Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | 2g3S9 | — |
early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 2g3S9, expiry date 30-SEP-2027) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 01-MAY-2025, the patient received the 2nd dose of Bexsero. On 01-MAY-2025, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: early dose since HCP was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 mo). The outcome of the drug dose administration interval too short was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter reported that she had a patient that was given his first dose on 28th February 2025 and the second dose was actually administered on 01st May 2025, she was not informed of the change to dosing schedule for Bexsero and was following the old schedule. Note to PV-I am submitting as early dose since healthcare professional was under impression it was 2 dose schedule (old schedule) and if her plan was to give 2 doses, this would be an early 2nd dose under 2 dose schedule (0, 6 months) which led to shortening of vaccination schedule.
Bexsero