Rapid Risk Assessment: Shortage of acellular pertussis-containing vaccines and impact on immunisation programmes in the EU/EEA - 1st update, 3 February 2016

Risk assessment
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European Centre for Disease Prevention and Control. Shortage of acellular pertussis-containing vaccines and impact on immunisation programmes in the EU/EEA – 2 February 2016. Stockholm: ECDC; 2016.

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The vaccine shortage currently affecting some EU/EEA Member States caused several countries to modify their vaccination schedules. In general, the supply situation remains similar to 2015, and some countries had to make short-term arrangements with other countries to avoid interruption of their programmes. Further information on the measures taken by countries is provided in the document.​

Executive summary

n order to provide information on the current situation affecting some EU/EEA Member States regarding the shortage of acellular pertussis-containing combination vaccines for use in immunisation programmes, ECDC has published an updated rapid risk assessment. This document is the first update of the ECDC rapid risk assessment from 8th October 2015. The update indicates that in general the supply situation appears similar to what was previously reported. Some countries had to make short-term arrangements with other countries to avoid interruption of their programmes.The updated rapid risk assessment informs that since 2015 nine EU/EEA Member States have adjusted their immunisation policies to address the shortage. Further information on the measures taken by countries is provided in the document. The options presented in the previous rapid risk assessment to be considered by the Member States in response to the shortage remain valid, and these have been further specified in the updated document.

The updated rapid risk assessment focuses on acellular pertussis-containing combination vaccines used in national vaccination programmes in the EU/EEA Member States. The vaccine shortage is believed to be due to reduced production capacities for the acellular pertussis antigen that enters the final vaccine formulation of numerous combination vaccines, increased global demand for those combination vaccines that are also used throughout the EU/EEA Member States, and vaccine lots failing to meet the necessary release criteria.
The rapid risk assessment highlights the importance of preserving the primary immunisation schedule in order to ensure the early and adequate protection of newborns. If alternative vaccines or other vaccine presentations are available, their use should be prioritised, in conjunction with appropriate monitoring of safety and effectiveness, rather than modifying the vaccination schedule. Preference should be given to the use of combination vaccines with the highest number of antigens.