Stefanelli, Anna Teresa Palamara, Silvio Brusaferro, Giovanni Rezza, Patrizio Pezzotti, Massimo Fabiani

DOI
10.1016/s1473-3099(23)00374-2
PMID
37478877
PMCID
OpenAlex
W4384701934
Study type
Cohort study
Publisher
Elsevier BV
Article type
journal-article
Integrity
current

Why this research matters now

Second mRNA booster doses provided additional protection against severe COVID-19 in adults aged 60 years and older beyond that offered by the first booster. The bivalent vaccine targeting the original strain plus BA.4-5 offered greater protection than monovalent boosters and sustained effectiveness up to four months, informing booster recommendations for older populations during omicron BA.5 circulation.

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Structured evidence summary

Research question

The study aimed to estimate the relative effectiveness of second booster doses using monovalent or bivalent mRNA vaccines in preventing severe COVID-19 among older adults in Italy.

Study design

This retrospective matched cohort study linked Italian vaccination registry and surveillance system data from September 2022 to January 2023. Each person aged 60 years or older who received a second booster was matched 1:1 with someone who had received only the first booster at least 120 days earlier. Cox proportional hazard models were used to estimate relative vaccine effectiveness.

Population and setting

The study included 2,129,559 matched pairs of individuals aged 60 years or older in Italy during a period when omicron BA.5 was the predominant circulating subvariant.

Main findings

Against severe COVID-19 during days 14-118 post-administration, relative vaccine effectiveness was 50.6% for the bivalent original/BA.4-5 booster, 49.3% for the bivalent original/BA.1 booster, and 26.9% for the monovalent booster. The bivalent original/BA.4-5 booster showed similar effectiveness in those aged 60-79 years (53.6%) and those 80 years or older (48.3%). Protection decreased over time but remained evident at four months post-administration.

Public-health relevance

Second mRNA booster doses provided additional protection against severe COVID-19 in adults aged 60 years and older beyond that offered by the first booster. The bivalent vaccine targeting the original strain plus BA.4-5 offered greater protection than monovalent boosters and sustained effectiveness up to four months, informing booster recommendations for older populations during omicron BA.5 circulation.

Important limitations

This summary is limited to the supplied single-article abstract and metadata and requires the original paper for decision-grade interpretation.

GIDS interpretation

The classifier links indicate this article addresses COVID-19 surveillance, vaccination, and vaccine effectiveness in Italy. It may be discoverable through disease-specific (COVID-19, SARS), geographic (Italy), or topic-based (surveillance, vaccination, vaccine effectiveness) queries within the GIDS literature corpus.

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Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

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Evidence relationships

This article has 11 auditable classifier relationships to diseases, places, topics, and study design.

about diseaseabout diseaseaddresses topicaddresses topicaddresses topicevaluates interventionhas pathogen typestudied instudied population settingstudies pathogenuses study design