Swissmedic authorises Celtura

13.11.2009 - Swissmedic, the Swiss Agency for Therapeutic Products, authorised a further vaccine against Swine Flu A(H1N1). The product is Celtura, by the firm Novartis.
This authorisation by Swissmedic brings the number of vaccines against the A(H1N1) influenza to three.

Unlike the vaccines already authorised in October - Focetria and Pandemrix - the antigen components of Celtura are not based on hen's eggs but on a cell culture. This manufacturing process is new, and has been reviewed by Swissmedic.

On the basis of the clinical data available, Celtura has been authorised for children above the age of three and for adults of all age groups. The said data has also shown that for adults aged over 40, sufficient immunisation is only attained after a second vaccination with the product. A second vaccination for such persons must therefore be administered three weeks after the first.

Swissmedic has not received any further applications for the authorisation of vaccines against the A(H1N1) pandemic at present. The Swiss Agency for Therapeutic Products will provide information on modifications to the existing authorisation for vaccines against the pandemic as soon as new data is available. In doing so, it will take international developments in this area into consideration.

Undesirable effects

Patients are urged to contact their doctor or pharmacists in the case of severe or unusual symptoms following vaccination. Swissmedic is providing health care professionals with a special online system to report suspected undesirable effects in order to constantly monitor the safety of the A(H1N1) vaccine.

For further information, such as details of current recommendations regarding vaccination issued by the Federal Commission for issues related to vaccines, please consult the website by the Federal Office of Public Health (FoPH).