Merck gets shot in the arm with expanded label for Gardasil

Leslie Hanson
Октября 11, 2018

The Food and Drug Administration approved Gardasil 9 for women and men through 45.

The approval was constructed from a study among women ages 27-45, showing that the previous version of the vaccine had great impact preventing the persistent infection of HPV, genital warts, vaginal and vulvar precancers, cervical cancer, and cervical precancers related to the types of virus covered by the vaccine.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range", said Peter Marks, the director of the Center for Biologics Evaluation and Research.

The Centers for Disease Control reports that every year, around 14 million Americans become infected with HPV and about 79 million Americans total have HPV, so it's incredibly common.

In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as well as five additional kinds. Gardasil 9, which is the version offered in the USA, protects people from nine strains of HPV, seven of which can cause cancer in the cervix, vagina, anus, penis and throat, and two of which can cause genital warts.

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Gardasil, which was first approved by the FDA in 2006, contains a dead copy of the virus, which prompts the body to create its own antibodies against the virus. In the trial, participants reported the usual side effects associated with any vaccine: injection site pain, swelling, redness and headaches.

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HPV caused about 90% of all cervical cancers.

But even someone who has already been exposed to a few strains — but not to all nine in the vaccine — can still gain protection against the strains they have not encountered. "So definitely it's worthwhile to get vaccinated if you think you're at risk and you're concerned about developing cancer from HPV", Rohr-Allegrini said. She adds that HPV is an epidemic and highly contagious.

The HPV vaccine known as Gardasil protects against nine different strains.

But does the new age approval mean that adults who never got the HPV vaccine should get one now? But about 33,700 people are diagnosed with HPV-induced cancers each year, the CDC says.

Lastly, Merck cautioned that Gardasil 9 does not eliminate the necessity for women to continue to stay up to date with their recommended cervical cancer screenings.

The condition received much media attention in 2013 after actor Michael Douglas blamed his diagnosis of throat cancer on HPV and oral sex. According to a report from the The New York Times, the FDA is now looking into making a recommendation for the use of the vaccine in older people for scenarios like these.

The federal government has expanded the use of a vaccine that protects against the sexually transmitted disease HPV.

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