Have Delays in Vaccine Market Access Improved in Europe and the US Over the Last Decade?
Author(s)
Samantha James, MBBS, MIPH1, Anna D'Ausilio, MSc2, Jennifer Boss, MSc3, Ruth Chapman, BA, MSc, PhD3, Kassandra Schaible, MPH4, Aleksandra Zapała-Szufel, .5.
1Thermo Fisher Scientific (PPD Evidera), Paris, France, 2Thermo Fisher Scientific (PPD Evidera), Milan, Italy, 3Thermo Fisher Scientific (PPD Evidera), London, United Kingdom, 4Thermo Fisher Scientific (PPD Evidera), Pittsburgh, PA, USA, 5Thermo Fisher Scientific (PPD Evidera), Warsaw, Poland.
1Thermo Fisher Scientific (PPD Evidera), Paris, France, 2Thermo Fisher Scientific (PPD Evidera), Milan, Italy, 3Thermo Fisher Scientific (PPD Evidera), London, United Kingdom, 4Thermo Fisher Scientific (PPD Evidera), Pittsburgh, PA, USA, 5Thermo Fisher Scientific (PPD Evidera), Warsaw, Poland.
OBJECTIVES: To determine if delays between vaccine licensure and National Immunization Technical Advisory Group (NITAG) evaluation have improved over the last decade.
METHODS: A literature review was conducted to determine the time from licensure to NITAG/HTA recommendation for vaccines approved by the European Medicines Agency (EMA), United States Food and Drug Administration (US FDA) and United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of respiratory syncytial virus (RSV) disease. Six countries (France, Ireland Italy, Poland, UK and US) were selected based on their decision-making, funding and tendering archetype. Delays for RSV vaccines were compared with published delays for pneumococcal, human papillomavirus and quadrivalent influenza vaccines.
RESULTS: Three RSV vaccines were approved for use in older adults (Abrysvo [Pfizer Inc.], Arexvy [GlaxoSmithKline Biologicals] and mResviac [Moderna Inc.]), younger adults (Abrysvo), high-risk younger adults (Arexvy and mResvia) and pregnant women (Abyrsvo). Vaccines for pregnant women were reviewed by NITAG/HTA in all countries except Poland. Vaccines for older adults were reviewed by NITAG/HTA in all countries except mResvia in Ireland. No RSV vaccines were reviewed by NITAG/HTA for use in younger adults. NITAG/HTA recommendations for RSV vaccines were made within 8 to 19 months of licensure in Europe (8, 10, 10, 11 and 19 months in Italy, France, UK Ireland and Poland, respectively) versus 2 months in the US. In comparison, NITAG recommendations for earlier vaccines were made within ten months of licensure in the US (James 2025), two to six years in Poland and Ireland (Laigle 2021), and more than six years in France, Italy and UK (Laigle 2021).
CONCLUSIONS: The time between vaccine licensure and NITAG recommendation has dramatically improved in Europe and the US over the last decade. Nevertheless, a substantial discrepancy remains, with delays being four to nine times longer in Europe than in the US.
METHODS: A literature review was conducted to determine the time from licensure to NITAG/HTA recommendation for vaccines approved by the European Medicines Agency (EMA), United States Food and Drug Administration (US FDA) and United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of respiratory syncytial virus (RSV) disease. Six countries (France, Ireland Italy, Poland, UK and US) were selected based on their decision-making, funding and tendering archetype. Delays for RSV vaccines were compared with published delays for pneumococcal, human papillomavirus and quadrivalent influenza vaccines.
RESULTS: Three RSV vaccines were approved for use in older adults (Abrysvo [Pfizer Inc.], Arexvy [GlaxoSmithKline Biologicals] and mResviac [Moderna Inc.]), younger adults (Abrysvo), high-risk younger adults (Arexvy and mResvia) and pregnant women (Abyrsvo). Vaccines for pregnant women were reviewed by NITAG/HTA in all countries except Poland. Vaccines for older adults were reviewed by NITAG/HTA in all countries except mResvia in Ireland. No RSV vaccines were reviewed by NITAG/HTA for use in younger adults. NITAG/HTA recommendations for RSV vaccines were made within 8 to 19 months of licensure in Europe (8, 10, 10, 11 and 19 months in Italy, France, UK Ireland and Poland, respectively) versus 2 months in the US. In comparison, NITAG recommendations for earlier vaccines were made within ten months of licensure in the US (James 2025), two to six years in Poland and Ireland (Laigle 2021), and more than six years in France, Italy and UK (Laigle 2021).
CONCLUSIONS: The time between vaccine licensure and NITAG recommendation has dramatically improved in Europe and the US over the last decade. Nevertheless, a substantial discrepancy remains, with delays being four to nine times longer in Europe than in the US.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA170
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Vaccines