Immunogenicity of Monovalent mRNA-1273 and BNT162b2 Vaccines in Children <5 Years of Age.

BACKGROUND AND OBJECTIVES: The messenger RNA (mRNA)-based coronavirus disease 2019 vaccines approved for use in children <5 years of age have different antigen doses and administration schedules that could affect vaccine immunogenicity and effectiveness. We sought to compare the strength and breadth of serum binding and neutralizing antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicited by monovalent mRNA-based coronavirus disease 2019 vaccines in young children. METHODS: We conducted a prospective cohort study of children 6 months to 4 years of age who completed primary series vaccination with monovalent mRNA-1273 or BNT162b2 vaccines. Serum was collected 1 month after primary vaccine series completion for the measurement of SARS-CoV-2-specific humoral immune responses, including antibody binding responses to Spike proteins from an ancestral strain (D614G) and major variants of SARS-CoV-2 and antibody neutralizing activity against D614G and Omicron subvariants (BA.1, BA.4/5). RESULTS: Of 75 participants, 40 (53%) received mRNA-1273 and 35 (47%) received BNT162b2. Children receiving either primary vaccine series developed robust and broad SARS-CoV-2-specific binding and neutralizing antibodies, including to Omicron subvariants. Children with a previous history of SARS-CoV-2 infection developed significantly higher antibody binding responses and neutralization titers to Omicron subvariants, which is consistent with the occurrence of identified infections during the circulation of Omicron subvariants in the region. CONCLUSIONS: Monovalent mRNA-1273 and BNT162b2 elicited similar antibody responses 1 month after vaccination in young children. In addition, previous infection significantly enhanced the strength of antibody responses to Omicron subvariants. The authors of future studies should evaluate incorporation of these vaccines into the standard childhood immunization schedule.

Vertebral body tethering for non-idiopathic scoliosis: initial results from a multicenter retrospective study.

PURPOSE: Vertebral body tethering (VBT) has been described for patients with idiopathic scoliosis. Results of the technique for non-idiopathic scoliosis have not yet been reported. METHODS: An international multicenter registry was retrospectively queried for non-idiopathic scoliosis patients who underwent VBT with minimum 2-year follow-up. Success at 2 years was defined as Cobb angle < 35 degrees and no fusion surgery. RESULTS: Of the 251 patients treated with VBT, 20 had non-idiopathic scoliosis and minimum 2-year follow-up. Mean age at surgery was 12.4 years (range 10 to 17 years). Mean major Cobb angle at enrollment was 56 degrees. Of those, 18 patients had a major thoracic curve and two had a major lumbar curve. Of the 20 patients, nine met criteria for success (45%). Eight of the 20 patients had poor outcomes (four fusions, four with curve > 50 degrees). Success was associated with smaller preoperative Cobb angle (50 vs. 62 degrees, p = 0.01) and smaller Cobb angle on initial postop imaging (28 degrees vs. 46 degrees, p = 0.0007). All patients with Cobb angle < 35 degrees on 1st postop imaging had a successful result, with the exception of one patient who overcorrected and required fusion. Syndromic vs. neuromuscular patients had a higher likelihood of success (5 of 7, 71%, 2 of 10, 20%, p = 0.03). CONCLUSION: Selected non-idiopathic scoliosis can be successfully treated with VBT, but failure rates are high and were associated with large curves, inadequate intraoperative correction and neuromuscular diagnosis. Achieving a Cobb angle less than 35 degrees on 1st standing radiograph was associated with a successful outcome which was achieved in 45% of patients. LEVEL OF EVIDENCE: Level IV (retrospective review study).

Noninvasive Hemoglobin Monitoring for Postoperative Pediatric Orthopaedic Patients: A Preliminary Study.

BACKGROUND: Hemoglobin (Hgb) levels are frequently checked through venipuncture [invasive hemoglobin (iHgb)] in pediatric orthopaedic patients after high blood loss procedures. This needlestick may causes further anxiety and fear in hospitalized children. Noninvasive hemoglobin (nHgb) monitoring has been effectively utilized in the adult intensive care and postoperative total joint arthroplasty setting. nHgb monitoring has not yet been validated in children for routine postoperative Hgb assessment in pediatric orthopaedics. METHODS: In this prospective study, 46 pediatric orthopaedic patients were enrolled who were undergoing surgery and postoperative standard of care iHgb testing. On postoperative day 1, Hgb levels were obtained through venipuncture and nHgb monitor (Pronto-7; Masimo) within a 2-hour period. Patient preferences, iHgb and nHgb values, time to result, and provider preferences were recorded. Cost data were estimated based on the standard Medicare payment rates for lab services versus the cost of nHgb probe. RESULTS: nHgb results were obtained after 1 attempt in 38 patients (83%), after multiple attempts in 7 patients (15%), and could not be obtained in 1 patient. The mean time to obtain nHgb value was significantly shorter than that to obtain iHgb results (1.3±1.5 vs. 40±18.1 min; P <0.0001). The mean nHgb value was significantly higher than the mean iHgb value (11.7±1.5 vs. 10.6±1.1 g/dL, P <0.0001). nHgb exceeded iHgb by 2 g/dL or more in 12 (26%) patients (2.64±0.9 vs. 0.54±0.84 g/dL; P <0.0001). The concordance correlation coefficient between the 2 Hgb methods was 0.59, indicating moderate agreement. Forty-three (93%) of our patients and 34 (74%) of the care providers preferred nHgb over iHgb if results were equivalent. At our institution, the cost per iHgb monitoring is approximately $28 per blood draw as compared with $5 for nHgb monitoring. Interestingly, no patients required postoperative transfusion during the study period, as asymptomatic patients with no cardiac disease are typically observed unless the Hgb is <6. CONCLUSIONS: nHgb monitoring in postoperative pediatric patients overestimated Hgb levels compared with the standard of care methods; however, nHgb had high patient and provider satisfaction and had moderate agreement with iHgb. As no patients required transfusion, postoperative Hgb checks could likely be discontinued in some portion of our population. LEVEL OF EVIDENCE: Level Ib-Diagnostic study.

Combined Percutaneous Tracheostomy and Endoscopic Gastrostomy Tubes in COVID-19: A Prospective Series of Patient Outcomes.

Background: A significant number of patients with severe respiratory failure related to COVID-19 require prolonged mechanical ventilation. Minimal data exists regarding the timing, safety, and efficacy of combined bedside percutaneous tracheostomy and endoscopy gastrostomy tube placement in these patients. The safety for healthcare providers is also in question. This study's objective was to evaluate the effectiveness and safety of combined bedside tracheostomy and gastrostomy tube placement in COVID-19 patients. Design and Methods: This is a single arm, prospective cohort study in patients with COVID-19 and acute respiratory failure requiring prolonged mechanical ventilation who underwent bedside tracheostomy and percutaneous endoscopic gastrostomy placement. Detailed clinical and procedural data were collected. Descriptive statistics were employed and time to event curves were estimated and plotted using the Kaplan Meier method for clinically relevant prespecified endpoints. Results: Among 58 patients, the median total intensive care unit (ICU) length of stay was 29 days (24.7-33.3) with a median of 10 days (6.3-13.7) postprocedure. Nearly 88% of patients were weaned from mechanical ventilation postprocedure at a median of 9 days (6-12); 94% of these were decannulated. Sixty-day mortality was 10.3%. Almost 90% of patients were discharged alive from the hospital. All procedures were done at bedside with no patient transfer required out of the ICU. A median of 3.0 healthcare personnel total were present in the room per procedure. Conclusion: This study shows that survival of critically ill COVID-19 patients after tracheostomy and gastrostomy was nearly 90%. The time-to-event curves are encouraging regarding time to weaning, downsizing, decannulation, and discharge. A combined procedure minimizes the risk of virus transmission to healthcare providers in addition to decreasing the number of anesthetic episodes, transfusions, and transfers patients must undergo. This approach should be considered in critically ill COVID-19 patients requiring prolonged mechanical ventilation.

Effect of post-harvest interventions on surficial carrot bacterial community dynamics, pathogen survival, and antibiotic resistance.

Strategies to mitigate antibiotic-resistant bacteria (ARB), including human pathogens, on raw vegetables are needed to reduce incidence of resistant infections. The objective of this research was to determine the effectiveness of standard post-harvest interventions, sanitizer washing and cold storage, to reduce ARB, including antibiotic resistant strains of the human pathogen E. coli O15:H7 and a common spoilage bacterium Pseudomonas, on raw carrots. To provide a background inoculum representing potential pre-harvest carryover of ARB, carrots were dip-inoculated in dairy cow manure compost slurry and further inoculated with known ARB. Inoculated carrots were washed with one of three treatments: sodium hypochlorite (50 ppm free chlorine), peroxyacetic acid (40 ppm peroxyacetic acid; 11.2% hydrogen peroxide), tap water (no sanitizer), or no washing (control). Washed carrots were air dried, packaged and stored at 10 °C for 7d or 2 °C for up to 60 d. Enumeration was performed using total heterotrophic plate counts (HPC), HPCs on antibiotic-containing media ("ARBs"), E. coli O157:H7, and Pseudomonas sp. immediately after washing (0 d) and after 7 d of storage. In addition to the cultured bacteria, changes to the surficial carrot microbiota were profiled by sequencing bacterial 16S rRNA gene amplicons to determine the effect of sanitizer wash, storage temperature, and time of storage (0, 1, 7, 14 and 60 d). Storage temperature, addition of a sanitizer during wash, and duration of storage significantly affected the bacterial microbiota (Wilcoxon, p < 0.05). Inclusion of either sanitizer in the wash water significantly reduced the log CFU/g of E. coli O157:H7 and Pseudomonas sp., as well as HPCs enumerated on cefotaxime- (10 µg/ml), sulfamethoxazole- (100 µg/ml), or tetracycline (3 µg/ml) supplemented media compared to the unwashed control (ANOVA, p < 0.05). However, no significant reductions to bacteria resistant to vancomycin or clindamycin occurred after washing and storage. Members of the Proteobactetria, Firmicutes, Actinobacteria, Planctomycetes, and Acidobacteria comprised the bacterial carrot microbiota. The diversity of the carrot microbiota was significantly affected by the temperature of storage and by extended storage (60 d), when spoilage began to occur. There were no significant differences to the relative abundance of bacterial groups associated with the type of sanitizer used for washing. Results of this study indicate that inclusion of a sanitizer in wash water, followed by storage at 2 °C, might be an effective strategy to prevent re-growth of pathogenic E. coli O157:H7 and reduce levels of bacteria resistant to certain antibiotics on carrots.