2018; (131): 56413. 40. den Hartog G, Schepp RM, Kuijer M, et al. SARS -CoV-2: specific antibody detection for seroepidemiology: a multiplex analysis approach accounting for accurate seroprevalence. J Infect Dis 2020;222:1452 –61. 41. den Hartog G , Vos ERA, van de Hoogen LL, at al. Persistence of antibodies to SARS - CoV-2 in relation to symptoms in a nationwide prospective study. Clin Infect Dis. 2021 Feb 24. doi: 10.1093/cid/ciab1 72. 42. Philips KF. A new test of non -inferiority for anti -infective trials. Statist Med. 2003;22:201 -12. Version number: 6.0, 27 December 2021 45 of 49 43. Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid -19 vaccine in solid-organ transplant recipients . N Engl J Med 2021; 385:661 -662. 44. https://www.fda.gov/news -events/press -announcements/coronavirus -covid -19- update -fda-authorizes -additional -vaccine -dose -certain -immunocompromised . 45. https://www.npr.org/sections/coronavirus -live- updates/2021/09/01/ 1033474298/moderna -fda-covid -19-booster - shot?t=1631269620560 . Version number: 6.0, 27 December 2021 46 of 49 Appendix 1: Toxicity grading scale for solicited systemic and local adverse events. Mild Moderate Severe Arthralgia No interference with activity Some interference with activity Significant; prevents daily activity Fatigue No interference with activity Some interference with activity Significant; prevents daily activity Fever 38.0°C – 38.4°C 38.5°C – 38.9°C 39.0°C - 40°C Chills No interference with activity Some interference with activity Significant; prevents daily activity Headache No interference with activity Repeated use of non- narcotic pain reliever > 24 hours or some interference with activity Significant; any use of narcotic pain reliever or prevents daily activity Myalgia No interference with activity Some interference with activity Significant; prevents daily activity Nausea No interference with activity or 1 – 2 episodes/24 hours Some interference with activity or > 2 episodes/24 hours Prevents daily activity, requires outpatient IV hydration Size (diameter) of erythema/redness 2.5 – 5 cm 5.1 – 10 cm > 10 cm Size (diameter) of induration/swelling 2.5 – 5 cm 5.1 – 10 cm > 10 cm Pain (at injection site) Does not interfere with activity Repeated use of non-narcotic pain reliever > 24 hours or interferes with activity Any use of narcotic pain reliever or prevents daily activity Version number: 6.0, 27 December 2021 47 of 49 Appendix 2: Adverse events of special interest Body system/ Classification AESI Auto-immune diseases Guillain -Barre Syndrome (GBS) Acute disseminated encephalomyelitis (ADEM) Narcolepsy Acute aseptic arthritis Type I Diabetes Cardiovascular system Acute cardiovascular injury including: Microangiopathy, Heart failure, Stress cardiomyopathy, Myocarditis Circulatory system Single Organ Cutaneous Vasculitis Nerves and central nervous System Generalized convulsion Meningoencephalitis Transverse myelitis Respiratory system Acute respiratory distress syndrome Skin and mucous membrane, bone and joints system Erythema multiforme Other system Anaphylaxis Death (any causes) Other Any AE that is considered of special interest in relation to vaccination by the treating physician Version number: 6.0, 27 December 2021 48 of 49 Appendix 3: ECOG performance status ECOG performance status 0 Fully active, able to carry on all pre -disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, conf ined to bed or chair more than 50% of waking hours 4 Completely disabled.