1 µg CoV2 SAM

The solicited administration site adverse events assessed were pain, redness and swelling.

The solicited systemic events assessed were abdominal pain, arthralgia, diarrhea, fatigue, fever, headache, myalgia, nausea, vomiting. Fever is defined as temperature ≥38.0°Celsius (C)/100.4°Fahrenheit (F) regardless the location of measurement.

An unsolicited AE is defined as an AE that was not included in a list of solicited events using a Participant eDiary, or any solicited event with onset after the 7-day period post each vaccination.

The hematological and biochemical laboratory parameters assessed include alanine aminotransferase (ALT),alkaline phosphatase (ALP),aspartate aminotransferase (AST),bilirubin,creatinine,urea nitrogen,eosinophils,erythrocytes,hemoglobin,leukocytes,lymphocytes,neutrophils,partial thromboplastin time (PTT) and platelets. Categories reported for each parameter when comparing Day 1 baseline and post-baseline hematological and biochemical laboratory results are defined as follows:\<range at baseline \[Day 1\]\>, \<range at post-baseline time point\> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets. Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: \<range at baseline \[Day 1\]\>, \<range at post-baseline time point\> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets. Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: \<range at baseline \[Day 1\]\>, \<range at post-baseline time point\> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets. Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: \<range at baseline \[Day 1\]\>, \<range at post-baseline time point\> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

The hematological and biochemical laboratory parameters assessed include ALT, ALP, AST, bilirubin, creatinine, urea nitrogen, eosinophils, erythrocytes, hemoglobin, leukocytes, lymphocytes, neutrophils, PTT and platelets. Categories reported for each parameter when comparing Day 1 (baseline) and post-baseline hematological and biochemical laboratory results are defined as follows: \<range at baseline \[Day 1\]\>, \<range at post-baseline time point\> for example, Below-Within, where each range is classified as below, within, or above the applicable laboratory reference range. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter; Unknown = No results are available for the specified visit and laboratory parameter.

A medically attended adverse event (MAE) is defined as an AE for which the participant received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (i.e., nurse practitioner or physician assistant or medical doctor) for any reason.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgment.

AESIs assessed include pIMDs and COVID-19 cases. pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any suspected, probable or confirmed case of COVID-19 was reported.