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Pandemic pharmacovigilance weekly update - Status at 27 November 2009 (12/3/09, extracts, edited)
Pandemic pharmacovigilance weekly update - Status at 27 November 2009 (12/3/09, extracts, edited)
[Source Full PDF Document: LINK. EDITED.]
European Medicines Agency
Patient Health Protection
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
London, 3 December 2009
Doc. Ref. EMEA/784681/2009
Pandemic pharmacovigilance weekly update - Status at 27 November 2009
This update has been prepared by the European Medicines Agency (EMEA) to provide information on the evolution of the H1N1 pandemic, an estimate of how many doses of centrally authorised pandemic vaccines and antivirals have been distributed or administered in Europe, a summary of the adverse reactions reported to the Agency after use of the vaccines and antivirals, and other information on the benefits and risks of the vaccines and antivirals. Centrally authorised pandemic medicines concerned by this update are the vaccines Celvapan, Focetria and Pandemrix and the antiviral Tamiflu.
This report includes suspected reactions that were observed after the vaccine was administered. This does not mean they have been caused by the vaccine. They could be a symptom of another illness or they could be associated with another product taken by the patient. Healthcare professionals are actively encouraged to report events following vaccination.
The information has been obtained from EudraVigilance. EudraVigilance is a database and management system managed at the EMEA for collecting and evaluating reports of suspected adverse reactions to medicinal products in the European Economic Area (EEA). It allows the transfer of reports from national regulatory agencies and marketing authorisation holders to the EMEA, and the early detection and monitoring of possible safety signals in relation to reported adverse reactions.
Reports are collected on a continuous basis. This update includes reports received in Eudravigilance after the Marketing Authorization of the centrally authorised pandemic vaccines up to 27 November.
Note that a single patient may experience several reactions that will be included in a single report. Therefore the number of reactions may not be equal to the number of patients.
The weekly update may also include information on vaccine safety made available by Member States.
Key message:
The benefit/risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive. To date, no unexpected serious safety issues have been identified. The most frequent adverse reactions that have been reported are non-serious and as expected.
The EMEA issued a press release on 20 November 2009 reaffirming the efficacy and safety of the centrally authorised vaccines. With vaccination campaigns ongoing in the European Union, it is estimated that about 10 million people have been vaccinated so far.
The vaccine adverse effects reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the expected safety profile of the three vaccines.
New clinical trial data showed greater incidence of fever following the second dose of Pandemrix in infants from 6 months to 35 months. An assessment of these data is ongoing.
For further information on the established adverse reactions included in authorised product information for centrally authorised pandemic vaccines (Celvapan, Focetria, Pandemrix) and antivirals (Tamiflu), visit the EMEA Pandemic influenza (H1N1) website.
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[Source Full PDF Document: LINK. EDITED.]
European Medicines Agency
Patient Health Protection
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68
E-mail: mail@emea.europa.eu http://www.emea.europa.eu
London, 3 December 2009
Doc. Ref. EMEA/784681/2009
Pandemic pharmacovigilance weekly update - Status at 27 November 2009
This update has been prepared by the European Medicines Agency (EMEA) to provide information on the evolution of the H1N1 pandemic, an estimate of how many doses of centrally authorised pandemic vaccines and antivirals have been distributed or administered in Europe, a summary of the adverse reactions reported to the Agency after use of the vaccines and antivirals, and other information on the benefits and risks of the vaccines and antivirals. Centrally authorised pandemic medicines concerned by this update are the vaccines Celvapan, Focetria and Pandemrix and the antiviral Tamiflu.
This report includes suspected reactions that were observed after the vaccine was administered. This does not mean they have been caused by the vaccine. They could be a symptom of another illness or they could be associated with another product taken by the patient. Healthcare professionals are actively encouraged to report events following vaccination.
The information has been obtained from EudraVigilance. EudraVigilance is a database and management system managed at the EMEA for collecting and evaluating reports of suspected adverse reactions to medicinal products in the European Economic Area (EEA). It allows the transfer of reports from national regulatory agencies and marketing authorisation holders to the EMEA, and the early detection and monitoring of possible safety signals in relation to reported adverse reactions.
Reports are collected on a continuous basis. This update includes reports received in Eudravigilance after the Marketing Authorization of the centrally authorised pandemic vaccines up to 27 November.
Note that a single patient may experience several reactions that will be included in a single report. Therefore the number of reactions may not be equal to the number of patients.
The weekly update may also include information on vaccine safety made available by Member States.
Key message:
The benefit/risk balance of the pandemic vaccines and antivirals used for the current H1N1 influenza pandemic continues to be positive. To date, no unexpected serious safety issues have been identified. The most frequent adverse reactions that have been reported are non-serious and as expected.
The EMEA issued a press release on 20 November 2009 reaffirming the efficacy and safety of the centrally authorised vaccines. With vaccination campaigns ongoing in the European Union, it is estimated that about 10 million people have been vaccinated so far.
The vaccine adverse effects reported so far have mainly been symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the expected safety profile of the three vaccines.
New clinical trial data showed greater incidence of fever following the second dose of Pandemrix in infants from 6 months to 35 months. An assessment of these data is ongoing.
For further information on the established adverse reactions included in authorised product information for centrally authorised pandemic vaccines (Celvapan, Focetria, Pandemrix) and antivirals (Tamiflu), visit the EMEA Pandemic influenza (H1N1) website.
(...)
-
------