The European Medicines Agency’s 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 authorisation of new veterinary vaccines in the European Union.

Vaccine platform technologies play an important role in animal and public health preparedness and the ability to respond to emerging threats. They have a set of core components common to all the vaccines on a 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 day-old chicks or embryonated chicken eggs against specific viral diseases. 

The 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. 

For new vaccine platform technologies that are not yet 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 the vaccines to be linked to the vPTMF. A vPTMF is specific to a single company.

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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 to each individual vaccine.

(Source: EMA)

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