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Parliamentary questions
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11 July 2018
E-002905/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-002905/2018

Vaccines like all medicines are authorised according to EU legal requirements(1) and only after their quality, safety and efficacy have been evaluated. Vaccines are monitored for safety and adverse reactions through their lifecycle. Signals on safety risks are reported at the EU level and evaluated by the European Medicines Agency (EMA) and regulatory actions are taken, as appropriate.

The EMA provides guidelines(2) with the requirements on clinical evaluation of vaccines. It addresses the studies to be performed of new vaccines and may also be applicable to the further development of already licensed vaccines.

Experience with vaccine development has shown that the pharmacokinetic (PK) properties of antigens included in vaccines do not provide useful information for determining dose recommendations and this is the main purpose of doing such studies.

Vaccines are biological medicines that have different characteristics from chemical substances. Since the metabolic pathways of vaccines are generally understood (they are metabolised into small peptide and eventually to amino acids), and the action of vaccines is mediated locally at the site of injection and draining lymph nodes, PK studies are generally not required for vaccines.

However, in some cases PK evaluation is needed in particular when vaccines contain novel adjuvants/excipients or when delivered in the body using new delivery systems. This will have to be evaluated on a case-by-case basis, taking into account the expected impact on efficacy and safety and available preclinical information.

(1)Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended
(2)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003875.pdf

Last updated: 11 July 2018Legal notice