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The guidance and procedures for the generation of mock-up
vaccines was developed at EMEA in 2003-2004. The principles incor-
porated in these guidelines are also widely accepted by the
international regulatory community such as the WHO and non-
European authorities such as Japan and Australia. These guidelines
define scientific ‘dossier’ requirements and procedural steps for such
applications via the centralized procedure.
The European vaccine manufacturers (EVM), and individual
influenza vaccine manufacturers were involved in the development
of these guidelines and EMEA has developed its own Pandemic
Influenza Crisis Plan. In this context, EMEA has well-established
links with the influenza vaccine manufacturers – Joint-EMEA
Industry Task Force (JEIF) – and has initiated regular meetings to
facilitate preparedness. This has stimulated debate and allowed
industry, regulators and experts to discuss a variety of topics of
importance for the development of both pandemic and
pre-pandemic vaccines.
In 2007 the first mock-up vaccine, Daronrix
®
, was
authorized. Since then, three further mock up vaccines
have been authorized: Focetria
®
, Pandemrix
®
and
Celvapan. European Public Assessment Reports for all
these can be found on the EMEA website.
4
Other manu-
facturers are developing mock-up vaccines, too.
EMEA Pandemic Influenza Crisis Management
Plan for the evaluation and maintenance of
pandemic influenza vaccines and antivirals
The EMEA Pandemic Influenza Crisis Management Plan
for the evaluation and maintenance of pandemic
influenza vaccines and antivirals (EMEA Pandemic
Influenza Crisis Plan) outlines the management struc-
tures and detailed procedures that will support the
various activities to be undertaken in the event of an
influenza pandemic. This and other pandemic EMEA
documents are published on the EMEA website.
5
The primary objective of the plan is to define and
implement the EMEA policy and, consequently, the strat-
egy for the rapid and efficient handling of actions required
by the EMEA Secretariat related to pandemic influenza
vaccines and antivirals, in liaison with CHMP, competent
authorities of the member states, the European
Commission (DG SANCO and DG Enterprise), ECDC
and the vaccine marketing authorization (licence)
holders, or applicants. The plan is underpinned by a series
of detailed work instructions and SOPs (see EMEA
website
6
). Since an influenza pandemic would have far-
reaching consequences to the work of EMEA, the agency
has also developed its Pandemic Business Continuity
Plan, including specific issues and precautions for staff
during an influenza pandemic.
WHO would identify the start of the influenza
pandemic. This information would be provided to the
commission (DG SANCO), which would notify EMEA.
A procedure has also been developed on surveillance
and how the start of a pandemic would be recognized
and communicated, such that the EMEA crisis manage-
ment plan could be initiated, even when imminent
WHO/DG SANCO announcement of pandemic activi-
ties is expected.
In these initial stages of a pandemic, antivirals would
be the only treatment for the disease. With this in mind,
on the request of the European Commission, in 2007
EMEA (CHMP) conducted and updated a review of
quality, safety and efficacy aspects of antivirals, which
can possibly be used in the case of a pandemic.
Procedures are currently being developed on how to
react to any safety signals arising from the use of non-
centrally authorized antivirals or from the use of bulk
active substance of centrally authorized antivirals. A
strategy is under discussion for the use of antivirals
during a pandemic, specifically regarding the collection
and evaluation of safety data. This will allow authori-
ties to react promptly to emerging safety signals during
the pandemic should they arise.
EMEA is a decentralized body of the EU
Image: EMEA