FDA staff note miscarriages in Glaxo vaccine data


September 4, 2009

WASHINGTON (Reuters) – A proposed GlaxoSmithKline PLC vaccine helped protect women from the virus that causes cervical cancer but more miscarriages were reported compared with another immunization, U.S. reviewers said in documents released on Friday.


Food and Drug Administration staff said an independent statistical analysis concluded data “do not establish a causal relationship” between the Cervarix vaccine and miscarriages but the findings “were insufficient to rule out a small effect in pregnancies conceived in the three months immediately after vaccination.”


FDA reviewers said they will ask an advisory panel that meets Wednesday about the miscarriages and other issues.


Glaxo shares rose 1.2 percent to $39.05 on the New York Stock Exchange.


(Reporting by Lisa Richwine)

Comment from Leslie

Let’s see – Cervarix causes miscarriages and stocks go up.  Hmmm.  This is the same hoopla that we went through with the Gardasil vaccine – the girls were having problems and MD’s & Merck kept saying that there was no “causal relationhip.” BS and nonsense.


Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.