HEAltH MAttErS 11
pandemIc
safety
& pandemIc vaccIne
Many patients and staff have questions about
detected once the vaccine is being used
in large numbers of people. Most of the
the safety of the H1N1 vaccination. In this article,
adverse reactions seen to date in relation to
Dr JoaN GIlVarry, Director of Human Products
these vaccines were in clinical trials with
Safety Monitoring with the Irish Medicines Board,
the ‘mock-up’ vaccines that included an
H5N1 strain of influenza virus. The most
outlines the background to the development of the H1N1 frequently occurring adverse reaction
vaccination and its safety for use in Ireland.
was injection site pain. Other common
side effects reported were injection site
reactions, which included induration,
A
‘mock-up’ pandemic influenza erythema, swelling, pruritis and bleeding at
vaccine is a vaccine that mimics a the site. Pyrexia, sweating, chills, headache,
future pandemic influenza vaccine lymphadenopathy, arthralgia, myalgia and
in terms of its composition, manufacturing fatigue were also commonly reported.
and control. It may be considered as less commonly occurring were nausea,
identical to the final vaccine intended vomiting, stomach pain, diarrhoea and mild
for use in a pandemic, except for it not allergic-type reactions (for example, mild
containing antigenic material from the rashes and localised/generalised itching).
actual viral strain responsible for the the reactions were generally mild in nature,
pandemic. During the period from 2003 of short duration and similar to those
until the present pandemic was declared, induced by seasonal influenza vaccines.
the Irish Medicines Board (IMB) with the there were fewer reactions after the second
European Medicines Agency (EMEA) dose of the vaccine compared with the
continuously reviewed results from studies first dose.
with the ‘mock-up’ vaccines and assessed and effective (based on available evidence) Serious allergic reactions (such as
their safety and effectiveness. Once the for use across all population sub-groups. anaphylaxis) are expected to be rare.
A(H1N1)v virus emerged as the pandemic Further clinical data are expected over Emergency treatment should always be
virus, the manufacturers initiated vaccine the coming weeks and months for these available for treatment of these cases. to
production using the strain recommended vaccines, including data from ongoing and ensure extensive safety evaluation, each
by the World Health Organisation (WHO) planned clinical trials. It is expected that vaccine is now subject to a comprehensive
and the evaluation then focused on these the product information will be updated on European post-marketing safety
pandemic vaccines. an ongoing basis as new data becomes surveillance plan. this will involve close
As a result of the EMEA’s assessment available. therefore it is recommended that monitoring of any reported side effects, and
of the data from studies for the mock- prior to administration of these vaccines; any other safety issues.
up vaccine, three pandemic A(H1N1) the latest Summary of Product Information the prompt identification of any new
v vaccines have been licensed for use (SPCs) and Patient Information Leaflets safety concern with use of the pandemic
in the current pandemic (H1N1) 2009: (PILs) are referenced on the IMB website at vaccines will rely on the detection and
Pandemrix, Celvapan and Focetria. The www.imb.ie. reporting of adverse reactions to the IMB.
two vaccines currently being used in Ireland this online reporting system is accessible
are Pandemrix and Celvapan and while SafeTy profIle via the pandemic flu webpage on the IMB
there are differences between these two As with all medicines and vaccines adverse homepage (www.imb.ie). Analysis of all
vaccines in terms of their composition and reactions will occur and very rare adverse safety issues will be carried-out by the
their manufacture, both are considered reactions that might be specific to the IMB, other European Member States and
by the EMEA and the IMB as equally safe A(H1N1)v pandemic strain can only be the EMEA.
11646 Dom Flu HSE Matters A4.indd 1 06/11/2009 14:12
health matters is 4.indd 11 27/11/2009 20:34:58
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