Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | — | — |
second dose was given one year after the first one; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 1st dose of Bexsero vaccine a year ago). On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: second dose was given one year after the first one). The outcome of the drug dose administration interval too long 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: 14-MAY-2025 A registered nurse wanted to know how much time could pass between the first and second dose of Bexsero that keeps valid the administration. Information found in the prescribing information was given regarding the two and three-dose schedule administration. Then, the health care provider asked if it would be valid if the second dose was given one year after the first one. The agent asked if one or more patients received the second dose in this condition, to which the health care provider responded it maybe 2 or 3 patients around 18 years old but did not have any data from them nor from the vaccines used. The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.