Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study

Prisha Patel; Judith C Macdonald; Jayanthi Boobalan; Matthew Marsden; Ruben Rizzi; Marianne Zenon; Jinma Ren; Haitao Chu; Joseph C Cappelleri; Satrajit Roychoudhury; Julie O'Brien; Konoha Izaki-Lee; Donna Boyce

doi:10.3389/fmed.2023.1275817

Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study

Front Med (Lausanne). 2023 Nov 8:10:1275817. doi: 10.3389/fmed.2023.1275817. eCollection 2023.

Authors

Affiliations

¹ International Regulatory Science and Policy, Pfizer, Tadworth, United Kingdom.
² International Regulatory Science and Policy, Pfizer, Kuala Lumpur, Malaysia.
³ Global Regulatory Sciences, Pfizer, Tadworth, United Kingdom.
⁴ BioNTech SE, Mainz, Germany.
⁵ International Regulatory Science and Policy, Pfizer, Johannesburg, South Africa.
⁶ Statistical Research and Data Science Center, Pfizer, Collegeville, PA, United States.
⁷ Statistical Research and Data Science Center, Pfizer, Groton, CT, United States.
⁸ International Regulatory Science and Policy, Pfizer, Dublin, Ireland.
⁹ School of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, United Kingdom.
¹⁰ Global Regulatory Sciences, Pfizer, Collegeville, PA, United States.

Abstract

The appropriate use of regulatory agilities has the potential to accelerate regulatory review, utilize resources more efficiently and deliver medicines and vaccines more rapidly, all without compromising quality, safety and efficacy. This was clearly demonstrated during the COVID-19 pandemic where regulators and industry rapidly adapted to ensure continued supply of existing critical medicines and review and approve new innovative medicines. In this retrospective study, we analyze the impact of regulatory agilities on the review and approval of Pfizer/BioNTech's BNT162b2 mRNA COVID-19 Vaccine globally using regulatory approval data from 73 country/regional approvals. We report on the critical role of reliance and provide evidence that demonstrates reliance approaches and certain regulatory agilities reduced review times for the COVID-19 vaccine. These findings support the case for more widespread implementation of regulatory agilities and demonstrate the important role of such approaches to improve public health outcomes.

Keywords: agilities; convergence; regulatory; reliance; vaccines.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. The authors declare that this study received funding from Pfizer and BioNTech. The funders had the following involvement with the study: study design, collection, analysis, interpretation of data, preparation of manuscript and decision to publish.