A/H1N1 Flu Vaccine Monitoring

On this A/H1N1 pandemic influenza vaccines web page the Uppsala Monitoring Centre is making available information that can support the efforts of monitoring agencies in communicating about vaccine safety issues and that can support the analysis of AEFI PMS data.

Country, vaccine, AEFI on website

Collections of AEFI data are compiled by :

This chart gives vaccine in use by country, with web link (where available) to AEFI information.

COUNTRY VACCINE(S) AEFI ON WEBSITE
Australia Panvax Safety alerts & advisory statements
Austria Celvapan -
Belgium Pandemrix Belgian AEFI reports
Canada Arepanrix; Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant) Weekly Vaccine Surveillance Report
China Inactivated H1N1 Influenza Vaccine produced by 9 local manufacturers Progress of H1N1 control measures (in Chinese)
Taiwan, China AdimFlu-S, Focetria Weekly Summary of Adverse Events Following 2009 A/H1N1 Vaccination
Croatia Focetria Pandemic portal for AEFIs reported for Focetria, and weekly update (in Croatian)
Cyprus Pandemrix Website will be publishing a bi-weekly report on the safety surveillance
Denmark Pandemrix Danish Medicines Agency Information on influenza A (H1N1)
Finland Pandemrix -
France Celvapan, Focetria, Pandemrix, Panenza Bulletins Suivi de pharmacovigilance des vaccins grippaux A (H1N1)
Germany Celvapan, Focetria, Pandemrix Paul Ehrlich-Institut Information on suspected cases of complications and adverse reactions after vaccinations / / The PEI publishes summary reports in addition to the searchable database
Greece Pandemrix, Focetria -
Hong Kong Pananza Centre for Health Protection - Vaccination Statistics and Related Reports
Hungary Flulaval P -
Iceland Pandemrix -
Ireland Celvapan, Pandemrix Update on National Monitoring Experience with Pandemic H1N1 Vaccines
Israel Focetria, Pandemrix -
Italy Focetria Weekly safety reports update from the Italian Medicines Agency
Japan Inactivated A/H1N1 Influenza Vaccines (Without Adjuvant); 4 manufacturers (see table below) Japanese influenza A(H1N1) safety reporting
Korea, Rep of Green Flu S -
Malaysia Pandemrix National Pharmaceutical Control Bureau 
Montenegro Panenza Agency for Medicinal Products and Medical Devices of Montenegro (CALIMS) activities may be followed on their website
Netherlands Focetria, Pandemrix Lareb search engine for medicinal products / / Overviews of the received reports concerning suspected adverse reactions after pandemic influenza vaccination
New Zealand Celvapan -
Norway Pandemrix; Celvapan Information on influenza A(H1N1) (in Norwegian)
Poland - (no vaccination programme planned)
Serbia Focetria -
Singapore Panvax, Pandemrix Safety monitoring of H1N1 vaccines in Singapore
Slovakia Panenza Information on vaccine Panenza in Slovak language; updates will be made at this site also (in Slovak)
Spain Pandemrix, Focetria, Panenza Pharmacovigilance Plan for H1N1 flu vaccines (in Spanish) / / Summary of AEFI reports in Spain with Pandemic H1N1 Vaccines (in Spanish)
Sweden Pandemrix Swedish Medical Products Agency Summary of adverse drug reaction reports in Sweden with Pandemrix
Switzerland Pandemrix, Focetria, Celtura Swissmedic Latest information about vigilance for H1N1 flu vaccines
Thailand Panenza Bureau of Epidemiology, Ministry of Public Health (partly in Thai)
UK Pandemrix, Celavapan UK Medicines and Healthcare products Regulatory Agency Swine flu information
USA

Influenza A (H1N1) 2009 Monovalent Vaccines manufactured by CSL Limited;
Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc, MedIImmune, LCC

 Vaccine Adverse Event Reporting System (VAERS) data / / The USA also publishes overview reports in addition to the searchable VAERS database
Rest of the World - The official document describing the vaccine deployment by WHO (Pandemic (H1N1) 2009 vaccine deployment update - 9 March 2010)

Please notify us of corrections and additional information to update the tables at: vaccine@who-umc.org

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A/H1N1 pandemic influenza vaccines

This table gives links to vaccine product information.

VACCINE MANUFACTURER PRODUCT INFORMATION
AdimFlu-S Adimmune -
Arepanrix [PQ*] GlaxoSmithKline Product Information Leaflet Arepanrix(TM) H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine [web page]
Celtura [PQ*] Novartis CELTURA® Fertigspritze - Fachinformation, Version final (in German) [web pdf]
Celvapan Baxter EPARs for authorised medicinal products for human use (Celvapan) [web page]
Fluval P Omninvest (Hungary) Fluval P (in Hungarian) [MS Word document]
Focetria [PQ*] Novartis EPARs for authorised medicinal products for human use (Focetria) [web page]
Green Flu S Green Cross Corp -
Humenza Sanofi Pasteur Summary of Product Characteristics (pdf)
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) Denka Seiken Co -
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) Kaketsuken (The Chemo-Sero-Therapeutic Research Institute) -
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) The Kitasato Institute -
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) Research Foundation for Microbial Diseases of Osaka University (Biken) -
Inactivated H1N1 Influenza Vaccine Hualan Biological -
Inactivated H1N1 Influenza Vaccine Zhejiang Tianyuan Bio-Pharmaceutical -
Influenza A (H1N1) 2009 Monovalent Vaccine CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine package insert (CSL) [pdf file]
Influenza A (H1N1) 2009 Monovalent Vaccine (also known as Fluvirin (A/H1N1) [PQ*]) Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine package insert (Novartis) [pdf file]
Influenza A (H1N1) 2009 Monovalent Vaccine [PQ*] Sanofi Pasteur, Inc Influenza A (H1N1) 2009 Monovalent Vaccine package insert (Sanofi Pasteur) [pdf file]
Influenza A (H1N1) 2009 Monovalent Vaccine MedIImmune, LCC Influenza A (H1N1) 2009 Monovalent Vaccine package insert (MedIImmune) [pdf file]
Influenza A (H1N1) 2009 Monovalent Vaccine ID Biomedical Corporation of Quebec Influenza A (H1N1) 2009 Monovalent Vaccine [pdf file]
Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant) Glaxo Smith Kline Product Information Leaflet - Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant) [web page]
Pandemrix [PQ*] Glaxo Smith Kline EPARs for authorised medicinal products for human use (Pandemrix) [web page]
Panenza [PQ*] Sanofi Pasteur Product characteristics (in French) [pdf]
Panflu Sinovac Biotech -
Panvax H1N1 [PQ*] CSL Panvax H1N1 product information [web page]
[PQ*] United Nations prequalified vaccines

Ingredients table

This table gives the ingredients of the vaccines listed in the table above (based on linked vaccine product information). (Adobe pdf, 50Kb, updated 24 February 2010)

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A/H1N1 pandemic influenza vaccines links

Click on one of the following links and a window will open for each of the external websites listed concerning pandemic influenza vaccines (all English unless otherwise noted).

World Health Organization Pandemic (H1N1) 2009
European Medicines Agency Pandemic influenza (H1N1) website
Pan American Health Organization Pandemic (H1N1) 2009
Centers for Disease Control and Prevention 2009 H1N1 Flu
US Food and Drug Administration 2009 H1N1 (Swine) Flu
European Centre for Disease Prevention and Control (ECDC) Pandemic (H1N1) 2009
Eurosurveillance (scientific journal) Communications on H1N1
The New England Journal of Medicine H1N1 Influenza Center
British Medical Journal Pandemic Flu
International Federation of Pharmaceutical Manufacturers and Associations Novel H1N1 Influenza and the research-based pharmaceutical and vaccine indústry

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Other Links

*Brighton Collaboration case definitions
*Safety of pandemic vaccines WHO Pandemic (H1N1) 2009 briefing note 6
*Safety of pandemic vaccines WHO Pandemic (H1N1) 2009 briefing note 16
*Safety of pandemic vaccines WHO Pandemic (H1N1) 2009 briefing note 20
*CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine Adopted by CHMP in November 2006 Revision 1.0 adopted by CHMP on 25 June 2009

Pandemic Flu Vaccine Monitoring page last updated 1600 GMT 12 July 2010