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The United States Food and Drug Administration (FDA) announced their decision to include those ages 27-45 in the population approved to receive the Gardasil 9 vaccine for the prevention of Human Papillomavirus (HPV).
The approval is based on the results of a 3.5-year evaluation and long-term follow-up of the study. A total of 13,000 men and women participated in the clinical trials.
Gardasil 9, approved in 2014, replaced the previous vaccine, which only protected against first four HPV types. The current formula aids to prevent those four plus another five HPV types. Before October 5, 2018, the vaccine was only approved for those ages 9-26.
Peter Marks, M.D., Ph.D., heralded the approval as “an important opportunity to help prevent HPV-related diseases and cancers in a broader age range.” Marks, who is the director of the FDA’s Center for Biologics Evaluation and Research added:
The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.
The data suggests a similar efficacy across both gender and age groups. Those receiving the injection commonly reported minor adverse reactions similar to most other vaccinations; injection site pain, swelling, redness, and headaches.
Written by Cathy Milne-Ware
Source:
FDA: FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
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