Received Jul 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (NOVAVAX)) | NOVAVAX | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
STROKE; Initial information received on 26-Jun-2026 regarding a solicited serious case received from a Physician, in the scope of company sponsored study. This case involves a 55-year-old female subject who experienced stroke, during study participation. The subject's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided. The subject's past vaccine included Covid-19 vaccine (MODERNA) administered in13-Aug-2025. On 26-Mar-2026 at 18:57, the subject received dose 1 of suspect investigational NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO at unknown dose and route for prophylactic vaccination. On 05-Jun-2026, i.e., 10 days following the first dose and last dose intake of NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO (batch number and expiry date: unknown), the subject had stroke (Cerebrovascular accident). This event was assessed as serious due to life-threatening and caused/prolonged hospitalization criteria. On the same day, the subject recovered from the event stroke. Maximum intensity was moderate. The event was not qualified as an Adverse Event of Special Interest (AESI). Action taken with NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO was not applicable. Corrective treatment: Not reported. Stroke was considered to be not related to NVX-COV2705 (OMICRON JN.1) ADJUVANTED VACCINE VS PLACEBO by the reporter and not reportable by the company based on company causality assessment. Rationale for final investigator causality: unknown etiology. Relationship between stroke and the study procedure was not related by the reporter and not reportable by the company based on company causality assessment.