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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
11. REFERENCES
1 World Health Organization. WHO Director-General's opening remarks at the media
briefing on COVID-19. Available from: https://www.who.int/dg/speeches/detail/
who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---
11-march-2020. Published: 11 Mar 2020. Accessed: 01 Apr 2020.
2 World Health Organization. Coronavirus disease 2019 (COVID-19) situation report - 70.
In: Data as reported by national authorities by 10:00 CET 30 March 2020. Geneva,
Switzerland: World Health Organization; 2020.
3 Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19):
information for clinicians on investigational therapeutics for patients with COVID-19.
Available from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-
options.html. Updated: 25 Apr 2020. Accessed: 26 Jun 2020.
4 Rauch S, Jasny E, Schmidt KE, et al. New vaccine technologies to combat outbreak
situations. Front Immunol 2018;9:1963.
5 Sahin U, Karikó K, Türeci Ö. mRNA-based therapeutics—developing a new class of
drugs. Nat Rev Drug Discov 2014;13(10):759-80.
6 BioNTech RNA Pharmaceuticals GmbH. CorVAC/BNT162 Investigator’s Brochure.
Mainz, Germany: BioNTech RNA Pharmaceuticals GmbH; 25 Mar 2020.
7 Feldman RA, Fuhr R, Smolenov I, et al. mRNA vaccines against H10N8 and H7N9
influenza viruses of pandemic potential are immunogenic and well tolerated in healthy
adults in phase 1 randomized clinical trials. Vaccine 2019;37(25):3326-34.
8 US Food and Drug Administration. Guidance for industry: toxicity grading scale for
healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials.
Rockville, MD: Center for Biologics Evaluation and Research; September 2007.
9 Agresti A. Introduction: distributions and inference for categorical data. In: Agresti A,
ed. Categorical data analysis. 2nd ed. Hoboken, NJ: John Wiley & Sons; 2002:1-35.
10 Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med
1985;4(2):213-26.
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