References
- Hervé C, Laupèze B, Del GG, et al. The how’s and what’s of vaccine reactogenicity. NPJ Vaccines. 2019 Sep 24;4(1):39. doi: 10.1038/s41541-019-0132-6
- Crowe B, Brueckner A, Beasley C, et al. Current practices, challenges, and statistical issues with product safety labeling. Stat Biopharm Res. 2013;5(3):180–193. doi: 10.1080/19466315.2013.791640
- CBER. Emergency use authorization for vaccines to prevent COVID-19; Guidance for Industry. 2022 [cited 2022 Dec]. Available from: https://www.fda.gov/media/142749/download.
- Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021 Feb 4;384(5):403–416. doi: 10.1056/NEJMoa2035389
- Haas JW, Bender FL, Ballou S, et al. Frequency of adverse events in the placebo arms of COVID-19 vaccine trials: a systematic review and meta-analysis. JAMA Netw Open. 2022 Jan 4;5(1):e2143955. doi: 10.1001/jamanetworkopen.2021.43955
- Wernicke JF, Faries D, Milton D, et al. Detecting treatment emergent adverse events in clinical trials : a comparison of spontaneously reported and solicited collection methods. Drug Saf. 2005;28(11):1057–1063. doi: 10.2165/00002018-200528110-00006
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020 Dec 31;383(27):2603–2615. doi: 10.1056/NEJMoa2034577
- FDA. Vaccines and related biological products advisory committee meeting December 10, 2020. [cited 2022 Dec]. Available from: https://www.fda.gov/media/144245/download.
- Lal H, Cunningham AL, Godeaux O, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087–2096. doi: 10.1056/NEJMoa1501184
- Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99–111. doi: 10.1016/S0140-6736(20)32661-1
- Sadoff J, Gray G, Vandebosch A, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187–2201. doi: 10.1056/NEJMoa2101544
- EMA. COVID-19 vaccine (Ad26.COV2-S [recombinant]); Summary of product characteristics. 2021 [cited 2022 Dec]. Available from: https://www.ema.europa.eu/en/documents/product-information/jcovden-previously-covid-19-vaccine-janssen-epar-product-information_en.pdf.
- EMA. COVID-19 vaccine (ChAdOx1-S [recombinant]); Summary of product characteristics. 2021 [cited 2022 Dec]. Available from: https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-astrazeneca-product-information-approved-chmp-29-january-2021-pending-endorsement_en.pdf.
- CBER. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. 2007. [cited 2022 Dec]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical.
- UMC. The use of the WHO-UMC system for standardised case causality assessment. 2018. [cited 2022 Jun]. Available from: https://who-umc.org/media/164200/who-umc-causality-assessment_new-logo.pdf.
- Gidudu JF, Walco GA, Taddio A, et al. Immunization site pain: case definition and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2012 Jun 22;30(30):4558–4577. doi: 10.1016/j.vaccine.2012.03.085
- Marcy SM, Kohl KS, Dagan R, et al. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine. 2004 Jan 26;22(5–6):551–556. doi: 10.1016/j.vaccine.2003.09.007
- FDA. Computerized systems used in clinical investigations. 2007. [cited 2022 Dec]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations.
- ALCOA+. ALCOA+ principles. 2021. [cited 2022 Dec]. Available from: https://pharmaguidesop.com/2020/08/what-is-alcoa-plus-alcoa-details-alcoa-principle.html.
- DMID. Pediatric toxicity tables 2007. [cited 2017 Oct]. Available from: http://www.niaid.nih.gov/LabsAndResources/resources/DMIDClinRsrch/Documents/dmidpedtox.pdf.
- DAIDS. DAIDS table for grading the severity of adult and pediatric adverse events, corrected version 2.1. 2017. [cited 2022 Dec]. Available from: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.
- CBER. Vaccines and related biological products advisory committee meeting. 2021 October 26. [cited 2022 Dec]. Available from: https://www.fda.gov/media/153447/download.
- WHO. Guidelines on clinical evaluation of vaccines: regulatory expectations. 2017 [cited 2022 Dec]. Available from: https://cdn.who.int/media/docs/default-source/prequal/vaccines/who-trs-1004-web-annex-9.pdf?sfvrsn=9c8f4704_2&download=true.
- NMPA. Announcement of the State Food and Drug Administration on issuing technical guidelines for clinical comparability research of preventive vaccines (2019 No 94). 2019 [cited 2021 Dec]. Available from: https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20191224104601789.html.
- WHO. Global manual on surveillance of adverse events following immunization. 2016 [cited 2022 Dec]. Available from: https://www.who.int/publications/i/item/10665206144.
- FDA CaC. Guidance for Industry and Investigators. Safety reporting requirements for INDs and BA/BE studies (US). 2012 [cited 2022 Dec]. Available from: https://www.fda.gov/files/drugs/published/Safety-Reporting-Requirements-for-INDs-%28Investigational-New-Drug-Applications%29-and-BA-BE-%28Bioavailability-Bioequivalence%29-Studies.pdf.
- Regulations CoF. Part 312—Investigational new drug application. 1987 [cited 2021 Dec]. Available from: https://www.ecfr.gov/cgi-bin/text-idx?SID=841d69f34da8bdb3b0b1f7fa59e8157a&mc=true&node=pt21.5.312&rgn=div5%20-%20se21.5.312_164.
- EMA. ICH Topic E 2 A: Clinical safety data management: definitions and standards for expedited reporting. 1995 [cited 2022 Dec]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-15.pdf.
- EMA. Regulation (EU) no 536/2014 of the European parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 2014 [cited 2022 Dec]. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf.