Low-cost pneumonia vaccine breaks into global market

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By Ann Danaiya Usher

The Lancet, May 18, 2019

 

The Executive Director of the Serum Institute Suresh Jadhav says that he expects the approval process to be completed before the end of the year.

Gavi has already included the new product in its line-up for next year, with a list price of $6 per immunised child. A Gavi spokesperson explained that a country wishing to introduce the new vaccine or to switch to the Serum Institute of India's product must first express demand for the vaccine. UNICEF then initiates procurement activities with the manufacturer. This process can start right away, although supply arrangements can only be finalised when the WHO prequalification is complete.”

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National, regional, and state-level all-cause and cause-specific under-5 mortality in India in 2000–15: a systematic analysis with implications for the Sustainable Development Goals

By Li Liu, Yue Chu, Shefali Oza, Dan Hogan, Jamie Perin, Diego G Bassani, et al.

 The Lancet Global Health, June 1, 2019

 

India had the largest number of under-5 deaths of all countries in 2015, with substantial subnational disparities. We estimated national and subnational all-cause and cause-specific mortality among children younger than 5 years annually in 2000–15 in India to understand progress made and to consider implications for achieving the Sustainable Development Goal (SDG) child survival targets.

 

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National, regional, and state-level burden of Streptococcus pneumoniae and Haemophilus influenzae type b disease in children in India: modelled estimates for 2000–15

By Brian Wahl, Apoorva Sharan, Maria Deloria Knoll, Prof Rajesh Kumar, Li Liu, Yue Chu, et al.

 The Lancet Global Health, June 1, 2019

 

India accounts for a disproportionate burden of global childhood illnesses. To inform policies and measure progress towards achieving child health targets, we estimated the annual national and state-specific childhood mortality and morbidity attributable to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) between 2000 and 2015.

 

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National, regional, and global levels and trends in neonatal mortality between 1990 and 2017, with scenario-based projections to 2030: a systematic analysis

By Lucia Hug, Monica Alexander, Danzhen You, Leontine Alkema on behalf of the UN Inter-agency Group for Child Mortality Estimation

The Lancet Global Health, June 1, 2019

 

Reducing neonatal mortality is an essential part of the third Sustainable Development Goal (SDG), to end preventable child deaths. To achieve this aim will require an understanding of the levels of and trends in neonatal mortality. We therefore aimed to estimate the levels of and trends in neonatal mortality by use of a statistical model that can be used to assess progress in the SDG era. With these estimates of neonatal mortality between 1990 and 2017, we then aimed to assess how different targets for neonatal mortality could affect the burden of neonatal mortality from 2018 to 2030.

 

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The AEIOU of essential diagnostics: align, expand, implement, oversee, and update

By Julia E von Oettingen, Ophira Ginsburg, Sandeep P Kishore, Sonak D Pastakia, Lee F Schroeder, Dan A Milner, et al.

The Lancet Global Health, June 1, 2019

 

Heart attack, diabetes, cancer: these common clinical diagnoses can (and should) be confirmed with a diagnostic test. However, in large parts of the world, up-to-date, cost-effective, and simple diagnostic tools remain unavailable.  Patients and health-care providers in such settings are often reliant on so-called syndromic medicine, whereby diagnoses are made on the basis of clinical judgment and treatment is administered empirically. This approach is less than ideal, because it carries the risk of misdiagnosis, unnecessary or harmful treatments, adverse sequelae, and even death.

 

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Machine Learning at the Clinical Bedside—The Ghost in the Machine

By Joseph J. Zorc, James M. Chamberlain, Lalit Bajaj

 

JAMA Pediatrics, May 13, 2019

In this issue of JAMA Pediatrics, Bertsimas et al1 describe a novel machine-learning approach to derive a revised version of the head injury prediction rule developed by the Pediatric Emergency Care Applied Research Network (PECARN). The PECARN rule was derived and validated using a prospectively collected data set of more than 42 000 patients to classify which children with head injury are at very low risk of clinically significant intracranial abnormalities.2 The ultimate goal of such a decision rule is to reduce unnecessary computed tomographic imaging and associated radiation. Bertsimas et al1 analyzed a public use data set from the PECARN study using a technique called optimal classification trees. The revised rule has improved specificity and predictive value, identifying 33% more children younger than 2 years, and 14% more children 2 years or older as having a very low risk for intracranial injury compared with the PECARN rule, without missing any additional cases of intracranial injury. Although this is good use of the public use data sets now required for federally funded research, interpreting machine-learning techniques may be challenging for clinicians to understand and apply as the techniques become increasingly complex. Although we live in an era of precision medicine, with the ability to tailor personalized recommendations, it is also an era emphasizing shared decision making between clinicians and patients. It may be difficult for clinicians to counsel patients about the implications of a rule that is perceived as a black box or ghost in the machine, which may provide recommendations for unclear reasons.

 

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Human bocaviruses and paediatric infections

By Andreas Christensen, Olli Kesti, Varpu Elenius, Anna L. Eskola, Henrik Døllner, Can Altunbulakli, Cezmi A. Akdis, Maria Söderlund-Venermo, Tuomas Jartti

The Lancet Child & Adolescent Health, June 2019

 

 

Human bocavirus 1 (HBoV1), belonging to the Parvoviridae family, was discovered in 2005, in nasopharyngeal samples from children with respiratory tract infections. Three additional bocaviruses, HBoV2-4, were discovered in 2009-10. These viruses have mainly been found in faecal samples and their role in human diseases is still uncertain. HBoV1 causes a wide spectrum of respiratory diseases in children, including common cold, acute otitis media, pneumonia, bronchiolitis, and asthma exacerbations. HBoV1 DNA can persist in airway secretions for months after an acute infection. Consequently, acute HBoV1 infection cannot be diagnosed with standard DNA PCR; quantitative PCR and serology are better diagnostic approaches. Because of their high clinical specificity, diagnostic developments such as HBoV1 mRNA and antigen detection have shown promising results. This Review summarises the knowledge on human bocaviruses, with a special focus on HBoV1.

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Serum Procalcitonin Levels in Children with Clinical Syndromes for Targeting Antibiotic Use at an Emergency Department of a Kenyan Hospital

By Samuel O Akech, MMED, PhD  Doris W Kinuthia, MMED  William Macharia, MMED, MSC

 

Journal of Tropical Pediatrics, May 2019

 

Serum procalcitonin (PCT) was measured in 228 children aged 1 month to 15 years at an emergency department of a hospital located in an area without local malaria transmission in children with suspected infections; 21% (49) children had a clinical syndrome for suspected bacterial infections (Syndrome+ve). In children with Syndrome+ve criteria, 27/49 (55.1%) had PCT ≥0.5 µg/l but only 59/179 (32.9%) of those Syndrome−ve had abnormal PCT, χ2 = 8.0, p = 0.005; positive likelihood ratio = 2.0 [95% confidence interval (CI) 1.2–3.3]; negative likelihood ratio = 0.8 (95% CI 0.7–1.0). In patients with pneumonia, 9/15 (60%) with severe pneumonia had PCT ≥0.5 µg/l compared to 11/21 (52.4%) with non-severe pneumonia, χ2 = 0.2, p = 0.65. Children with clinical signs of pneumonia or clinical signs suggestive of bacterial infections fulfilling clinical syndromic definitions for suspected bacterial infections commonly have elevated PCT level. PCT levels are associated with disease severity and antibiotic trials guided by PCT levels may be needed where cultures are not available..

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Mapping diphtheria-pertussis-tetanus vaccine coverage in Africa, 2000–2016: a spatial and temporal modelling study

By Jonathan F Mosser, MD, William Gagne-Maynard, MS, Puja C Rao, MPH, Aaron Osgood-Zimmerman, MS, Nancy Fullman, MPH, Nicholas Graetz, MPH, et al.

The Lancet, May 2019

 

Estimated third-dose (DPT3) coverage increased in 72·3% (95% uncertainty interval [UI] 64·6–80·3) of second-level administrative units in Africa from 2000 to 2016, but substantial geographical inequalities in DPT coverage remained across and within African countries. In 2016, DPT3 coverage at the second administrative (ie, district) level varied by more than 25% in 29 of 52 countries, with only two (Morocco and Rwanda) of 52 countries meeting the Global Vaccine Action Plan target of 80% DPT3 coverage or higher in all second-level administrative units with high confidence (posterior probability ≥95%). Large areas of low DPT3 coverage (≤50%) were identified in the Sahel, Somalia, eastern Ethiopia, and in Angola. Low first-dose (DPT1) coverage (≤50%) and high relative dropout (≥30%) together drove low DPT3 coverage across the Sahel, Somalia, eastern Ethiopia, Guinea, and Angola.

 

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Day clinic versus hospital care of pneumonia and severe malnutrition in children under five: a randomized trial

By Hasan Ashraf  Nur H. Alam  Marufa Sultana  Selina A. Jahan  Nurshad Begum  Sharmin Farzana  Mohammod J. Chisti  Mohiuddin Kamal, et al.

 

Tropical Medicine & International Health, May 2, 2019

 

Randomized clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomization of variable length from 8-20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients

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Influenza Vaccine Effectiveness in Preventing Influenza-associated Hospitalizations During Pregnancy: A Multi-country Retrospective Test Negative Design Study, 2010–2016

By Mark G Thompson, Jeffrey C Kwong, Annette K Regan, Mark A Katz, Steven J Drews, Eduardo Azziz-Baumgartner, Nicola P Klein, Hannah Chung, Paul V Effler, Becca S Feldman, Kimberley Simmonds, Brandy E Wyant, Fatimah S Dawood,  Michael L Jackson, Deshayne B Fell, Avram Levy, Noam Barda, Lawrence W Svenson, Rebecca V Fink, Sarah W Ball, Allison Naleway

Clinical Infectious Diseases, May 2019

 

The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) consisted of public health or healthcare systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and the United States (California, Oregon, and Washington). Sites identified pregnant women aged 18 through 50 years whose pregnancies overlapped with local influenza seasons from 2010 through 2016. Administrative data were used to identify hospitalizations with acute respiratory or febrile illness (ARFI) and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for influenza viruses. Overall IVE was estimated using the test-negative design and adjusting for site, season, season timing, and high-risk medical conditions

 

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Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants

By William S Pomat, Anita H J van den Biggelaar, Sandra Wana, Jacinta P Francis, Vela Solomon, Andrew R Greenhill, Rebecca Ford, Tilda Orami, Megan Passey, Peter Jacoby, Lea-Ann Kirkham, Deborah Lehmann, Peter C Richmond

Clinical Infectious Diseases, May 2019

 

PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age.

 

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Persistence of Nasopharyngeal Pneumococcal Vaccine Serotypes and Increase of Nonvaccine Serotypes Among Vaccinated Infants and Their Mothers 5 Years After Introduction of Pneumococcal Conjugate Vaccine 13 in The Gambia

By Effua Usuf, Christian Bottomley, Ebrima Bojang, Isatou Cox, Abdoulie Bojang, Rebecca Gladstone, Beate Kampmann, Philip C Hill, Anna Roca

Clinical Infectious Diseases, May 2019

 

The widespread use of pneumococcal conjugate vaccine (PCV) has brought about a dramatic decrease in pneumococci of vaccine serotypes (VTs) but nonvaccine serotypes (NVTs) have emerged.

 

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Infectious Diseases Society of America Position Statement on Telehealth and Telemedicine as Applied to the Practice of Infectious Diseases

By Jeremy D Young, Rima Abdel-Massih, Thomas Herchline, Lewis McCurdy, Kay J Moyer, John D Scott, Brian R Wood, Javeed Siddiqui

Clinical Infectious Diseases, May 2019

 

Over the last 2 decades, telemedicine has effectively demonstrated its ability to increase access to care. This access has the ability to deliver quality clinical care and offer potential savings to the healthcare system. With increasing frequency, physicians, clinics, and medical centers are harnessing modern telecommunications technologies to manage a multitude of acute and chronic conditions, as well as incorporating telehealth into teaching and research. The technologies spanning telehealth, telemedicine, and mobile health (mHealth) are rapidly evolving, and the Infectious Diseases Society of America (IDSA) has prepared this updated position statement to educate its membership on the use of telemedicine and telehealth technologies. IDSA supports the appropriate and evidence-based use of telehealth technologies to provide up-to-date, timely, cost-effective subspecialty care to resource-limited populations.

 

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Impaired Proinflammatory Response in Stringently Defined Otitis-prone Children During Viral Upper Respiratory Infections

By Dabin Ren, Qingfu Xu, Anthony L Almudevar, Michael E Pichichero

Clinical Infectious Diseases, May 2019

 

Viral upper respiratory infections (URIs) are common and often precipitate acute otitis media (AOM), caused by bacterial otopathogens, in young children. Acute inflammatory responses initiated in the early phase of viral URI contribute to preventing the development of AOM. Stringently-defined otitis-prone (sOP) children are susceptible to recurrent AOM.

 

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Prevalence and Etiology of Community-acquired Pneumonia in Immunocompromised Patients

By Marta Francesca Di Pasquale, Giovanni Sotgiu, Andrea Gramegna, Dejan Radovanovic, Silvia Terraneo, Luis F Reyes, Jan Rupp, Juan González del Castillo, Francesco Blasi, Stefano Aliberti, Marcos I Restrepo

Clinical Infectious Diseases, May 1, 2019

 

The correct management of immunocompromised patients with pneumonia is debated. We evaluated the prevalence, risk factors, and characteristics of immunocompromised patients coming from the community with pneumonia.

 

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Bacterial and viral respiratory tract microbiota and host characteristics in children with lower respiratory tract infections: a matched case-control study

By Wing Ho Man, MD, Marlies A van Houten, MD, Marieke E Mérelle, MD, Arine M Vlieger, MD,Mei Ling J N Chu, BSc, Nicolaas J G Jansen, MD, et al.

The Lancet Respiratory Medicine, May 2019

 

Lower respiratory tract infections (LRTIs) are a leading cause of childhood morbidity and mortality. Potentially pathogenic organisms are present in the respiratory tract in both symptomatic and asymptomatic children, but their presence does not necessarily indicate disease. We aimed to assess the concordance between upper and lower respiratory tract microbiota during LRTIs and the use of nasopharyngeal microbiota to discriminate LRTIs from health.

 

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Characterisation of children hospitalised with pneumonia in central Vietnam: A prospective study

By Phuong T.K.Nguyen, Hoang T. Tran, Dominic A.Fitzgerald, Thach S.Tran, Stephen M.Graham, Ben J. Marais

European Respiratory Journal, May 2019 

 

 

Of 4206 admissions, 1758 (41.8%) were classified as “no pneumonia” using WHO criteria and only 252 (6.0%) met revised criteria for “severe pneumonia”. The inpatient death rate was low (0.4% of admissions) with most deaths (11/16; 68.8%) occurring in the “severe pneumonia” group. An adverse outcome was recorded in 18.7% of all admissions; 60.7% of the “severe pneumonia” group. Children were hospitalised for a median of 7 days at an average cost of 253 USD per admission. Risk factors for adverse outcome included WHO classified “severe pneumonia”, age <1 year, low birth weight, previous recent admission with an acute respiratory infection and recent tuberculosis exposure, while breastfeeding, day care attendance and preadmission antibiotic use were associated with reduced risk.

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May 2019 Member Newsletter

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Photo by Martin Kharumwa of Save the Children, South Sudan. A seven-month-old child lies on a hospital bed in Bor, South Sudan after being treated for pneumonia.                             

 

 

            

 A COMMENT FROM THE COORDINATOR                

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The Children’s Oxygen Administration Strategies Trial (COAST)

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Above, photo by Jonathan Hyams, Save the Children, Bangladesh, July 2018: Laila,* holds an oxygen mask to the face of her son Sohai,* two, at Save the Children’s primary healthcare centre (PHCC) in Cox’s Bazar, Bangladesh. Sohai* was admitted to the inpatient ward at the PHCC, suffering from acute pneumonia.

 

by Kathryn Maitland, Professor of Tropical Paediatric Infectious Diseases at Imperial College, London and KEMRI-Wellcome Trust

 

Although oxygen is a basic element of hospital care, strongly recommended as a life-saving therapy for children with severe pneumonia and specifically for children with hypoxaemia (oxygen saturations, SpO2 less than 90%), the evidence underpinning these recommendations is weak. Yet, many African hospitals lack the facility to measure oxygen saturations (using pulse oximetry) and thus, therapeutic oxygen is often poorly targeted. Furthermore, despite a high demand, there is often very limited resources of oxygen therapy which is both costly (if using bottled oxygen) and erratic (if using oxygen concentrators) as electricity is unreliable. Although oxygen has been used in supportive treatment for a large part of the last century, the recognition of oxygen toxicity as a problem has been relatively recent. Toxicity is related to the concentration of oxygen and length of exposure. Worldwide, there is an increasing recognition of the harms of oxygen therapy. The evolving literature on its harms has resulted in oxygen no longer being recommended for a number of indications. Thus, there is a justifiable scientific question about whether oxygen can be safely and effectively administered, and results in better outcomes in children with severe pneumonia.

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