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Strasbourg, 15 September 2009

Questions and Answers on vaccines against pandemic (H1N1) 2009 influenza

What is the Commission services' intention outlining a vaccination strategy against pandemic (H1N1) 2009 influenza?

The Commission services' blueprint for a vaccination strategy is based on the common EU Health Security Committee statement on target and priority groups for vaccination against pandemic (H1N1) 2009 influenza, agreed by the European Union Health Security Committee on 25 August 2009. It fully recognises and respects the right of the Member States to develop their own vaccination strategy against pandemic (H1N1) 2009 influenza.

The Commission Staff Working Document on vaccination strategies intends to support Member States by setting out possible options – based on the current scientific evidence and epidemiological trends – that Member States might take into account when determining strategies fitting their specific national conditions. This includes different vaccination schemes, epidemiological trends, health service structures and available resources.

On what basis will the Commission authorise a vaccine against pandemic (H1N1) 2009 influenza and how can the Commission guarantee that the vaccine will be safe and effective?

The European Commission authorises a vaccine for marketing on the basis of a positive scientific opinion adopted by the scientific committee of the European Medicines Agency (EMEA), called the 'Committee for Medicinal Products for Human Use' (CHMP).

The CHMP carefully examines the known and suspected risks and benefits of any vaccine for which an application for a central marketing authorisation has been submitted. The Committee will only recommend the authorisation of a vaccine to the Commission if this risk-benefit evaluation is positive.

The Commission suggests enhanced pharmacovigilance. Once authorised, the safety and efficacy of the pandemic influenza vaccines will be monitored closely and specific legal obligations exist for marketing authorisation holders and competent authorities. The CHMP assesses this new data as it becomes available and, when deemed necessary from a risk-benefit perspective, adopts a scientific opinion in relation to the marketing authorisation. On this basis, the Commission may vary, suspend or revoke the marketing authorisation of the vaccine.

When does the Commission expect to authorise vaccines against pandemic (H1N1) 2009 influenza?

The EU has prepared itself early for a pandemic through establishing provisions for an accelerated assessment for pandemic influenza vaccines.

At present, CHMP is reviewing data relating to the authorisation of Influenza (H1N1) vaccines and is applying an accelerated scientific review process. Following adoption of a scientific opinion by the CHMP, swift subsequent Commission Decision on the marketing authorisation will be ensured with the objective to have substantial amounts of safe vaccines available across the EU 27.

However, in a situation where the disease still evolves and companies continue to generate scientific data, the outcome of the assessment by the CHMP and the date of authorisation by the Commission of such vaccines are currently difficult to predict.

It should be noted that national authorisations of vaccines follow different procedures and it is up to Member States to decide on any acceleration of the scientific assessment and regulatory procedure.

What are adjuvants?

Adjuvants are compounds which are used in a vaccine to enhance a person's immune response to the antigen. Many vaccines contain adjuvants.

Adjuvants have already been used in seasonal influenza vaccines and have been tested extensively. The use of adjuvants allows a reduction of the amount of virus antigen in a given dose. This has an impact on the number of doses, which can be produced with a defined amount of virus-antigen. This allows reducing the amount of antigen in the vaccine, which means that many more doses of vaccine can be produced. In this way, more people can be vaccinated in a timely manner against pandemic (H1N1) 2009 influenza.

What is the Commission doing to ensure that EU citizens will have equal access to vaccines against pandemic (H1N1) 2009 influenza?

The Commission considers that EU citizens shall enjoy the same level of protection. Therefore, the Commission urges all Member States to cooperate closely to ensure that there are no gaps in vaccination coverage, which would endanger public health, and compromise Europe's overall pandemic preparedness. In order to promote equitable access to vaccines against pandemic (H1N1) 2009 influenza, the Commission is working on joint procurement of pandemic (H1N1) 2009 influenza vaccines with those Member States that have expressed an interest to participate. This also includes the possibility of resale between Member States of any excess amounts of vaccine.

As discussions with the Member States are currently ongoing, it is premature to pre-empt how any joint procurement will be implemented in practice.

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