European Medicines Agency announces first certification of a veterinary vaccine platform technology master file

The European Medicines Agency‘s (EMA) Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a vaccine platform technology master file (vPTMF) which will support and accelerate the development and authorization of new veterinary vaccines in the EU.

Vaccine platform technologies play an important role in animal and public health preparedness and the ability to respond to emerging animal and public health threats. They have a set of core components common to all vaccines based on the same platform, and can be adapted rapidly for use against emerging diseases.

The Innovax vPTMF certified by the CVMP is based on a turkey herpesvirus vector backbone. It is a retrospective certification as the platform is already used in several authorised vaccines indicated for active immunisation of one-day-old chicks or embryonated chicken eggs against relevant viral diseases. To submit marketing authorisation applications for new vaccines based on the same platform technology, the Innovax vPTMF certificate holder will have to generate and submit data not included in the vPTMF; generally, pertaining to the variant part of the platform that is specific for each individual vaccine.

The vPTMF certification system facilitates and expedites the approval of vaccines using the same platform technology. It allows developers to rapidly advance vaccine candidates in response to emerging health threats, as they can rely on the data already certified.

There are two ways to certify a vPTMF. For new vaccine platform technologies which have not yet been authorised in the EU, the vPTMF is reviewed along with the full application for the new vaccine. For platform technologies that are already in use in centrally authorised vaccines, the vPTMF is reviewed in a separate procedure. The company can choose which of its vaccines to link to the vPTMF. A vPTMF is specific to a single company.

Procedural advice on vPTMF certification and a guideline on data requirements for vPTMF are available on EMA’s website. Companies interested in using the vPTMF certification system are encouraged to contact EMA to discuss their developments.

Read the original release from the EMA here.