Latest Information
Update on National Monitoring Experience with Pandemic H1N1 Vaccines
Up to Tuesday, 2 February 2010, 1291 reports of suspected adverse reactions to the pandemic (H1N1) 2009 vaccines have been received by the Irish Medicines Board (IMB).
The reports received to date remain consistent with the expected pattern of adverse effects for the pandemic vaccines.
The IMB will provide updates on a regular basis as national monitoring information becomes available in relation to the use of the vaccines.
Download IMB National Monitoring Update (04/02/2010)
The European Medicines Agency also publishes weekly 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
European Medicines Agency reaffirms efficacy and safety of H1N1 pandemic vaccines
The European Medicines Agency (EMEA) has reviewed further data on the centrally authorised pandemic vaccines, Celvapan, Focetria and Pandemrix. As a result, the EMEA 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.
Accordingly, the EMEA’s Committee for Medicinal Products for Human Use has recommended (19 November 2009) to the European Commission that the product information for Pandemrix and Focetria be updated. A formal decision from the Commission is expected shortly. Details of the proposed changes to the product information for both Pandemrix and Focetria are available via the EMEA website.
The EMEA, 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 EMEA Press Release 20/11/09.
Vaccine Product Information
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 Focetria that has been approved by the European Commission. It corresponds to the Commission's decision of 23 December 2009.
Summary of Product Characteristics for Focetria Vaccine
Patient Information Leaflet for Focetria 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 22 December 2009.
Summary of Product Characteristics for Pandemrix Vaccine
Patient Information Leaflet for Pandemrix Vaccine
Authorisation of Pandemic (H1N1) Vaccines
The EMEA recommended (2 October 2009) to the European Commission that a third pandemic vaccine, Celvapan, be granted a marketing authorisation. This followed a decision by the Commission to grant authorisations for Focetria and Pandemrix.
The European Commission subsequently granted a marketing authorisation for Celvapan on 6 October 2009.
Links to relevant EMEA press releases and other documents relating to the authorisation of the H1N1 vaccines are provided below:
EMEA Press Release 02/10/09
EMEA Press Release 25/09/09
Explanatory Note regarding licensing of Pandemic (H1N1) 2009 Vaccines
The EMEA 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 EMEA Press Release 24/07/09 and the related Questions & Answers document.
EMEA Pandemic Influenza Website
This website provides information about the role and activities of the EMEA in relation to the H1N1 influenza pandemic. It also provides information on the development and approval of medicines for use in the European Union (EU) during the pandemic.
Arepanrix
Arepanrix is a H1N1 vaccine currently only in use in Canada. This vaccine is not available for use in Ireland.
A single batch of Arepanrix vaccine has this week been quarantined in Canada due to a suspected (not confirmed) increase in reporting of anaphylaxis. 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 19/10/2010
For latest informatoin 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
- End-