Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis.

Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains.

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.

Background: The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children are unknown.

Methods: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 3:1 ratio to receive two 25-μg injections of mRNA-1273 or placebo, administered 28 days apart.

Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age.

Background: Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in children 6 to 11 years of age are unknown.

Methods: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled expansion evaluation of the selected dose.

Treatment of infantile-onset spinal muscular atrophy with nusinersen: final report of a phase 2, open-label, multicentre, dose-escalation study.

Background: Nusinersen showed a favourable benefit-risk profile in participants with infantile-onset spinal muscular atrophy at the interim analysis of a phase 2 clinical study. We present the study's final analysis, assessing the efficacy and safety of nusinersen over 3 years.

Methods: This phase 2, open-label, multicentre, dose-escalation study was done in three university hospital sites in the USA and one in Canada.

Safety and efficacy of nusinersen in spinal muscular atrophy: The EMBRACE study.

Introduction: The EMBRACE study (Clinical Trials No. NCT02462759) evaluated nusinersen in infants/children with infantile- or later-onset spinal muscular atrophy (SMA) who were ineligible for the ENDEAR and CHERISH studies.

Methods: Participants were randomized to intrathecal nusinersen (12-mg scaled equivalent dose; n = 14) or sham procedure (n = 7) in part 1 (~14 months) and subsequently received open-label nusinersen for ~24 months in part 2 of the study.

Pediatric emergency medicine point-of-care ultrasound: summary of the evidence.

The utility of point-of-care ultrasound is well supported by the medical literature. Consequently, pediatric emergency medicine providers have embraced this technology in everyday practice. Recently, the American Academy of Pediatrics published a policy statement endorsing the use of point-of-care ultrasound by pediatric emergency medicine providers.

Bedside ultrasound in the diagnosis of skull fractures in the pediatric emergency department.

Bedside ultrasound has become a diagnostic tool that is commonly used in the emergency department. In trained hands, it can be used to diagnose multiple pathologies. In this case series, we describe the utility of ultrasound in diagnosing skull fractures in pediatric patients with scalp hematomas.

Point-of-care ultrasound diagnosis of pediatric cholecystitis in the ED.

Objective: The diagnosis of cholecystitis or biliary tract disease in children and adolescents is an uncommon occurrence in the emergency department and other acute care settings. Misdiagnosis and delays in diagnosing children with cholecystitis or biliary tract disease of up to months and years have been reported in the literature. We discuss the technique and potential utility of point-of-care ultrasound evaluation in a series of pediatric patients with suspected cholecystitis or biliary tract disease.

Effect of bedside ultrasound on management of pediatric soft-tissue infection.

Background: Superficial soft-tissue infections (SSTI) are frequently managed in the emergency department (ED). Soft-tissue bedside ultrasound (BUS) for SSTI has not been specifically studied in the pediatric ED setting.

Objective: To evaluate the effect of a soft-tissue BUS evaluation on the clinical diagnosis and management of pediatric superficial soft-tissue infection.

Bedside ultrasound in pediatric emergency medicine fellowship programs in the United States: little formal training.

Background: Bedside ultrasound (BUS) can provide critical information in a rapid and noninvasive manner to the emergency physician. It is widely used in emergency departments (ED) throughout the nation. Literature shows that BUS shortens patient stay and increases patient satisfaction.

Ultrasound soft-tissue applications in the pediatric emergency department: to drain or not to drain?

Soft tissue infections frequently prompt visits to the pediatric emergency department. The incidence of these infections has increased markedly in recent years. The emergence of community-acquired methicillin-resistant Staphylococcus aureus is associated with an increasing morbidity, mortality, and frequency of abscess formation.