Monthly pediatrics bulletin — September 28, 2026

Period covered: August 29 to September 28, 2026. A month marked by major regulatory approvals in rare diseases and pediatric nephrology, the American Academy of Pediatrics 2026-2027 immunization guidance, and surveillance data (neonatal mortality in Africa and Asia, adolescent vaccination in the United States, Dominican epidemiology). In neonatology we found no new verifiable randomized trial in the past four weeks: the papers in circulation (dexamethasone eye drops for retinopathy, vitamin K, French nirsevimab data) date from July and August, so that section relies on surveillance data. We also found no verifiable publications this month from Japan, China, Korea, Russia or the Arab world despite searches in those languages; this month's items from outside North America and Western Europe come from sub-Saharan Africa and Bangladesh, the Dominican Republic, and one multinational trial. Fifteen verified items.

Neonatology

1. Eight in ten neonatal deaths and stillbirths in seven high-mortality countries were preventable (CHAMPS network)

[Publication] [Sub-Saharan Africa and Bangladesh]
On September 8 the CDC published in MMWR Surveillance Summaries the eight-year summary (2016-2024) of the CHAMPS network in Bangladesh, Ethiopia, Kenya, Mali, Mozambique, Sierra Leone and South Africa: of 18,784 eligible deaths, 8,500 were fully investigated with minimally invasive tissue sampling, laboratory testing and verbal autopsy. Among 3,230 neonatal deaths, complications of prematurity (about 40%), perinatal asphyxia (38%) and sepsis (37%) were the leading causes, with 44% of cases having two or more causes; among 3,199 stillbirths, perinatal asphyxia or hypoxia appeared in nearly 80%. Gram-negative bacilli accounted for about 86% of pathogen-associated neonatal deaths, with Klebsiella pneumoniae in nearly half; the expert panel judged 80.7% of deaths preventable or possibly preventable.
Why it matters: this is the best series of pathologically confirmed causes of neonatal death in low-income countries, but the sites are not nationally representative, facility deaths are over-captured, and "preventability" is an expert judgment. The applicable lesson is the weight of multidrug-resistant gram-negative sepsis and intrapartum asphyxia, both live problems in Dominican maternity units.
https://doi.org/10.15585/mmwr.ss7506a1

2. Dominican Republic: neonatal deaths remain 81% of infant mortality

[Epidemiological alert] [Dominican Republic]
According to epidemiological bulletin No. 36 of the Ministry of Public Health (notifications through September 12), released September 24-26, the country has recorded 1,349 infant deaths in 2026 versus 1,372 in the same period of 2025 (about 2% fewer); neonatal deaths fell from 1,118 to 1,100 and represent 81.5% of infant deaths. Maternal deaths fell from 126 to 101 (20% fewer; 52 Dominican, 47 Haitian).
Why it matters: the reduction is marginal and the neonatal share barely moves, which suggests that further gains will come not from vaccination or diarrhea control but from delivery care, neonatal resuscitation and management of the preterm infant and sepsis, that is, from hospital quality. These are official surveillance figures, not a study, and the bulletin itself does not break down causes.
https://listindiario.com/la-republica/sector-salud/20260926/pais-registra-50-mas-casos-dengue-ano_923706.html

Infectious diseases, vaccines and emergency care

3. AAP expands respiratory syncytial virus immunization to more high-risk children in their second season

[Guideline] [United States]
The American Academy of Pediatrics policy statement for the 2026-2027 season, published in Pediatrics on September 2, maintains immunization of all infants under 8 months born during or entering their first season (unless protected by maternal RSVpreF vaccination at least 14 days before delivery) and broadens the high-risk criteria for the second season (8 to 19 months): infants born before 32 weeks regardless of support needs, hemodynamically significant congenital heart disease, anatomic pulmonary abnormalities or neuromuscular disorders, Down syndrome and other chromosomal differences, in addition to the previous groups. Nirsevimab and clesrovimab are recommended without preference under 8 months; only nirsevimab is indicated for the second season. The AAP estimates 50,000 to 80,000 RSV hospitalizations per year among US children under 5.
Why it matters: the expansion is reasonable but rests on risk extrapolation, not on second-season trials in those subgroups. In the Dominican Republic none of the three products is in the public schedule; the guidance helps orient private use and advocacy before the authorities.
https://www.aap.org/en/news-room/news-releases/aap/2026/american-academy-of-pediatrics-issues-recommendations-for-rsv-immunizations-2026-2027/

4. 2026-2027 COVID-19 vaccine: AAP recommends universal dosing at 6 to 23 months and risk-based dosing at 2 to 18 years

[Guideline] [United States]
In the policy statement and technical report published the same September 2, the AAP Committee on Infectious Diseases recommends vaccinating all children aged 6 to 23 months and a single dose for those aged 2 to 18 with risk conditions, in congregate care, never vaccinated, or living with high-risk household contacts, offering it to any other child on parental request. Supporting data: infants under 6 months had a cumulative hospitalization rate of 251 per 100,000 in 2024-2025, higher than adults aged 65 to 74; about 73% of hospitalized children aged 2 to 17 had a qualifying condition, and fewer than 4% of eligible hospitalized children were up to date. Myocarditis is estimated at 1.2 to 6.9 cases per million doses.
Why it matters: the AAP departs from current US federal recommendations, confirming the schism in that country's vaccine policy; the infant hospitalization data are solid, the effectiveness data are observational. In the Dominican Republic the pediatric vaccine is not routinely available, so the practical impact is informational.
https://doi.org/10.1542/peds.2026-079045

5. HPV vaccination coverage among US adolescents has stalled for four years

[Publication] [United States]
The CDC 2025 NIS-Teen report (MMWR 75(34), 18,692 adolescents aged 13 to 17) shows that 77.7% received at least one HPV vaccine dose and only 63.4% completed the series, unchanged since 2021 and far from the 80% target. Tdap and MenACWY remain near 89%, with slight declines. HPV coverage is 12 points lower in rural than urban areas across all income levels, and ranges from 49.5% (Mississippi) to 94.1% (Rhode Island) by state.
Why it matters: this is a telephone survey with a 21% response rate and provider verification in only 42%, so it may underestimate by about 5 points; even so, the plateau is real and coincides with rising vaccine hesitancy. A useful reminder now that the single-dose HPV schedule makes it easier to complete protection in one visit.
https://doi.org/10.15585/mmwr.mm7534a1

6. Dominican Republic: dengue up 50% and pertussis multiplies, though within the safety corridor

[Epidemiological alert] [Dominican Republic]
Epidemiological bulletin No. 36 of the Ministry of Public Health reports 338 confirmed dengue cases and one death in 2026 versus 220 cases in the same period of 2025 (50% more), with 16 cases in week 36 and the curve below the alarm threshold; the country remains among the lowest cumulative incidences in the Americas. Pertussis rose from 1 to 8 cases, meningococcal disease from 14 to 20 and non-neonatal tetanus from 14 to 19; leptospirosis nearly doubled (275 cases, 19 deaths, concentrated in Puerto Plata after flooding), while malaria fell 82% (137 cases). Severe acute respiratory infections have been declining since week 27.
Why it matters: absolute numbers are low, but the rebound in pertussis and meningococcal disease calls for a review of pentavalent coverage and continued clinical suspicion in infants with paroxysmal cough; the rainy season justifies reviewing dengue warning signs with emergency staff.
https://n.com.do/2026/09/25/rd-acumula-338-casos-de-dengue-y-137-de-malaria-en-lo-que-va-del-2026/

General pediatrics, development, nutrition and adolescence

7. STEP Young: 40% of children aged 6 to 11 with obesity moved out of the obesity category on semaglutide

[Industry] [Denmark, multinational trial]
Novo Nordisk announced on September 7 the topline results of the phase 3 STEP Young trial: 165 children aged 6 to under 12 with obesity (more than 85% with class II or III obesity), randomized to once-weekly subcutaneous semaglutide (maximum dose 1.7 or 2.4 mg by weight) or placebo, both with a reduced-calorie diet and physical activity, for 68 weeks. The primary endpoint (percentage change in BMI) was met, but the company did not disclose the magnitude; the confirmatory secondary endpoint shows that 40.4% of treated children fell below the 95th percentile versus 0% on placebo. Safety is described as consistent with prior studies, with no signals on growth or puberty.
Why it matters: this is a manufacturer press release, without primary-endpoint or adverse-event figures, in a small trial required as a post-marketing commitment; full data will be presented at ObesityWeek (November 14-17). There is no authorization under age 12 and, in the Dominican setting, price and the lack of structured lifestyle programs are bigger barriers than the evidence.
https://www.globenewswire.com/news-release/2026/09/07/3357042/0/en/novo-nordisk-step-young-phase-3-data-40-4-of-children-living-with-obesity-achieved-a-bmi-below-the-obesity-threshold-with-semaglutide-and-lifestyle-modification.html

8. Vosoritide increases growth velocity by 2.3 cm/year in hypochondroplasia (CANOPY-HCH-3)

[Clinical trial] [Multinational, 9 countries]
Published in NEJM Evidence on September 9 and presented at ESPE 2026: 81 children aged 3 to under 18 with confirmed hypochondroplasia and height below -2 SD, randomized 1:1 to daily subcutaneous vosoritide (n = 41) or placebo (n = 40) for 52 weeks at 23 sites. Annualized growth velocity changed by +1.95 cm/year with vosoritide versus -0.39 cm/year with placebo (difference 2.33 cm/year; 95% CI 1.85 to 2.82; P < 0.0001); height improved by 2.35 cm and Z-score by 0.39. No attributable serious adverse events or discontinuations.
Why it matters: a well-designed, pre-registered trial, but one year long, BioMarin-funded, excluding children under 3 and without adult height data; the manufacturer has already submitted the indication extension to the FDA and EMA (possible 2027 launch). In the Dominican context the drug is neither available nor affordable, but it is worth knowing to counsel families.
https://doi.org/10.1056/EVIDoa2600257

9. Emergency visits for suicide or self-harm among US children and adolescents rose 74% from 2016 to 2022

[Publication] [United States]
A Nationwide Emergency Department Sample study (published in Annals of Emergency Medicine on September 3) of 5.4 million weighted visits by children aged 5 to 17 with a primary mental health diagnosis: suicide-related visits rose from 224,850 to 391,491 (74% more) and all mental health visits by 24% (668,054 to 858,638). Half of suicide-related visits occurred at low-pediatric-volume departments, where about 30% of children with mental health problems were transferred to another hospital.
Why it matters: these are visit counts, not children, with administrative codes and no causal explanation, but the trend matches every prior series. The operational message is that every emergency department, not only pediatric ones, must be ready for initial screening and containment of the adolescent in crisis, something directly applicable to Dominican general hospitals.
https://doi.org/10.1016/j.annemergmed.2026.07.015

10. FDA approves baricitinib for severe alopecia areata in adolescents aged 12 to 17

[FDA regulatory] [United States]
Lilly announced on September 25 the expansion of baricitinib (an oral JAK inhibitor) to patients 12 and older with severe alopecia areata, based on the phase 3 BRAVE-AA-PEDS trial: 257 adolescents with SALT ≥ 50 (baseline median 100, that is, total loss) randomized to 4 mg, 2 mg or placebo. At week 36, at least 80% scalp coverage was achieved by 42% on 4 mg, 27% on 2 mg and 5% on placebo. It retains the JAK-inhibitor boxed warning (serious infections, thrombosis, malignancy) and requires tuberculosis screening and monitoring of blood counts, transaminases and lipids.
Why it matters: clear efficacy in a disease with enormous psychosocial impact, but with a safety profile that has short follow-up in adolescents; prescribing should remain with dermatology under strict monitoring.
https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-olumiant-baricitinib-pediatric-patients-12

11. Tezepelumab meets co-primary endpoints in eosinophilic esophagitis from age 12 (CROSSING)

[Industry] [United States and United Kingdom]
Amgen and AstraZeneca announced in mid-September topline results of the phase 3 CROSSING trial: 368 patients aged 12 to 80 with eosinophilic esophagitis, randomized to subcutaneous tezepelumab every 4 weeks or placebo; the anti-TSLP antibody improved esophageal histology and dysphagia scores at week 24, with effect sustained through week 52. No efficacy or adverse-event figures have been released.
Why it matters: it would be the second biologic in this disease after dupilumab, but for now it is a release without data; conference presentation and publication should precede any conclusion.
https://www.contemporarypediatrics.com/view/tezepelumab-meets-co-primary-and-secondary-endpoints-in-phase-3-eosinophilic-esophagitis-trial

Pediatric surgery and subspecialties

12. Obinutuzumab: first FDA approval for childhood-onset idiopathic nephrotic syndrome in 70 years

[FDA regulatory] [United States, multinational trial]
On September 25 the FDA approved obinutuzumab (anti-CD20) to reduce relapse risk in patients aged 2 and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in complete remission. It is based on the open-label phase 3 INShore trial: 85 patients aged 2 to 25 (63.5% under 12) randomized to intravenous obinutuzumab (days 1, 15, 168 and 182) or mycophenolate for 52 weeks, with steroid taper. Sustained complete remission at week 52: 95.5% versus 73.2% (difference 23.4 points; P = 0.003); relapses 4 versus 23; lower cumulative steroid dose. Grade 3 or higher adverse events: 25% versus 7.3%, with 36% infusion-related reactions; the label warns of hepatitis B reactivation, progressive multifocal leukoencephalopathy and higher risk of serious infections, and requires live vaccines at least 28 days beforehand.
Why it matters: the trial is small, open-label and funded by Roche/Genentech, and by week 76 the difference was no longer significant, suggesting the effect fades unless redosed; even so, it is the first randomized evidence of an anti-CD20 against a standard steroid-sparing agent. Rituximab, cheaper and widely used off-label, remains the realistic option in the Dominican setting.
https://www.gene.com/media/statements/ps_092526

13. FDA approves apitegromab, first muscle-targeted therapy for spinal muscular atrophy

[FDA regulatory] [United States]
On September 11 the FDA approved apitegromab (Scholar Rock's anti-myostatin antibody) as an add-on for patients aged 2 and older with spinal muscular atrophy already receiving nusinersen or risdiplam. In the phase 3 SAPPHIRE trial (188 non-ambulatory patients aged 2 to 21; primary analysis in 156 aged 2 to 12), the 10 mg/kg intravenous dose every 4 weeks improved the Hammersmith Functional Motor Scale Expanded by 2.2 points versus placebo at one year, and 34.2% achieved a gain of 3 points or more versus 13.5% on placebo. Adverse effects: respiratory infections, vomiting, cough and increased fracture risk.
Why it matters: the functional benefit is modest but real in a population already plateaued on gene-targeted therapy; the primary analysis excluded patients over 12 and the manufacturer funded the trial. It is an additional (not replacement) treatment of very high cost, relevant mainly for the few Dominican patients who access nusinersen or risdiplam through special channels.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-therapy-target-muscle-loss-spinal-muscular-atrophy

14. First gene therapy for Sanfilippo syndrome type A (mucopolysaccharidosis IIIA)

[FDA regulatory] [United States]
On September 17 the FDA approved rebisufligene etisparvovec (Fayuvi, Ultragenyx), a single-dose intravenous AAV9 gene therapy delivering the SGSH gene, for children with mucopolysaccharidosis IIIA, a neurodegenerative disease with mean survival of 15 years. The approval rests on a single-arm open-label study in children aged 2 to 5, with a median follow-up of 4.8 years, in which treated children maintained or improved cognitive function versus the expected decline of a historical cohort. Common adverse events: transaminase elevation, vomiting, fever, cytopenias; warning for thrombotic microangiopathy and corticosteroid prophylaxis for at least 8 weeks.
Why it matters: a milestone for families, but the evidence is a historical comparison without a concurrent control group, with uncertainty about durability and long-term oncogenic risk. It strengthens the case for expanded newborn screening, because benefit requires treating before deterioration.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-pediatric-patients-sanfilippo-syndrome-type

15. Zilganersen, first approved treatment for Alexander disease

[FDA regulatory] [United States]
On September 3 the FDA approved zilganersen (Ionis), a quarterly intrathecal antisense oligonucleotide that degrades GFAP messenger RNA, for Alexander disease from infancy. The pivotal trial randomized 49 patients aged 1.5 to 53 years 2:1 versus untreated control: in patients over 5 with impaired gait, walking speed improved by a relative 33% at week 61 (P = 0.04); in those aged 2 to 4 a motor composite improved, and plasma GFAP fell 33.6%. Under age 2, approval rests on pharmacokinetic modeling and four infants in a safety substudy. Adverse effects: vomiting, back pain, post-lumbar-puncture syndrome and cases of aseptic meningitis.
Why it matters: the first drug for an ultra-rare leukodystrophy (under 1 per million), with an effect on a functional endpoint in a tiny sample and a borderline P value; extrapolation to infants is the most fragile part. Mostly of conceptual interest: it shows intrathecal antisense drugs can modify an astrocytopathy.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-alexander-disease

Cross-cutting

Guidelines and other items this month: IDSA updated its histoplasmosis guidance on September 16 (including when to treat pediatric pulmonary disease with itraconazole); the FDA granted Breakthrough Device Designation to an intravenous insulin dosing algorithm for hospitalized children under 2 (not yet cleared); and Abbott launched on September 7 the first ready-to-feed whole-milk infant formula in the United States (commercial announcement, no clinical data). Regional coverage: we found no verifiable publications this month in the pediatric journals of Japan, China, Korea, Russia, Turkey or the Arab world; in Brazil, the Brazilian Society of Pediatrics' resuscitation guideline for infants under 34 weeks (June 2026) remains current, with no news this month.

Upcoming meetings and dates

AAP National Conference & Exhibition, San Diego, October 2-6, 2026 (with virtual access). ObesityWeek 2026, Washington, November 14-17 (full STEP Young data). FDA decision on satralizumab for MOGAD from age 12 expected by January 10, 2027. jENS 2027 (joint European Neonatal Societies), September 21-25, 2027. The Dominican Society of Pediatrics has announced its 2027 National Congress (80th anniversary); we found no scientific activity of its own announced for October.

Monthly pediatrics bulletin — September 28, 2026
Fifteen verified items from the past month: NEJM Evidence, Pediatrics, MMWR, Annals of Emergency Medicine, FDA announcements and the Dominican epidemiological bulletin.
Three worth your time:
• Obinutuzumab achieved sustained remission at 52 weeks in 95.5% vs 73.2% with mycophenolate in steroid-dependent nephrotic syndrome (INShore, n = 85) and the FDA approved it from age 2; open-label, manufacturer-funded, and the difference fades by week 76.
• The AAP expands second-season nirsevimab to preterm infants <32 weeks, significant heart disease, neuromuscular disorders and Down syndrome (8-19 months); risk extrapolation, not new trials.
• CHAMPS (CDC): among 8,500 investigated deaths in seven countries, prematurity, asphyxia and Klebsiella sepsis dominate neonatal mortality and 81% were preventable; sites not representative, but the lesson applies to maternity units everywhere.
Full bulletin, with a critical reading of each study and links to the primary sources:
https://boletinesmedicos.com/en/pediatria/2026-09-28.html
#Pediatrics #Neonatology #ChildHealth #Nephrology #Vaccines

Pediatrics bulletin, Sept 2026: FDA approves obinutuzumab for childhood nephrotic syndrome, sustained remission 95.5% vs 73.2% (n=85). AAP expands second-season nirsevimab to preterm <32 wk. 15 items: https://boletinesmedicos.com/en/pediatria/2026-09-28.html