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					HCP Q&A pandemic influenza A(H1N1) vaccine                             3 November 2009


Information for Healthcare Practitioners Regarding Pandemrix™
Frequently Asked Questions
Pandemrix™: GSK’s Pandemic (H1N1)v Vaccine

      What is the indication for Pandemrix™?
    According to the SPC approved by the European Medicines Agency (EMEA), the
    indication for Pandemrix™ is prophylaxis of influenza in an officially declared
    pandemic situation.
    Pandemic influenza vaccine should be used in accordance with official guidance.

      What is the composition of Pandemrix™?
    The active substance of Pandemrix™ is split influenza virus, inactivated, containing
    antigen propagated in eggs from healthy chicken flocks equivalent to:
    A/California/7/2009 (H1N1)v-like virus: 3.75 micrograms haemagglutinin per 0.5 mL
    dose. The vaccine is formulated with thiomersal as a preservative.
    The vaccine also contains GSK’s proprietary AS03 Adjuvant System to stimulate a
    better immune response. The main components of the adjuvant are squalene, DL-α-
    tocopherol and polysorbate 80.
    Pandemrix™ will consist of two vials – one containing pandemic (H1N1)v 2009
    antigen and the second, GSK’s AS03 adjuvant system. Contents of the two vials will
    be combined before administration. Once the two components (the antigen and the
    adjuvant) are mixed, the vaccine should be used within 24 hours.

        Is the vaccine safe?
    Influenza vaccines have been used for more than 60 years and have an established
    record of safety in all age groups. While some serious adverse events have been
    reported, these have been rare.
    It is anticipated that the side effects for Pandemrix™ will be similar to that of the
    pandemic influenza ‘mock-up’ file for GSK’s H5N1 vaccine. The most common side
    effects with the H5N1 vaccine are headache, arthralgia (joint pain), myalgia (muscle
    pain), reactions at the site of the injection (hardening, swelling, pain and redness),
    fever and fatigue (tiredness).
    Experience with previous large-scale immunisation programmes has shown that it is
    likely that adverse events will be reported. The adverse events that are reported
    may be the result of underlying conditions or new conditions that occur
    coincidentally to vaccination and some may be true side effects of the vaccine.
    GSK's (H1N1)v pandemic influenza vaccine will be assessed in clinical studies to
    determine the likely benefit and risk of the vaccine. However, it should be
    acknowledged that the population studied in clinical trials will be limited.
    The regulatory procedures in place for the licensing of new pandemic vaccines,
    including procedures for expediting regulatory approval, are rigorous and do not
    compromise safety or quality controls.
    Pandemrix™ (GSK’s current pandemic (H1N1)v vaccine) has been approved in
    Europe, and is being assessed in 16 clinical studies in healthy adults, the elderly
    and children (including infants) to determine the likely benefit and risk of the
    vaccine. GSK expects over 9,000 individuals to be involved. Previously, the

The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm             Page 1
HCP Q&A pandemic influenza A(H1N1) vaccine                              3 November 2009

    pandemic influenza ‘mock-up’ file against H5N1 received regulatory approval in
    Europe and several Asian countries.

      Does the vaccine contain thiomersal? Why?
    Pandemrix™ is presented in a 10-dose vial (multi-dose vials) containing thiomersal
    as a preservative. A preservative is added in some multi-dose vials. Thiomersal
    (also known as thimerosal, mercurothiolate and sodium 2-ethylmercuriothio-
    benzoate) has been used in vaccines for over 60 years. It plays an important role as
    a preservative to prevent microbial contamination in the vaccine. A physician can
    vaccinate multiple subjects with a vaccine from a multidose vial and the sterility of
    the vaccine is maintained.

       Are there concerns regarding thiomersal?
    Upon review of the current epidemiologic evidence and pharmacokinetic profile of
    thiomersal, the Global Advisory Committee on Vaccine Safety concluded that there
    is currently no evidence of mercury toxicity in infants, children, or adults exposed to
    thiomersal in vaccines. The safety of thiomersal-containing vaccines is reviewed at
    regular intervals. Recent reviews by the European Medicines Agency (EMEA) and
    the US Institute of Medicine (IOM) have found that currently available scientific
    evidence does not support an association between vaccination with thiomersal-
    containing vaccines and neurodevelopmental disorders.

       What is squalene and why is it contained in the adjuvant?
    Squalene is a naturally occurring substance found in plants, animals and humans. It
    is synthesized in the liver and circulates in the human bloodstream. Squalene is also
    sometimes used as a component of some adjuvants that enhance the immune
    response. It is also found in a variety of foods, cosmetics, over-the-counter
    medications and health supplements.
    GSK has already produced a significant body of clinical safety data for pre-
    pandemic and pandemic H5N1 / AS03 vaccines. Over 12,000 adults above 18 years
    of age have been given a 2-dose course of the H5N1 pandemic vaccine. In total,
    over 39,000 people in clinical trials have demonstrated that our proprietary Adjuvant
    System AS03 used in influenza vaccines has an acceptable safety and
    reactogenicity profile. Pandemrix™ (GSK’s pandemic (H1N1)v vaccine) is being
    assessed in 16 clinical studies in healthy adults, the elderly and children (including
    infants) to determine the likely benefit and risk of the vaccine. GSK expects over
    9,000 individuals to be involved.

      What is an adjuvant? Is it safe? What does it do / why is it required?
    Adjuvants are components added to vaccine formulations to enhance the
    immunogenicity of antigens. The best-known examples are aluminium salts, which
    have been used for over 60 years, and to this day are still the predominant
    adjuvants in human vaccines. Vaccines with inactivated pathogens or purified
    subunit antigens are usually less immunogenic compared to vaccines with live-
    attenuated pathogens (which contain weakened forms of the organism that cause
    the disease), and therefore usually require the addition of adjuvants. Adjuvants also
    play an important role in pandemic vaccines as they have the potential to help
    expand the supply of available influenza vaccines, by making it possible to use less
    antigen in each dose.
The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm               Page 2
HCP Q&A pandemic influenza A(H1N1) vaccine                             3 November 2009


       Has the AS03 adjuvant system been tested in other vaccines?
    In preparing for a pandemic, GSK has studied and produced significant clinical data
    for pandemic vaccines using various influenza strains, including H5N1, and the
    company’s adjuvant (AS03).
    In clinical trials to date, not involving the (H1N1)v pandemic vaccine, over 39,000
    people have been vaccinated with AS03-adjuvanted vaccines and available data
    show these vaccines to be generally well tolerated with acceptable safety profiles.
    Pandemrix™ (GSK’s pandemic (H1N1)v vaccine) has been approved in Europe.
    GSK has also received approval from regulators for Prepandrix™ (GSK’s pre-
    pandemic H5N1 vaccine) in the EU and some countries in Asia.

     How should the vaccine be administered?
    Immunisation should be carried out by intramuscular injection.

    Pandemrix™ consists of two containers:
    - a multidose vial containing the antigen (suspension),
    - a multidose vial containing the adjuvant (emulsion).

    Prior to administration, the two components should be mixed.

    Instructions for mixing and administration of the vaccine:
    1.    Before mixing the two components, the emulsion and suspension should be
          shaken and inspected visually for any foreign particulate matter and/or
          abnormal physical appearance. In the event of either being observed, discard
          the vaccine.
    2.    The vaccine is mixed by withdrawing the contents of the vial containing the
          emulsion by means of a syringe and by adding it to the vial containing the
          suspension.
    3.    After the addition of the emulsion to the suspension, the mixture should be
          well shaken. The mixed vaccine is a whitish emulsion. In the event of other
          variation being observed, discard the vaccine.
    4.    The volume of the Pandemrix™ vial after mixing is 5 mL. The vaccine should
          be administered in accordance with the recommended posology.
    5.    The vial should be shaken prior to each administration.
    6.    Each vaccine dose of 0.5 mL (full dose) or 0.25 mL (half dose) is withdrawn
          into a syringe for injection and administered intramuscularly. The vaccine
          should be allowed to reach room temperature before use.
    7.    After mixing, use the vaccine within 24 hours and do not store above 25°C.

    Any unused product or waste material should be disposed of in accordance with
    local requirements.
    Source: Updated Pandemrix™ SPC

     How should I use the stickers provided with the vaccine?
     The stickers are presented by sheet of 10. A total of 50 sheets are provided with the
     vaccine in order to cover the 500 doses contained in the single shoe box. Each
     sticker mentions the trade name of the vaccine and the batch number of the
     reconstituted vaccine (this batch number is also mentioned on the shoe box label).

The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm             Page 3
HCP Q&A pandemic influenza A(H1N1) vaccine                             3 November 2009

    It is important to ensure that the stickers and the vaccine doses contained in a
    single shoe box remain associated until administration of the vaccine.
    Once administering the vaccine to a subject and for tracking purpose, the physician
    should remove one sticker and stick it in the medical record or vaccination card of
    the subject.

    What are the possible side effects of the vaccine?
    Like all medicines, Pandemrix™ can cause side effects, although not everybody
    gets them. Allergic reactions may occur following vaccination, in rare cases leading
    to shock.

    According to the SPC approved by the EMEA, the following side effects have
    occurred with Pandemrix™ in clinical studies in adults, including the elderly and in
    children aged from 3-9 years:

    Very common (these may occur with more than 1 in 10 doses of the vaccine):
    •     Headache
    •     Tiredness
    •     Pain, redness, swelling or a hard lump at the injection site
    •     Fever
    •     Aching muscles, joint pain

    Common (these may occur with up to 1 in 10 doses of the vaccine):
    •   Warmth, itching or bruising at the injection site
    •   Increased sweating, shivering, flu-like symptoms
    •   Swollen glands in the neck, armpit or groin

    Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
    •   Tingling or numbness of the hands or feet
    •   Sleepiness
    •   Dizziness
    •   Diarrhoea, vomiting, stomach pain, feeling sick
    •   Itching, rash
    •   Generally feeling unwell
    •   Sleeplessness

    In children aged 3-9 years fever occurred more often when the adult dose (0.5 mL of
    vaccine) was given compared to administration of half the adult dose (0.25 mL of
    vaccine). Also fever occurred more often in children aged 6-9 years compared to the
    children aged 3-5 years.

    These side effects usually disappear within 1-2 days without treatment.

    The side effects listed below have occurred in the days or weeks after vaccination
    with vaccines given routinely every year to prevent flu. These side effects may occur
    with Pandemrix™.

    Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
    •   Generalised skin reactions including urticaria (hives)
The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm             Page 4
HCP Q&A pandemic influenza A(H1N1) vaccine                               3 November 2009

    Rare (these may occur with up to 1 in 1,000 doses of the vaccine):
    •    Allergic reactions leading to a dangerous decrease of blood pressure, which, if
         untreated, may lead to shock. Doctors are aware of this possibility and have
         emergency treatment available for use in such cases
    •    Fits
    •    Severe stabbing or throbbing pain along one or more nerves
    •    Low blood platelet count which can result in bleeding or bruising

    Very rare (these may occur with up to 1 in 10,000 doses of the vaccine):
    •     Vasculitis (inflammation of the blood vessels which can cause skin rashes,
          joint pain and kidney problems)
    •     Neurological disorders such as encephalomyelitis (inflammation of the central
          nervous system), neuritis (inflammation of nerves) and a type of paralysis
          known a Guillain-Barré Syndrome

    Please refer to the SPC for further information.

      Can the vaccine be administered to pregnant or breast-feeding women?
    As stated by the SPC approved by the EMEA, there are currently no data available
    on the use of Pandemrix™ in pregnancy. Data from pregnant women vaccinated
    with different inactivated non-adjuvanted seasonal vaccines do not suggest
    malformations or foetal or neonatal toxicity. Animal studies with Pandemrix™ do not
    indicate reproductive toxicity.
    The use of Pandemrix™ may be considered during pregnancy if this is thought to be
    necessary, taking into account official recommendations.
    Pandemrix™ may be used in lactating women.

       Can the vaccine be co-administered with other vaccines?
    As stated by the SPC approved by the EMEA, there are no data on co-
    administration of Pandemrix™ with other vaccines. However, if co-administration
    with another vaccine is considered, the other vaccine should be injected into
    separate limbs. In such cases, possible side effects may be more intense. In the
    clinical development plan, GSK is investigating the co-administration with seasonal
    influenza vaccine.

       Is there any data on the stability of the vaccine outside the fridge?
    GSK recommends that all of our vaccines are stored between 2-8°C. However, the
    licence for Pandemrix™ currently states that after the antigen and adjuvant has
    been reconstituted (mixed), the vaccine should be used within 24 hours and should
    not be stored above 25°C.

      Is GSK putting into place a safety monitoring strategy? If so, what is it?
    Yes. GSK monitors and evaluates adverse events that are reported for all of its
    medicines, including vaccines.
    GSK notes and strongly endorses the WHO’s position that post-marketing
    surveillance of the ‘highest possible quality’ is essential to ensure extensive safety
    evaluation of all pandemic vaccines.
    Pandemrix™ will be assessed in clinical studies. However, it should be
    acknowledged that the population studied in clinical trials will be limited, due to the
The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm                Page 5
HCP Q&A pandemic influenza A(H1N1) vaccine                              3 November 2009

    need to provide the vaccine to governments as quickly as possible. This means that
    additional studies and ongoing monitoring will be conducted once the vaccine is
    launched.
    GSK will share results of post-launch safety and effectiveness studies among the
    appropriate regulatory authorities.

       If an adverse event needs to be reported, what information needs to be
    provided in the safety report in order to facilitate evaluation and identification
    of the vaccine that was administered to the subject?
    In order to allow for rapid identification of the vaccine for which you are reporting an
    adverse event, it is important to identify the trade name of the vaccine
    (Pandemrix™) and the lot number of the vaccine that was administered. This can be
    done either by attaching the sticker provided to the patient’s vaccination record
    (stickers provided with the vaccine identify the trade name and the unique lot
    number which is attributed to the adjuvant/antigen combination) or you can identify
    the trade name (Pandemrix™) and the two different lot numbers which are printed
    on the labels of the antigen and adjuvant vials.

Vaccines for pandemic influenza A(H1N1)v

      Will current seasonal influenza vaccines offer any protection against
    influenza A(H1N1)v infection?
    The best scientific evidence available today suggests that current seasonal vaccines
    are unlikely to provide protection against the new influenza pandemic (H1N1)v
    2009.

      What is the difference between the seasonal influenza vaccine and the
    pandemic vaccine against influenza A (H1N1)v?
    The seasonal influenza vaccine is a trivalent inactivated virus, containing 15
    micrograms haemagglutinin per strain per 0.5 mL dose. It is non-adjuvanted. The
    vaccine complies with the annual strain recommendation from the WHO.
    The pandemic vaccine against influenza A (H1N1)v is a split inactivated vaccine
    containing 3.75 micrograms haemagglutinin of a monovalent antigen per 0.5 mL
    dose. The vaccine also contains an adjuvant designed to stimulate a stronger and
    potentially broader immuno response.

      What happens if people have had the pandemic (H1N1)v 2009 influenza?
    Are they immune or do they still need to get the vaccine?
    People who have had the pandemic (H1N1)v 2009 influenza will have a natural
    protection against the strain that infected them. However, influenza viruses are
    constantly mutating, which makes it extremely difficult to predict their impact.
    Continued surveillance will be necessary.

      In the 1976 H1N1 pandemic the vaccine given for that strain was linked to
    cases of Guillain-Barré Syndrome. What is Guillain-Barré Syndrome and is it a
    risk with GSK’s adjuvanted (H1N1)v pandemic vaccine?
    Guillain-Barré Syndrome (GBS) is a disorder characterized by progressive
    symmetrical paralysis and loss of reflexes, usually beginning in the legs. The
    paralysis characteristically involves more than one limb (most commonly the legs),
The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm               Page 6
HCP Q&A pandemic influenza A(H1N1) vaccine                              3 November 2009

    is progressive, and usually proceeds from the end of an extremity toward the torso.
    Areflexia (loss of reflexes) or hyporeflexia (diminution of reflexes) may occur in the
    legs and arms.
    During the 1976 influenza vaccination campaign, the risk of GBS after
    administration of the 1976 swine flu vaccine was approximately 12 cases per million
    persons vaccinated, which stopped the vaccination campaign and led to the
    withdrawal of the vaccine. The reason why GBS developed in association with that
    specific vaccine has never been firmly established, but this rare event has
    decreased greatly during the past 15 years (to around 0.7 reports/million
    vaccinations).
    The potential for the development of a similar risk with future vaccines can never be
    firmly excluded. However, GSK’s (H1N1)v pandemic vaccine will be manufactured
    according to established standards and post marketing surveillance will be
    conducted to monitor potential development of any serious adverse events following
    administration of vaccine.
    Safety monitoring systems are an integral part of strategies for the implementation
    of the new pandemic influenza vaccines.

Pandemic influenza A(H1N1)v

       What is the new influenza A(H1N1)v?
    The currently circulating influenza A(H1N1)v virus is a new virus subtype of
    influenza affecting humans, which contains a novel combination of gene segments
    from pig, bird and human influenza viruses. New viruses are often the result of a re-
    assortment of genes from two other viruses (swap of genes). This influenza
    A(H1N1)v virus is the result of a combination of two swine influenza viruses that
    contained genes of avian and human origin.

      Is it possible to catch swine flu twice?
    Yes, but only if the virus mutates. A person infected with the swine flu virus
    produces antibodies against it, which will recognise and fight off the virus if the body
    ever meets it again. However, if the virus mutates, the immune system may not
    recognise this different strain.

      If the (H1N1)v strain mutates, will Pandemrix™ still be effective?
    There are currently no data available to show that Pandemrix™ provides cross-
    protection against drifted strains of the H1N1 virus.
    Based on clinical trial results from the H5N1 pandemic influenza vaccine, there is
    however a possibility that some cross-protection would exist. GSK will evaluate the
    cross-immunogenic property of Pandemrix™.


Pandemrix™ and Prepandrix™ are trade marks of the GlaxoSmithKline group of
companies.




The latest Pandemrix Product Information can be viewed on the EMEA website
http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm               Page 7

				
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