Exposure to MF59-adjuvanted influenza vaccines during pregnancy—A retrospective analysis

Pregnant women are at increased risk for complications and death associated with pandemic H1N1 influenza infection and they are prioritized for vaccination by public health authorities. Few data are available on the safety of adjuvants as components of pandemic vaccines that could be given systematically to pregnant women. Here we review nonclinical and clinical data on pregnancy outcomes associated with exposure to MF59^®, an adjuvant used in licensed H1N1 pandemic vaccines. Evaluation of the reproductive and developmental toxicity of MF59 alone and of a candidate MF59-adjuvanted H5N1 vaccine in animals demonstrated no evidence of teratogenicity or impact on fetal or early perinatal development. The clinical trial database encompassing all Novartis vaccine studies from 1991 to 2009 was searched to compare pregnancy outcomes in subjects exposed to MF59-adjuvanted or unadjuvanted influenza vaccines. Analysis of the clinical trial database found that the distribution of pregnancy outcomes (normal, abnormal, or ending in induced abortion) was similar in subjects exposed to MF59-adjuvanted and unadjuvanted influenza vaccine at any time in pregnancy and also, specifically, in early pregnancy: the respective proportions reported as a normal pregnancy outcome were 70% and 75%, respectively, overall, and 61% and 68%, respectively, in early pregnancy. Although data from the clinical database are too few to draw definitive conclusions on risks associated with exposure to MF59-adjuvanted influenza vaccines during pregnancy, available observations, so far, indicate no signals of a risk. Further data will be forthcoming from planned post-licensure studies of adjuvanted H1N1 vaccines as they are distributed in the pandemic response.     

The active components of effective training in obstetric emergencies

Confidential enquiries into poor perinatal outcomes have identified deficiencies in team working as a common factor and have recommended team training in the management of obstetric emergencies. Isolated aviation-based team training programmes have not been associated with improved perinatal outcomes when applied to labour ward settings, whereas obstetric-specific training interventions with integrated teamwork have been associated with clinical improvements. This commentary reviews obstetric emergency training programmes from hospitals that have demonstrated improved outcomes to determine the active components of effective training. The common features identified were: institution-level incentives to train; multi-professional training of all staff in their units; teamwork training integrated with clinical teaching and use of high fidelity simulation models. Local training also appeared to facilitate self-directed infrastructural change.     

Epigenetic modulation at birth – altered DNA-methylation in white blood cells after Caesarean section

Aim:  Delivery by C-section (CS) has been associated with increased risk for allergy, diabetes and leukaemia. Whereas the underlying cause is unknown, epigenetic change of the genome has been suggested as a candidate molecular mechanism for perinatal contributions to later disease risk. We hypothesized that mode of delivery affects epigenetic activity in newborn infants.
Methods:  A total of 37 newborn infants were included. Spontaneous vaginal delivery (VD) occurred in 21, and 16 infants were delivered by elective CS. Blood was sampled from the umbilical cord and 3–5 days after birth. DNA-methylation was analyzed in leucocytes.
Results:  Infants born by CS exhibited higher DNA-methylation in leucocytes compared with that of those born by VD (p < 0.001). After VD, newborn infants exhibited stable levels of DNA-methylation, as evidenced by comparing cord blood values with those 3–5 days after birth (p = 0.55). On postnatal days 3–5, DNA-methylation had decreased in the CS group (p = 0.01) and was no longer significantly different from that of VD (p = 0.10).
Conclusion:  DNA-methylation is higher in infants delivered by CS than in infants vaginally born. Although currently unknown how gene expression is affected, or whether epigenetic differences related to mode of delivery are long-lasting, our findings open a new area of clinical research with potentially important public health implications.     

MR imaging of facial nerve enhancement in Bell palsy or after temporal bone surgery

The authors evaluated magnetic resonance (MR) images obtained with intravenously administered gadolinium in ten patients who had facial paralysis and no facial nerve tumor. In patients with either Bell palsy (four patients) or facial paralysis after temporal bone surgery (six patients), intratemporal facial nerve enhancement was seen. Facial nerve enhancement on MR images proved to be a nonspecific finding.     

Craniosynostosis in X-linked hypophosphataemic rickets

A report of three cases of craniosynostosis in X-linked hypophosphataemic rickets (XLH) is presented. The literature is reviewed, suggesting that craniosynostosis is relatively common in XLH and that boys may be more at risk than girls. It is recommended that radiological screening be offered to all patients with XLH.