FDA Grants Full Approval for Spikevax in Children at Increased Risk of Disease
The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s Spikevax (mRNA-1273) COVID vaccine in children 6 months through 11 years who are at an increased risk of the disease.
Personalized Melanoma Vaccine Elicits Strong Immune Response
Results of a Dana-Farber Cancer Institute-initiated Phase I clinical trial for patients with melanoma show that an updated formula and delivery of the NeoVax personalized cancer vaccine called NeoVaxMI is safe, feasible and improves the vaccine-specific immune response compared to previous trials of the platform.
FDA Accelerates Approval for Rare Kidney Disease
The U.S. Food and Drug Administration has granted accelerated approval for Novartis’ Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
New Data Show One in 31 Kids Has Autism
Autism prevalence in the U.S. has increased from one in 36 children to one in 31, according to the Centers for Disease Control and Prevention’s (CDC) latest Autism and Developmental Disabilities Monitoring (ADDM) Network survey.
COVID-19 May Increase IVIG-Resistance in Kids Prior to Developing Kawasaki Disease
A recent study found there is significantly higher intravenous immune globulin (IVIG) resistance among children who contracted COVID-19 before developing Kawasaki disease
University of Toledo Awarded Funds to Explore Immune Response to Oral Thrush
The University of Toledo will receive $473,632 from the National Institute of Dental and Craniofacial Research to explore how the body’s immune system responds to the condition known as oral thrush.
Activating B Cells Key to TIL Cancer Therapy Effectiveness
Researchers at Moffitt Cancer Center have found that tapping into the body’s own immune system and activating a type of immune cell known as B cells could be the key to boosting the effectiveness of tumor-infiltrating lymphocyte, or TIL therapy.
Draft Budget Proposal Would Cut HHS Federal Health Programs by One-Third
A draft budget proposal circulating among federal officials suggests a cut in the U.S. Department of Health and Human Services’ discretionary spending by as much as one-third, or tens of billions of dollars.
HHS and NIH Invest in Universal Vaccine Platform for Pandemic-Prone Viruses
The U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) have announced the development of the next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated, whole-virus platform.
Moderna’s Flu Vaccine Shows Positive Late-Stage Trial Results
Moderna’s experimental mRNA-based influenze (flu) vaccine produced a stronger immune response than a currently available vaccine in a late-stage trial, clearing a path forward for the product and the company’s separate combination flu and COVID vaccine.
