UPDATE: FDA Panel Calls for More Data on Dynavax Hepatitis B Vaccine
Last Update: 11/15/2012 3:05:40 PM
--FDA panel says more safety information is needed on Dynavax's hepatitis B
vaccine
--Panel says vaccine appears effective
--FDA to make final approval decision
(Updates with additional information on proposed vaccine starting in fifth
paragraph.)
By Jennifer Corbett Dooren
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 the FDA's vaccines advisory committee, which is
made up of non-FDA medical experts. The panel voted 8-5 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 13-1 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.
Heplisav is designed to be administered twice in a one-month period, while the
other vaccines are given to adults as a three-dose series during a six-month time
period, which the company said has the potential to improve vaccination rates and
protection against hepatitis B in adults. The vaccine also contains a new
ingredient, called an adjuvant, that is designed to boost the body's immune
response to a vaccine. Because of the new ingredient, some advisory committee
panel members said additional safety information is needed.
The vaccine's safety was studied in about 5,800 patients, but none of the studies
lasted for more than a year, according to the FDA. About 1,400 study participants
received a GlaxoSmithKline vaccine as a comparison. Agency reviewers said there
were no major safety differences between the vaccines.
"There's a lot of enthusiasm around the table from the yes and no voters that
this is a very promising vaccine approach," said Robert Daum, the panel chairman
and doctor at the University of Chicago.
Hepatitis B is a liver disease caused by infection with the hepatitis B virus,
which is most often spread through sexual contact or the sharing of needles or
other drug-injection equipment. Since 1992, babies and toddlers in the U.S. have
been routinely vaccinated against hepatitis B, but many adults remain
unvaccinated. Last year, a federal vaccine advisory panel recommended certain
adults with diabetes receive the hepatitis B vaccine.
Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com
Subscribe to WSJ: online.wsj.com?mod=djnwires |
