Advance system testing: Vaccine benefit studies using multi-country electronic health data - The example of pertussis vaccination

Myint Tin Tin Htar, Maria de Ridder, Toon Braeye, Ana Correa, Chris McGee, Simon de Lusignan, Talita Duarte-Salles, Consuelo Huerta, Elisa Martín-Merino, Lara Tramontan, Giorgia Danieli, Gino Picelli, Nicoline van der Maas, Klara Berencsi, Lisen Arnheim-Dahlström, Ulrich Heininger, Hanne-Dorthe Emborg, Daniel Weibel, Kaatje Bollaerts, Miriam Sturkenboom

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Abstract

The Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE), a public-private consortium, implemented and tested a distributed network system for the generation of evidence on the benefits-risks of marketed vaccines in Europe. We tested the system by estimating the incidence rate (IR) of pertussis and pertussis-related complications in children vaccinated with acellular (aP) and whole-cell (wP) pertussis vaccine. Data from seven electronic databases from four countries (Denmark: AUH and SSI, Spain: SIDIAP and BIFAP, UK: THIN and RCGP RSC and Italy: Pedianet) were included in a retrospective cohort analysis. Exposure was defined as any pertussis vaccination (aP or wP). The follow-up time started 14 days after the first dose. Children who had received any pertussis vaccine from January 1990 to December 2015 were included (those who switched type, or had unknown type were excluded). The outcomes of interest were confirmed or suspected pertussis and pertussis-related pneumonia and generalised convulsions within one month of pertussis diagnosis and death within three months of pertussis diagnosis. The cohort comprised 2,886,367 children ≤5 years of age. Data on wP and aP vaccination were available in three and seven databases, respectively. The IRs (per 100,000 person-years) for pertussis varied largely and ranged between 0.15 (95% CI: 0.12; 0.19) and 1.15 (95% CI: 1.07; 1.23), and the trends over time was consistent with those observed from national surveillance databases for confirmed pertussis. The pertussis IRs decreased as the number of wP and aP vaccine doses increased. Pertussis-related complications were rare (89 pneumonia, 7 generalised convulsions and no deaths) and their relative risk (vs. non-pertussis) could not be reliably estimated. The study demonstrated the feasibility of the ADVANCE system to estimate the change in pertussis IRs following pertussis vaccination. Larger sample sizes would provide additional power to compare the risk for complications between children with and without pertussis. The feasibility of vaccine-type specific effectiveness studies may be considered in the future.

Original languageEnglish
Pages (from-to)B31-B37
JournalVaccine
Volume38
Issue number2
Early online date31 Oct 2019
DOIs
Publication statusPublished - 22 Dec 2020

Keywords

  • Children
  • Database study
  • Feasibility study
  • Pertussis incidence
  • Pertussis vaccination
  • Pertussis-related complications

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