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Largest Study to Date Supports Gardasil's Safety in First Year of Use


 

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

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