Wednesday, October 21, 2009

Cervarix: Squalene Adjuvant Approved in US

Despite data showing twice the rate of miscarriages in women who received Cervarix, FDA approved this new HPV vaccine from GlaxoSmithKline for the US market: the first-ever vaccine licensed in the US with a squalene-containing novel adjuvant, named ASO4.

Recall that only 10 months ago FDA was trying to figure out how to study the safety of these adjuvants. And FDA's chief scientist and head of the vaccine center (CBER) at FDA, Dr. Jesse Goodman, expressed significant safety concerns. What did FDA learn about analyzing adjuvant safety during the past ten months? What side effects may be attributable to this new vaccine additive? There is little unconflicted data in the medical literature to tell us.

Perhaps in fairness to Merck, FDA (on the same day it approved Cervarix) expanded the indications for Cervarix' competitor, Gardasil vaccine. Gardasil may now be used in boys to prevent sexually-transmitted genital warts, starting at age nine.

There exist a few reports of deaths and devastating neurological illnesses that developed in girls after receiving Gardasil vaccine. Contrary to what some have thought, Gardasil does not contain novel adjuvants. Cervarixdoes.

Posted by Meryl Nass, M.D. at 12:34 AM 2 comments

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