Cervarix: Novel (but NOT Squalene-containing) 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 novel adjuvant, named ASO4.

According to a GSK press release, "In clinical trials, the most common side effects after vaccination with CERVARIX included pain, redness and swelling, fatigue, headache, joint and muscle aching, gastrointestinal symptoms and fever. Serious adverse events were generally comparable between the groups receiving CERVARIX and the control groups."

Recall that only 10 months ago FDA was trying to figure out how to study the safety of novel adjuvants. And FDA's chief scientist and then-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. Cervarix does.

UPDATE: ASO4 contains MPL, not squalene, which is a different novel lipid adjuvant component.