In a 6 to 5 vote, the FDA's Vaccines and Related Biological Products Advisory Committee has determined that Connecticut-based Protein Sciences hasn't proven that its innovative flu vaccine FluBlok--which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells--is safe. The shot was being watched because it can be produced more quickly than traditional chicken-egg-based vaccines.
Members of the panels said that Protein Sciences' clinical trials weren't large enough to support mass production. However, 9 of the 11 panelists said the shot was as effective as licensed vaccines in adults ages 18 to 49, according to a Bloomberg report. The committee recommended several additional post-licensure FluBlok studies that would provide more safety and efficacy data in certain patient populations, including the elderly, pregnant women, children and people with compromised immune systems, according to a Hartford Courant article.
FluBlok did have its champions on the panel, according to AFP. "This would have been a breakthrough for the United States and it would certainly have been helpful to have this available this fall," said panelist Theodore Eickhoff of the University of Colorado.
As a result of the vote, Protein Sciences says it will consider making FluBlok abroad. "Other countries--Australia, for example, and Europe--have already said they feel that our vaccine meets the criteria (for safety), but we have always focused on the US," Protein Sciences Chief Operating Officer Manon Cox told AFP.