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Review
. 2023 Nov 27;16(1):158.
doi: 10.1186/s40545-023-00652-y.

mRNA vaccine development during the COVID-19 pandemic: a retrospective review from the perspective of the Swiss affiliate of a global biopharmaceutical company

Tim Killeen  1   2 , Vanessa Kermer  3 , Rahel Troxler Saxer  4   5
Affiliations
Review

mRNA vaccine development during the COVID-19 pandemic: a retrospective review from the perspective of the Swiss affiliate of a global biopharmaceutical company

Tim Killeen et al. J Pharm Policy Pract. .

Erratum in

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has been the defining public health emergency of our time. In Switzerland, messenger RNA (mRNA) vaccines were and still are widely utilized as a critical component of the Federal Office of Public Health (FOPH)'s preventative mitigation strategy. The development, conditional approval and worldwide roll-out of mRNA vaccines against COVID-19 proceeded at an unprecedented pace and presented myriad challenges for manufacturers. In this review, we discuss, from the perspective of the Swiss affiliate of a global biopharmaceutical company, the clinical, regulatory, pharmacovigilance and logistical considerations of making a mRNA COVID-19 vaccine available to the Swiss population during a pandemic as rapidly as possible while ensuring strict adherence to safety and quality standards.

Trial registration: ClinicalTrials.gov NCT04368728.

Keywords: Clinical development; Coronavirus disease 2019; Messenger ribonucleic acid; Pandemic; Public health; Regulatory; Safety; Supply; Switzerland; Vaccines.

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Conflict of interest statement

All authors are employees and shareholders of Pfizer. The conception of and decision to write the article was the authors’ alone. Quality control was conducted by another Pfizer AG employee.

Figures

Fig. 1
Fig. 1
mRNA COVID-19 vaccines mechanism of action. Simplified graphical representation of the mode of action of mRNA vaccines against COVID-19. AAAAAA; poly-A tail of adenine nucleotides, APC; antigen presenting cells, CD; cluster of differentiation, LNP; lipid nanoparticles, mRNA; messenger ribonucleic acid, modRNA; modified ribonucleic acid, S; spike, SARS-CoV-19; severe acute respiratory syndrome coronovirus 2019, UTR; untranslated region. Image reproduced from Thomas SJ et al., Vaccine 2022;40(10):1483–92 (https://doi.org/10.1016/j.vaccine.2021.12.046) under Creative Commons CC-BY-NC-ND public licence available at https://creativecommons.org/licenses/by-nc-nd/4.0/
Fig. 2
Fig. 2
mRNA COVID-19 vaccines milestones. Timeline showing selected epidemiological, clinical and regulatory events during the first year of the COVID-19 pandemic with an emphasis on Switzerland. WHO; World Health Organization
Fig. 3
Fig. 3
Vaccine administration and adverse vaccination reaction reporting in Switzerland and Liechtenstein. Left: cumulative total administered doses of mRNA vaccines from the start of the Swiss vaccination program to the end of 2021 (mRNA-1273 and BNT162b2 were the only conditionally approved mRNA COVID-19 vaccines during this perioxd). Federal Office of Public Health, www.covid19.admin.ch. Right: cumulative totals of adverse vaccination reactions (blue; non-serious, green; serious) following mRNA vaccine administration reported to Swissmedic during the same period. Data on adverse vaccination reactions were generally released weekly during this period. Source: Federal Office of Public Health https://www.covid19.admin.ch/api/data/20220705-0r3tf4ch/sources/COVID19VaccSymptoms.csv. Accessed 15 Nov 2023
See this image and copyright information in PMC

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