WASHINGTON – U.S. Senator Herb Kohl today called the Acting Food and Drug Administration (FDA) Commissioner Dr. Joshua Sharfstein to testify before the Senate Agriculture Appropriations Subcommittee about efforts to develop a vaccine for the H1N1 flu virus.  Public health officials caution that the new flu virus could continue to move through the Southern Hemisphere in the coming months and reemerge in the United States in fall, with perhaps a greater ferocity.  Secretary of Agriculture Tom Vilsack also testified at today’s hearing.  Kohl is the chairman of the Agriculture Appropriations Subcommittee, which has jurisdiction over the FDA.

“The past two weeks Americans have witnessed lots of media coverage of the flu outbreak.  Fortunately, the immediate sense of crisis seems to be passing.  We’re no longer calling for schools to close, and the fear many people have felt in recent days should be subsiding.  But we still need to be vigilant.  If history is any guide, the second wave has historically been more lethal,” Kohl said.

“We need to make sure we have a vaccine for this and to make sure it’s safe, effective and there is enough for everyone.  Dr. Sharfstein, that’s your job,” Kohl added.

Dr. Sharfstein indicated that FDA has been working closely with the Department of Health and Human Services, the Centers for Disease Control, the World Health Organization and other governments to combat the H1N1 virus.  The FDA has an emergency response vaccine team in place that is already moving forward on a safe, effective vaccine for 2009 H1N1.  The lab work has begun to grow the virus and genetically reengineer it for a vaccine.  Once developed, there will need to be tests to determine its potency, as well as clinical trials, before a vaccine is approved.

Kohl asked whether a vaccine will be developed within the next four to six months.

Dr. Shafstein indicated that there are two elements to meeting that goal:  the vaccine manufacturing capacity, and the behavior of the virus.  Dr. Sharfstein is confident that there is a robust manufacturing capacity in place.  However, the unknowns about the virus could delay vaccine production.  He said a viable virus reference strain is needed, and then ongoing tests for chemical potency and the immune response in humans will be needed to achieve a safe, effective vaccine.  Each step has its own uncertainties, Dr. Sharfstein said, so it not possible to predict a vaccine readiness date.  He said it was also unclear at this early date whether the FDA will recommend an H1N1 vaccine in fall.