Biologics

Check Aluminum Levels in 13 Vaccines: Researcher

A professor of bioinorganic chemistry at England’s Keele University is petitioning FDA to assure accurately reported and consistent levels of aluminum in Adacel, Bostrix, Energix-B, Havrix, Infanrix, Infanrix hexa, Kinrix, Pediarix, Pedvax-HIB, Pentacel, Prevnar-13, Synflorix, and Vaqta. The petition submitted by Christopher Exley calls on FDA to:

publicly release documentation sufficient to establish that the aluminum content in each of the 13 vaccines is consistent with the amount provided in its labeling; and
pause distribution of each of the vaccines until the agency has confirmed and publicly released documentation sufficient to establish that the aluminum content in each vaccine is consistent with the amount provided in its labeling.

The petition reports that Exley and four other researchers reviewed the aluminum content of multiple doses of each of the 13 childhood vaccines licensed and approved by FDA. They found that only three of the 13 contained the amount of aluminum indicated on its labeling. “Six vaccines (Pentacel, Havrix, Adacel, Pedvax, Prevnar 13, Vaqta) contained a statistically significant greater quantity while four vaccines (Infanrix, Kinrix, Pediarix, and Synflorix) contained a statistically significant lower quantity,” the petition says. “These deviations from each product’s labeling render the product adulterated and misbranded and violates federal statutes and regulations, and therefore requires immediate action from FDA, including ceasing distribution of these vaccines until this issue has been corrected.”

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