Biologics

FDA Not Delaying Pediatric Covid Vaccines: Marks

CBER director Peter Marks briefed the House Select Subcommittee on the Coronavirus Crisis 5/6 and denied news reports the agency was planning to delay authorizing Moderna’s Covid-19 vaccine for children under five years old so that it can be considered at the same time as Pfizer’s vaccine. However, he acknowledged that if the vaccine reviews end up being completed within a short time—such as a week—then they may be considered by FDA’s advisory committee together, according to a subcommittee summary of the briefing.

Marks emphasized that reviewing vaccines for young children involves more “complexity” than the review of adult vaccines, and the agency’s review process may require more time due to this. He stated that FDA has to take a “very close look” at the vaccines’ side effect profile in young children because common side effects from vaccinations—such as fevers—that are not typically associated with adverse outcomes in adults can, in rare cases, cause severe conditions in young children, according to the summary. Having to deal with new variants circulating has also made the reviews more complex, Marks said.

Unlike the original vaccines that were reviewed in 2020 in adults and demonstrated greater than 90% effectiveness, Marks said for children under five the agency will likely allow a vaccine that has a lower than 50% efficacy because current vaccine efficacy has waned substantially due to the variants. He said that if the vaccines “seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize.” He further stated that FDA would “look carefully at all data” when assessing the vaccines—including the efficacy against severe disease — and made clear that “the goal here is to get some protection in sooner rather than later.”

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

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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