American Academy Of Pediatrics

Trump Administration's MAHA Report Calls for Sweeping Reforms to Address Childhood Health Crisis

a day ago

• The Make America Healthy Again (MAHA) Commission has released a 73-page report identifying poor diet, environmental chemicals, sedentary lifestyles, and overmedicalization as key drivers of the childhood chronic disease crisis. • Chaired by HHS Secretary Robert F. Kennedy Jr., the commission calls for a whole-of-government approach to address rising rates of obesity, diabetes, autism, and mental health issues, with over 40% of US children now having at least one chronic condition. • The report criticizes "corporate capture" of health policy, citing pharmaceutical industry lobbying and FDA-industry relationships, while proposing reforms in food quality, environmental safety, and independent scientific research.

FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children

5 days ago

• The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups. • Under the new framework, COVID-19 vaccines will remain readily available through streamlined approvals only for adults 65 and older and those with health conditions that increase risk of severe COVID-19. • The policy shift, spearheaded by FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, represents a significant departure from the previous "one-size-fits-all" approach to COVID-19 vaccination recommendations.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

Utah Becomes First State to Ban Fluoride in Public Water Systems

a month ago

• Utah has made history as the first U.S. state to ban community water fluoridation after Governor Spencer Cox signed legislation that will take effect on May 7, 2025. • The controversial ban comes amid debates over fluoride's safety, with supporters citing individual choice while dental experts warn it could increase cavity rates, especially in low-income communities. • Research indicates fluoridation reduces cavities by approximately 27-30% in adults and children, raising concerns that the ban may lead to worsening oral health outcomes across the state.

Team Sports Enhance Cognitive Development and Academic Success in Children, Studies Show

a month ago

• Children participating in team sports like soccer and volleyball demonstrate superior executive function skills compared to those in individual sports or no sports, according to a Dutch longitudinal study published in JAMA Network Open. • Structured sports participation increases high school graduation rates, with boys showing a 15% higher likelihood and girls a 7% higher likelihood of obtaining diplomas by age 20, research from the University of Montreal reveals. • Girls engaged in organized and artistic sports achieved 8% and 23% higher grades respectively, highlighting the significant cognitive and academic benefits of team-based physical activities.

Pediatric Flu Deaths Reach Highest Level Since 2009 as Vaccination Rates Decline

a month ago

• The U.S. has recorded 216 pediatric influenza deaths this season, the highest number since the 2009 swine flu pandemic, with experts warning the final count will likely increase further. • Childhood flu vaccination rates have dropped significantly to 49% this season from 64% five years ago, with only 37% of children vaccinated by November 2024. • Despite two flu strains (H1N1 and H3N2) circulating widely this season, early data showed the vaccine was effective at preventing serious illness, with experts emphasizing its importance in reducing hospitalizations and deaths.

Ziresovir Shows Breakthrough Efficacy Against RSV in Infants Under 6 Months with Long-Term Benefits

a month ago

• Phase III trial results published in The Lancet Child & Adolescent Health demonstrate ziresovir is the first RSV-targeted antiviral to show significant clinical efficacy in hospitalized infants under 6 months of age. • Treatment with ziresovir led to a 54.5% greater reduction in bronchiolitis symptoms and significantly faster viral clearance compared to placebo, with improvements in respiratory rate, wheezing, and chest retractions. • Two-year follow-up data revealed long-term respiratory benefits, including 3.6 times lower incidence of recurrent wheezing and reduced asthma rates, suggesting early antiviral intervention may prevent chronic respiratory conditions.

FDA Sets PDUFA Date for Lower-Dose Neffy Nasal Spray in Young Pediatric Patients with Anaphylaxis

4 months ago

• The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray). • This lower dose is intended for pediatric patients weighing 33 to 66 lbs (15 to 30 kg), expanding treatment options for this vulnerable population. • Neffy was initially approved in August 2024 for anaphylaxis in adults and children over 66 lbs, offering a needle-free alternative to epinephrine injections. • Pending approval, Neffy 1 mg could be available in the second quarter of 2025, providing a more accessible and less intimidating treatment option for young children.