Strategic Optimization of Patient Flow and Staffing Schemes during the COVID-19 Pandemic through Operations Management in a Neonatal Intensive Care Unit.

Background: The COVID-19 pandemic posed challenges in making time-bound hospital management decisions. The University of the Philippines -Philippine General Hospital (UP-PGH) is a tertiary COVID-19 referral center located in Manila, Philippines. The mismatch of increasing suspected or confirmed COVID-19 infected mothers with few documented cases of infected infants has caused significant patient overflow and manpower shortage in its NICU. Objective: We present an evaluated scheme for NICU bed reallocation to maximize capacity performance, staff rostering, and resource conservation, while preserving COVID-19 infection prevention and control measures. Methods: Existing process workflows translated into operational models helped create a solution that modified cohorting and testing schemes. Staffing models were transitioned to meet patient flow. Outcome measurements were obtained, and feedback was monitored during the implementation phase. Results: The scheme evaluation demonstrated benefits in (a) achieving shorter COVID-19 subunit length of stay; (b) better occupancy rates with minimal overflows; (c) workforce shortage mitigation with increased non-COVID workforce pool; (d) reduced personal protective equipment requirements; and (e) zero true SARS-CoV-2 infections. Conclusion: Designed for hospital operations leaders and stakeholders, this operations process can aid in hospital policy formulation in modifying cohorting schemes to maintain quality NICU care and service during the COVID-19 pandemic.

Factors Associated with Adverse Outcomes among SARS-CoV-2 Positive Children in a Tertiary Government COVID-19 Referral Hospital in the Philippines.

Background and Objective: Pediatric COVID-19 epidemiology and factors associated with adverse outcomes - mortality, need for invasive mechanical ventilation, and ICU admission, are largely unstudied. We described the clinico-demographic characteristics of Filipino pediatric COVID-19 patients and determined the factors associated with adverse outcomes. Methods: This is a retrospective cohort study of 180 hospitalized SARS-CoV-2-confirmed cases 0-18 years old from April 2020 to August 2021 in a tertiary COVID-19 referral hospital in Manila, National Capital Region. Crude associations were determined using chi-squared or Fisher's exact tests; and medians were compared using the Mann-Whitney test. Factors predictive of mortality were determined using Cox proportional hazards regression analysis. The survivor functions were depicted in graphs. Results: About 41.67% had mild disease, 58.33% were males, 39.4% aged 0-4 years, and 69.44% had at least one comorbidity. About 9.44% died (adjusted 9.2 persons per 1000 patient-days, 95% CI 5.5%-15.2%), 17.78% needed invasive mechanical ventilation, and 20% needed ICU admission. Independently, severe-critical COVID-19 (HRc 11.51, 95% CI 3.23, 41.06), retractions (HRc 10.30, 95% CI 3.27, 32.47), alar flaring (HRc 4.39, 95% CI 1.53, 12.58), cyanosis (HRc 4.39, 95% CI 1.72, 14.11), difficulty of breathing (HRc 7.99, 95% CI 2.25, 28.71), poor suck/appetite (HRc 4.46, 95% CI 1.59, 12.40), ferritin (HRc 1.01, 95% CI 1.00, 1.01), IL-6 (HRc 1.01, 95% CI 1.00, 1.01), aPTT (HRc 1.05, 95% CI 1.01, 1.10), IVIg (HRc 4.00, 95% CI 1.07, 14.92) and corticosteroid (HRc 6.01, 95% CI 2.04, 17.67) were significant hazards for mortality. In adjusted Cox analysis, only retractions (HRa 34.96, 95% CI 3.36, 363.79), seizure (HRa 9.98, 95% CI 1.76, 56.55), and corticosteroids (HRa 8.21, 95% CI 1.12, 60.38) were significantly associated with mortality while alar flaring appeared to be protective (HRa 0.10, 95% CI 0.01, 0.95). Several clinical characteristics were consistently associated with adverse outcomes. Conclusions: Majority of hospitalized pediatric COVID-19 patients were very young, males, had mild disease, and had at least one comorbidity. Mortality, invasive mechanical ventilation, and ICU admission were relatively low. Except for alar flaring which appeared to be protective, retractions, seizure, and use of corticosteroids were associated with adverse outcomes.

Expert review of global real-world data on COVID-19 vaccine booster effectiveness and safety during the omicron-dominant phase of the pandemic.

INTRODUCTION: COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. However, the emergence of the Omicron variant and subvariants as the globally dominant strains have raised doubts about the effectiveness of currently available vaccines and prompted debate about potential future vaccination strategies. AREAS COVERED: Using the publicly available IVAC VIEW-hub platform, we reviewed 52 studies on vaccine effectiveness (VE) after booster vaccinations. VE were reported for SARS-CoV-2 symptomatic infection, severe disease and death and stratified by vaccine schedule and age. In addition, a non-systematic literature review of safety was performed to identify single or multi-country studies investigating adverse event rates for at least two of the currently available COVID-19 vaccines. EXPERT OPINION: Booster shots of the current COVID-19 vaccines provide consistently high protection against Omicron-related severe disease and death. Additionally, this protection appears to be conserved for at least 3 months, with a small but significant waning after that. The positive risk-benefit ratio of these vaccines is well established, giving us confidence to administer additional doses as required. Future vaccination strategies will likely include a combination of schedules based on risk profile, as overly frequent boosting may be neither beneficial nor sustainable for the general population.

Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study.

OBJECTIVE: This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (EupentaTM) based on the occurrence of adverse events (AEs) following vaccination. METHODS: This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks. RESULTS: In all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit. CONCLUSIONS: The study vaccine  had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.

Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age.

An inactivated poliovirus vaccine candidate using Sabin strains (sIPV) grown on the PER.C6® cell line was assessed in infants after demonstrated immunogenicity and safety in adults. The study recruited 300 infants who were randomized (1:1:1:1) to receive one of 3 dose levels of sIPV or a conventional IPV based on Salk strains (cIPV). Poliovirus-neutralizing antibodies were measured before the first dose and 28 days after the third dose. Reactogenicity was assessed for 7 days and unsolicited adverse events (AEs) for 28 days after each vaccination. Serious AEs (SAEs) were recorded throughout the study. Solicited AEs were mostly mild to moderate. None of the SAEs reported in the study were judged vaccine related, including one fatal SAE due to aspiration of vomitus that occurred 26 days after the third dose of low-dose sIPV. After 3 sIPV vaccinations and across all dose levels, seroconversion (SC) rates were at least 92% against Sabin poliovirus types and at least 80% against Salk types, with a dose-response in neutralizing antibody geometric mean titers (GMTs) observed across the 3 sIPV groups. Compared to cIPV, the 3 sIPV groups displayed similar or higher SC rates and GMTs against the 3 Sabin types but showed a lower response against Salk types 1 and 2; this was most visible for Salk type 1. While the PER.C6® cell line-based sIPV showed an acceptable safety profile and immunogenicity in infants, lower seroprotection against type 1 warrants optimization of dose level and additional clinical evaluation.

Invasive meningococcal disease in Malaysia, Philippines, Thailand, and Vietnam: An Asia-Pacific expert group perspective on current epidemiology and vaccination policies.

Invasive meningococcal disease (IMD) imposes a significant burden on the global community due to its high case fatality rate (4-20%) and the risk of long-term sequelae for one in five survivors. An expert group meeting was held to discuss the epidemiology of IMD and immunization policies in Malaysia, Philippines, Thailand, and Vietnam. Most of these countries do not include meningococcal immunization in their routine vaccination programs, except for high-risk groups such as immunocompromised people and pilgrims. It is difficult to estimate the epidemiology of IMD in the highly diverse Asia-Pacific region, but available evidence indicate serogroup B is increasingly dominant. Disease surveillance systems differ by country. IMD is not a notifiable disease in some of them. Without an adequate surveillance system in the region, the risk and the burden of IMD might well be underestimated. With the availability of new combined meningococcal vaccines and the World Health Organization roadmap to defeat bacterial meningitis by 2030, a better understanding of the epidemiology of IMD in the Asia-Pacific region is needed.

Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.

BACKGROUND: Solithromycin is a new macrolide-ketolide antibiotic with potential effectiveness in pediatric community-acquired bacterial pneumonia (CABP). Our objective was to evaluate its safety and effectiveness in children with CABP. METHODS: This phase 2/3, randomized, open-label, active-control, multicenter study randomly assigned solithromycin (capsules, suspension or intravenous) or an appropriate comparator antibiotic in a 3:1 ratio (planned n = 400) to children 2 months to 17 years of age with CABP. Primary safety endpoints included treatment-emergent adverse events (AEs) and AE-related drug discontinuations. Secondary effectiveness endpoints included clinical improvement following treatment without additional antimicrobial therapy. RESULTS: Unrelated to safety, the sponsor stopped the trial prior to completion. Before discontinuation, 97 participants were randomly assigned to solithromycin (n = 73) or comparator (n = 24). There were 24 participants (34%, 95% CI, 23%-47%) with a treatment-emergent AE in the solithromycin group and 7 (29%, 95% CI, 13%-51%) in the comparator group. Infusion site pain and elevated liver enzymes were the most common related AEs with solithromycin. Study drug was discontinued due to AEs in 3 subjects (4.3%) in the solithromycin group and 1 (4.2%) in the comparator group. Forty participants (65%, 95% CI, 51%-76%) in the solithromycin group achieved clinical improvement on the last day of treatment versus 17 (81%, 95% CI, 58%-95%) in the comparator group. The proportion achieving clinical cure was 60% (95% CI, 47%-72%) and 68% (95% CI, 43%-87%) for the solithromycin and comparator groups, respectively. CONCLUSIONS: Intravenous and oral solithromycin were generally well-tolerated and associated with clinical improvement in the majority of participants treated for CABP.

A Narrative Review of Pneumococcal Disease in Children in the Philippines.

This narrative review describes the epidemiology of invasive pneumococcal diseases, nasopharyngeal carriage, and antibiotic resistance of Streptococcus pneumoniae serotypes, and vaccination coverage in children in the Philippines. Epidemiological data show that, despite the availability of the free-of-cost 13-valent pneumococcal conjugate vaccine for infants as part of the National Immunization Program, the burden of pneumococcal disease in young children remains high in the Philippines. The significant variability in data reported between studies highlights an urgent need for active and comprehensive disease surveillance for more accurate estimates of pneumococcal disease in the country. Although data from 2001 to 2013 show high rates of pneumococcal carriage in children in the Philippines aged < 5 years, contemporary data are lacking, again emphasizing the need for active surveillance programs. The introduction of pneumococcal conjugate vaccines has resulted in substantial declines in disease caused by pneumococcal serotypes included in the vaccines, but the emergence of pneumococcal disease due to nonvaccine serotypes is an ongoing concern. Surveillance of actively circulating serotypes is critical to better understand vaccine coverage. Antimicrobial resistance of S. pneumoniae remains a significant threat to public health worldwide; data regarding antibiotic resistance in young children in the Philippines are limited, but reports generally show low rates of antibiotic resistance in this group. National immunization rates have increased in recent years, yet many individuals are still unprotected from pneumococcal disease. Overall, there is a critical need for contemporary and accurate disease surveillance in the Philippines. Such data would provide better estimates of pneumococcal disease incidence, serotype distribution, and antibiotic resistance to better inform vaccination strategies and to ensure that children in the Philippines are best protected against pneumococcal disease.