H1N1 VACCINE MONITORING http://www.who-umc.org/DynPage.aspx?

id=85898#links

COUNTRY VACCINE(S) Manufacturer Cell line Mercury MF 59 ASO3 OTHER AEFI ON WEBSITE
Australia Panvax CSL eggs 50mcg Safety alerts & advisory statements
Austria Celvapan Baxter VERO cells polysorbate80 whole cell virus -
Belgium Pandemrix GSK eggs yes yes -
Canada Arepanrix GSK eggs yes no yes Weekly Vaccine Surveillance Report
Croatia Focetria Novartis eggs yes yes -
Denmark Pandemrix GSK eggs yes yes Danish Medicines Agency Information on influenza A (H1N1)
Finland Pandemrix GSK eggs yes yes -
France Celvapan Baxter VERO cells polysorbate80 whole cell virus Bulletins Suivi de pharmacovigilance des vaccins grippaux A (H1N1)
France Focetria Novartis eggs yes yes Bulletins Suivi de pharmacovigilance des vaccins grippaux A (H1N1)
France Pandemrix GSK eggs yes yes Bulletins Suivi de pharmacovigilance des vaccins grippaux A (H1N1)
Germany Celvapan Baxter VERO cells polysorbate80 whole cell virus Paul Ehrlich-Institut Information on suspected cases of complications and adverse reactions after vaccinations
Germany Focetria Novartis eggs yes yes Paul Ehrlich-Institut Information on suspected cases of complications and adverse reactions after vaccinations

Germany Pandemrix GSK eggs yes yes

Paul Ehrlich-Institut Information on suspected cases of complications and adverse reactions after vaccinations
Greece Pandemrix GSK eggs yes yes

Greece Focetria Novartis eggs yes yes

Hungary Flulaval P Omninvest (Hungary) -

Iceland Pandemrix GSK eggs yes yes -

Ireland Celvapan Baxter VERO cells polysorbate80 whole cell virus

Update on National Monitoring Experience with Pandemic H1N1 Vaccines

Ireland Pandemrix GSK eggs yes yes

Update on National Monitoring Experience with Pandemic H1N1 Vaccines

Israel Focetria Novartis eggs yes yes

Israel Pandemrix GSK eggs yes yes

Italy Focetria Novartis eggs yes yes Weekly safety reports update from the Italian Medicines Agency
4 manufacturers (see
Japan no no
table below) -
Korea, Rep of Green Flu S Green Cross Corp -
Netherlands Focetria Novartis eggs yes yes Lareb search engine for medicinal products
Netherlands Pandemrix GSK eggs yes yes Lareb search engine for medicinal products
New Zealand Panvax CSL -
Norway Pandemrix GSK eggs yes yes
Norway Celvapan Baxter VERO cells polysorbate80 whole cell virus Information on influenza A(H1N1) (in Norwegian)

Poland -
(no vaccination programme planned)
Serbia Focetria Novartis eggs yes yes -
Singapore Panvax CSL -
Slovakia -
(no pandemic vaccine in use; no reports received)
Spain Celvapan Baxter VERO cells polysorbate80 whole cell virus
Spain Pandemrix GSK eggs yes yes
Spain Focetria Novartis eggs yes yes
Spain Panenza Sanofi Pasteur -
Sweden Pandemrix GSK eggs yes yes Swedish Medical Products Agency Summary of adverse drug reaction reports in Sweden with Pandemrix
Switzerland Pandemrix GSK eggs yes yes
Switzerland Focetria Novartis eggs yes yes

Switzerland Celtura Novartis yes polysorbate80 Swissmedic Latest information about vigilance for H1N1 flu vaccines

UK Celvapan Baxter VERO cells polysorbate80 whole cell virus

UK Medicines and Healthcare products Regulatory Agency Swine flu information
UK Pandemrix GSK eggs yes yes
UK Medicines and Healthcare products Regulatory Agency Swine flu information
Influenza A (H1N1)
2009 Monovalent
Vaccines manufactured
by CSL Limited;
USA
Novartis Vaccines and
Diagnostics Limited;
eggs 25mcg no no
Sanofi Pasteur, Inc,
MedIImmune, LCC VAERS Data

[Top of page]
A/H1N1 pandemic influenza vaccines
 This table gives links to vaccine product information.
VACCINE MANUFACTURER PRODUCT INFORMATION
Arepanrix GlaxoSmithKline Product Information Leaflet Arepanrix? H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine [web page]
Celtura 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 Novartis EPARs for authorised medicinal products for human use (Focetria) [web page]
Green Flu S Green Cross Corp -

Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) Denka Seiken Co

-
Kaketsuken (The
Chemo-Sero-
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant)
Therapeutic Research
Institute) -

Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant) The Kitasato Institute

-
Research Foundation
for Microbial Diseases
Inactivated A/H1N1 Influenza Vaccine (Without Adjuvant)
of Osaka University
(Biken) -
Inactivated H1N1 Influenza Vaccine Hualan Biological -
Zhejiang Tianyuan
Inactivated H1N1 Influenza Vaccine -
Bio-Pharmaceutical

Influenza A (H1N1) 2009 Monovalent Vaccine CSL Limited

Influenza A (H1N1) 2009 Monovalent Vaccine package insert (CSL) [pdf file]

Novartis Vaccines and

Influenza A (H1N1) 2009 Monovalent Vaccine
Diagnostics Limited
Influenza A (H1N1) 2009 Monovalent Vaccine package insert (Novartis) [pdf file]

Influenza A (H1N1) 2009 Monovalent Vaccine 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 Pandemic Monovalent Vaccine

Glaxo Smith Kline
(Without Adjuvant)

Product Information Leaflet - Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant) [web page]
Pandemrix Glaxo Smith Kline EPARs for authorised medicinal products for human use (Pandemrix) [web page]
Panenza Sanofi Pasteur Product characteristics (in French) [pdf]
Panflu Sinovac Biotech -
Panvax H1N1 CSL Panvax H1N1 product information [web page]