Side effects from Pandemrix® from 4 to 10 November 2009

The Danish Medicines Agency has received the first side effect reports related to the Pandemrix® vaccine against influenza. The reports concern 13 persons that have experienced side effects from vaccination. The person vaccinated will often experience more than one side effect, and the 13 reports therefore describe a total of 34 side effects.

The side effect reports were received by the Danish Medicines Agency in the period 4 to 10 November 2009. From today, we will update the list of reported side effects on a weekly basis.

Consumption
The Danish State Serum Institute has dispensed a total of 360,000 vaccine doses, but we do not know the exact number of persons vaccinated.

Who have reported the side effects?
10 of the reports were submitted by doctors, 3 by persons that had been vaccinated.

Age distribution
One report concerns a two-year-old child, the other reports concern adults aged between 25 and 62 years. In three of the reports, the age had not been disclosed.

Gender distribution
The reports are distributed on eight women and five men.

Categorisation of side effects (adverse reactions)
The adverse reactions fall into four categories:

1. reactions at the injection site
2. allergic reactions
3. other known adverse reactions
4. unknown adverse reactions.

Notes on specific reports
None.

Overall evaluation
The first adverse reaction reports after vaccination with Pandemrix® in Denmark primarily describe known and expected adverse reactions that appear from the summary of product characteristics. See the factbox to the right.

General information about adverse reaction data
An adverse reaction report contained in the pharmacovigilance database does not necessarily imply that the adverse reaction is associated with the medicine (causality).

• The Danish Medicines Agency registers information about an adverse reaction in the database even if it is only suspected that there might be an association between the medicine and the adverse reaction. Therefore, the information in the database may include real adverse reactions from a medicine as well as random incidences due to e.g. a disease in the patient or another medicine which the patient is receiving at the same time.
• The Danish Medicines Agency is only notified of a small proportion of all adverse reactions. Therefore, the information in the pharmacovigilance database cannot indicate the frequency of the adverse reactions.
• A single adverse reaction report may contain more than one adverse reaction. Therefore, the number of registered adverse reactions is usually higher than the number of adverse reaction reports.
• An adverse reaction is considered to be serious if it results in the patient’s death, is life-threatening, requires hospitalisation, results in significant disability, or if the patient is unable to work or go to school.
• The Danish Medicines Agency sends information about all serious adverse reactions to the marketing authorisation holder, to the European pharmacovigilance database and to the WHO.
• All reports must form part of the periodic safety update reports which the marketing authorisation holder must regularly send to the Danish Medicines Agency. A periodic safety update report describes all reported adverse reactions from all countries in which the medicine is marketed. The periodic safety update reports thus provide a good overview, and they form an important basis for continuous updates of the summary of product characteristics and the package leaflet.
• An unknown adverse reaction is an adverse reaction that is not listed in the summary of product characteristics. If it appears that it is a new, as yet unacknowledged adverse reaction, the adverse reaction will be added to the summary of product characteristics.

For further information, please contact Chief Medical Officer Doris I. Stenver, Consumer Safety Division, tel.: +45 4488 9247 or mobile +45 2246 0979.

Danish Medicines Agency, 11 November 2009