How long before a vaccine is included in a EU immunisation schedule?

2013 07 31 Written by Nico

Over the last decade several innovative vaccines have been authorised and introduced in immunisation schedules across Europe. Sustained R&D investments to deliver innovative vaccines capable or targeting unmet medical need should go hand-in-hand with efforts to ensure timely access to these once they become available on the market.

A study conducted by Vaccines Europe concluded that time from registration to population access to new vaccines can take considerable time in European countries. Reasons might be found in the regulatory framework, decision-making processes or the assessment of vaccines by evaluating bodies. In particular, national assessments underlying immunisation policy decisions (recommendation phase) absorb most of the access time.

A retrospective survey was conducted to measure access time to new vaccines against three diseases (pneumococcal conjugate vaccine, rotavirus vaccine and human papillomavirus vaccine) in 17 European countries. In addition, the survey also identified which phase of the decision-making process needed more time. Finally, a cross-sectional survey was performed to retrieve qualitative information on the country-specific decision-making frameworks for the introduction of new “vaccination programs”.

The study highlights that median access time to new vaccines was 6.4 years post marketing authorization and that the time needed before a positive recommendation was granted corresponds to >90% of the entire access period in most countries where study vaccines were available. Furthermore, the study revealed that processes with established timelines and clarity in regard to vaccine evaluation criteria used could ameliorate the effectiveness of the decision-making process.

The findings have been published in  ’Vaccine’, the pre-eminent journal for those interested in vaccines and vaccination. Follow this link to read the abstract.