The European Medicines Agency (EMA) has released a revised guideline on the clinical evaluation of vaccines for a six-month public consultation.

Vaccination is one of the greatest breakthroughs in modern medicine. According to the World Health Organization (WHO), immunisation saves an estimated two to three million lives every year and protects against many dangerous diseases, including, for example, cervical cancer, diphtheria, hepatitis B, measles, mumps, pertussis (whooping cough), and tetanus. Additionally, vaccines can help limit the spread of antibiotic resistance as vaccination is a very effective way to stop people and animals getting infected, thereby preventing the need for antibiotics.

Vaccines undergo a rigorous scientific review to ensure that they are safe and effective. The updated guideline introduces additional safeguards for European Union citizens and ensures that the evaluation is in line with the most up-to-date scientific knowledge and technological developments.

EMA’s draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly.

The revised version of the guideline also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later. The need to develop vaccine for pathogens that may cause future epidemics and for which conducting clinical trials outside of outbreaks might be problematic, is also addressed.

Once the revised guideline is adopted by the Committee for Medicinal Products for Human Use (CHMP), the current guideline on the clinical evaluation of new vaccines and the Annex on summaries of product characteristics (SmPCs) for vaccines will no longer apply.

EMA invites stakeholders to send their comments by 30 October 2018 to vwp@ema.europa.eu using the template provided in the guideline.