Mind The Gap: Delays Between Vaccine Licensure And NITAG Recommendation In The US Versus Europe
Author(s)
Samantha James, MBBS, MIPH1, Ruth Chapman, BA, MSc, PhD2, Kassandra Schaible, MPH3, Anna D'Ausilio, MSc4.
1Associate Director, Thermo Fisher Scientific, Paris, France, 2Senior Director, Thermo Fisher Scientific, London, United Kingdom, 3Associate Director, Thermo Fisher Scientific, Boston, MA, USA, 4Director, Thermo Fisher Scientific, Milan, Italy.
1Associate Director, Thermo Fisher Scientific, Paris, France, 2Senior Director, Thermo Fisher Scientific, London, United Kingdom, 3Associate Director, Thermo Fisher Scientific, Boston, MA, USA, 4Director, Thermo Fisher Scientific, Milan, Italy.
OBJECTIVES: To compare delay between vaccine licensure and National Immunization Technical Advisory Group (NITAG) evaluation in the US versus Europe.
METHODS: A literature review was conducted to determine the time from vaccine licensure in the US to review by the Advisory Committee on Immunization Practices (ACIP) and publication of the decision by the Centers for Disease Control and Prevention (CDC). The vaccines included in the review were a pneumococcal vaccine (Prevnar13), a human papillomavirus (HPV) vaccine (Gardasil-9), and a quadrivalent influenza vaccine (Fluarix Quadrivalent). These were selected to facilitate comparison with previously published analyses of the delay between licensure and NITAG recommendation in Europe.
RESULTS: In the US, ACIP recommendations were made within 10 months of vaccine licensure, except for one instance with a delay of 2.6 years (expanded use of PCV13 for older adults). In two cases, ACIP issued guidance prior to licensure, recommending expanded use for PCV13 and Gardasil 9 for high-risk populations, a respective four years and ten months ahead of regulatory approval. Recommendations made by ACIP were generally published by the CDC within four months for PCV13 and Gardasil-9, and within 10 months for Fluarix. Overall, the time from licensure to published NITAG decision did not exceed two years for any of the included vaccines. In contrast, a study published by Laigle et al (2021) demonstrated that the time from licensure to NITAG recommendation in Europe exceeded six years in almost 50% of the 28 countries studied (including France, Germany, Italy, and the United Kingdom), with only four countries (Cyprus, Estonia, Lithuania, and Malta) reporting a delay of less than two years.
CONCLUSIONS: The time between vaccine licensure and NITAG recommendation is substantially shorter in the US than in almost all European countries. Our research demonstrates there is potential to improve vaccine market access in Europe.
METHODS: A literature review was conducted to determine the time from vaccine licensure in the US to review by the Advisory Committee on Immunization Practices (ACIP) and publication of the decision by the Centers for Disease Control and Prevention (CDC). The vaccines included in the review were a pneumococcal vaccine (Prevnar13), a human papillomavirus (HPV) vaccine (Gardasil-9), and a quadrivalent influenza vaccine (Fluarix Quadrivalent). These were selected to facilitate comparison with previously published analyses of the delay between licensure and NITAG recommendation in Europe.
RESULTS: In the US, ACIP recommendations were made within 10 months of vaccine licensure, except for one instance with a delay of 2.6 years (expanded use of PCV13 for older adults). In two cases, ACIP issued guidance prior to licensure, recommending expanded use for PCV13 and Gardasil 9 for high-risk populations, a respective four years and ten months ahead of regulatory approval. Recommendations made by ACIP were generally published by the CDC within four months for PCV13 and Gardasil-9, and within 10 months for Fluarix. Overall, the time from licensure to published NITAG decision did not exceed two years for any of the included vaccines. In contrast, a study published by Laigle et al (2021) demonstrated that the time from licensure to NITAG recommendation in Europe exceeded six years in almost 50% of the 28 countries studied (including France, Germany, Italy, and the United Kingdom), with only four countries (Cyprus, Estonia, Lithuania, and Malta) reporting a delay of less than two years.
CONCLUSIONS: The time between vaccine licensure and NITAG recommendation is substantially shorter in the US than in almost all European countries. Our research demonstrates there is potential to improve vaccine market access in Europe.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA95
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
STA: Vaccines