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1.
Ther Innov Regul Sci ; 2022 Apr 26.
Article in English | MEDLINE | ID: covidwho-1803265

ABSTRACT

The literature thoroughly describes the challenges of pediatric drug development for rare diseases. This includes (1) generating interest from sponsors, (2) small numbers of children affected by a particular disease, (3) difficulties with study design, (4) lack of definitive outcome measures and assessment tools, (5) the need for additional safeguards for children as a vulnerable population, and (6) logistical hurdles to completing trials, especially with the need for longer term follow-up to establish safety and efficacy. There has also been an increasing awareness of the need to engage patients and their families in drug development processes and to address inequities in access to pediatric clinical trials. The year 2020 ushered in yet another challenge-the COVID-19 pandemic. The pediatric drug development ecosystem continues to evolve to meet these challenges. This article will focus on several key factors including recent regulatory approaches and public health policies to facilitate pediatric rare disease drug development, emerging trends in product development (biologics, molecularly targeted therapies), innovations in trial design/endpoints and data collection, and current efforts to increase patient engagement and promote equity. Finally, lessons learned from COVID-19 about building adaptable pediatric rare disease drug development processes will be discussed.

2.
MMWR Morb Mortal Wkly Rep ; 71(13): 495-502, 2022 Apr 01.
Article in English | MEDLINE | ID: covidwho-1771891

ABSTRACT

CDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted.


Subject(s)
COVID-19 , Influenza Vaccines , Adolescent , Adult , Ambulatory Care , COVID-19/prevention & control , COVID-19 Vaccines , Emergency Service, Hospital , Hospitalization , Humans , Immunization, Secondary , SARS-CoV-2 , Vaccines, Synthetic
4.
J Occup Health ; 63(1): e12267, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1355861

ABSTRACT

Fatigue in resident physicians has been identified as a factor that contributes to burnout and a decline in overall wellbeing. Fatigue risk exists because of poor sleep habits and demanding work schedules that have only increased due to the COVID-19 pandemic. At this time, it is important not to lose sight of how fatigue can impact residents and how fatigue risk can be mitigated. While fatigue mitigation is currently addressed by duty hour restrictions and education about fatigue, Fatigue Risk Management Systems (FRMSs) offer a more comprehensive strategy for addressing these issues. An important component of FRMS in other shiftwork industries, such as aviation and trucking, is the use of biomathematical models to prospectively identify fatigue risk in work schedules. Such an approach incorporates decades of knowledge of sleep and circadian rhythm research into shift schedules, taking into account not just duty hour restrictions but the temporal placement of work schedules. Recent research has shown that biomathematical models of fatigue can be adapted to a resident physician population and can help address fatigue risk. Such models do not require subject matter experts and can be applied in graduate medical education program shift scheduling. It is important for graduate medical education program providers to consider these alternative methods of fatigue mitigation. These tools can help reduce fatigue risk and may improve wellness as they allow for a more precise fatigue management strategy without reducing overall work hours.


Subject(s)
Education, Medical, Graduate , Fatigue/prevention & control , Internship and Residency , Work Schedule Tolerance , COVID-19/epidemiology , COVID-19/therapy , Humans , Pandemics , SARS-CoV-2 , United States/epidemiology
6.
Neonatology ; 117(6): 736-741, 2020.
Article in English | MEDLINE | ID: covidwho-949225

ABSTRACT

BACKGROUND: Bubble CPAP may be used in infants with suspected or confirmed COVID-19. Electrostatic filters may reduce cross infection. This study aims to determine if including a filter in the bubble CPAP circuit impacts stability of pressure delivery. METHODS: A new electrostatic filter was placed before (pre) or after (post) the bubble CPAP generator, or with no filter (control) in an in vitro study. Pressure was recorded at the nasal interface for 18 h (6 L/min; 7 cm H2O) on 3 occasions for each configuration. Filter failure was defined as pressure >9 cm H2O for 60 continuous minutes. The filter was weighed before and after each experiment. RESULTS: Mean (SD) time to reach the fail point was 257 (116) min and 525 (566) min for filter placement pre- and post-CPAP generator, respectively. Mean pressure was higher throughout in the pre-generator position compared to control. The filter weight was heavier at end study in the pre- compared to the post-generator position. CONCLUSIONS: Placement of the filter at the pre-generator position in a bubble CPAP circuit should be avoided due to unstable mean pressure. Filters are likely to become saturated with water over time. The post-generator position may accommodate a filter, but regular pressure monitoring and early replacement are required.


Subject(s)
COVID-19/prevention & control , Continuous Positive Airway Pressure/instrumentation , Filtration/methods , Respiratory Distress Syndrome, Newborn/therapy , Ventilators, Mechanical , Equipment Design , Humans , In Vitro Techniques , Infant , Infant, Newborn , Pressure , Respiration , Tidal Volume
7.
MMWR Morb Mortal Wkly Rep ; 69(34): 1166-1169, 2020 Aug 28.
Article in English | MEDLINE | ID: covidwho-732630

ABSTRACT

Although non-Hispanic American Indian and Alaska Native (AI/AN) persons account for 0.7% of the U.S. population,* a recent analysis reported that 1.3% of coronavirus disease 2019 (COVID-19) cases reported to CDC with known race and ethnicity were among AI/AN persons (1). To assess the impact of COVID-19 among the AI/AN population, reports of laboratory-confirmed COVID-19 cases during January 22†-July 3, 2020 were analyzed. The analysis was limited to 23 states§ with >70% complete race/ethnicity information and five or more laboratory-confirmed COVID-19 cases among both AI/AN persons (alone or in combination with other races and ethnicities) and non-Hispanic white (white) persons. Among 424,899 COVID-19 cases reported by these states, 340,059 (80%) had complete race/ethnicity information; among these 340,059 cases, 9,072 (2.7%) occurred among AI/AN persons, and 138,960 (40.9%) among white persons. Among 340,059 cases with complete patient race/ethnicity data, the cumulative incidence among AI/AN persons in these 23 states was 594 per 100,000 AI/AN population (95% confidence interval [CI] = 203-1,740), compared with 169 per 100,000 white population (95% CI = 137-209) (rate ratio [RR] = 3.5; 95% CI = 1.2-10.1). AI/AN persons with COVID-19 were younger (median age = 40 years; interquartile range [IQR] = 26-56 years) than were white persons (median age = 51 years; IQR = 32-67 years). More complete case report data and timely, culturally responsive, and evidence-based public health efforts that leverage the strengths of AI/AN communities are needed to decrease COVID-19 transmission and improve patient outcomes.


Subject(s)
Alaskan Natives/statistics & numerical data , Coronavirus Infections/ethnology , Health Status Disparities , Indians, North American/statistics & numerical data , Pneumonia, Viral/ethnology , Adolescent , Adult , Aged , Betacoronavirus/isolation & purification , COVID-19 , COVID-19 Testing , Child , Child, Preschool , Clinical Laboratory Techniques , Coronavirus Infections/diagnosis , Coronavirus Infections/therapy , Female , Humans , Incidence , Infant , Infant, Newborn , Male , Middle Aged , Pandemics , Pneumonia, Viral/diagnosis , Pneumonia, Viral/therapy , SARS-CoV-2 , Severity of Illness Index , Treatment Outcome , United States/epidemiology , Young Adult
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