Swissmedic grants authorisations for pandemic flu vaccines

30.10.2009 -  Swissmedic, the Swiss Agency for Therapeutic Products, granted authorisations for two vaccines against A(H1N1) swine flu on 23 & 27 October: Pandemrix A(H1N1) from GlaxoSmithKline and Focetria from Novartis.
The Swissmedic authorisations mean that Switzerland now has vaccines against the A(H1N1) flu.


Swissmedic has data that show that a single shot with the A(H1N1) flu antigen, mixed with the AS03 adjuvant, leads to sufficient antibody formation.
However, in the case of Pandemrix we mainly have data for adults, but still do not have any data for pregnant women and very little data for children. For this reason, Swissmedic has not yet authorised the administration of Pandemrix to pregnant women, children under the age of 18 and adults over 60. However, adults over 60 can be inoculated with Pandemrix under recommendations from the Swiss Federal Office of Public Health (FOPH).


Novartis submitted two authorisation applications for A(H1N1) vaccines in Switzerland. Both vaccines contain the MF59 adjuvant that has already been used in seasonal flu vaccines for some time.
Similarly to Pandemrix, the Novartis vaccine now authorised by Swissmedic (Focetria) is produced using hens' eggs.
As this vaccine was already authorised by the European Medicines Agency (EMEA) before the application was submitted in Switzerland, Swissmedic based its decision largely on the EMEA authorisation. In accordance with this, Focetria is recommended for use in adults and children over six months old. In the case of pregnant women and breastfeeding mothers the attending doctor must weigh up the potential advantages and disadvantages of an inoculation, in accordance with latest vaccine recommendations from the FOPH.

A second Novartis A(H1N1) vaccine (Celtura), with the same MF59 adjuvant, is produced on the basis of cell cultures. Swissmedic is still currently testing this novel combination.

Adverse effects
Patients are requested to consult their doctor or pharmacist in the event of severe or unusual symptoms following the vaccination. Swissmedic has set up a special on-line system so that medical professionals can report any adverse effects, and this will allow Swissmedic to monitor the safety of the A(H1N1) vaccines.

Swissmedic will provide regular information about other pandemic vaccine authorisations as soon as it becomes available. In doing so Swissmedic also takes into account any international developments in this field.