Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec 13;10(12):2136.
doi: 10.3390/vaccines10122136.

Vaccine Preparedness for the Next Influenza Pandemic: A Regulatory Perspective

Norman W Baylor  1 , Jesse L Goodman  2
Affiliations

Vaccine Preparedness for the Next Influenza Pandemic: A Regulatory Perspective

Norman W Baylor et al. Vaccines (Basel). .

Abstract

The response to SARS-CoV-2 demonstrated the tremendous potential of investments in vaccine research and development to impact a global pandemic, resulting in the rapid development and deployment of lifesaving vaccines. However, this unprecedented speed was insufficient to either effectively combat initial waves of the pandemic or adapt in real time to new variants. This review focuses on opportunities from a public health oriented regulatory perspective for enhancing research, development, evaluation, production, and monitoring of safety and effectiveness to facilitate more rapid availability of pandemic influenza vaccines. We briefly review regulatory pathways and processes relevant to pandemic influenza, including how they can be strengthened and globally coordinated. We then focus on what we believe are critical opportunities to provide better approaches, tools, and methods to accelerate and improve vaccine development and evaluation and thus greatly enhance pandemic preparedness. In particular, for the improved vaccines needed to respond to a future influenza pandemic better and more rapidly, moving as much of the development and evaluation process as possible into the pre-pandemic period is critical, including through approval and use of analogous seasonal influenza vaccines with defined immune correlates of protection.

Keywords: SARS-CoV-2; pandemic influenza; regulatory; vaccines.

PubMed Disclaimer

Conflict of interest statement

J.L.G. (former Chief Scientist, US FDA) reports serving on the board of GSK, a manufacturer of drugs and vaccines, chairing its Science Committee, for which he receives compensation and equity, as a volunteer member of the board of the US Pharmacopeia, a non-profit organization supporting quality and standards for medical products and food and as a volunteer member of a scientific advisory committee for IAVI. He also reports that his spouse is employed by the non-profit organization CEPI. N.W.B. (former Director, Office of Vaccines Research and Review, US FDA) reports serving on the scientific advisory board of Valneva, a specialty vaccine manufacturer, for which he receives compensation; serves as a board trustee of the Sabin Vaccine Institute; and provides regulatory advice to the regulated pharmaceutical industry in his role as non-executive chair of the board at Biologics Consulting, Inc.

References

    1. Saville M., Cramer J.P., Downham M., Hacker A., Lurie N., Van der Veken L., Whelan M., Hatchett R. Delivering Pandemic Vaccines in 100 Days—What Will It Take? N. Engl. J. Med. 2022;387:e3. doi: 10.1056/NEJMp2202669. - DOI - PubMed
    1. Analysis of Pandemic Preparedness and Response Architecture, Financing Needs, Gaps and Mechanisms. Prepared for the G20 Joint Finance and Health Task Force. Mar 27, 2022. [(accessed on 12 January 2022)]. Available online: https://thedocs.worldbank.org/en/doc/5760109c4db174ff90a8dfa7d025644a-02....
    1. FDA Office of the Chief Scientist Advancing Regulatory Science for Public Health. [(accessed on 18 March 2022)];2010 October; Available online: https://www.fda.gov/media/79184/download.
    1. Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. [(accessed on 26 March 2022)]; Available online: https://www.fda.gov/media/73691/download.
    1. Weibel D., Sturkenboom M., Black S., de Ridder M., Dodd C., Bonhoeffer J., Vanrolleghem A., van der Maas N., Lammers G.J., Overeem S., et al. Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines—Multi-country assessment. Vaccine. 2018;36:6202–6211. doi: 10.1016/j.vaccine.2018.08.008. - DOI - PMC - PubMed

LinkOut - more resources