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Drug Safety 25 IRISH MEDICINES BOARD SPECIAL EDITION NEWSLETTER IMB Update on Pandemic A(H1N1)v vaccines Pandemrix Vial Label Early batches of the GSK vaccine, Pandemrix, were manufactured prior to approval of the final label. These batches have a slightly different vial label to the later batches but are of an equivalent quality and are appropriate for use. The difference is that the vial label does not include the trade name ‘Pandemrix’ but instead is labeled as PrePandemic/Pandemic Influenza Vaccine. The outer packaging and product literature includes the name ‘Pan - demrix’. Any reports of suspected adverse reactions should include the trade name, Pandemrix, and the batch number. It is recommended that patient records should include the trade name, Pandemrix, and the batch number of the vaccine administered to ensure trace - ability. Stickers will be supplied with the vaccines, which include the trade name ‘Pan - demrix’ and the batch number to facilitate traceability. he European Commission on the recom - both products are the focus of this update. mendation of the European Medicines These ‘pandemic’ vaccines were licensed TAgency (EMEA) has granted licences for three using the so-called ‘mock-up’ approach. This vaccines against influenza A(H1N1)v. These approach involved the development of vaccines are: ‘mock-up’ vaccines in advance of the pan - demic, based on information generated with Celvapan (Baxter), a different virus strain that could have itself Pandemrix (GlaxoSmithKline). caused a pandemic (an H5N1 influenza virus Focetria (Novartis), strain). Once the A(H1N1)v virus strain caus - ing the current pandemic was identified by The IMB understands that the Baxter vac - the World Health Organisation (WHO), the cine, Celvapan and the GSK vaccine, Pan - manufacturers were able to replace the H5N1 demrix , will be made available in Ireland by strain in the ‘mock-up’ vaccines with the the Department of Health and Children in H1N1 strain resulting in the final ‘pandemic’ accordance with the national immunisation vaccines for use now. strategy for the pandemic. Consequently, Drug Safety – October 2009 – Issue Number 34 Correspondence/Comments should be sent to the Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: 676 4971 Fax: 676 2517 The ‘pandemic’ vaccines were licensed on Current Recommendations on the basis of information on quality, safety Dosage and immunogenicity, including informa - tion from clinical trials involving more than The current recommendation is for a two- 6,000 subjects, generated at the time of the dose vaccination schedule, at an interval of licensing of the mock-up vaccines, as well as three weeks, for adults, including pregnant on information relating to the change in women, and children from six months of strain from H5N1 to H1N1. Further clinical age. The IMB anticipates the availability of trials in adults and in children are ongoing further data from ongoing clinical studies and more results will become available in over the coming months and these recom - the coming weeks and months. mendations may be updated. Product Information Use of the vaccines in Pregnancy Details of the Product Information for each The available evidence suggests that in of the vaccines including the Summary of pregnant women the risk for complica - Product Characteristics (SmPC) and the tions due to seasonal influenza increases Package leaflet (PL) are available on the with the duration of pregnancy with the IMB and EMEA websites, as is an EU risk being lower in the first trimester, but explanatory document on the scientific con - not negligible. The risk was highest during siderations regarding the licensing of the the third trimester. Moreover, the presence pandemic vaccines. It is strongly recom - of co-morbidities in a pregnant woman mended that the Product Information is strongly increased the risk of complica - read in conjunction with this explanatory tions. document as it provides further detailed information on the use of these vaccines. Clinical trials with the ‘mock-up vaccines’ and to some extent the vaccines that Extensive amounts of new safety and effi - include the A(H1N1)v strain provide cacy data are expected from the widespread immunogenicity results in women of child - use of the vaccines in vaccination pro - bearing age. Based on experience from grammes across the EU. Procedures are in other influenza vaccines, it is assumed that place to allow for the rapid review of all immunogenic responses in non-pregnant such data and it is likely that the product women can be extrapolated to pregnant information (SmPC and PL) will be updated women. at regular intervals. Healthcare Profession - als are requested to monitor the IMB and The current recommendation is a two-dose EMEA websites throughout the pandemic vaccination schedule for pregnant women, for updated information as it becomes at an interval of three weeks. Vaccine available. safety in pregnant women and effective - ness will be closely monitored, as part of the post-marketing surveillance plan. Observational studies using established pregnancy registries are planned. Drug Safety – October 2009 – Issue Number 34 Correspondence/Comments should be sent to the Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: 676 4971 Fax: 676 2517 2 Use of the vaccines in Children Based on a large amount of scientific data, the WHO and the EMEA have con - With respect to pandemic influenza vac - cluded that the evidence favours the rejec - cines, limited data have been collected in tion of a causal relationship between children within the development of ‘mock- thiomersal-containing vaccines and up’ vaccines. The current recommendation autism. Additional publications have is for a two-dose vaccination schedule, at underscored the lack of an association an interval of three weeks, for children between thiomersal and neuro-develop - from six months of age. Paediatric studies mental disorders. with A(H1N1)v are currently ongoing with all pandemic vaccines, and the IMB is A European Review previously concluded expecting further data from these studies that there is no evidence of harm from over the coming months and the recom - thiomersal in vaccines other than the pos - mendation may be updated. sibility of hypersensitivity (allergic) reac - tions. The presence of thiomersal in the Known Safety profile composition of vaccines is stated on the label and a warning regarding the risk of Most of the adverse events seen to date in sensitisation in relation to thiomersal and relation to these vaccines were in clinical other preservatives is included in the trials with the H5N1 strain and were mild product information. The IMB wishes to in nature, of short duration and qualita - emphasise that immunisation with vac - tively similar to those induced by seasonal cines containing thiomersal continues to influenza vaccines. There were fewer reac - offer valuable benefits to the general pop - tions after the second dose of the vaccine ulation, including infants. The benefits of compared with the first dose. The most fre - vaccination far outweigh the risks, if any, quently occurring adverse reaction was of exposure to thiomersal-containing vac - injection site pain, which was usually cines. mild. Other common side effects reported in trials to date were fatigue, malaise, Adjuvant induration, erythema, swelling, pruritis and bleeding at the injection site. Pyrexia, Pandemrix contains an ‘adjuvant’ (a sub - sweating, chills, headache, lympha- stance that enhances the immune denopathy, arthralgia and myalgia were response so that less viral material can be also commonly reported. used in each dose of vaccine). Benefits of using an adjuvant include better cross- Thiomersal protection against drifted influenza strains, as suggested by results with H5N1 Pandemrix contains thiomersal, a com - vaccines, and increased production pound containing mercury that is used as capacity potentially improving vaccine a preservative in medicines. The use of availability. The adjuvant in Pandemrix thiomersal in Pandemrix extends the time- (ASO3) has been tested in clinical trials period over which the multi-dose vial of involving several thousand subjects and the vaccine may be used. the safety profile is considered to be acceptable. Drug Safety – October 2009 – Issue Number 34 Correspondence/Comments should be sent to the Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: 676 4971 Fax: 676 2517 3 the pandemic adverse reaction on-line Post Marketing safety of the reporting form is included with this Bul - Vaccines letin along with advice on what informa - tion should be included in a report (see attached insert). Advice to Healthcare Professionals on Pandemic Pharmacovigilance The IMB requests that healthcare profes - As limited safety data on novel H1N1 sionals provide details of: influenza vaccines are currently available, additional pharmacovigilance activities • Vaccine trade name (it is essential to are essential to monitor and assess their specify the trade name of the vaccine safety with widespread use. to facilitate differentiation from the seasonal influenza vaccine) It is critical that healthcare professionals • Batch number report all serious suspected adverse reac - • Dates of initial and second (if appli - tions to the IMB as soon as possible and cable) vaccination with sufficient
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