Assessment of production batch information of vaccines in the Clinical Practice Research Datalink

Date of ISAC Approval: 
Lay Summary: 
Batch identifiers (BID) of vaccines are unique identifiers issued by manufacturers for shipments. BID of vaccines are recorded in the Clinical Practice Research Datalink database. Depending on its quality, this information could be used to detect administrations of vaccines with high specificity on the vaccine type or brand. Sometimes, manufacturing incidents result in adverse reactions to vaccines. In this context, another use of the recorded BIDs could be the detection and evaluation of safety signals (potential adverse reactions) associated with one or a limited number of batches. We investigated the validity of the reported BIDs in the year 2015 for the GSK vaccines in general and for GSK's rotavirus vaccine (Rotarix) in particular by attempting to match with the valid batch numbers issued by GSK for the vaccine shipments to the UK (as available from the Global Industrial Operations (GIO) database internal to GSK).
Technical Summary: 
The aim of this study was to assess the quality of batch numbers of vaccines recorded in the CPRD. The quality of the vaccines batch identifiers (BID) recorded in CPRD in 2015 was evaluated for GSK vaccines including Infanrix, Rotarix, Priorix, Menitorix, Boostrix, Nimenrix, Engerix-B, Twinrix/Ambirix, Fluarix QIV, Havrix and others less represented. The analysis matched the valid BID issued by GSK for the vaccine shipments to the UK, as available from the GSK GIO database, to BID recorded in CPRD. In a first step, we assessed the quality of the GSK vaccines BIDs recorded in the CPRD database based on the GSK GIO database. Each GSK vaccine product/brand contains a specific four characters prefix in its BID. We computed the proportion of vaccines BIDs recorded in the CPRD that were fully matched to GSK vaccines BIDS among those presenting GSK-specific prefixes. In a second step, we computed the sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive values (NPV) for the detection of Rotarix vaccinations through BIDs, considering Rotarix vaccinations detected through medcodes and immstype as the reference. This evaluation was conducted from 01-Jul-2013, date of the introduction of Rotarix in the UK National Immunization Programme, until 31-Dec-2015. During this period Rotarix was the only rotavirus vaccine used in UK.
Health Outcomes to be Measured: 
Immunisation with GSK vaccines; Immunisation with Rotarix

Francois Haguinet - Chief Investigator - GSK Vaccines
Ms Corinne Willame - Collaborator - GlaxoSmithKline - UK
Dr Emmanuel Aris - Collaborator - GSK
Francois Haguinet - Corresponding Applicant - GSK Vaccines
Olivia Mahaux - Collaborator - GlaxoSmithKline - UK
Mr Vincent Bauchau - Collaborator - UCB Pharma SA - UK