Availability of veterinary vaccines

Vaccination is one of the most effective tools for preventing animal diseases and for promoting animal health and welfare, safe food production and public health. Despite their importance, there are often challenges to ensuring that suitable veterinary vaccines are available in a timely manner on the European Union (EU) market. The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are implementing an action plan to help increase the availability of veterinary vaccines in the EU.

Veterinary vaccines play a major role in protecting animal health by preventing and controlling serious epizootic diseases. They also have an impact on human health by ensuring safe food supplies and preventing animal-to-human transmission of infectious diseases.

In addition, veterinary vaccines can be an efficient tool in reducing the need to use antibiotics in animals, thereby contributing to the fight against antimicrobial resistance.

The EU Medicines Agencies Network Strategy identifies increasing the availability of veterinary medicines as a priority area for action by the European medicines regulatory network.

Also on this topic

• Vaccine availability survey

Joint EMA and HMA action plan

In 2016, EMA and the Heads of Medicines Agencies (HMA) drew 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, and set up a joint steering group.

In March 2018, EMA and HMA published a detailed report on progress in implementing the action plan:

• Report on the operation of the Steering Group for the Joint EMA/HMA action plan on availability of veterinary vaccines 2016-2017

The table below presents highlights from the report.

Action	Output	Status
Review a list of factors identified by industry as constraining veterinary vaccine availability	Steering group and CADVVA have conducted a detailed review including an impact assessment of industry recommendations: Joint EMA/HMA Veterinary Vaccine Availability Action Plan - Analysis of industry recommendations	Complete
Considerations relating to the risk-based approach to extraneous agent detection in veterinary vaccines	CVMP Immunologicals Working Party (IWP) has begun reflections on this topic	Ongoing
EMA and CVMP to explore feasibility of introducing Vaccine Antigen Master File (VAMF) concept for veterinary vaccines	CADVVA provided initial reflections on AnimalhealthEurope request, EMA has prepared a preliminary business case on the concept, which is currently under discussion at CVMP	Ongoing
Develop a reflection paper on measures to improve availability of veterinary vaccines against emergency animal health diseases	CVMP IWP has begun reflections on this topic	Ongoing
Improve regulatory predictability as to when field efficacy trials will and will not be required for marketing authorisation of a veterinary vaccine	Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability to CVMP based on the outcome of the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU ..., accepted by CVMP in November 2017. These reflect the Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines of a joint focus group meeting in June 2017 with regulators, industry and academic experts.	Ongoing
Provide support to development of new vaccines and associated technology through existing mechanisms such as scientific advice and Innovation Task Force (ITF)	Scientific advice and ITF platforms continue to provide support for the development of new veterinary vaccines in Europe	Ongoing
Identify training opportunities in the area of veterinary vaccines, in cooperation with EU Network Training Centre (EU NTC)	EMA/CVMP delivered training for immunologicals assessors in October 2016 focussing on assessing efficacy of immunological veterinary medicinal products, and in October 2017 focussing on quality assessment Steering group and CADVVA are considering training on approaches to harmonise assessment across the regulatory network, e.g. via harmonised interpretation of scientific guidelines, and exploring the feasibility of involving industry in training on issues relating to veterinary vaccine availability	Ongoing
Develop guidance on standards for manufacture of autogenous vaccines	CMDv published a recommendation for the manufacture, control and use of inactivated autogenous veterinary vaccines within the EEA in March 2017	Complete
Review minor use / minor species (MUMS) and limited markets guideline	EMA published revised guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS) and limited markets on 20 April 2017. The guidance provided is in effect since 1 November 2017	Complete
CVMP and IWP to reflect on existing measures to promote availability of vaccines for epizootic diseases (foot-and-mouth disease, bluetonge and avian influenza) and if new or updated guidance is required, e.g. multi-strain dossier guidance	EMA published draft revised guideline on the data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot-and-mouth disease (FMD) for consultation until 31 March 2018	Ongoing
CVMP and IWP to reflect on ways to take into account different types of vaccine (e.g. live vs inactivated vaccines, food-producing vs companion animals) and different authorisation circumstances (e.g. normal or exceptional situations) as part of guidance on the benefit-risk assessment of veterinary medicinal products	CADVVA has begun reflections on this topic	Ongoing
Advise EC on potential changes to legal framework for veterinary medicines to help improve vaccine availability	Steering group and CADVVA will provide advice on request, based on experience from implementing the action plan	To be started

Background

The action plan aims to implement the conclusions of a Joint European Medicines Agency / Heads of Medicines Agencies workshop on requirements for the authorisation of veterinary vaccines in the European Union as Link of March 2015:

• Report on the joint European Medicines Agency / Heads of Medicines Agencies workshop on requirements for the authorisation of vaccines within the European Union

The workshop looked at how to improve availability while maintaining a high level of protection for animal and public health and the environment. As an important element, it examined whether the authorisation requirements for veterinary vaccines in the EU are proportionate to the benefits and risks of these products.

Pharmaceutical industry representatives provided an industry perspective on factors constraining the availability of veterinary vaccines in the EU, which is an important contribution to the reflections of the regulatory network.

The action plan aims to bring together several ongoing regulatory activities concerning availability into a single, overall plan to facilitate:

• best use of resources in the European medicines regulatory network;
• efficient cooperation between all actors involved, including marketing authorisation holders, regulatory authorities and the European Commission (EC).

EMA and HMA are maintaining the action plan as a living document as the work of the joint steering group progresses.

Key actors

In February 2016, HMA and EMA established a joint steering group to strategically oversee the plan's implementation. Members include senior regulators from the network, with the EC and European Directorate for the Quality of Medicines and HealthCare (EDQM) participating as observers. Industry observers will be invited to participate in relevant topics.

In March 2016, EMA's Committee for Veterinary Medicinal Products (CVMP) established an ad-hoc expert group on veterinary vaccine availability (CADVVA) to support the steering group in implementing the actions under CVMP responsibility. The expert group includes a small number of CVMP members with immunological expertise and experience in vaccine authorisation. It began its work in May 2016.

Along with the above groups, the HMA, CVMP and its Immunologicals Working Party (IWP), the veterinary Coordination Group for Mutual Recognition and Decentralised procedures (CMDv) and the pharmaceutical industry are actively involved in implementing the action plan, for instance through joint workshops and focus groups to address certain high-priority issues.

The joint EMA and HMA steering group welcomes input from stakeholders on how best to improve veterinary vaccine availability in the EU. Stakeholders are invited to submit suggestions by email to: [e-mail].

Other initiatives on veterinary vaccines

EMA has developed a number of tools and measures over time to promote timely access of veterinary vaccines to the EU market, which have helped to facilitate availability. These include:

• MUMS and limited markets policy, for immunologicals;
• scientific advice;
• Innovation in medicines as Link and Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) as Link (ADVENT);
• accelerated assessment;
• authorisation under Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue;
• contribution to the Disease Control Tools project (DISCONTOOLS) survey;
• reduced fees for vaccines against epizootic diseases under certain circumstances;
• multi-strain dossier approach.

Most of these tools were successfully used during the avian influenza epidemic in 2006 and bluetongue crisis in 2008, when the Agency called on existing resources to enable timely authorisation of four avian influenza and eight bluetongue vaccines under emergency circumstances.