EMA Bolsters Clinical Trial Transparency and Launches Vaccine Information Drive

The European Medicines Agency (EMA) is taking what consumer advocacy groups call unexpectedly “rapid action” to ensure clinical trial results are made public as required by law, and has launched a new initiative to support evidence-based decision-making on vaccines. A recent analysis found that results for less than half of the studies registered in a key European database were reported within the required time frame, with complete results fully reported for only 42%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.

The analysis was the first to examine the Clinical Trial Information System (CTIS), created in 2022 to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials, and in the coming months and years, sponsors will be legally required to make results public.

In parallel, the EMA has launched a communications initiative called Vaccine Essentials, providing healthcare professionals with accessible summaries of vaccine-preventable diseases and explaining how the quality, safety and efficacy of vaccines are evaluated. The initiative shows how regulators require strong evidence to approve vaccines and highlights how real-world evidence is collected from millions of doses after vaccines become available. The Agency has also assembled a new advisory group on vaccine confidence, bringing together international experts to advise on building and maintaining trust in the regulatory system.

The first Vaccine Essentials factsheet focuses on Meningococcal group B (MenB) vaccines. Developed with the European Academy of Paediatrics and based on a peer-reviewed publication, it is designed to support clinicians in discussing the burden of meningitis and its prevention. MenB vaccines can prevent invasive meningococcal disease (IMD), a serious disease that mostly affects young children, adolescents and young adults; in 2024, there were 2,263 reported cases of IMD, including 202 deaths, in the EU/European Economic Area. The three-page digest is the first in a planned series, with future editions possibly covering measles, RSV, HPV and other vaccine-preventable infections.

Meanwhile, a broad range of European healthcare professionals and student organisations, united in the Coalition for Vaccination, have issued a joint statement warning that vaccination coverage in many European countries remains suboptimal due to vaccine hesitancy, shortages, misinformation and structural barriers, particularly following the COVID-19 pandemic. The Coalition said that recent changes to vaccination recommendations by the US Centers for Disease Control and Prevention (CDC) have led to confusion, distrust and an increase in vaccine misinformation, and that European countries and the EU must not make the same mistake. The Coalition welcomed the European Commission's new EU Cardiovascular Health Plan, which confirms vaccination against influenza, SARS-CoV-2, RSV, pneumococcal disease and herpes zoster as safe and effective, and highlighted the goal of Europe's Beating Cancer Plan to eliminate cervical cancer through HPV vaccination. It called on the European Commission, working with the European Centre for Disease Prevention (ECDC) and the EMA, to improve public understanding and transparency in vaccine approval processes, counter misinformation, and strengthen independent vaccine safety surveillance.

The World Health Organisation (WHO) Executive Board reaffirmed its commitment to the Immunization Agenda 2030, with Member States urging stronger risk communication and community engagement backed by evidence-based messaging. The Coalition for Vaccination was convened by the European Commission in 2019 and is co-chaired by the European Federation of Nurses Associations (EFN), the Standing Committee of European Doctors (CPME) and the Pharmaceutical Group of the European Union (PGEU).

Separately, an analysis of access to medicines in England shows that regulatory approval is only one step on the journey to patient access on the NHS. Before medicines or vaccines can be used in the UK, they must be licensed by the Medicines and Healthcare Regulatory Agency (MHRA), and then assessed for clinical and cost-effectiveness: in England, this is carried out by the National Institute for Health and Care Excellence (NICE) for medicines and the Joint Committee on Vaccination and Immunisation (JCVI) for vaccines, while Scotland uses the Scottish Medicines Consortium (SMC). The analysis, which tracked all indications approved by the EMA from January 2022 to December 2025, found that EMA approvals represent only a proportion of global medicine and vaccine approvals; if all indications approved worldwide were considered, including those regulated by the US Food and Drug Administration (FDA), the proportion available to NHS patients in England would be even smaller.