The HPV vaccine Gardasil® provides protection for cervical cancer. The vaccine has been on the Danish market since 2006. As of 1 January 2009, the vaccine is included in the Danish childhood immunisation programme as an offer for all 12-year-old girls.
On 6 February, the Danish daily press brought a story stating that doctors have observed several instances where atopic dermatitis has flared up again after the patients had been vaccinated with Gardasil®.
Atopic dermatitis is a relatively frequent disease in the target group of the HPV vaccine. It is also a disease which frequently flares up. Therefore, it is not surprising to see many co-occurrences of the vaccination and the debut of reappearance of atopic dermatitis.
There is no reason to suspect that atopic dermatitis is a new side effect from Gardasil®. Neither Danish nor international experience suggest that it could be the case.
The Danish adverse drug reaction database contains 28 reports on different allergic reactions, such as eczema, rash and nettle rash, and only one of these reports describes atopic dermatitis, and the case in question concerns a girl born in 1993.
The report in question does not describe whether it is the first time, the patient has atopic dermatitis, or whether it was already known that the patient had this disease, which would mean that it was a flare-up.
The Danish State Serum Institute (Statens Serum Institut), which sells and distributes Gardasil® in Denmark, states that since September 2008 and up until today, they have sold around 220,000 doses of the vaccine. The number of Danes vaccinated with Gardasil® is unknown.
Doctors and patients or relatives are encouraged to report any suspected side effects to the Danish Medicines Agency via the website meldenbivirkning.dk.
The Danish Medicines Agency will frequently inform about side effects reported from the use of Gardasil®. Later this month, the Danish Medicines Agency will publish information about side effects from the last quarter of 2008 on this website.
The summary of product characteristics for Gardasil® is available via the factbox to the right.
For further information, please contact Chief Medical Officer Doris I. Stenver, Consumer Safety Division, on tel.: +45 4488 9247 or on mobile no.: +45 2246 0979.
Danish Medicines Agency, 16 February 2009