EPI-NEWS NATIONAL SURVEILLANCE OF COMMUNICABLE DISEASES Editor: Peter Henrik Andersen Dept. of Epidemiology Tel.: +45 3268 3268 • Fax: +45 3268 3874 Statens Serum Institut • 5 Artillerivej • DK 2300 Copenhagen S www.ssi.dk • [email protected] • ISSN: 1396-4798

FAQs ON PANDEMIC VACCINE (PANDEMRIX®) No. 43, 2009 As from week 45 physicians in gen- Should immunosuppressed indi- (haemagglutinin) puri- eral practice are expected to initiate viduals receive vaccination? fied from inactivated influenza virus vaccination against influenza A Patients with congenital as well as after culture in unfertilised eggs. (H1N1)v using Pandemrix®. Practi- acquired immunodefiencies includ- The pandemic vaccine furthermore cal information concerning vaccina- ing splenectomised, HIV-infected contains an excipient (adjuvant tion was sent to GPs by the National and pharmacologically immunosup- AS03) which consists of squalene (an Board of Health at the beginning of pressed patients should receive vac- oil present in plants and animals), October and further information is cination due to the increased risk of DL-alpha tocopherol (Vitamin E1) available in EPI-NEWS 41/09, at serious disease associated with influ- and emulsifier (polysorbate 80). www.sst.dk, and at www.ssi.dk enza infection. Furthermore, the vaccine contains (Danish language) In the below text, When possible, vaccination should the preservative thiomersal. An adult we answer a series of frequently take place three weeks prior to ini- vaccine dose contains 5 micrograms asked questions in this context. tiation of immunosuppressive ther- of thiomersal, corresponding to 2.5 More questions are continually being apy. micrograms of ethylmercury. answered at www.ssi.dk (Danish lan- guage). As from week 45, physicians Who should not be vaccinated? Does the vaccine contain live virus? and other health professionals may Persons with type 1 allergy to the ex- No. Consequently, it cannot cause call +45 32 68 30 37 with any queries cipients, e.g. egg and chicken pro- influenza illness. concerning the pandemic vaccine. tein, formaldehyde and gentamicin, The service is active on all work days should not be vaccinated. Why does the vaccine contain exipi- until 6 pm. As is the case with other vaccines, ents (adjuvants)? Furthermore, the National Board of vaccination should be postponed in The adjuvant AS03 has been added to Health has set up a hotline covering case of acute illness or fever. increase the efficacy. The immune general requests on influenza A system’s antibody response is im- (H1N1)v, including questions on risk May persons with allergic contact proved, leading to a longer lasting groups and the pandemic guideline. dermatitis be vaccinated? and better protection and may also The hotline is active throughout the Allergy to the excipient formalde- provide broader coverage against any opening hours of the National Board hyde will frequently manifest as con- influenza virus alterations. The use of of Health: +45 72 22 85 22. tact dermatitis. This does not consti- adjuvants also reduces the amount of The Danish Medicines Agency may tute a contraindication, and the risk antigen needed. be contacted for queries concerning may be reduced by ensuring intra- adverse events: +45 44 88 97 57 or muscular vaccination. Why does the vaccine contain [email protected] thiomersal? The vaccine is supplied in vials con- Why is vaccination not recom- Should persons who have had influ- taining ten doses which are not al- mended for everyone? enza this year be vaccinated? ways used immediately after suspen- On the basis of current knowledge Persons who have had laboratory- sion and first use. Contamination may on new influenza A (H1N1)v, the confirmed new influenza A (H1N1)v occur during handling and therefore National Board of Health estimates will not benefit from receiving the the preservative thiomersal has been that the overwhelming majority of pandemic vaccine (but may be vac- added to the vaccine. those who become infected will ex- cinated against seasonal influenza). perience a mild disease course. Persons who have had influenza-like What is thiomersal? Vaccination against influenza is pri- disease which was not confirmed as Thiomersal contains an organomercu- marily given with a view to prophy- influenza A (H1N1)v should be vac- ric compound (ethylmercury) different laxis against severe influenza illness cinated provided they belong to a from the one ingested with a normal or its complications. risk group. (There is no need to test diet (methylmercury). The two mer- Risk group persons are at increased for antibodies prior to such vaccina- cury compounds are eliminated from risk of experiencing a more severe tion). the body in different ways, and they disease course when infected with also differ with regard to the extent to influenza A (H1N1)v. Consequently, Is influenza vaccination required for which they are absorbed in brain tis- risk group persons, as defined by the pilgrimage to Mecca? sue and by the extent to which they National Board of Health, EPI-NEWS Pandemic vaccination is not a visa are degraded to inorganic mercury. 41/09 and any nursing staff who may requirement for persons going on pil- come in to contact with such persons grimage to Mecca. The Saudi Ara- Does the amount of thiomersal con- should receive vaccination. bian health authorities recommend vaccination against seasonal as well tained in the vaccine comprise a SPECIAL GROUPS as pandemic influenza when such health risk? Does the foetus obtain protection if vaccination is available. In Denmark, Thiomersal has been used in vaccines a pregnant woman is vaccinated? only persons comprised by the rec- for about 60 years. It is estimated that There are no studies to demonstrate ommendations from the National several billion vaccine doses contain- if this is the case, but is possible that Board of Health will be eligible for ing thiomersal have been adminis- the foetus may achieve some degree pandemic vaccination. tered worldwide. There is no docu- of protection from the vaccination of mentation that thiomersal, applied in the child-bearing woman. THE VACCINE the doses contained in the vaccine, comprises a health risk to those vacci- Lactating women and vaccination What does the pandemic vaccine nated. Pandemrix® is approved for admini- contain? (SEE OVERLEAF) stration to lactating women. The antigen is a surface protein

Continued… the protection may diminish or cease intramuscularly. The substance is approved for use as to exist. What interval should there be from a preservative in vaccines by pharma- How long does the vaccine protect? the first to the second Pandemrix® ceutical authorities worldwide and by There are no data on the long-term vaccine? the WHO. coverage of the pandemic vaccine, The first and second Pandemrix® The quantity contained in a dose of but studies on this issue are being vaccine should be administered at a Pandemrix® (2.5 micrograms per planned. 3-week interval at a minimum. adult dose) is considerably smaller than the amount of mercury you nor- Does the vaccine have side effects? May the Pandemrix® vaccine be mally ingest with your food in a week. Like other vaccines the pandemic given in conjunction with other vac- vaccine can be associated with side cines? Have threshold values been estab- effects. The most frequent side ef- Pandemrix® may be given in con- lished for the intake of mercury via fects are soreness, redness and junction with the seasonal influenza food? swelling at the vaccination site, mus- vaccine and other vaccines. Admini- A group of experts of the UN's Food cle and joint pains, headache and fe- stration in conjunction with other and Agriculture Organization (FAO) ver within 1-2 days after the vaccina- vaccines probably increases the risk and WHO have estimated that a tion. The side effects generally re- of side effects. Separate injection weekly intake of mercury correspond- cede within 1-3 days. sites on opposite extremities should ing to 1.6 micrograms per kilo body These side effects are expected and be used. weight is acceptable. Such level is harmless. In comparison with the or- thought to be safe even for the more Is an interval needed with respect to dinary influenza vaccine they are vulnerable, i.e. pregnant women and other vaccines when these are not expected to occur somewhat more foetuses. administered in conjunction with frequently. The approved threshold values for Pandemrix® Serious side effects are expected to mercury (methylmercury) in e.g. chil- No, vaccination with other vaccines occur very rarely. As is usually the dren’s food is 50 micrograms per kilo may be given in conjunction or at case in connection with the introduc- and for fish it is 500 micrograms per any interval with respect to Pandem- tion of new vaccines, the Danish kilo. Consequently, the ethylmercury rix®. Medicines Agency will ensure that content of Pandemrix® is many fold comprehensive monitoring is estab- Practical handling before vaccina- less than the methylmercury amounts lished and that any serious side ef- tion allowed in foodstuffs. fects are assessed. If injury is caused Pandemrix® is supplied to the physi- How was the vaccine tested? by vaccination, the Danish Patient cians who will administer it in pack- The pandemic vaccine was tested Insurance will pay damages in ac- ages containing two types of vials: using H5N1 (avian influenza anti- cordance with standard provisions. suspension with antigen and emul- gen) in a series of studies comprising sion with adjuvant. Prior to admini- How should presumed side effects approx. 12,000 persons and it has stration, the solutions should be kept of Pandemrix® be reported? been found to be safe and effective. at room temperature, shaken and All presumed side effects after vac- Pandemrix® is the same vaccine, the mixed. This produces a whitish cination with Pandemrix® should be only difference is that the antigen multi-dose vaccine corresponding to reported to the Danish Medicines used is H1N1v. The same principle ten adult doses. This solution should Agency on the special vaccine form of production is used every year in be shaken before every dose with- found at www.meldenbivirkning.dk the production of the seasonal vac- drawal and administration. (Danish language). Remember to cine. Also see the summary of product state the vaccine’s batch number Several major studies are underway, characteristics at when filling-in the form. and the results from these will be in- www.produktresume.dk (Danish cluded in the continual assessments What is a serious adverse event? language). An adverse event is serious if it: and recommendations made by the How to store the vaccine - causes death Danish authorities as they are pub- After first use the mixed vaccine - is life-threatening lished. should not be returned to the refrig- - calls for hospitalisation or con- erator, but stored at less than 25 °C tinuation of previous admission to Is the pandemic vaccine effective and used within 24 hours. against new influenza A H1N1v? hospital The physician should only remove - causes extended or substantial dis- The vaccine is expected to provide a from the refrigerator the vials which ability or incapacity very high degree of protection he or she expects to use. against the new influenza. - entails congenital malformation or The degree of protection is expected congenital anomaly. PAGE TWO OF EPI-NEWS to be highest among persons with an The normal page two of EPI-NEWS What is an unexpected adverse intact immune response and less ef- including tables detailing notifica- event? fective in persons with a weakened tions, tests/isolates and the influenza An adverse event is unexpected if it: immune response. sentinel curve will not be printed this is not stated in the summary of prod- The vaccine is expected to prevent a week, but it is available at uct characteristics for Pandemrix®, total of 70-90% of all disease cases www.ssi.dk (Danish language). see www.produktresume.dk (Danish among young, healthy persons. In (Department of Epidemiology) language). the elderly, the degree of protection will be more limited. HANDLING OF THE VACCINE If the influenza virus A H1N1v 21 October 2009 changes much during the epidemic, Pandemrix® is to be administered