WASHINGTON--A federal advisory panel Thursday said more safety information is needed for a proposed Hepatitis B vaccine being developed by Dynavax Technologies Corp. (DVAX), which could delay the vaccine's approval.
The company is seeking Food and Drug Administration approval for use of the vaccine, called Heplisav, in adults who are 18 to 70 years old.
Dynavax's vaccine was reviewed by FDA's vaccines advisory committee, which is made up of non-FDA medical experts. The panel voted 5-to-8 against a question that asked if the company submitted enough data to support the vaccine's safety. One person abstained from voting. However, the same panel voted 13-to-1 saying that data submitted by the company supported the vaccine's effectiveness.
Some of the panel members who voted against the vaccine's safety said larger and longer studies should be conducted before the vaccine is approved, but others suggested it might be done after approval. The FDA will make the final decision.
There are already Hepatitis B vaccines on the market from GlaxoSmithKline PLC (GSK, GSK.LN) and Merck & Co. (MRK), according to the FDA.