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# Lessons Learned from Covid Vaccine Development
- URL: https://www.fdaweb.com/lessons-learned-from-covid-vaccine-development/
- Published: 2023-02-22T12:00:00.000Z
- Updated: 2026-09-14T18:16:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153826

CBER director **Peter Marks** says principles implemented during the Covid-19 pandemic may have implications for the future development of vaccines and possibly other medical products, “ushering in the start of a new era in regulation.” Writing in *Expert Review of Vaccines*, Marks [says](https://www.tandfonline.com/doi/full/10.1080/14760584.2023.2182294?ref=fdaweb.com) that in setting out to rapidly develop needed new vaccines, it quickly became apparent that it would be important to follow certain principles:

- that potential vaccine developers understand the safety and efficacy profiles to be targeted with the new vaccines;
- clarifying the pathway forward toward providing access to a broad population;
- making an amalgam of previous time-saving efforts to ensure timely vaccine investigation and commercial scale production; and
- resolving in real-time any issues potentially adversely affecting vaccine development efficiency.

“Obviously, all of the above approaches must remain solidly based in the available scientific evidence if we are to combat vaccine hesitancy and maintain the type of trust in vaccines that is essential for successful vaccination campaigns,” Marks concludes. “Vaccines have been among the most effective interventions ever introduced in support of public health, and it is our obligation to ensure that their regulation evolves to address the challenges of our time, while ensuring the soundness of their quality, safety, and effectiveness.”