| Title |
Enhanced Safety Surveillance of Seasonal Quadrivalent Influenza Vaccines in English Primary Care: Interim Analysis
|
|---|---|
| Published in |
Advances in Therapy, July 2018
|
| DOI | 10.1007/s12325-018-0747-4 |
| Pubmed ID | |
| Authors |
Simon de Lusignan, Gaël Dos Santos, Rachel Byford, Anne Schuind, Silvia Damaso, Vishvesh Shende, Chris McGee, Ivelina Yonova, Filipa Ferreira |
| Abstract |
The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance. AEIs were collected within 7 days of vaccination from ten general practices predominantly administering inactivated quadrivalent influenza vaccine (IIV4, Fluarix Tetra, GSK). Vaccinees completed an adverse drug reaction (ADR) card. ADR card and medically attended AEIs data were recorded in practice electronic health records. We report the outcome of the first 5 weeks of safety surveillance (September 12, 2016-October 16, 2016); in an exploratory analysis, rates of AEI for IIV4 are compared to those passively reported through a sentinel network. Practices vaccinated 13.1% (12,864/98,091) of their registered population; 5.6% (95% CI 5.20-6.00) of them reported AEIs, none serious. The most frequent were respiratory 2.60% (95% CI 2.33-2.88), musculoskeletal 1.82% (95% CI 1.59-2.05) and neurological 1.05% (95% CI 0.88-1.23). AEIs were more frequently reported for adults than for children; 5.91% (95% CI 5.49-6.34) compared to 1.49% (95% CI 0.69-2.29); 47.18% of the adults reported AEI using the ADR card, none were returned for subjects < 18 years old. The frequency of AEIs reporting was higher, 6.88% (95% CI 6.35-7.42) vs. 3.30% (95% CI 2.68-3.96, 100/3028, p < 0.000), through ESS than passive surveillance. The ESS did not reveal any safety signal and we demonstrated the feasibility of conducting ESS following EMA recommendations. The use of a customised ADR card led to a doubling of AEIs reports over passive surveillance in adults. GlaxoSmithKline Biologicals SA, Wavre, Belgium. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Science communicators (journalists, bloggers, editors) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 60 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 60 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 8 | 13% |
| Student > Bachelor | 7 | 12% |
| Student > Postgraduate | 6 | 10% |
| Student > Ph. D. Student | 5 | 8% |
| Unspecified | 5 | 8% |
| Other | 14 | 23% |
| Unknown | 15 | 25% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 14 | 23% |
| Nursing and Health Professions | 7 | 12% |
| Unspecified | 5 | 8% |
| Social Sciences | 3 | 5% |
| Agricultural and Biological Sciences | 3 | 5% |
| Other | 10 | 17% |
| Unknown | 18 | 30% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 July 2018.
All research outputs
#18,643,992
of 23,096,849 outputs
Outputs from Advances in Therapy
#1,673
of 2,385 outputs
Outputs of similar age
#252,271
of 326,767 outputs
Outputs of similar age from Advances in Therapy
#34
of 49 outputs
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