BNT165c

A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the study participant. Confirmation by an investigator or medically qualified person was required for all Grade 3 or 4 reactogenicity events. Grades were defined as: Grade 1 - Mild; does not interfere with the study participant's activity; Grade 2 - Moderate; interferes with the study participant's activity; Grade 3 - Severe; prevents study participant's daily activity; and Grade 4 - Potentially life-threatening; emergency room visit or hospitalization for severe pain. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.

A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue/tiredness, muscle pain/joint pain, and fever. The intensity of AEs was graded by the participant but only an investigator or medically qualified person was able to classify a systemic reaction as Grade 3 or 4. Grades were defined as: Grade 1 - Mild; does not interfere with the study participant's activity; Grade 2 - Moderate; some interference with the study participant's activity; Grade 3 - Severe; prevents the trial participant's daily routine activity; and Grade 4 - Potentially life-threatening; Emergency room visit or hospitalization. Fever was categorized as 38.0 - 38.4 °C, 38.5 - 38.9 °C, 39.0 - 40.0 °C \& \>40.0 °C. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.

An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grade 1 - Mild; does not interfere with the trial subject's usual function; Grade 2 - Moderate; interferes to some extend with the trial subject's usual function Grade 3 - Severe; interferes significantly with the trial subject's usual function; and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses. Includes all unsolicited AEs and also solicited events that persisted beyond 7 days post-dose, qualify as an SAE, or are delayed local reactions.

An MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Includes all unsolicited AEs and also solicited events that qualify as an MAAE.

An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death or was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment. Includes all unsolicited AEs and solicited events that qualify as an SAE.