There is currently no regulatory pathway by which adjuvants may be submitted for approval as products by themselves—or may be paired with a separately manufactured antigen, perhaps one produced by another company. Regulators acknowledge that could stand in the way of, for instance, converting the already-manufactured vaccine in the national stockpile (which was purchased under the 90-mcg-dose license granted Sanofi Pasteur earlier this year but is held in bulk) to an adjuvanted vaccine that could be stretched much further.
"There probably are more concerns about an antigen made with one manufacturing process and an antigen made with another manufacturing process and whether when those are mixed with ideal adjuvant X in two potentially different circumstances or time points, that could raise a bunch of issues about formulation, stability, immunogenicity, safety," Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said at the FDA meeting (see Bibliography: FDA 2007: Committee meeting transcript)...."I have heard a lot of people say they expect problems with adjuvanted vaccines," said Hedwig Kresse, an associate analyst for infectious diseases with the British-based market analysts Datamonitor. "It is a technology that definitely has some potential, but there are a lot of issues that need to be addressed first" (see Bibliography: Kresse 2007).
Saturday, November 7, 2009
A well-researched piece on adjuvants from CIDRAP (Oct. 30, 2007), by Maryn McKenna. US citizens will need to be concerned about novel adjuvants when the next pandemic strikes, but people in the rest of the world will be offered swine flu vaccine with these adjuvants now. Excerpts:
Posted by Meryl Nass, M.D. at 1:35 PM