June 2006: FDA Approves First-Ever HPV Vaccine
The FDA approves Gardasil®, the first-ever vaccine to protect against cervical cancer. The agency expedites the evaluation period as part of a priority-review process, granting approval in only 6 months. The vaccine, produced by Merck & Co., is hailed by experts as "one of the most important advances in women's health in recent years."
At the time of its initial release, Gardasil is approved for use in females between the ages of 9 and 26 years. It is delivered via intramuscular injections to the upper arm in three separate doses over a 6-month period. According to the Centers for Disease Control and Prevention (CDC), clinical trials with over 29,000 participants were conducted to assess the safety of Gardasil before it was licensed. The trials determined that Gardasil provides immunization against HPV types 6, 11, 16, and 18.
The FDA clarifies that Gardasil is ineffective for women already infected with HPV or those with rarer types of HPV infections. Thus, the agency also highlights the need for continued emphasis on routine cervical cancer screening during gynecologic exams.
According to the World Health Organization, 49 countries approve Gardasil for use by the end of 2006. Doctors across the globe have high hopes for the vaccine's potential to revolutionize public health. In an interview with Medscape, Jaime de la Garza, MD, of Mexico's Instituto Nacional de Cancerología, points out that in developing countries, rates of cervical cancer and deaths from the disease are high. He says that "if we can get vaccines such as these to patients, it will make a big difference."
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Cite this: Timeline: 10 Years of the HPV Vaccine - Medscape - Aug 05, 2016.