Health authorities in Spain’s Basque Country have launched an investigation after expired doses of the childhood hexavalent vaccine were administered to 253 patients, mostly infants.
Osakidetza, the Basque public health service responsible for delivering healthcare across the region, began contacting the affected families this week.
The issue was detected on January 15, the agency said in a statement on Wednesday.
Basque Health Minister Alberto Martinez said consultations with the national medicines agency AEMPS, the Basque Vaccine Advisory Council and the vaccine manufacturer concluded that the expired doses pose no health risks or adverse effects to recipients.
But Martinez said the lapse was “serious” and apologised to the families affected.
“Given the seriousness of what happened, we have opened an internal investigation to clarify and identify the link in the supply chain where the error may have occurred and thus implement corrective measures to prevent a recurrence of such events,” Martinez said in a statement.
The childhood hexavalent vaccine protects against six diseases: diphtheria, tetanus, pertussis (whooping cough), polio, Hepatitis B, and Haemophilus influenzae type B.
In Spain’s system of regional autonomy, the Basque Country holds self-government over health policy and services through its own Department of Health and Osakidetza.
The central Spanish government maintains national regulatory oversight on medicines and broad health standards via AEMPS, but day-to-day implementation and response to local incidents remain under Basque control.
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