Sex: U
Vaccine: HEP
Symptoms: Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: Congenital anomaly; Maternal exposure before pregnancy; This retrospective pregnancy case was reported in a literature article and described the occurrence of congenital anomaly in a infant exposed to Hepatitis B vaccine in utero while the mother was treated for prophylaxis.   On an unknown date, the mother received Hepatitis B vaccine.   The infant was exposed to Hepatitis B vaccine at an unknown time during the pregnancy.  The infant was diagnosed with congenital anomaly (serious criteria congenital anomaly) and fetal exposure during pregnancy. On an unknown date, the outcome of the congenital anomaly and fetal exposure during pregnancy were unknown.   It was unknown if the reporter considered the congenital anomaly to be related to Hepatitis B vaccine.  Additional details were provided as follows: This retrospective pregnancy case was reported in a literature article and described the occurrence of congenital anomaly and fetal exposure during pregnancy, in a patient of unspecified age and gender, whose mother was vaccinated with Engerix B(GlaxoSmithKline) before pregnancy for prophylaxis.   The patient mother was a part of study that retrospectively analyzed women enrolled in the HEPLISAV-B clinical trials who had pregnancy documented during trial participation and follow up. In this study, outcomes in women who became pregnant during participation in the clinical development program were evaluated. The last menstrual period (LMP) recorded was compared to timing of last dose of vaccine. [In this study, HEPLISAV-B was evaluated in 11 clinical trials, 7 of which were head-to-head comparisons to Engerix-B. Among pregnant women in both groups (Heplisav-B v/s Engerix B), median age (30.5 versus 31.0), were similar]. The patient mother became pregnant during her participation in clinical development program. No information on patient medical or family history or concurrent condition or concomitant medication was reported.  On an unknown date, the patient mother received Engerix B (administration route and site unspecified, batch number not provided). 8 days after receiving Engerix B (last active injection), the patient mother had her LMP. The patient was exposed to Engerix B in utero.   On an unspecified date, an unknown period after vaccination exposure in utero, the patient was born via unknown method of delivery. The patient was diagnosed with congenital anomaly. The patient was not a pre-term baby. Additionally, the patient mother was found to be seroprotected (more than 1000 mIU/mL). [In this study, seroprotection was defined as anti-HBs more than or equal to10 mIU/mL. Seroprotection rates were 8/14 at 28 weeks in the Engerix-B arms. In the Engerix-B group, peak anti-HBs levels were more than or equal to 10 IU/L and less than 100 IU/L in 4/19 subjects and more than or equal to 100 in 10/19. 7 in the Engerix-B arms were vaccine non-responders (i.e. peak recorded anti-HBs level less than 10 IU/L)]. The case was considered as serious due to congenital anomaly. Treatment was unknown. Outcome of the event was unknown. The authors concluded "These data from the clinical development program show HEPLISAV-B in pregnant women to induce higher rates of immunogenicity over a shorter dosing regimen with similar fetal outcomes compared with Engerix-B. These results should be further verified with additional studies or data to confirm the safety and efficacy of HEPLISAV-B in pregnant women".   Upon internal check following correction has been completed: The event maternal exposure before pregnancy was updated instead of fetal exposure during pregnancy.  MAH Comment: Dear Colleague, As determined causality updated ' from 'unknown  to No' for the event congenital anomaly due to insufficient information.