This website is intended for healthcare professionals only.

Hospital Healthcare Europe
Hospital Pharmacy Europe     Newsletter          

Press Releases

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

mRNA-1273 vaccine response non-inferior to young adults in children from 6 months

10th November 2022

The mRNA-1273 vaccine has been shown to generate an antibody response in children from 6 months that is non-inferior to young adults

The mRNA-1273 vaccine directed against COVID-19 has been shown to produce an antibody response in children aged from 6 months to 5 years that was comparable to the response elicited by young adults, aged 18 to 25 according to the findings of a study by US researchers.

It has become recognised that the efficient transmission of COVID-19 from school-age children and adolescents to household members can occur and lead to the hospitalisation of adults with secondary cases of the virus. While both COVID-19 infections and deaths are less frequent in children compared to adults it has been estimated that of 4.1 million COVID-19 deaths, 0.4% (16,100) occurred in those under 20 years of age and of which, 47% were in those age 0 to 9 years. Vaccination against COVID-19 is known to be effective at reducing hospitalisation and death in adults and the mRNA-1273 vaccine is also known to be safe and effective at inducing an immune response and preventing COVID-19 in children 6 to 11 years of age. However, whether the vaccine remains safe and able to elicit a satisfactory antibody response in children from 6 months of age is uncertain and was the purpose of the present study.

The US researchers undertook a phase 2 – 3 trial to determine the most appropriate dose in younger children. This revealed that a 25-μg dose of the mRNA-1273 vaccine was safe in children from 6 months of age. The team then randomised children aged 6 months to 23 months and between 2 and 5 years in a 3:1 ratio to two 25-μg doses administered 28 days apart or matching placebo. The aim of the study was to assess whether the antibody response was non-inferior to that generated by those aged 18 to 25.

mRNA-1273 vaccine antibody response in children from 6 months

A total of 1761 children with a median age of 16 months (51.7% male) received two doses of the vaccine and of whom, 89.4% tested negative for COVID-19. The median duration of follow-up was 68 days.

When assessed at day 57, the neutralising antibody geometric mean concentration was 1781 (95% CI 1272 – 1563) among those aged 6 – 23 months. This compared to a mean concentration of 1391 in those aged 18 to 25 (who had received 2 x 100 μg doses) and met the pre-defined criteria for non-inferiority. A similar and non-inferior response was also generated in those aged 2 – 5 years. In addition, there were no major safety concerns with adverse events mainly low-grade and transient.

In terms of vaccine effectiveness, within the 6 – 23-month group, infection occurred in 3.4% of the mRNA-1273 vaccine group and 6.6% of the placebo group, giving a vaccine efficacy of 50.6% (95% CI 21.4 – 68.6%). Among those aged 2 to 5, the vaccine efficacy was 36.85 (95% CI 12.5 – 54%) during the period of time when Omicron was the predominately circulating variant.

The authors concluded that two 25-μg doses of the vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults.

Citation
Anderson EJ et al. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Eng J Med 2022

Does having young children affect the severity of COVID infection in their parents?

12th August 2022

Study evaluated risk of severe COVID-19 among adults with and without exposure to young children in a large, integrated healthcare system in the US

Having young children (YC) does not protect the parents against infection with COVID-19 but does result in a significantly lower risk of more severe illness, according to an analysis by US researchers.

Data from China during the early part of the COVID-19 pandemic suggested that while children of all ages appeared susceptible to infection, the clinical manifestations were generally less severe than those of adult patients. Moreover, several factors have been postulated to account for these differences and include lower levels of the ACE2 receptor in children, cross-reactive humoral immunity and T cell immunity from the common cold (which is also a coronavirus) and how children generally produce lower levels of inflammatory cytokines

In fact, one study identified COVID-19 spike glycoprotein-reactive antibodies among uninfected individuals which were particularly prevalent in children and adolescents which suggests a degree of cross-immunity. This is perhaps no surprise due to the continued exposure to colds during early life and one study has shown that attendance at a large day care centre was associated with more common colds among pre-school children during the preschool years but that this was protective against the common cold during the early school years, presumably through acquired immunity.

With children therefore likely to have some level of cross-immunity to infection with COVID-19, does having YC affect the severity of infection in their parents? This was the question addressed by the current study.

Researchers examined data in the Kaiser Permanente Northern California database, which provides comprehensive healthcare information and looked for adults with and without children. The children were categorised into different age bands: YC (aged 0 to 5 years), 6 – 11 years and 12 to 18 years. Those parents with YC were considered to be the study population of interest and the three comparative groups were propensity matched 1:1 based on the risk of infection, age, sex and co-morbidities.

Exposure to young children and COVID-19 outcomes

A total of 3,126,427 adults, of whom 24% had children under 18 years of age were included in the analysis. Within the whole cohort, 274,316 adults (8.8%) with a mean age of 36.2 years (51.4% female) had YC.

When researchers compared the risk of infection with COVID-19 among adults without children to those with YC, there was a significantly reduced risk (incidence risk ratio, IRR = 0.85, 95% CI 0.83 – 0.87, p < 0.0001). But among adults without children, there was a significantly higher risk of hospitalisation for COVID-19 (IRR = 1.27, 95% CI 1.10 – 1.46, p = 0.0014) and for admission to an intensive care unit (IRR = 1.49).

Furthermore, when the researchers re-calculated this risk of severe illness relative to the total population within the different groups, i.e., the risk of a severe COVID-19 outcome among adults who became infected, there was a 49% higher rate of hospitalisation and a 76% higher risk of intensive care admission.

The authors concluded that while having YC did not reduce the risk of becoming infected with COVID-19, it was associated with a far less severe illness and suggested that cross-immunity might play a role in protecting against more severe COVID-19.

Citation
Soloman MD et al. Risk of severe COVID-19 infection among adults with prior exposure to children. Proc Natl Acad Sci USA 2022

Once-daily inhaled steroid use in asthmatic children improves adherence

18th February 2022

Once-daily dosing of inhaled steroids in young children with asthma improved medicine adherence compared with a twice daily regime

The use of a once-daily dosing regime for inhaled steroids in young children is associated with an improvement in medication adherence according to a study by researchers at the Department of Pediatrics, Faculty of Medicine, Université de Montréal, Canada.

Asthma is caused by inflammation and a subsequent narrowing of the small airways in the lungs, leading to the typical symptoms, which include any combination of cough, wheeze, shortness of breath and chest tightness.

According to the World Health Organization, in 2019, asthma affected an estimated 262 million people in 2019 and caused 461000 deaths. Moreover, among children aged 5-14 years, asthma is among the top 10 causes of disability-adjusted life years.

Inhaled steroids are the most effective drugs used in asthma to suppress airway inflammation and suitable for both adults and children. However, adherence to inhaled steroids remains low with one systematic review finding that 24% of asthma exacerbations and 60% of asthma-related hospitalisations could be attributed to poor inhaled steroid adherence.

Simplifying regimes for instance, use of a once-daily inhaled steroid has been shown to significantly increase adherence compared to twice daily usage. However, this study was in adults and there is a lack of robust data for children.

Consequently, in the present study, the Canadian team wanted to examine the real-life impact of prescribing inhaled steroids once-daily compared to twice-daily and how this affected adherence. They performed a retrospective analysis of children visiting an asthma clinic at their hospital who had been prescribed daily inhaled steroid therapy and compared those prescribed either once or twice daily therapy.

They set the primary outcome as the secondary adherence to the inhaled steroid based on the proportion of prescribed days covered (PPDC), which was the total number of days for which the drug was dispensed divided by the total number of days for which the drug was prescribed. The secondary outcome as secondary adherence as either good (> 75%) or poor (< 75%).

Once-daily inhaled steroid use and PPDC

A total of 232 participants with a mean age of 5.8 years (61% male) of whom 110 were prescribed once-daily inhaled steroids were included in the analysis and followed-up for a median of 10.7 months.

The once-daily regime was associated with a higher PPDC compared to twice daily (66.8% vs 58%). After adjustment, children prescribed a once-daily regime had a significantly higher PPDC (7.2%, 95% CI 1.3 – 13.1%) and a higher odds of having a PPDC > 75% (Odds ratio, OR = 1.80, 95% CI 1.01 – 3.26).

However, there were no significant differences between once and twice daily regimes on the time to the first asthma exacerbation (hazard ratio, HR = 0.71, 95% CI 0.38 – 1.31).

Based on these findings, the authors concluded that once-daily dosing improved absolute adherence compared to twice-daily but added that further studies are required to determine whether better adherence leads to clinically meaningful improvements in asthma control.

Citation
Drouin O et al. Adherence to inhaled corticosteroids prescribed once- vs twice-daily in children with asthma Ann Allergy Asthma Immunol 2022

x