Maternal RSV Vaccination, Infant Nirsevimab, or Both
Maternal RSV vaccination and infant nirsevimab immunization, administered either alone or sequentially, were safe and provided high RSV-A and -B nAb titers in infants that persisted through 3 months after delivery. While most infants will not need to receive both products to be protected, our results suggest that maternal RSV vaccination and infant nirsevimab immunization may be safely sequentially administered.
KEY FINDINGS: Maternal RSVpreF vaccine and infant nirsevimab administration, either alone or in combination, were safe and provided high RSV nAb titers in infants through interim follow-up.
BACKGROUND: Although both maternal respiratory syncytial virus (RSV) prefusion F vaccination (RSVpreF) and infant nirsevimab immunization have been approved for the prevention of RSV lower respiratory tract infections, the 2 have not been evaluated in a single study, and their sequential administration has not been studied systematically.
DETAILS: Authors performed a prospective, randomized, open-label, phase 4 study at 8 US sites of mother-infant pairs randomized 1:1:1:1 during pregnancy: maternal RSVpreF vaccine alone, maternal RSVpreF vaccine/infant nirsevimab at birth, maternal RSVpreF vaccine/infant nirsevimab at 3 months, or infant nirsevimab alone at birth. We are following the mother-infant pairs for 12 months to ascertain safety, infant tolerability, and the magnitude and durability of RSV-A and -B neutralizing antibodies (nAbs). Authors report interim data from September 19, 2024, to May 15, 2025, including 4-month infant follow-up. In total, 181 mothers were enrolled. Both products alone and in combination were safe. No related serious adverse events were observed in mothers or infants. Nirsevimab was well tolerated, and all local and systemic reactogenicity was mild to moderate in severity. RSVpreF vaccination boosted maternal RSV-A nAb titers 17.35-fold at the time of delivery, and titers were durable through 3 months postdelivery. The geometric mean transfer ratio of RSV-A nAbs was higher than 1.3 and similar across groups. RSV nAbs were highly elevated in infants at 6 weeks and 3 months, irrespective of group, with modest differences in waning.
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Source: Rostad, C. A., Mary Healy, C., Nayak, J. L., et al. Maternal RSV Vaccination, Infant Nirsevimab, or Both: Interim Analysis of a Randomized Trial. Pediatrics. 2026; 157(6): e2025075223. Published: June, 2026. DOI: 10.1542/peds.2025-075223
High-Quality Donor Kidneys Frequently Allocated to Adults Despite Pediatric Priority
Among deceased-donor kidneys with KDPI-10 below 35%, 23.4% were allocated to higher-priority adults. For ideal pediatric-quality kidneys, this proportion was 34.3%, with 77.5% received by multiorgan transplant recipients. KDPI-8 is unlikely to materially change pediatric access to ideal donor kidneys.
KEY FINDINGS: Despite pediatric allocation priority, a substantial proportion of high-quality donor kidneys continues to be allocated to adults with greater priority, predominantly multiorgan transplant recipients. The revised KDPI-8 calculation is not expected to materially alter the proportion of ideal pediatric-quality kidneys prioritized for children, although it changes the clinical composition of the donor pool by increasing the proportion of HCV-seropositive donors and reducing the proportion of donors after circulatory death. These findings highlight persistent limitations of KDPI-based allocation for pediatric candidates and support continued evaluation of policies that balance equity, donor-recipient matching, and long-term transplant outcomes.
BACKGROUND: Children receive allocation priority for deceased-donor kidneys with a kidney donor profile index (KDPI) <35%, although certain adult candidates retain higher priority. The recent transition from the 10-variable KDPI (KDPI-10) to the revised 8-variable KDPI (KDPI-8), which excludes donor race and hepatitis C virus (HCV) status, raised questions regarding its potential effect on pediatric access to high-quality donor kidneys.
DETAILS: This retrospective cohort study analyzed 60,587 deceased donors and their kidney recipients recorded in the Organ Procurement and Transplantation Network registry from January 1, 2018, through December 31, 2023. The investigators compared donor characteristics and kidney allocation patterns using KDPI-10 and KDPI-8. Ideal pediatric-quality donors were defined as donors with a KDPI <35%, donation after brain death, age <35 years, creatinine <=1.5 mg/dL, and no infectious risk, diabetes, or hypertension. Among kidneys from donors with KDPI-10 <35%, 23.4% were allocated to adults in categories with greater priority than pediatric candidates. Among ideal pediatric-quality kidneys, 34.3% were allocated to these higher-priority adult recipients, and 77.5% of these transplants were received by multiorgan transplant recipients. The proportion of donors meeting ideal pediatric-quality criteria was similar with KDPI-10 and KDPI-8 calculations (32.7% vs 33.5%). However, the KDPI-8 group included more Black donors (15.3% vs 9.9%) and HCV-seropositive donors (11.1% vs 3.6%) and fewer donors after circulatory death (12.7% vs 20.3%).
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Source: Sonnenberg, E. M., Amaral, S., Zhang, S., et al. Allocation of Kidney Allografts From Donors With Kidney Donor Profile Index <35% and the Impact of Kidney Donor Profile Index Revisions on Access to Transplantation for Children. American Journal of Kidney Diseases. 2026; Published: August 22, 2026. DOI: 10.1053/j.ajkd.2026.02.643.
Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Ranitidine Cross-Contamination
Four nationwide-distributed lots of Cetirizine Hydrochloride Tablets USP 5 mg are being voluntarily recalled because of potential ranitidine cross-contamination. Patients with ranitidine hypersensitivity may be at risk for severe allergic reactions or anaphylaxis. No recall-related adverse events had been reported.
KEY FINDINGS: Unique Pharmaceutical Laboratories has initiated a voluntary nationwide recall of four lots of Cetirizine Hydrochloride Tablets USP 5 mg because of potential cross-contamination with ranitidine. The affected product was distributed nationwide in 100-count HDPE bottles under the Rising Pharma Holdings Inc. brand. Patients with hypersensitivity to ranitidine ingredients may be at risk for serious reactions, including severe hypersensitivity and life-threatening anaphylaxis. No adverse events related to the recalled product had been reported at the time of the announcement.
The recall was initiated after a pharmacy technician identified a discrepancy while counting tablets during dispensing. A product complaint described red dots and discoloration on some cetirizine tablets. The recalled lots are GY825029, GY825030, GY825031, and GY825032, each with an expiration date of 10/2028 and NDC 16571-401-10.
The manufacturer and distributor are arranging the return of the affected products. Clinicians should consider the recall when evaluating patients who may have received the affected medication and should assess and manage any suspected adverse reactions appropriately.
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Source: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine. FDA. Published: July 20, 2026.
Obesity, Rather Than High Body Surface Area Alone, Predicts Clinically Significant Asparaginase Toxicity During Induction Therapy for Acute Lymphoblastic Leukemia
Among 4,925 children and young adults with ALL, obesitynot high BSA alonewas the strongest predictor of clinically significant asparaginase toxicity. Patients with obesity and high BSA had the highest risk of hepatic toxicity and thromboembolism, whereas induction toxicities were not associated with increased end-of-induction MRD positivity.
KEY FINDINGS: This large multicenter analysis demonstrates that obesity-not elevated BSA alone-is the principal patient-related risk factor for clinically significant asparaginase toxicity during induction therapy for ALL. The greatest excess risk occurred in patients with both obesity and high BSA, particularly for hepatic toxicity and thromboembolic events, while pancreatitis risk was unaffected. Older age independently increased toxicity risk, especially hyperbilirubinemia. Notably, induction-phase AAT did not compromise early treatment response, as measured by EOI MRD. These findings suggest that obesity should be prioritized when identifying patients for enhanced toxicity surveillance and future preventive strategies, whereas high BSA in the absence of obesity does not appear to justify dose modification based solely on body size.
BACKGROUND: Asparaginase remains a cornerstone of induction therapy for acute lymphoblastic leukemia (ALL), but treatment-limiting toxicities frequently interrupt therapy and may compromise long-term outcomes. Previous studies have produced conflicting evidence regarding whether older age, obesity, or high body surface area (BSA) independently increase the risk of asparaginase-associated toxicities (AAT). This large Children’s Oncology Group analysis evaluated the relative contributions of these risk factors and examined whether induction-phase AAT affected early treatment response measured by end-of-induction (EOI) minimal residual disease (MRD).
DETAILS: This retrospective analysis included 4,925 patients aged 1-30 years enrolled in the Children’s Oncology Group trials AALL0232 and AALL0434. All patients received a single induction dose of pegaspargase 2500 IU/m² without dose capping. Investigators assessed grade >=3 hyperbilirubinemia, grade >=4 alanine aminotransferase (ALT) elevation, grade >=2 thromboembolism, and grade >=3 acute pancreatitis. Multivariable analyses evaluated the independent effects of age, obesity, and BSA, while EOI MRD positivity (>=0.01%) was analyzed to determine whether AAT adversely influenced early leukemia response. Among 4,925 patients, 290 (6%) experienced at least one clinically significant AAT during induction. Toxicity rates increased with advancing age and obesity. After adjustment for confounding variables, obesity independently increased the likelihood of AAT (OR 2.5; 95% CI 1.88-3.24), whereas high BSA alone was not an independent predictor. Patients with both obesity and high BSA had the greatest risk of overall AAT (OR 3.3; 95% CI 2.22-4.77), while high BSA without obesity was not associated with increased risk (OR 1.4; 95% CI 0.94-2.04). Older patients (>=10 years) demonstrated more than a twofold increase in AAT risk compared with younger children.
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Obesity combined with high BSA significantly increased the risk of hyperbilirubinemia (OR 3.5; 95% CI 2.2-5.7), severe ALT elevation (OR 3.3; 95% CI 1.7-6.6), and thromboembolism (OR 3.1; 95% CI 1.5-6.5). Acute pancreatitis showed no significant association with obesity or BSA. Importantly, development of AAT did not increase the likelihood of EOI MRD positivity (36.6% vs 33.5%; Ps= .318), suggesting that induction toxicities did not adversely affect early disease response.
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Source: Orgel, E., Maese, L. D., Devidas, M., et al. Toxicity From Asparaginase During Acute Lymphoblastic Leukemia Induction: A Report From the Children's Oncology Group. Blood Advances. 2026; 10(14):4923-4930. Published: July 28, 2026. DOI: 10.1182/bloodadvances.2026019870
Accuracy of Fetal Echocardiography for Detecting Associated Lesions and Predicting Surgical Management in Dextro-Transposition of the Great Arteries and Double Outlet Right Ventricle with Subpulmonary Ventricular Septal Defect
In a cohort of 99 fetuses with D-TGA or DORV-SPV, fetal echocardiography showed high diagnostic accuracy for simple D-TGA but lower accuracy for complex lesions. Serial assessment frequently altered VSD characterization, while fetal aortic measurements and aortic-to-pulmonary artery ratios (AUC above 0.9) accurately predicted postnatal CoA repair.
KEY FINDINGS: Fetal echocardiography demonstrated excellent diagnostic performance for simple D-TGA but substantially lower accuracy in complex D-TGA and DORV-SPV with associated lesions. Serial fetal assessment frequently altered qualitative VSD size estimation, while many small postnatally confirmed VSDs did not require surgical repair. Quantitative fetal aortic measurements and aortic-to-pulmonary artery ratios showed strong discriminatory ability (AUC >0.9) for identifying fetuses requiring postnatal CoA repair, supporting their role in improving prenatal risk stratification and surgical planning.
BACKGROUND: Associated cardiac lesions, including ventricular septal defect (VSD), coarctation of the aorta (CoA), and pulmonary stenosis (PS), substantially influence prenatal counseling and postnatal surgical management in fetuses with dextro-transposition of the great arteries (D-TGA) and double outlet right ventricle with subpulmonary ventricular septal defect (DORV-SPV). This study assessed the diagnostic accuracy of fetal echocardiography (FE) for identifying associated lesions and predicting the postnatal surgical approach.
DETAILS: This single-center retrospective cohort study included 99 fetuses with D-TGA or DORV-SPV managed at Lucile Packard Children's Hospital (Palo Alto, California, USA) between January 2013 and January 2024. Eligible fetuses were liveborn, had a documented prenatal surgical plan, and underwent postnatal management at the study center. In 65% of cases, serial fetal echocardiograms were available. Prenatal diagnoses and predicted surgical plans were compared with postnatal echocardiographic findings and the surgical procedures ultimately performed. Receiver-operating characteristic (ROC) analysis evaluated the predictive performance of fetal aortic and pulmonary artery measurements for postnatal CoA repair. Among the 99 fetuses, postnatal diagnoses included 45 with simple D-TGA, 38 with complex D-TGA, 15 with DORV, and 1 case reclassified from prenatal DORV-SPV to truncus arteriosus. Diagnostic concordance between fetal and postnatal echocardiography was highest for simple D-TGA (95% (42/44)) and D-TGA with VSD and PS (100% (3/3)), followed by D-TGA with VSD (93% (25/27)). Lower concordance was observed for DORV-SPV (60% (3/5)), DORV-SPV with CoA (40% (4/10)), D-TGA with VSD and CoA (29% (2/7)), D-TGA with isolated CoA (0% (0/2)), and DORV-SPV with PS (0% (0/1)). Surgical-plan prediction showed a similar pattern, with the greatest accuracy in simple D-TGA and D-TGA with VSD and PS. Qualitative assessment of VSD size frequently changed across serial fetal examinations, with defects generally appearing larger prenatally but often smaller on postnatal echocardiography. Only 50% of small VSDs identified postnatally required repair. All infants undergoing postnatal CoA repair had an associated VSD. ROC analysis demonstrated that fetal aortic measurements and aortic-to-pulmonary artery dimension ratios achieved area under the curve values greater than 0.9 for predicting the need for postnatal CoA repair.
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Source: Chandrasekar, H., Kaplinski, M., Maskatia, S. A., et al. Accuracy of Fetal Echocardiography in Detecting Lesions Associated With, and Predicting Surgical Plan for, Dextro-Transposition of the Great Arteries and Double Outlet Right Ventricle With Subpulmonary Ventricular Septal Defect and Predicted Transposition Physiology. Ultrasound in Obstetrics & Gynecology. 2026; 68(1):v79-87. Published: January 30, 2026. DOI: 10.1002/uog.70169
Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts
Early initiation of a 5-day oral ensitrelvir regimen within 72 hours after symptom onset in an index patient significantly reduced the risk of developing Covid-19 among household contacts while maintaining a safety profile comparable to placebo. Clinical benefit was observed across major patient subgroups, including individuals at increased risk for severe disease, and treatment was associated with reduced household transmission. These findings support ensitrelvir as an effective postexposure prophylactic option for household contacts and suggest potential utility in other high-risk exposure settings where rapid outbreak control is needed.
KEY FINDINGS: Early initiation of a 5-day oral ensitrelvir regimen within 72 hours after symptom onset in an index patient significantly reduced the risk of developing Covid-19 among household contacts while maintaining a safety profile comparable to placebo. Clinical benefit was observed across major patient subgroups, including individuals at increased risk for severe disease, and treatment was associated with reduced household transmission. These findings support ensitrelvir as an effective postexposure prophylactic option for household contacts and suggest potential utility in other high-risk exposure settings where rapid outbreak control is needed.
BACKGROUND: Household transmission remains a major contributor to the spread of SARS-CoV-2, particularly among individuals at increased risk for severe Covid-19. Although vaccination and prior infection have reduced disease severity, waning immunity and emerging variants continue to sustain transmission. Previous trials evaluating oral antiviral agents for postexposure prophylaxis in household contacts have not demonstrated significant protection, highlighting the need for effective preventive therapies. This phase 3 trial evaluated whether oral ensitrelvir, a SARS-CoV-2 3C-like protease inhibitor, could prevent Covid-19 among household contacts exposed to an infected index patient.
DETAILS: This phase 3, double-blind, randomized, placebo-controlled trial was conducted between June 2023 and mid-September 2024 across the United States, Argentina, Japan, South Africa, and Vietnam. Eligible household contacts were 12 years of age or older, had a negative SARS-CoV-2 test at enrollment, and were randomized within 72 hours after symptom onset in the index patient. Participants received either ensitrelvir 375 mg on day 1 followed by 125 mg once daily on days 2-5 or matching placebo. The primary endpoint was laboratory-confirmed Covid-19 by day 10 in the modified intention-to-treat population, defined as RT-PCR positivity accompanied by at least one prespecified Covid-19 symptom lasting 48 hours or longer. Secondary endpoints included laboratory-confirmed SARS-CoV-2 infection regardless of symptoms, subgroup analyses, and safety outcomes. Overall, 2,387 household contacts were randomized, including 1,030 participants in the ensitrelvir group and 1,011 in the placebo group within the modified intention-to-treat population. The mean participant age was 42.4 years, 71.1% were enrolled within 48 hours after symptom onset in the index patient, and 37.0% had at least one risk factor for severe Covid-19. By day 10, laboratory-confirmed Covid-19 occurred in 2.9% of participants receiving ensitrelvir compared with 9.0% receiving placebo, corresponding to a risk ratio of 0.33 (95% CI, 0.22-0.49; P<0.001) and an approximate 67% relative risk reduction in the modified intention-to-treat population. In the intention-to-treat population, Covid-19 developed in 4.4% and 10.2% of participants, respectively (risk ratio, 0.43; 95% CI, 0.32-0.59; P<0.001). Laboratory-confirmed SARS-CoV-2 infection irrespective of symptoms was also lower with ensitrelvir (14.0% vs. 21.5%; risk ratio, 0.66; 95% CI, 0.55-0.79). Subgroup analyses demonstrated generally consistent efficacy across age groups and participants with risk factors for severe disease. Among participants with risk factors, Covid-19 developed in 2.4% of the ensitrelvir group compared with 9.9% of the placebo group. Ensitrelvir was also associated with a 34% relative reduction in household SARS-CoV-2 transmission. Adverse events occurred at similar frequencies in the ensitrelvir and placebo groups (15.1% vs. 15.5%), with serious adverse events reported in 0.2% of participants in each group. No Covid-19-related hospitalizations or deaths occurred. Transient reductions in high-density lipoprotein concentrations were observed with ensitrelvir but returned toward baseline by day 15 and were not associated with clinical events.
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