Commissioner Olivér Várhelyi, on behalf of the European Commission, has defended the EU's approach to authorising avian influenza vaccines, stressing that the exceptional approvals are strictly temporary, transparent, and subject to annual re-evaluation. In a written answer to a parliamentary question from ECR MEP Sergio Berlato, Várhelyi outlined the Commission's position on the risks, benefits, and accompanying measures for vaccination against highly pathogenic avian influenza (HPAI).
The answer responds to Berlato's question of 2 March 2026, which raised concerns about the experimental nature of authorised vaccines, the need for transparency on efficacy data, structural prevention measures, and the impact on exports and competitiveness.
Várhelyi emphasised that authorisations under Regulation (EU) 2019/6 are granted only when the benefit of immediate availability outweighs the risks from missing documentation. These authorisations are valid for one year and require re-examination to confirm that exceptional circumstances persist and the benefit-risk balance remains positive. The European Medicines Agency's assessment reports, including data on quality, efficacy, and risks to humans, animals, and food safety, are publicly available in the EU Product Database, ensuring full transparency.
On structural prevention, the Commission acknowledged that poultry holding density is a major contributing factor to large HPAI epidemics, as per EFSA's 2017 assessment. Member States are encouraged to consider this risk when designing prevention strategies, with vaccination positioned as a complementary tool alongside biosecurity and other measures.
Regarding trade and competitiveness, Várhelyi noted that only France currently implements preventive vaccination in poultry, and only a few trading partners apply trade restrictions limited to certain products from vaccinated poultry. The Commission did not indicate any plans for a formal impact assessment on exports or supply chain competitiveness.
The Commission signals a cautious, evidence-based approach, prioritising public health and animal health while maintaining flexibility for Member States. It does not propose new EU-level mandates or additional studies, instead relying on existing regulatory frameworks and voluntary national measures.
The annual re-examination of vaccine authorisations will continue, and the Commission may update guidance as new EFSA or EMA assessments become available. No immediate legislative or regulatory proposals are foreseen.