21/07/2011 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has finalised its review of Pandemrix which was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy. This followed an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden.
While stressing that further research is necessary, the CHMP recommends that Pandemrix should only be used in people under 20 years of age if the recommended annual seasonal trivalent influenza vaccine is not available. The overall benefit-risk balance of Pandemrix remains positive.
See EMA Press Release and Q&A document for further information.
15/04/2011 - The European Medicines Agency has recommended an update to product information highlighting preliminary results from epidemiological studies on narcolepsy but emphasised that further research is needed and that it remains a signal requiring further investigation. See relevant EMA Press Release.
18/02/2011 - The European Medicines Agency is reviewing further data on narcolepsy and a possible association with Pandemrix. A causal relationship has not been established and further study results are awaited. See EMA Press Release for further information.
Update on National Monitoring Experience with Pandemic H1N1 Vaccines
In the past two weeks (Tuesday 16 March to Tuesday 30 March 2010), 27 reports of suspected adverse reactions to the Pandemic H1N1 vaccines (Pandemrix and Celvapan) have been received by the Irish Medicines Board (IMB). A single report may include more than one suspected reaction. The reports received to date remain consistent with the expected pattern of adverse effects for the pandemic vaccines.
A detailed report on the adverse reactions received by the IMB to date can be found via the link below.
IMB National Monitoring Update (01/04/2010)
As of 31 March 2010, the HSE vaccination clinics have closed. Due to the decreasing numbers of patients being vaccinated, and an expected reduction in the number of adverse reaction reports, the IMB will discontinue publication of routine updates. The safety of the H1N1 vaccines will continue to be monitored and further safety updates will be provided as appropriate.
The European Medicines Agency also publishes pandemic H1N1 update reports. These reports provide information on adverse reactions reported for both pandemic vaccines and antivirals in the European Union.
Visit the Agency's Pandemic Influenza Website for the latest report.
Irish Medicines Board - Drug Safety Newsletter - Special Edition (19/10/2009) and H1N1 Vaccines - Questions and Answers document
EMA Pandemic Influenza Website
This website provides news updates from the EMA in relation to the H1N1 influenza pandemic. The website also provides information about the role and activities of the EMA in relation to the pandemic and, in addition, outlines how medicines being used in the European Union (EU) during the pandemic were developed and approved.
Vaccine Product Information
The H1N1 vaccines in use in Ireland are Celvapan and Pandemrix.
The information below is the most recent information on Celvapan that has been approved by the European Commission. It corresponds to the Commission's decision of 22 December 2009.
Summary of Product Characteristics for Celvapan Vaccine
Patient Information Leaflet for Celvapan Vaccine
The information below is the most recent information on Pandemrix that has been approved by the European Commission. It corresponds to the Commission's decision of 8 February 2010.
Summary of Product Characteristics for Pandemrix Vaccine
Patient Information Leaflet for Pandemrix Vaccine
Up to date product information for Arepanrix, Focetria and Humenza is available from the EMA pandemic website.
Authorisation of Pandemic (H1N1) Vaccines
19 February 2010 - The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended to the European Commission that a conditional marketing authorisation be granted for the pandemic vaccine Humenza. This is the fifth pandemic vaccine recommended for use by the Committee, and the second to be assessed using what is known as the 'emergency procedure'. A Commission decision is expected shortly.
The CHMP has also given a positive opinion (20 January 2010) for the granting of a marketing authorisation for a fourth vaccine, Arepanrix. A Commission decision in respect of this vaccine is also expected in due course.
Three other pandemic vaccines, Celvapan, Focetria and Pandemrix, were previously granted marketing authorisations by the European Commission as recommended by the CHMP. The marketing authorisations for both Pandemrix and Focetria were granted on 29 September 2009. The authorisation for Celvapan was granted on 6 October 2009. These vaccines were assessed using the alternative 'mock-up procedure'.
Further information regarding the European Union's authorisation procedures for vaccines, which are managed by the EMA, is available from the EMA pandemic website. See also the explanatory note below concerning vaccines authorised via the core dossier procedure.
Explanatory Note regarding licensing of Pandemic (H1N1) 2009 Vaccines
The EMA began its review of pandemic H1N1 vaccines in July 2009 with a commitment from the Committee for Medicinal Products for Human Use, to fast-track the review of data as vaccine manufacturers make them available. For more information on the review process go to EMA Press Release 24/07/09 and the related Questions & Answers document.
European Medicines Agency reaffirms efficacy and safety of H1N1 pandemic vaccines
20 November 2009 – The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines, Celvapan, Focetria and Pandemrix. As a result, the EMA has reaffirmed the positive balance of benefits and risks in the context of the current H1N1 influenza pandemic. Celvapan and Pandemrix are the vaccines being used in Ireland.
In addition, the data on Focetria and Pandemrix indicate that a single dose of these vaccines is able to trigger an immune response that may be sufficient to give protection against the H1N1 pandemic influenza in some age groups. However, for certain groups, such as younger children and immunocompromised patients, the recommendation remains that two doses should be given to ensure that their immune system responds adequately to the vaccination.
The EMA, together with the national competent authorities including the Irish Medicines Board, is continuously monitoring the safety profile and efficacy of H1N1 pandemic influenza vaccines. As further information becomes available, it will make additional recommendations as necessary.
For more information go to EMA Press Release 20/11/09.
25 November 2009 - A single batch of Arepanrix vaccine has this week been quarantined in Canada due to a suspected (not confirmed) increase in reporting of anaphylaxis. Arepanrix is a H1N1 vaccine currently only in use in Canada. This vaccine is not available for use in Ireland.
Anaphylaxis is a known, although rare risk with any vaccine and is thought to occur at a frequency of between one and ten cases per million doses of vaccine given. The prescribing information for the H1N1 vaccines warn of this possible risk and the need to ensure that appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event.
The Irish Medicines Board continues to advise healthcare professionals to be prepared to treat an allergic reaction when administering any vaccine including both of the H1N1 vaccines in use in Ireland, Celvapan and Pandemrix. For both these vaccines, the number of reports of anaphylaxis received throughout the EU remains in line with the broadly accepted frequency estimates of vaccine induced anaphylaxis.
For latest information on Anti-viral Medication - Updated 19/10/2009
For latest information on Adverse Reaction Reporting
For latest information on Counterfeit Antiviral Medicine
Further information on the advice provided by the Pandemic Influenza Expert Group is available on the Health Protection Surveillance Centre website at www.hpsc.ie