Improving the availability of vaccines for animals within the EU
CVMP agrees proposals to increase clarity for when field efficacy trials are needed in the development of veterinary vaccines
The Committee for Veterinary Medicinal Products (CVMP), at its November meeting, accepted recommendations to clarify the need for conducting field efficacy trials , i.e. trials in animals under real-life conditions in the field, to support the authorisation of veterinary vaccines. Improving clarity on this topic will facilitate the availability of veterinary vaccines in the European Union (EU).
These recommendations were made by the joint European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Steering Group on veterinary vaccine availability on the basis of the outcome of a joint EMA/HMA stakeholder focus group meeting held in June 2017, which brought together regulators, industry and academic experts.
According to EU legislation, the efficacy and safety of veterinary vaccines should be demonstrated in laboratory trials, and then supplemented by data from field trials, unless an acceptable justification can be provided for not providing this data. The role of veterinary field trials is primarily to confirm that the performance of the product observed under controlled experimental conditions is verified under actual conditions of use.
According to veterinary vaccine developers, field trials can be challenging to carry out because of practical matters and due to issues related to trial design whilst adding only limited value to an authorisation dossier. A common issue encountered is connected to trials where animals are not exposed to the disease under real-life conditions, leading to inconclusive outcomes, while conducting these trials can be very costly.
One of the main recommendations from the stakeholder meeting was that the CVMP should provide more clarity in terms of those cases in which field efficacy trials are, and are not, required, so that there is a greater level of regulatory predictability for veterinary vaccine manufacturers for the development of new vaccines.
EMA and HMA have previously drawn up a joint action plan to facilitate timely access to the EU market for new or improved veterinary vaccines, in the interest of animal and public health and animal welfare. One of the commitments of this plan was to reflect in depth with stakeholders on the role that field efficacy trials play in support of authorisation of veterinary vaccines. This commitment was addressed through the recent stakeholder focus group meeting.