Biologics

Moderna Delaying Pediatric Covid Vaccine EUA Filing

Ongoing safety concerns with Moderna’s Covid-19 vaccine and its potential use in adolescents has led to a filing delay for an emergency user authorization (EUA) to use a smaller dose vaccine in the pediatric population (6-11 years of age). Last month, it was reported (see story) that FDA was delaying its decision on expanding the vaccine’s use in adolescents (12 to 17 years of age) while it further investigates myocarditis risks. The agency reportedly has been assessing the risk among younger men vaccinated with the Moderna vaccine after several Nordic countries limited its use due to similar risk concerns.

in July, asked Pfizer/BioNTech and Moderna to expand their trials of Covid vaccines to include several thousand school children before they seek final emergency use authorization for their vaccines (see earlier story). The expanded testing is intended to assess the risk of myocarditis, a rare inflammation of the heart muscle that has been seen in young adults shortly after vaccination and is more common in younger age groups.

Moderna also acknowledged 10/31 that FDA is now requiring additional time to complete its assessment of Moderna’s EUA request for the vaccine in adolescents, for the same reason. The agency told Moderna that the review may not be completed before January 2022.

Moderna says that, to date, over 1.5 million adolescents have received the vaccine. The observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database “does not suggest an increased risk of myocarditis in this population,” it says. “Moderna is committed to conducting its own careful review of new external analyses as they become available. The company does not yet have access to data from some recent international analyses.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome