Updated Gardasil Vaccine Now Approved

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The Gardasil vaccine is intended to give protection against diseases caused by Human Papillomavirus or HPV. Now, the Food and Drug Administration (FDA) has approved a new form of the vaccine, Gardasil 9. This new form of Gardasil protects against 9 strains of the HPV virus where the current formulation only protects against 4 strains.

What is HPV?

HPV or human papillomavirus is a virus that is transmitted from sexual contact with someone who has the virus. It is the most common sexually transmitted infection.

What does Gardasil protect you from?
Gardasil and Gardasil 9 offer protection from diseases caused by HPV, including cervical, vaginal, and vulvar cancer, and genital warts.

What strains of HPV does the current vaccine, Gardasil, cover?

The current vaccine, Gardasil, offers protection from the 4 strains of HPV: 6, 11, 16, and 18.

What strains of HPV will the new vaccine, Gardasil 9, cover?

The new vaccine, Gardasil 9, will offer protection from the same 4 strains of HPV as the original Gardasil (6, 11, 16, and 18), with the addition of 5 more strains (31, 33, 45, 52, and 58).

How is the Gardasil 9 vaccine given?

Like the original Gardasil, Gardasil 9 is administered in a three-shot series.

You will start with one shot, followed by separate shots at two and six months later.

When were Gardasil and Gardasil 9 approved by the FDA?
Gardasil 9 was approved by the FDA on December 10, 2014. Gardasil has been approved since June 8, 2006.

When will Gardasil 9 be available to patients?

According to the manufacturer, Merck, Gardasil 9 is expected to be available by early February 2015. See this news release for more information.

How is the newly approved Gardasil 9 an improvement over the current Gardasil vaccine?
Gardasil 9 protects against 5 additional strains of HPV. Those 5 additional strains are considered the most common cervical cancer-causing types worldwide. Seven of the 9 HPV strains covered by Gardasil 9 cause approximately 90% of all cervical cancer cases.

In contrast, the original Gardasil only protected against strains responsible for about 70% of cervical cancer cases.

Want more information on Gardasil 9?

You can find the press release from the FDA regarding the approval of Gardasil 9 here.

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