Safety of post-exposure rabies prophylaxis during pregnancy: A follow-up study from Guangzhou, China

Abstract

This study aimed to assess the safety profile of post-exposure prophylaxis (PEP) for rabies in pregnant women. All of the subjects received the Essen vaccination regimen. Systemic and local reactions were monitored within 72 hours following the immunization, and the subjects were followed until six months after delivery. No moderate or severe adverse effects occurred in any subject following the vaccination. Among the 72 subjects in this follow-up study, four had voluntary abortions, one subject had an accidental miscarriage, and the remaining 67 subjects delivered babies vaginally or by caesarean section. All of the infants exhibited normal development.The purified Vero cell rabies vaccine and the purified chick embryo cell vaccine were both safe for the PEP of pregnant women and did not interfere with the development of the fetuses or infants. Education is needed in China to stop pregnancy terminations due to concerns about rabies vaccination risk. :

Post-exposure prophylaxis (PEP) for rabies with purified chick embryo cell vaccine: a systematic literature review and meta-analysis

“…The majority of intervention studies were conducted in Asia (China, India, Philippines, Thailand) [7,9,10, and eight studies in Europe (Austria, Croatia, Czech Republic, Germany, Lithuania, Serbia) [8,[41][42][43][44][45][46][47]. All the observational studies were conducted in Asian countries [19,[48][49][50][51][52][53][54][55][56][57][58][59][60][61]].…”

“…The AEs were local pain (22.5%), fatigue (18.3%), fever (2.8%), local erythema (1.4%), and headache (1.4%). No miscarriages, stillbirths, or fetal malformations were reported, and birth weights were within ranges considered normal for neonates in China [49].…”

“…The review identified 48 reports of reactogenicity and safety of PCECV, including four studies that assessed children or pregnant women [25,48,49,54]. The most frequently reported systemic AEs were myalgia, headache, fever, or having a feverish feeling, and overall, our descriptive analysis indicated that adverse reactions including headache, erythema, induration, and lymphadenopathy may be more often reported among individuals receiving PCECV by ID than IM administration.…”

Vaccines and immunoglobulins

“…Today's vaccine is much better tolerated than earlier preparations. Case reports and series regarding the active and/or passive immunization with more than 330 pregnant women demonstrate no adverse effects (Huang 2013, Toovey 2007, Chutivongse 1995. Maternal antibodies appear to cross the placenta.…”

A systematic review of ethical issues in vaccine studies involving pregnant women

“…Yet, no publications included in this review detailed how perceived safety concerns among participants were addressed during enrollment, and only one study included in this review discussed how safety concerns affected study participation. In a prospective cohort of pregnant women exposed to rabies, study investigators reported that several participants withdrew from the study, or refused post-exposure prophylaxis due to perceived safety concerns 20 . However, the need for further health education to eliminate perceived safety concerns was expressed 20 …”