Autogenous vaccines

Vaxxinova is the leading company in production of autogenous vaccines for the aquaculture industry. We adapt and develop vaccines and vaccination regimes for the individual farms. If required we can assist in the application processes, diagnostics and storage of agents in our biobank.

Autogenous vaccines are tailor made vaccines based on bacterial- or virus strain(s) from individual aquaculture farms or from a specific geographical area.

Autogenous vaccines should only be used when commercial vaccines are not available, or do not provide adequate or sufficient protection.

For guidelines and requirements for approving applications for autogenous vaccines contact The Norwegian Medicines Agency (NOMA)

Procedure for prescribing autogenous vaccines in Norway

The prescribing fish health service contacts Vaxxinova with a potential problem and the need for vaccine. Vaxxinova may upon request provide recommendations on product composition and vaccination regime.

The fish health service applies to the Norwegian Medicines Agency (NOMA) for approval for use of autogenous vaccine (special exemption license).

When the special exemption license has been granted by NOMA, the prescribing veterinarian must apply to the Food Safety Authority (FSA) in order to get an authorization to use the product in the actual farm. An application for the use of autogenous vaccines can be submitted to the FSA; post@mattilsynet.no and marked with “use permit – autogenous vaccine”.

You can send the isolate to Vaxxinova in parallel when starting the application process.

After receiving the special exemption license and user license of autogenous vaccine from NOMA and FSA, the fish health services can send the prescription to the pharmacy (e.g. VESO or STIM).

When Vaxxinova has received the isolate and order from the pharmacy, we will start the development and production of the autogenous vaccine.

Normal lead time, from receipt of order and causative agent in pure form  to the autogenous vaccine being ready for delivery to the farm, is 8-12 weeks.

Contact

Eivind Isdal