FDA's Vaccines and Related Biological Products Advisory Committee meets on Tuesday, September 9. It will consider the safety and efficacy of an HPV vaccine for girls from GlaxoSmithKline called Cervarix. In an earlier post, I noted that the safety of Cervarix (which includes the squalene-containing adjuvant ASO4) was controversial. No US vaccines contain this type of novel adjuvant. Here is some safety information:
the pivotal trials submitted to the FDA showed a disturbing if not statistically significant increase in spontaneous abortions in the three months after the young women were given the vaccine -- 11.6 percent versus 5 percent in the sham vaccine group. Glaxo's discussions with the FDA about conducting a large post-approval trial to gauge whether this was vaccine-related will undoubtedly be a major topic of discussion at Tuesday's advisory committee meeting.