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Press Releases

Take a look at a selection of our recent media coverage:

R21/Matrix-M vaccine protective against malaria in children over 2 year period

13th September 2022

The R21/Matrix-M vaccine provides acceptable efficacy against malaria in children two years after the primary vaccination regime

The malaria vaccine, R21/Matrix-M has been shown to provide a high degree of efficacy against the disease in children, two years after the initial primary vaccination regime and a 12 month booster according to the findings of a study by a research team based at the Jenner Institute, University of Oxford and in collaboration with researchers from Burkina Faso.

Malaria is a life-threatening disease caused by Plasmodium falciparum (P falciparum), a parasite that is transmitted via the bite of infected female Anopheles mosquitoes that is both preventable and curable. According to the World Health Organisation (WHO), in 2020, there were an estimated 241 million global cases of malaria and 627 000 deaths. Moreover, in a 2021 report WHO noted how Sub-Saharan Africa continues to carry the heaviest malaria burden, accounting for about 95% of all malaria cases and 96% of all deaths in 2020. Additionally, about 80% of deaths in the region are among children under 5 years of age. WHO set a target in 2013 that a vaccine for malaria should show greater than or equal to 75 percent efficacy. Previous work demonstrated that three vaccination of low-dose R21/Matrix-M, administered at 4-week intervals before the malaria season, with a fourth dose 1 year later, provided an efficacy of 77%.

In the current study, the same research group who undertook the original, randomised, placebo-controlled trial with the R21/Matrix-M vaccine, have provided an update, reporting on the vaccine efficacy over the 12 months following the first booster, i.e., a 24 month period after the primary vaccination regime. The researchers used a primary case definition of clinical malaria as an axillary temperature of 37·5°C or greater.

R21/Matrix-M efficacy against malaria in children

The researchers included 409 children with a mean age of 11.6 years (49% male) at their first vaccine dose and who were followed after their 12 month booster dose, administered before the second malaria season. The data set included 132 given the low dose, group 1 (5 μg R21 adjuvanted with 25 μg Matrix-M), 137 the higher dose, group 2 (5 μg R21 adjuvanted with 50 μg Matrix-M) and 140 who received a control vaccine. Adequate use of insecticide-treated nets before the second malaria season was 89% overall and indoor residual spraying was done in 43% of households.

Based on the primary case definition, there were 242 cases with at least one episode of malaria from 14 days to 12 months after the booster vaccination. Among those in group 1, this represented a vaccine efficacy of 70% (95% CI 59 – 78) and 80% (95% CI 72 – 85) in group 2 compared the control group, after adjustment for sex, age and adequate bednet use.

When researchers re-assessed R21/Matrix-M at 24 months after the primary vaccination regime, the vaccine efficacy was 66% (95% CI 55 – 74) for group 1 and 75% (95% CI 66 – 81) for group 2.

The authors concluded that when delivered seasonally, the R21/Matrix-M malaria vaccine maintained high efficacy and that these findings suggest the vaccine strategy could have a substantial impact in areas of highly seasonal malaria transmission in Africa.

Datoo MS et al. Efficacy and immunogenicity of R21/Matrix-M vaccine against clinical malaria after 2 years’ follow-up in children in Burkina Faso: a phase 1/2b randomised controlled trial Lancet Infect Dis 2022

Autoimmune thyroiditis in children associated with thyroid cancer

5th September 2022

Autoimmune thyroiditis has been found to be independently linked to an increased risk of thyroid cancer in children with thyroid nodules

The presence of autoimmune thyroiditis is independently associated with a higher risk of thyroid cancer among children with thyroid nodules according to the findings of a cross-sectional study by researchers based at Harvard Medical School, US.

Autoimmune thyroiditis (AIT) is characterised by the presence of thyroid autoantibodies in serum and is the most common cause of thyroid disorder among children and adolescents although it is mostly asymptomatic. AIT, also known as Hashimoto’s thyroiditis, is frequently associated with papillary thyroid cancer and may indeed be a risk factor for developing this type of cancer. However, other work suggests that a correlation between AIT and a higher incidence of thyroid cancer is still undefined. In children there is also some uncertainty of this relationship. Some data suggest that AIT seems to influence the development of thyroid nodules, but not cancer, whereas other data indicate a relationship with malignancy. Whilst the presence of thyroid nodules are more common in children with AIT, whether this increases the risk of thyroid cancer is unclear, although there is a clear relationship between the presence of AIT, nodules and malignancy in adults.

In the present study, the researchers sought to better understand the relationship between AIT in children and thyroid cancer, among a cohort who underwent thyroid nodule evaluation over an extended period of time. Included participants were < 19 years of age and who had undergone fine needle aspiration of a nodule between 1998 and 2020. The presence of thyroid cancer was defined by histopathology for resected nodules and the researchers set the primary outcome as the presence of thyroid cancer.

Autoimmune thyroiditis and cancer in children

A total of 385 individuals with a mean age of 15.5 years (81% female) with 458 nodules, were included in the retrospective analysis.

Thyroid cancer was present in 108 nodules (24%) and AIT was seen 95 (25%) of the study population. The most common type of thyroid cancer was papillary (82%) followed by follicular carcinoma (14%).

The presence of clinical AIT was independently associated with an increased risk of thyroid cancer (odds ratio, OR = 2.19, 95% CI 1.32 – 3.62). Moreover, thyroid cancer was directly associated with the diameter of the nodules (OR = 1.05, 95% CI 1.03 – 1.06, p < 0.001) and inversely associated with age (OR = 0.90, 95% CI 0.83 – 0.97, p = 0.007). Interestingly, female sex and the presence of multiple nodules were both independently associated with a lower risk of thyroid cancer.

The authors concluded that among children with thyroid nodules, the presence of AIT was associated with an increased risk of thyroid cancer. They suggested that a clinical diagnosis of AIT may inform the assessment of thyroid cancer risk and surgical decision-making in children who had thyroid nodules.

Keefe G et al. Autoimmune Thyroiditis and Risk of Malignancy in Children with Thyroid Nodules Thyroid 2022

Higher tisagenlecleucel doses associated with better outcomes in children with relapsed ALL

Higher tisagenlecleucel doses in children with B cell acute lymphoblastic leukaemia are associated with more favourable disease outcomes

Higher doses of the CAR T cell therapy tisagenlecleucel lead to better overall, event-free and relapse-free survival in children with relapsed or refractory acute lymphoblastic leukaemia, according to the findings of a retrospective study by US researchers.

Acute lymphoblastic leukaemia (ALL) is a malignant transformation and proliferation of lymphoid progenitor cells in the bone marrow, blood and extra-medullary sites and 80% of cases occur in children. While chemotherapy is used first line, in cases where this initial treatment is either refractory or if patients relapse, chimeric antigen receptor-modified T cells (CAR T-cells) against CD19, have been shown to be effective.  In a Phase I-IIa study in paediatric and young adult patients with relapsed or refractory B-cell ALL, the use of a single infusion of tisagenlecleucel provided durable remission with long-term persistence. In this trial, the target dose of transfused cells was 2.0 to 5.0 x 106 CAR transduced viable T-cells per kg, for those weighing less than 50 kg and 1.0 to 2.5 x 108 T-cells for those weighing over 50 kg. However, whilst it is an effective therapy, what remains unclear is whether the dose of tisagenlecleucel impacts on disease-related outcomes such as overall survival. As a result, in the present study, the US researchers decided to retrospectively examine the impact of dose using data from the Pediatric Real World CAR Consortium which collects data from 15 paediatric oncology centres that are using commercial tisagenlecleucel. The team included patients with relapsed or refractory ALL and divided the infused cell doses into quartiles, D1 (0.1341.300 x 106), D2 (1.301-1.700 x 106), D3 (1.701- 2.400 x 106) and D4 (2.401-5.100 x 106). Overall survival (OS) was defined as the time from infusion to death from any cause, event-free survival (EFS), the time to the earliest non-response, relapse or death. Patients who did not respond were considered to have had a EFS event on day 28. Relapse-free survival (RFS) was only defined among responders, as the time from day 28 to relapse.

Tisagenlecleucel and disease outcomes

A total of 180 children with a mean age of 12.6 years (40.3% female) were included in the analysis and the median cell dose was 1.7 x 106 cells/kg and overall, 82.8% of patients had a treatment relapse and 51% described as having a high disease burden.

Overall survival for the entire cohort after 3 years was 58.9% (95% CI 47.6 – 72.9%) and the median follow-up time was 402.5 days. In multivariable regression, those on the highest dose (D4) had a significantly improved survival compared to those in D1, the lowest dose (hazard ratio, HR = 0.22, 95% CI 0.08 – 0.61, p = 0.008). For EFS, multivariable regression showed that again, those receiving the highest compared to the lowest dose, had improved survival (HR = 0.24, 95% CI 0.12 – 0.49, p < 0.001). Finally, RFS was also greater among those receiving the highest dose (HR = 0.18, 95% CI 0.07 – 0.49, p = 0.002). There were also no differences in toxicity across the different dose ranges.

The authors concluded that as higher doses were associated with superior survival in a real world setting, further work was required to examine the value of using higher tisagenlecleucel dosing.

Stefanski HE et al. Higher doses of tisagenlecleucel associate with improved outcomes: a report from the pediatric real-world CAR consortium Blood Ave 2022

Review finds quarter of children develop long COVID

2nd August 2022

A meta-analysis has identified how approximately a quarter of children and adolescents are likely to experience long COVID symptoms

The World Health Organization uses the term post COVID-19 conditions (i.e., long COVID), to define a condition that occurs among individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis. To date, the currently available literature on long covid relates to the symptoms developed in adults, although one recent analysis that specifically focused on children and young people and who were followed-up for a median of 125 days, observed a range of symptoms including a higher incidence of diarrhoea and fatigue. Nevertheless, the complete range and frequency of long covid symptoms that develop in children and adolescents remains unclear and was the subject of the current study by the Mexican and US team. The researchers looked for any type of study that included children and discussed long COVID, which they defined as the presence of one or more symptoms for longer than 4 weeks after the acute infection.

Children and long covid

The search identified a total of 21 eligible studies with 80,071 children and adolescents and which were included in the meta-analyses. The number of patients in each of the studies ranged from 53 to 57,763 and the participant ages from 0 to 18 years and the authors identified more than 40 long-term clinical manifestations of long covid.

The overall prevalence of long covid in children and adolescents was 25.2% (95% CI 18.2 –33.0) although among children who had been hospitalised, this increased to 29.2% (95% CI 17.8–41.9). A wide range of symptoms were detected, with the most common (16.5%) being mood symptoms (e.g., sadness, tension, anger, depression, and anxiety) fatigue (9.7%), sleep disorders (8.4%) which encompassed insomnia, hypersomnia, and poor sleep quality. Other symptoms included headache (7.8%) and respiratory symptoms (7.6%).

The authors calculated that in comparison to controls, children with long COVID had a higher risk of persistent dyspnoea (OR 2.69, 95% CI 2.3 – 3.1), anosmia/ageusia (OR 10.7, 95% CI 2.5 – 46.0), and/or fever (OR 2.2, 95% CI 1.2 – 4.1). Based on their findings, they concluded that the results of the meta-analysis supported the continued monitoring of the impact of long covid on children and adolescents.

Lopez-Leon S et al. Long-COVID in children and adolescents: a systematic review and meta-analysis Sci Rep 2022



Different emollient formulations appear to be equally effective in childhood eczema

29th May 2022

Different emollient formulations appear to be equally effective for the management of eczema symptoms in children according to a recent RCT

Differences in emollient formulations do not make an appreciable impact on patient-related outcomes in children with atopic eczema. This was the key finding of a pragmatic, randomised trial by UK researchers led a team from the Population Health Sciences, University of Bristol, UK.

In the UK, it is estimated that 11-20% of children and 5-10% of adults are affected by the inflammatory skin condition, atopic eczema. Emollients are the mainstay of treatment for all patients with atopic eczema (or simply eczema) and according to guidance from NICE should form the basis of management and always be used, even when the skin is clear. There are a wide range of emollients and emollient formulations available but little evidence to direct the choice of treatment although physicians play a pivotal role in assisting patients to select an emollient that they will accept and use consistently. There is a general perception that the greasier an emollient the more effective it is, as it is able to trap more moisture in the skin although greasier emollients can be less acceptable or tolerable.

Nevertheless, despite the perception that greasier emollient formulations are more effective, there is little, if any, evidence to support this claim. For the present study, the UK team set out to compare the effectiveness of four different emollient formulations; lotions, creams, gels and ointment for children with eczema. The Best Emollient for Eczema trial was a pragmatic, multi-centre, individually randomised, parallel group superiority trial of the four types of emollient. It enrolled children aged 6 months to less than 12 years of age with a healthcare professional diagnosis of eczema of mild or higher severity, as determined using the Patient Orientated Eczema Measure (POEM). This 7-item questionnaire of eczema symptoms (e.g. itching, redness, skin dryness etc) ranges from 0 to 28, with higher scores indicative of more severe disease. Eligible children were required to have score of > 2 and randomised 1:1:1:1 to receive lotions, creams, gel or ointment with an initial prescription for 500g or 500ml and which was to be applied twice daily and as needed. The primary outcome measure was the parent-reported POEM score and which was measured weekly over 16 weeks, with the minimum clinically important difference in POEM scores set at 3.

Emollient formulations and POEM scores

A total of 550 children with a median age of 4 years (46% female) were randomised to one of the four different emollients and the overall mean baseline POEM score was 9.3.

At week 16 there was no statistically significant difference (p = 0.77) between the different treatments based on the final POEM scores which were lotion (6.8), cream (7.6), gel (7.5) and ointment (7.0).

The authors concluded that their data suggest that there are no important differences between emollients, despite the widely held view that a more greasy formulation, which by trapping moisture, would be the most effective. They suggested that patients should be allowed to choose from a range of emollient formulations.

Ridd M et al. Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial Lancet Child Adolesc. Health 2022

Head injuries in children requiring hospitalisation two-fold higher during COVID-19

23rd May 2022

Head injuries leading to hospitalisation in children significantly increased during the COVID-19 period compared with pre-pandemic levels

Head injuries in children, and which resulted in hospitalisation, were more than two-fold higher during the COVID-19 pandemic compared with pre-pandemic levels, although the use of CT head scans was not appreciably different. This was the conclusion of a retrospective study by researchers from John Hopkin’s University, Baltimore, Maryland, USA.

Head injuries in children are a common cause for hospitalisation with a report by the US Centers for Disease Control and Prevention citing that in the US in 2016, 8.3% of boys and 5.6% of girls aged 3 –17 years had ever had a significant head injury in their lifetime. Head injuries are damage to the scalp, skull, or brain caused by trauma and in cases where this affects the brain, it is referred to as a traumatic brain injury. The most common causes of such head injuries are falls although other causes in older children are related to sports injuries or even motor vehicle accidents. Little is known about how the pandemic has impacted upon the incidence of head injuries in during during the pandemic although some work based on neuro-trauma admissions observed that while there was a decline in the number of head injury admissions during the pandemic, the severity of the injuries actually increased. However, no studies have compared the level of presentation during COVID-19 with the years prior to the pandemic.

For the present analysis, the US team retrospectively examined the proportion of emergency department visits for head injury in children and the severity of those injuries between March 2020 to June 2020. These data were then compared with data from between March 2019 – June 2019, i.e., pre-pandemic levels. For the analysis, researchers included anyone aged 0 to 21 and set the primary outcomes of interest as the presence of a medically attended head injury, hospital admission for the injury and the need for CT head scanning.

Head injuries in children and hospitalisations

There were a total of 8616 patients with a mean age of 7.4 years (51.4% male) seen with a head injury at the emergency department during the COVID-19 pandemic. This compared with 19,083 visits in the same period during 2019. Overall, there was a significant increase in the proportion of visits during COVID-19 (6.4% vs 5.5%, p = 0.004), for a head injury in children, giving an odds ratio (OR) of 1.2 (95% CI 1.1 – 1.4), even though the absolute number of visits was lower (1058 vs 553, pre-covid vs covid).

In addition, the proportion of visits requiring hospitalisation was more than two-fold higher (OR = 2.3, 95% CI 1.3 – 4.3), which was more likely in male patients (OR = 1.58). However, the need for a CT head scan was not significantly different (OR = 1.04, 955 CI 0.70 – 1.60). Interestingly, there was a lower level of hospital admissions associated with children aged < 2 years (OR = 0.3, 95% CI 0.2 – 0.6) which suggested that head injuries in this age group were less severe.

The authors concluded by suggesting that the higher level of head injuries in children observed during the pandemic period were potentially due to changes in certain factors including supervision and risk exposure in the home.

Satoskar S et al. Impact of the COVID-19 pandemic on pediatric emergency department utilization for head injuries J Investig Med 2022

Neurological manifestations seen in nearly half of children with COVID-19 and MIS-C

26th January 2022

Neurological manifestations have been found in nearly half of children hospitalised with COVID-19 or MIS-C according to a global study

A neurological manifestation has been found in 44% of children who had been hospitalised with either COVID-19 or multisystem inflammatory syndrome (MIS-C) according to researchers from the Global Consortium Study of Neurologic Dysfunction in COVID-19 (GCS-NeuroCOVID). This multinational research collaborative initiative was established in April 2020 and designed to collect information on the prevalence and outcomes of neurological manifestations associated with both acute infection with COVID-19 and those with MIS-C and the equivalent adult condition.

Among adults with COVID-19, neurological problems are common and in one study, 82% of patients reported experiencing such problems. In contrast, a study of 27 children with COVID-19 MISC-C, found that only four, previously healthy children, had new-onset neurological symptoms including encephalopathy, headaches, brainstem and cerebellar signs, muscle weakness, and reduced reflexes. However, all four children were admitted to an intensive care unit.

The evidence of neurological manifestations in children to date is based on small samples. As a result, for the present study, the team made use of the GCS-NeuroCOVID) database and searched for children (i.e., those aged under 18 years of age) hospitalised with COVID-19 related condition which was either confirmed through testing or based on the presence of recognised clinical symptoms. The diagnosis of MIS-C was based on the Centers for Disease Control and Prevention (CDC) guidance. The primary outcome of the study was the frequency and type of neurological manifestations both overall, and due to COVID-19 and MIS-C.

Neurological manifestations identified

A total of 1,493 children with a median age of 8 (47% female) were included in the analysis, of whom 86% had COVID-19 and the remainder MIS-C.

Children with a pre-existing medical condition were more likely to become infected with COVID-19 than MIS-C (p < 0.001) although children with MIS-C were more likely to be admitted to intensive care units (69% vs 29%).

Overall, 44% of the whole cohort (40% of those with COVID-19 and 66% of those with MIS-C) had at least one neurological manifestation. The most common findings were headache (16% vs 47%, COVID-19 vs MIS-C) and acute encephalopathy (15% vs 22%) and for both conditions, this difference was statistically significant (p < 0.05). Other manifestations included seizures (8%), anosmia (4%) and ageusia (3.6%). Children with neurological manifestations were also more likely to require admission to ICU (51% vs 22%, p < 0.001).

Using regression analysis, the researchers identified that for the whole cohort, several factors including older age (adjusted odds ratio, aOR = 1.20, 95% CI 1.07 – 1.13), MIS-C (aOR = 2.16), neurologic (aOR = 3.48) and a pre-existing metabolic condition (aOR = 1.65) were all significantly (p < 0.05) associated with the presence of neurological manifestations.

Commenting on these results, the authors noted how the frequency of observed neurological manifestations in the cohort was fortunately much lower than that reported in adults, which was 80%. They concluded that neurological symptoms were a common problem in children hospitalised with COVID-19 and that the presence of such symptoms was much more likely in older children and those with pre-existing neurological and metabolic conditions.


Fink EL et al. Prevalence and Risk Factors of Neurologic Manifestations in Hospitalized Children Diagnosed with Acute SARS-CoV-2 or MIS-C Pediatr Neurol 2022

Add-on dupilumab therapy reduces exacerbations in children with moderate-to-severe asthma

21st December 2021

Add-on dupilumab therapy for children with uncontrolled moderate-to-severe asthma led to a significant reduction in disease exacerbations

Add-on dupilumab treatment in children with uncontrolled moderate-to-severe asthma produced a significant reduction in the number of exacerbations over a 52-week period, according to results of a Phase III, randomised, double-blind, placebo-controlled trial by researchers from the Division of Allergy, Immunology, and Pulmonary Medicine, Monroe Carell Jr. Children’s Hospital Nashville, US.

The global prevalence of asthma in children varies across the world with an estimated 10.8% of 6–7-year-old children having the disease although rates are lower rates in Northern and Eastern Europe (4.5%) but much higher in North America (20.0%) and Oceania (29.2%). While there are differences in the definition of ‘severe’ asthma, it has been suggested that prevalence of severe childhood asthma may be up to 5% and there is more concerning evidence indicating that childhood asthma increases the risk of COPD in adults.

Asthma appears, in part, to be a Th2-driven inflammatory process, characterised by the release of the cytokines interleukin (IL)-4, IL-5 and IL-13 and higher levels of Th2 inflammation are associated with greater airway hyper-responsiveness and more severe disease though only around 50% of patients have this endotype. The monoclonal antibody, dupilumab, blocks the action of IL-4 and IL-13 and has been approved for the treatment of adults and adolescents with asthma.

In Europe, the EMA has approved add-on dupilumab (brand name Dupixent) to ‘treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma. Dupixent is only for use in patients with a type of inflammation of the airways called ‘type 2 inflammation’. 

For the present study, the US team recruited children aged 6 to 11 years with physician diagnosed moderate-to-severe asthma. Children were defined as those with type 2 inflammatory asthma phenotype defined by an eosinophil count of > 150 cells/cubic/ml or at least 300 cells/cubic/ml at baseline.

These children were randomised 2:1 to receive subcutaneous dupilumab (or matching placebo) every two weeks for 52 weeks at a dose of 100 mg (if their weight was <30 kg) or 200 mg (if weighing >30 kg). The primary endpoint was the annualised rate of severe exacerbations during the treatment period, defined as a deterioration of asthma control requiring systemic glucocorticoids for at least 3 days, hospitalisation or an emergency department visit that resulted in systemic glucocorticoid use. A key secondary outcome was the change from baseline to week 12 in the percentage of predicted prebronchodilator FEV1 (ppFEV1).


A total of 408 children with type 2 inflammatory asthma and a mean age of 8.9 years (66.4% male) were randomised to add-on dupilumab therapy or placebo. Among these children, 43% used high-dose inhaled glucocorticoids and had an average of 2.2 severe asthma exacerbations in the past year. An additional 259 children with an eosinophil count > 300 were similarly matched to dupilumab and placebo.

In the type 2 inflammation group, the adjusted annualised rate of severe asthma exacerbations was 0.31 (95% CI 0.22 – 0.42) in the add-on dupilumab group and 0.75 (95% CI 0.54 – 1.03) in the placebo group, giving a relative risk reduction, RR of 59.3% (p < 0.001). Similarly, among those with eosinophil counts > 300, the adjusted annualised rate of severe exacerbations was 0.24 (dupilumab) and 0.67 (placebo).

Overall, the percentage of participants who had no exacerbations during the 52-week study period was 77.1% in the dupilumab group and 59.6% in the placebo group and 79% vs 58.3% in the eosinophil vs placebo groups.

The changes in ppFEV1 were also significantly better for those in the add-on dupilumab group for both asthma phenotypes.

The authors concluded that dupilumab led to a meaningful improvement through asthma exacerbations and improvements in lung function in 6 to 11 year olds with moderate-to-severe asthma.


Bacharier LB et al. Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma. N Engl J Med 2021

Analysis shows skin peanut allergy patch safe and well tolerated over 3-year period

1st December 2021

Viaskin, an epicutaneous peanut allergy patch, has been found to be safe and well tolerated when used by children over a three-year period

The use of Viaskin, an epicutaneous patch used for children with a peanut allergy appears to be safe and well tolerated according to a three-year analysis presented by at the American College of Allergy, Asthma and Immunology Conference, November 2021.

A peanut allergy is thought to affect around 2% of the general population and in a study of 3218 children, the incidence was found to be 24.8%. The presence of a peanut allergy is challenging for those affected and requires a high level of vigilance directed towards the avoidance of accidental ingestion of peanut-containing foods.

The use of viaskin represents ‘epicutaneous’ immunotherapy and according to the manufacturer, DBV Technologies, is a proprietary technology platform that enables the delivery of biologically active compounds to the immune system through the skin.

The data presented at the American College of Allergy, Asthma and Immunology Conference was based on the REALISE trial, which included children with documented histories of peanut anaphylaxis and who were randomised, 3:1, to either viaskin peanut 250mcg (which contains 1/1000th of the protein found in a single peanut) or a placebo for a period of 6 months. Once this initial phase was completed, all subjects continued to receive the active treatment in an open-label extension, for a period of three years. For the REALISE study, the primary outcome was set as adverse Events (AEs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study period.

The 6-month safety data for viaskin has already been published and showed that the patch was well-tolerated.


REALISE recruited 393 children with a median age of 7 years (gender not reported) of whom, 14 (3.6%) had a history of severe anaphylaxis. Throughout the study period, most subjects experienced at least one TEAE although these were reported as being mild (97.4%) or moderate (70.4%) in severity and commonly consisted of application site erythema and pruritus which fortunately decreased over time.

Overall, 16 children experienced a total of 17 anaphylactic reactions (none severe) considered to be due to viaskin. In addition, there were 2 serious that were viakskin-related TEAEs (2 anaphylactic reactions: one leading to permanent study discontinuation). No difference in TEAEs in subjects with severe anaphylaxis history was apparent.

The authors concluded that ‘over 36-months, Viaskin Peanut was generally well tolerated, with decreasing frequency and intensity of local and systemic treatment-related AEs over time.’

The product is yet to be approved by the FDA, which has requested more data or the EMA.



Non-urgent attendances represent a substantial number of children’s emergency care visits

8th November 2021

Non-urgent attendances for younger children account for a fifth of all emergency care visits and which could be managed in other care setting.

A substantial number of emergency care (EC) visits for young children represent non-urgent attendance (NUA). This is the conclusion of a retrospective analysis of hospital database by a team from the School of Health and Related Research, The University of Sheffield, Sheffield, UK.

Data for the UK show that in 2018-19, there were 24.8 million attendances at accident and emergency (A&E) departments, which represents a 4% increase on the previous year and a 21% increase since 2009-10. While much attention has focused on adult attendance at A&E, visits by children and young people has been less well studied despite the fact that children make more frequent visits to A&E. For example, in 2015/16 there were 425 A&E attendances for every 1000 children and young people an 345 A&E attendances for every 1000 adults aged 25 and over.

Research suggests that non-urgent attendance to EC can vary between 20 and 40% and there is evidence that younger age is one of several associated factors, though specific data on characterising NUA in children is limited. For the present study, the Sheffield team sought to define the proportion of NUA by children which were amenable to treatment or management elsewhere, how these non-urgent attendances varied by patient age as well as the impact on waiting times in the EC department. Patient characteristics such as as age, gender, date of attendance, disposal, type of treatment etc were extracted from a hospital database containing information for more than a tenth of England’s population over a 3-year period. The team defined a non-urgent attendance as one in which there was no treatment/investigations or referrals that required the facilities of an EC department.


A total of 1,068,598 EC attendances from children aged 0 – 15 years were identified and included in the analysis. Overall, the proportion of visits deemed NUA was 21.4% (208,788). Compared to visits for children less than 1 years of age, the odds ratio for a NUA was much more likely in children aged 1 – 4 years (odds ratio, OR = 0.82, 95% CI 0.80 – 0.83). However, NUA decreased with increasing age, for example, among children aged 10 – 14 years, the proportion of NUA was 14.6% (OR = 0.40) compared with 20.5% (OR = 0.61) for those aged 5 – 9 years. The odds of a patient presenting with a NUA was also significantly higher (OR = 1.19, 95% CI 1.18 – 1.20) for those attending out of hours compared to in hours (i.e., 8 am to 6 pm, Monday to Friday).

The researchers also found that for a NUA, the mean waiting, treatment and department times were all lower compared with urgent cases. Extrapolating their findings, the authors estimated up to 1 million non-urgent attendance visits across England in 2018-19 for ages 14 years and under.

They concluded that targeting groups such as those age under 5 years, particularly in providing accessible, timely care outside of usual community care opening hours would be of benefit.


Simpson RM et al. Non-urgent emergency department attendances in children: a retrospective observational analysis. Emerg J Med 2021