Accomplishments and challenges in developing improved influenza vaccines: An evaluation of three years of progress toward the milestones of the influenza vaccines research and development roadmap
Issued Date
2025-08-13
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-105009427390
Journal Title
Vaccine
Volume
61
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine Vol.61 (2025)
Suggested Citation
Ostrowsky J.T., Vestin N.C., Mehr A.J., Ulrich A.K., Bigalke L., Bresee J.S., Friede M.H., Gellin B.G., Klugman K.P., Nakakana U.N., Wang T.Y., Weller C.L., Osterholm M.T., Lackritz E.M., Moore K.A., Ampofo W., Belongia E., Cavaleri M., Cohen C., Cowling B., Cox R.J., Gupta S., Gust I., Hensley S.E., Isakova-Sivak I., Johansen K., Knobler S., Krammer F., Lim J.C.W., McCauley J., Pebody R., Pitisuttithum P., Rappuoli R., Rocca T., Schultz-Cherry S., Settembre E.C., Southern J., Subbarao K., Tam J.S., Venkayya R. Accomplishments and challenges in developing improved influenza vaccines: An evaluation of three years of progress toward the milestones of the influenza vaccines research and development roadmap. Vaccine Vol.61 (2025). doi:10.1016/j.vaccine.2025.127431 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/111145
Title
Accomplishments and challenges in developing improved influenza vaccines: An evaluation of three years of progress toward the milestones of the influenza vaccines research and development roadmap
Author(s)
Ostrowsky J.T.
Vestin N.C.
Mehr A.J.
Ulrich A.K.
Bigalke L.
Bresee J.S.
Friede M.H.
Gellin B.G.
Klugman K.P.
Nakakana U.N.
Wang T.Y.
Weller C.L.
Osterholm M.T.
Lackritz E.M.
Moore K.A.
Ampofo W.
Belongia E.
Cavaleri M.
Cohen C.
Cowling B.
Cox R.J.
Gupta S.
Gust I.
Hensley S.E.
Isakova-Sivak I.
Johansen K.
Knobler S.
Krammer F.
Lim J.C.W.
McCauley J.
Pebody R.
Pitisuttithum P.
Rappuoli R.
Rocca T.
Schultz-Cherry S.
Settembre E.C.
Southern J.
Subbarao K.
Tam J.S.
Venkayya R.
Vestin N.C.
Mehr A.J.
Ulrich A.K.
Bigalke L.
Bresee J.S.
Friede M.H.
Gellin B.G.
Klugman K.P.
Nakakana U.N.
Wang T.Y.
Weller C.L.
Osterholm M.T.
Lackritz E.M.
Moore K.A.
Ampofo W.
Belongia E.
Cavaleri M.
Cohen C.
Cowling B.
Cox R.J.
Gupta S.
Gust I.
Hensley S.E.
Isakova-Sivak I.
Johansen K.
Knobler S.
Krammer F.
Lim J.C.W.
McCauley J.
Pebody R.
Pitisuttithum P.
Rappuoli R.
Rocca T.
Schultz-Cherry S.
Settembre E.C.
Southern J.
Subbarao K.
Tam J.S.
Venkayya R.
Author's Affiliation
University of Pennsylvania
University of Melbourne
The University of Hong Kong
Icahn School of Medicine at Mount Sinai
The Hong Kong Polytechnic University
Université Laval
Medizinische Universität Wien
Universitetet i Bergen
Mahidol University
Georgetown University
Organisation Mondiale de la Santé
St. Jude Children's Research Hospital
University of Ghana
Duke-NUS Medical School
Wellcome Trust
The Francis Crick Institute
Instituto Butantan
Marshfield Clinic
Federal State Budgetary Scientific Institution ‘Institute of Experimental Medicine’
Public Health Agency of Sweden
National Institute for Communicable Diseases
UK Health Security Agency
European Medicines Agency
International AIDS Vaccine Initiative
Invensys Process Systems USA
Task Force for Global Health
Independent Consultant
Fondazione Biotecnopolo di Siena
CSL Seqirus
Center for Infectious Disease Research and Policy
Gates Foundation Liaison
Adviser to South African Health Products Regulatory Authority
University of Melbourne
The University of Hong Kong
Icahn School of Medicine at Mount Sinai
The Hong Kong Polytechnic University
Université Laval
Medizinische Universität Wien
Universitetet i Bergen
Mahidol University
Georgetown University
Organisation Mondiale de la Santé
St. Jude Children's Research Hospital
University of Ghana
Duke-NUS Medical School
Wellcome Trust
The Francis Crick Institute
Instituto Butantan
Marshfield Clinic
Federal State Budgetary Scientific Institution ‘Institute of Experimental Medicine’
Public Health Agency of Sweden
National Institute for Communicable Diseases
UK Health Security Agency
European Medicines Agency
International AIDS Vaccine Initiative
Invensys Process Systems USA
Task Force for Global Health
Independent Consultant
Fondazione Biotecnopolo di Siena
CSL Seqirus
Center for Infectious Disease Research and Policy
Gates Foundation Liaison
Adviser to South African Health Products Regulatory Authority
Corresponding Author(s)
Other Contributor(s)
Abstract
Influenza vaccines that provide more effective immunity to seasonal influenza as well as protection against a broad range of emerging influenza viruses with pandemic potential are needed to reduce the public-health burden of influenza and enhance pandemic preparedness. The Influenza Vaccines Research and Development (R&D) Roadmap (IVR) was published in 2021 to serve as a strategic planning tool to advance influenza vaccine R&D. Following IVR publication, a 3-year monitoring, evaluation, and adjustment (ME&A) program was implemented to assess progress in meeting the milestones outlined in the IVR. As of mid-May 2025, 16 (17%) of the 93 milestones had been accomplished or partially accomplished, with the majority (67; 72%) in various stages of progress. Of the 35 milestones designated high-priority, five (14%) had been accomplished or partially accomplished, 29 (83%) are in progress, and no progress was identified for one (3%). Key accomplishments include: establishing longitudinal cohort studies to characterize immune responses to influenza virus infection and vaccination by age over time and by vaccine product; creating a comprehensive landscape of innovative influenza vaccine technologies in preclinical and clinical development; advancing next-generation and broadly protective influenza vaccine candidates into clinical trials; identifying relevant lessons learned from accelerated SARS-CoV-2 vaccine development during the COVID-19 pandemic; and initiating development of a full value of improved influenza vaccine assessment (FVIVA) to inform investment and guide the eventual uptake of improved vaccines globally. Persistent challenges include clarifying immune mechanisms for generating durable and broadly protective immunity, enhancing understanding of immune imprinting and the role of mucosal immunity in preventing infection and transmission, identifying correlates of protection, and exploring regulatory options for broadly protective influenza vaccine licensure. The IVR ME&A program provides a basis for ongoing critical review of progress in influenza vaccine R&D to inform decision-making on research priorities and funding.