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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from the week (Monday, May 19, to Friday, May 23, 2025), and click on each link to read and watch anything you may have missed.
On May 19, 2025, the FDA approved Bayer’s Jivi (antihemophilic factor [recombinant], PEGylated-aucl) for use in pediatric patients aged 7 to under 12 years with hemophilia A. The extended indication is based on results from the Alfa-PROTECT and PROTECT Kids studies, which confirmed the safety and efficacy of Jivi in this age group.
Jivi is an extended half-life recombinant factor VIII therapy initially approved in 2018 for patients aged 12 years and older. It is not indicated for children under 7 due to increased risks of hypersensitivity and reduced efficacy. The most common adverse events include hypersensitivity reactions, and patients with a history of allergic responses to PEG or animal proteins should not receive Jivi.
On May 19, 2025, the FDA approved Novavax’s biologics license application for NVX-CoV2705 (Nuvaxovid), a recombinant protein-based COVID-19 vaccine, making it the only non-mRNA COVID-19 vaccine approved in the U.S. The vaccine is indicated for individuals aged 12 to 64 years with at least one high-risk condition and for all adults aged 65 years and older.
Approval was based on pivotal phase 3 trials in both adolescents and adults. In adolescents aged 12 to 17 years, NVX-CoV2705 demonstrated safety, strong immunogenicity, and 79.5% efficacy against COVID-19. In adults, the vaccine showed 92.6% efficacy against variants of concern and maintained a favorable safety profile. Reactogenicity was generally mild to moderate and transient. The FDA has requested a phase 4 trial to further assess safety and efficacy in lower-risk adults aged 50 to 64.FDA approves NVX-CoV2705 COVID-19 vaccine
Click here for full approval details.
On May 20, 2025, the FDA introduced a new regulatory framework for COVID-19 vaccines, outlining updated approval criteria and restricting access to seasonal vaccines for healthy individuals without risk factors. According to the policy, published in The New England Journal of Medicine, the FDA will continue to base approvals for high-risk individuals—including those aged ≥65 years and individuals aged ≥6 months with at least one risk factor—on immunogenicity data alone.
For healthy individuals aged 6 months to 64 years, however, the FDA now anticipates randomized controlled trial data demonstrating clinical outcomes prior to approval of any new vaccines. Pediatric experts, including Tina Tan, MD, and Sharon Nachman, MD, raised concerns that these new requirements could delay vaccine access for healthy children and restrict availability in pediatric settings. Critics warned the changes may limit vaccine access and availability, particularly for healthy individuals seeking protection during the upcoming fall season.
On May 20, 2025, the FDA approved roflumilast foam 0.3% (ZORYVE; Arcutis) for the treatment of plaque psoriasis on the scalp and body in adults and adolescents aged 12 years and older. The approval addresses a significant need for patients with scalp and hair-bearing area involvement, where creams and ointments are often difficult to use.
Approval was supported by results from phase 2 and phase 3 trials (ARRECTOR and Trial 204), which demonstrated significant improvements in disease severity and itch reduction. In the ARRECTOR trial, 66.4% of participants treated with roflumilast achieved scalp clearance (vs 27.8% with vehicle; P < .0001), and 45.5% achieved body clearance (vs 20.1%; P < .0001).
Click here for full FDA approval details.
"I'm super excited," said Jennifer Soung, MD, director of clinical research at Southern California Dermatology and a clinical trial investigator. "Parents have been asking for many years, 'Is there anything else besides the topical steroid?' Prior to the approval of roflumilast, we really haven't had a highly effective nonsteroidal option.”
