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26 November 2009
Ms Jane Burgermeister
jmburgermeister@gmail.com
Dear Ms Burgermeister
The Minister for Health and Children, Mary Harney, T.D., has asked me to
thank you for your recent e-mail concerning the safety of vaccines given to
children.
As part of their preparation for a pandemic, the European Commission (EC)
and the European Medicines Agency (EMEA) and all the competent authorities
across the 27 member states introduced a procedure to allow the submission
and evaluation of “pre-pandemic” vaccines during the pre-pandemic period
leading to licences which could only be used during an officially declared
pandemic (World Health Organization [WHO] Phase 6). This approach was
agreed with all the scientific committees of the EMEA which includes the
Vaccine expert committee, the Paediatric expert committee and the Safety
Committee. These committees are made up of medical and scientific experts
from the Member States in the EU.
The principles applied when licensing these vaccines are based on the close
similarity between the strain in the mock-up vaccine and in the pandemic
vaccine:
The immune responses to a specific mock-up vaccine containing a
strain to which subjects within a specific age range were
immunologically naïve is expected to predict responses to the same
vaccine construct containing an alternative strain of the same
subtype or an alternative subtype of influenza A in a comparable
population.
The safety data generated with a specific mock-up vaccine in clinical
studies is expected to predict the safety profile observed with the
same vaccine construct containing an alternative strain of the same
subtype or an alternative subtype of influenza A in a comparable
population.
The pre-pandemic influenza vaccine is a vaccine that mimics the
future pandemic influenza vaccine in terms of its composition
construct (antigen content, excipients, and adjuvant system, if
used), manufacturing and control. The mock-up vaccine is produced in
the same way as is intended for the final pandemic vaccine but it
does not contain antigen from the actual pandemic strain.
There was prior experience with the manufacturing processes and
formulations of the pre-pandemic vaccines. These have been, where possible,
based on, or in many respects are similar to, established methodologies for
producing seasonal influenza vaccines. The use of established processes has
the advantage that the manufacturers’ experience and existing data can be
used, compared to completely novel manufacturing processes and
formulations.
On the basis of these underlying principles, the pre-pandemic vaccine
construct allowed for insertion of the pandemic strain into a vaccine
construct and enabled approval of the pandemic vaccine, where all the data
obtained with the corresponding pre-pandemic vaccine together with specific
data relating to the pandemic strain were taken into account. Given this
public health threat, the aim of the European agency and its Scientific
committees was to ensure vaccines were made available as soon as possible
based on a robust assessment of the data, before the beginning of the
Northern hemisphere flu season 2009-2010. For each of the three vaccines
approved each of the three vaccines approximately 500-5,000 subjects were
studied in clinical studies.
With vaccination campaigns ongoing in the European Union since mid-October,
a minimum of 5 million people have been vaccinated so far. This number
includes approximately 100,000 pregnant women and 100,000 children. The
European Agency, together with the Irish Medicines Board and all EU
competent authorities, are continuously monitoring the safety profile of
the vaccines. To date, the side effects reported have mainly been mild
symptoms such as fever, nausea, headache, allergic reactions and injection
site reactions, confirming the expected safety profile of the three
vaccines.
A large amount of information is available regarding the licensing and
safety profile of the vaccines, the product information and a Q and A in
relation to the Pandemic vaccine is available on the Irish Medicines Board
website at www.imb.ie and the European Medicines Agency website at
www.emea.europa.eu
The Faculties of Obstretrics and Gynaecology and of Paediatrics of the
Royal College of Physicians have issued statement supporting the use of the
vaccines in the interests of patients’ health.
I trust that this clarifies the matter for you.
Yours sincerely
Darragh Scully
Private Secretary
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**************** An Roinn Sláinte agus Leanaí *******************
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bharr dearmaid, téigh i dteagmháil leis an seoltóir agus scrios an
t-ábhar ó do ríomhaire le do thoil.
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