The Food and Drug Administration on Friday expanded the use of Gardasil 9, Merck’s vaccine against the human papillomavirus (HPV), to adults up to age 45.

The vaccine was previously only for preteens and young adults through 26. The new decision extends the use of Gardasil 9 for women and men through age 45.

The vaccine protects against HPV, which can cause cervical cancer, certain other cancers, and genital warts. The virus is very common and is spread through sex. In most cases, HPV doesn’t cause any problems, but some infections persist and eventually lead to cancer.

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The Centers for Disease Control and Prevention estimates about 14 million people become newly infected with HPV each year, mostly teens and young adults.

Gardasil was originally approved for girls in 2006, and them later for boys — partly to reduce the spread of HPV to girls. While Gardasil was approved for ages 9 through 26, the shots are especially recommended for boys and girls at ages 11 or 12, before they first have sex and could get infected. About half of U.S. teens now have had two or three doses.

Testing by Merck in older adults showed the vaccine also worked for them, too. In women ages 24 through 45, the original formulation of Gardasil was about 90 percent effective three years after the women received a third dose.

The latest version of Gardasil protects against nine strains of HPV, four more than the original.

According to the CDC, each year about 33,700 women and men are diagnosed with a cancer caused by an HPV infection, including 12,000 women with cervical cancer, which kills about 4,000 annually.

Merck said the list price for Gardasil 9 is $205 per dose. Two doses are needed for those vaccinated before 15, while three are recommended for older people.

— Linda A. Johnson

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  • Gardasil 9:
    Merck shows no authority, Mercks’ No Attorney for the MSDS sheets, is not stated on the Material Statistical Data Sheets label, as is required for such approvals, The law cannot prove Gradasil9 is safe or not safe

    • Who knows what that means? Lawyers and government officials do not determine toxicity, except for their own purposes. Safety is discovered by scientific inquiry and empiricism.

  • I am a survivor of laryngeal cancer from the HPV virus from 2016. I have tried to be an active proponent of the vaccine to patients and friends, so this is good news. I would like to get info on complications and side effects from the vaccine so I can be fully informed in my conversations
    Thank you
    Dr Hilaris

  • The facts are readily available, the author chose not to include any links to the data and statistics to promote controversy. Australia is looking at the end of some cancers. This is almost miraculous. The US with it’s for profit healthcare system, is way behind the curve. There is so much ignorance and media deception here that clearly a lot of people are either misinformed or choose to be, posting their “questions” here. 80 million American are infected, in spite of their beliefs. The denial created by a misinformation campaign is causing more deaths, condemning young people to death, by a now curable cancer.

    https://www.cdc.gov/hpv/parents/questions-answers.html

    • You distort the facts yourself. Australia has in recent years adopted mass vaccination against HPV, so in the future the cervical cancer rate will decline. It has a pre-inoculation infection rate that is similar to that of the United States, and that will endure for decades.

      The US, through government and insurers, spends lavishly on treating women with cervical cancer and pre-cancer, so profit has nothing to do with it. Since vaccination is probably much cheaper in the aggregate than treating cervical cancer, the profit-making insurers have an incentive to support vaccination.

      The stumbling block has been regulatory, not economic. If the FDA had not stood in the way of adults obtaining the vaccine, many would have done so. The per capita GDP (PPP) of Americans is about $10,000 higher than Australians, so most Americans have the wealth to afford the vaccine out of pocket. Some of the most anti-vax places in the US are also some of the wealthiest. Almost all youths can get the HPV vaccine through insurance or at no charge through county health clinics, so you are blinded by your ideology.

    • Dear Nicolas, This sure is an alternative take on the subject. “Spending lavishly” on cervical cancer, it shows you know it is expensive, and there is profit to be made there. Vaccines are relatively inexpensive compared to treating cervical cancer, and the other cancers that males can get from HPV.
      You want to blame regulations when it is really clear the refusal to get vaccinated and the foot dragging with expanding it to older people, was due to Ideological issues. We have a powerful Evangelical community that told people these vaccines would encourage sex in teens, and make them promiscuous. The Anti Vaxxers were active too, spreading doubt alternative facts and misinformation.
      The government insurers are funded through our tax dollars, you assume that there is no industry profit there, since it is avoided by mass media. One of the biggest problems with “Government Healthcare” are all of the corporations profiting at our expense. If we had universal healthcare, we would have already expanded these vaccinations, and saved lives.
      The insurers are only part of the equation, common sense would dictate that they endorse the vaccines, it would save them money. The hospitals and medical providers on the other hand could lose a profit generating part of their business.
      Australia and the other 27 developed nations, that all have better healthcare outcomes than the US should be serving as a model, instead we have Ideology driving our healthcare decisions. it is already costing us all around 1o thousand dollars a year.
      This kind of industry trolling must pay well Huh?

    • Mavis, insurers make money when they don’t spend money, not when they do, so it is illogical to suggest that they make money on cancer. Hospitals, doctors, pharma, etc., make money treating cancers.

      As I said, insurers would have an incentive for people to become vaccinated against HPV, and doctors would not. But, again, the problem has been regulatory.

  • This will save a lot of lives and prevent a lot of suffering and misery, while saving the system a lot of money. This should have been done years ago, it shows how dangerous, and expensive ignorance is. A lot of people died, or got cancer, while they were playing hanky panky with this vaccine.

    • Evidence is needed for that. It is necessary to know the following, at least: 1. How many people will get the vaccine who are not already infected with carcinogenic strains of HPV. 2. The expected cost per life saved. The cost per life saved might be very high compared to other interventions, such as convincing people to vape rather using tobacco or to eat fewer calories.

      There are vast differences in the cost effectiveness of life saving interventions. For instance, it has been estimated that the cost per life saved from sickle cell screening would be $236, while the cost per life saved from putting seat belts on school busses would be $2.8 million. Without good data nobody knows whether this vaccine is a good investment of medical dollars for saving adult lives. I don’t think there is any question that it is a good investment when administered to young people before they have their first sexual experience.

    • Nicolas,
      I don’t need a Math lesson. Insurers have a formula, basically they get a minimum of 20 percent administrative fees, on top of the costs of the cancer treatments, and “lavish” Cervical Cancer Surgeries.
      Typically the cost of a vaccine is trivial compared to the costs associated with surgeries, and treatments. Many of the more advanced cases can be pretty expensive, since the US has high rates of adverse events and complications.
      You are probably and Evangelical Troll, one of the people that told young girls if they stayed pure they wouldn’t get cancer. Those lives are costing lives, even in young children, they can get it too, they catch it from their parents.

      Vaping and dieting are not saving any lives, and are not in the same category as a HPV Vaccine!

      This is another argument for Bernie Sanders Universal Helathcare!

    • You left the other thread where I noted that Australia, which you touted based on a single metric, has the highest documented cancer rate among all countries. You are a socialist ideologue, so facts can never influence you. Hence you also belief that neither losing weight nor switching from smoking to vaping saves lives.

      I’m done here.

  • Quick grammar nerd note – in paragraph 3, where it says, “The vaccine prevents against HPV, can cause cervical cancer…” I think someone forgot to put a “which” after the comma. “…HPV, which can cause cervical cancer…” Vaccines already get a bad rap in some circles. I would hate for some readers to think that the vaccine is responsible for cervical cancer and other problems when it is HPV that is the culprit!

  • What percent of adults are infected with each of the carcinogenic strains of HPV? What is the cost per life saved by this vaccine compared to other preventive measures?

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