Reuters Health Information (2013-06-10): FDA wants more safety data on hepatitis B vaccine
FDA wants more safety data on hepatitis B vaccine
Last Updated: 2013-06-10 12:40:22 -0400 (Reuters Health)
(Reuters) - Dynavax Technologies Corp said the U.S. Food and Drug Administration asked for additional safety data on its experimental hepatitis B vaccine, Heplisav.
The company said it will meet with the FDA shortly to discuss the protocol for collecting additional safety data, which it expects to include in the current approval application.
Heplisav was denied approval by the FDA in February, saying the safety data provided by the company was insufficient to support an approval.
The FDA said Dynavax's safety database needed additional subjects, the company said on Monday.
The company said it was also working on the questions raised by the FDA regarding the manufacturing and testing of Heplisav.