Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 324BY | — |
Late Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose of vaccine on 27th August 2024). On 04-AUG-2025, the patient received the 2nd dose of Twinrix. On 04-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late Second dose). 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: 04-AUG-2025 Pharmacist reported that they had a couple that was leaving to go over the Country this December first so they were looking to do the expedite schedule. The first they got was about a year ago and the second dose, they got it today (on the day of reporting). So, looking at the schedule looks like they had to wait at least two weeks between getting dose number 3, but pharmacist question was for dose number four, said it had to be a year after the first dose that had already happened. So, was there a minimum interval between dose number 3 and 4 they would have to wait or could they just get dose number four when they came back. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025100212, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025100212: