Biologics

Millions of J&J Covid Doses in Storage: Report

An estimated 30 million to 50 million doses of Johnson & Johnson’s Covid vaccine made early this year are in storage at the Emergent BioSolutions facility in Baltimore waiting for FDA approval to ship, according to a Reuters report. The news service says it was informed by two sources that FDA must still inspect and authorize the plant before Emergent can ship newly manufactured drug substance.

“The exact number of doses sitting idle cannot be determined,” the report says, “because Emergent only makes raw vaccine substance and does not fill vials with finished product.”

FDA shut down operations at the Emergent facility in April after the J&J vaccine was found to be contaminated with material from AstraZeneca Covid shots that were also being manufactured in the facility at the time.

Reuters says that of the 100 million doses of vaccine material Emergent described in an April congressional hearing as being sidelined, FDA has so far cleared nine batches of J&J vaccine and three batches of AZ’s. It has not disclosed how many doses were in the batches.

FDA said in a statement that it conducted a limited inspection of the Emergent facility in July to confirm it had taken corrective actions following the production halt, Reuters says. FDA said it has not yet authorized the facility to ship doses and continues to review batches made before the production stop.

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