The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) recommends that a marketing authorisation be granted for a third vaccine for pandemic influenza A (H1N1). The European Commission expects to endorse the recommendation shortly.
The vaccine concerned is Celvapan®, which is manufactured by Baxter. Celvapan® will not become part of the Danish vaccination scheme for pandemic influenza A (H1N1).
Celvapan® differs from the two previously authorised vaccines (Pandemrix® and Focetria®), as Celvapan® is a non-adjuvanted vaccine. Adjuvant is an excipient added to the vaccine to enhance the immunological response to the vaccine and through this provide more protective antibody in the vaccinated person. Unlike the two other vaccines, Celvapan® does not contain the preservative thiomersal, and the vaccine must therefore be used immediately after opening.
Like the other pandemic vaccines, Celvapan® is authorised for vaccination against pandemic influenza A (H1N1). For this vaccine, it is recommended that the vaccine is injected twice at an interval of three weeks. The vaccine is approved for adults (including pregnant women) and for children from six months of age.
Baxter – like the manufacturers of the two other pandemic vaccines – has been directed to actively investigate and monitor the efficacy and safety of the vaccine as soon as it is being used, as well as to carry out a safety study among 9,000 persons to further elucidate the safety of the vaccine.
You can find further information on the other two authorised vaccines in the factbox to the right.
For further information, please contact Chief Medical Officer Steffen Thirstrup, tel.: +45 4488 9187 or +45 2246 7811.
Danish Medicines Agency, 2 October 2009
