Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.VaxGen has said that the Food and Drug Administration is maintaining its clinical hold on a phase II trial for its anthrax vaccine due to continued concerns about the product's stability.
Subscribe to our email newsletter
The Department of Health and Human Services (HHS) is under a contract with VaxGen to purchase 75 million doses of its recombinant anthrax vaccine, rPA102, had imposed a deadline of December 18 for the company to initiate its next clinical trial for the vaccine candidate. The HHS has yet to inform VaxGen what direction it intends to take with respect to the contract.
At a recent meeting with the FDA, VaxGen presented an expanded number of methods for measuring the vaccine’s potency and stability, and information toward further enhancing the stability of the vaccine’s formulation.
However, the FDA said the clinical hold will remain in place until sufficient vaccine stability has been demonstrated to resume clinical testing. VaxGen believes the FDA wishes to engage the company in additional, more detailed technical discussions about the analytical methods and formulation development.