Weekly review: New FDA approvals, CDC vaccination recommendations, and more

Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, August 12, to Friday, August 16, 2024), and click on each link to read and watch anything you may have missed.

FDA approves axatilimab-csfr to treat graft-versus-host disease

The FDA has approved axatilimab-csfr (Niktimvo; Incyte Corporation) for the treatment of chronic graft-versus-host disease (cGVHD), after failure of at least 2 prior lines of systemic therapy in adult and pediatric patients who weight at least 88 lbs (40 kg), according to a press release from the FDA.

Axatilimab-csfr is a colony stimulating factor-1 receptor-blicking antibody. Efficacy was determined in the AGAVE-201 (NCT04710576) randomized, open-label, multicenter clinical trial that investigated 3 dosages of axatilimab-csfr in adult and pediatric patients with recurrent or refractory cGVHD who had received at least 2 lines of systemic therapy and required additional treatment.

Click here for full details of the approval.

CDC recommends increased efforts to boost VFC vaccination coverage

In a new Vital Signs edition of the Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report (MMWR), the CDC analyzed data from the National Immunization Survey-Child (NIS-Child) from 2012 to 2022, evaluating vaccination coverage trends with ≥1 dose of measles, mumps, and rubella vaccine (MMR), 2–3 doses of rotavirus vaccine, and a combined 7-vaccine series, by VFC program eligibility status, and to examine differences in coverage among VFC-eligible children by sociodemographic characteristics.

"Although the VFC program has played a vital role in increasing and maintaining high levels of childhood vaccination coverage for 30 years, gaps remain," stated the authors. "Enhanced efforts must ensure that parents and guardians of VFC-eligible children are aware of, have confidence in, and are able to obtain all recommended vaccines for their children.

Click here for full details of the report.

ALTUVIIIO phase 3 data on bleed protection in children with hemophilia A

On May 10, 2024, the FDA approved an updated label for ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl] (Sanofi), with data demonstrating that once-weekly dosing provides bleed protection in children with hemophilia A.

Lynn Malec, MD, medical director, Comprehensive Center for Bleeding Disorder; associate investigator, The Versiti Blood Research Institute; and associate professor of Medicine and Pediatrics, The Medical College of Wisconsin, joined Contemporary Pediatrics to discuss the data from the phase 3 XTEND-Kids study (NCT04759131).

Click here for the full article.

Text messaging program increases vaping cessation rates for adolescents

An interactive and tailored text message program demonstrated increased self-reported vaping cessation rates for adolescents according to a recent study published in JAMA.

"Although several vaping cessation programs are available with evaluation efforts underway, there are no published randomized trials of interventions to stop e-cigarette use among adolescents," wrote the study's authors. "To fill this gap, a comparative effectiveness randomized clinical trial (RCT) of a vaping cessation intervention for adolescents was conducted. Delivered via text message, the intervention was proven effective among young adults in the only vaping cessation trial published to date. The present study tested the hypothesis that adolescents in the intervention group would be more likely to be abstinent at 7 months than participants in an assessment-only control group."

Click here for the full article.

Vulvar ulcerations in a pre-adolescent girl following COVID-19 vaccination

An 11-year-old healthy girl presents to her pediatrician for a 1-day history of a tender bump on the labia majora accompanied by fever and sore throat. She received her 4th dose of the Pfizer COVID-19 vaccine 3 days prior to symptom onset. She denies prior sexual activity or trauma to the affected area. She is suspected to have an infection and is prescribed a 7-day course of sulfamethoxazole-trimethoprim. Over the next 2 days, the lesion worsens despite compliance to antibiotics. She is evaluated by the gynecology department and undergoes incision and drainage due to concern for abscess formation. Three days after, she presented to the emergency department because of continued increase in swelling and size of the lesion.

Can you guess the diagnosis?