"Nothing is more important to Merck than the safety of our medicines and vaccines. Merck employees, and our families, use our vaccines, too. Our hearts go out to these families.
We are confident in the safety profile of GARDASIL. The safety and efficacy of GARDASIL was established in clinical trials involving more than 25,000 females and males. Safety has continued to be evaluated in several large post-licensure surveillance studies in more than 500,000 people following administration of more than a million doses of vaccine. And while difficult to determine number of doses administered, more than 125 million doses of GARDASIL have been distributed globally since 2006.
Merck has reviewed post-licensure reports of POI after administration of GARDASIL and has concluded that the evidence does not support a causal relationship to the vaccine. The cases have been reported to the US FDA and other regulatory agencies. There have been no reports of POI in the clinical trials with GARDASIL.
Parents should understand the extensive data supporting the safety profile of GARDASIL, and we encourage them to look to CDC and FDA, and to the advice of their own physicians, to make an informed choice about something as important as a vaccine to help prevent cervical cancer."