Biologics

AstraZeneca Can Export Vaccine Made at Emergent Bio: FDA

CBER says it will not object to AstraZeneca’s decision to export three lots of Covid-19 vaccine drug substance manufactured at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations until corrections are implemented (see earlier story). Late last month, FDA allowed Emergent to resume production of the Johnson & Johnson Covid-19 vaccine at the facility after Emergent executed an action plan and committed extensive resources to bring operations up to FDA GMP standards (see story)

AstraZeneca has not sought BLA approval or an emergency use authorization for its Covid-19 vaccine in the U.S., but the vaccine is authorized for use in other countries. Permitting the exportation of the vaccine drug substance (DS) would give the company increased vaccine availability for use in other countries.

In determining the fitness of the three lots for exportation, FDA says it relied on AstraZeneca’s evaluation of the drug substance’s attributes (e.g., potency, viral particle/infectious unit ratio) to demonstrate that manufacturing deviations did not have a negative impact on their quality. “We note that regulatory authorities in other countries should make their own judgment on the acceptability of these lots for use in their countries,” an agency memo says. “However, FDA does not intend to object to the exportation of these lots, or the exportation of vaccine made with DS from these lots by AZ or another entity provided that AZ includes the agreed upon information sheet with each pallet of AZ’s Covid-19 vaccine that is exported...,” it says.

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