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The FDA announced Friday that the Gardasil 9 HPV vaccine is now approved for men and women between the ages of 27 and 45, which will appeal to those who wish to reduce high rates of HPV infection and cancer. cervix in the United States.
The vaccine, which protects against nine different strains of the human papillomavirus causing cancer, had already been approved for people aged 9 to 26, and many felt that it would bring no benefit to people over the age of 26 years old.
But the FDA has now expanded this range, according to new findings that vaccination is still effective in people under 45 years old …88 percent effective, in fact. According to the press release of the agency:
In a study involving approximately 3,200 women aged 27 to 45 years, followed for an average of 3.5 years, Gardasil was effective in preventing a combined endpoint of persistent infection, genital warts, Precancerous vaginal and vaginal lesions, precancerous cervical lesions and cervical cancer related to the types of HPV covered by the vaccine. The approval of Gardasil 9 by the FDA in women aged 27 to 45 years is based on these findings and new data on the long-term follow-up of this study.
The efficacy of Gardasil 9 in men aged 27 to 45 is inferred from the data described above in women aged 27 to 45 years, as well as data on the efficacy of Gardasil in men younger (16 to 26 years old) …
Preadolescents are encouraged to get vaccinated before becoming sexually active in order to prevent the spread of infection, which can cause cervical cancer, the fourth most common type of cancer in women, as well as cancers. anus, penis, vulva, vagina and throat (not to mention genital warts). HPV is so ubiquitous – nearly half of the population aged 18 to 59 is currently infected – that the CDC says that almost all people will experience at least one strain in their lifetime. But even if you have been exposed to one strain, the vaccine still immunizes against others. Gardasil is not the only HPV vaccine on the market, but it protects against most strains, including HPV 16 and 18, responsible for the majority of cervical cancers in men and women. women (not to mention 90% of HPV-related cancers in men). , which is worth it, even for this slice of older age.
Looks like those who missed HPV the protection because they were too old to be considered worthy to be immune when the drug was young are about to be doubly screwed more than.
The vaccine works not only on a case by case basis, but on a larger scale, when it is properly implemented. The FDA's decision was taken just days after the publication of a major study in the Lancet Public Health. She said Australia, which has implemented a state-funded HPV vaccination program in 2007, is on the verge of eliminating cervical cancer. In 2016, 79% of girls and 73% of boys who were 15 years old were fully vaccinated against HPV, and research indicates that such high vaccination rates significantly reduce the risk of infection (by 87%), even for unvaccinated people. In contrast, less than half of American adolescents are fully immunized, although the CDC recommends that all preteens be vaccinated.
But approval is one thing, affordability is another. Gardasil 9 costs $ 205 per dose, according to ABC News, but the "fair price" that can be expected in Brooklyn, according to healthcarebluebook.com, is around $ 285. Those who get it before the age of 15 need only two injections, but three are recommended for older people. You also need to consider the cost of administering the vaccines, the "facility fee" and everything the doctors want to add, and the result could be much higher. A doctor I called on Monday told me that it would cost $ 250 for the injection more $ 250 visit fee, just for a dose.
The expansion is for people 27 years of age and older who are not yet infected with the most dangerous strains. Does my insurance cover the HPV vaccine? As NBC quickly pointed out, the FDA's approval "does not necessarily mean that health insurance will pay for it."
Gardasil 9 is covered by most insurance plans for people in the approved age range – from 9 to 26 years old – as it is a preventive care, supposedly only have no fees or share. Healthcare.gov lists "vaccination vaccines," and specifically HPV vaccination, in the list of services that "all health plans Marketplace and many other plans must cover," but it is followed by a specific warning: "Doses, recommended ages and Recommended populations vary. According to Verywell Health, sex is also important, although the immunization of both sexes is important: "The age group for which the vaccine is covered, as well as its coverage for women and men or for women, also varies. . "Even the Gardasil website is cautious, claiming that" Although many private health plans cover GARDASIL 9, the availability and level of coverage may vary. "
It is also unclear whether FDA approval for 27 to 45 years indicates that insurance companies will accept the vaccine as "preventative" for this group. The approval is very recent, but some sites, including the American Cancer Society, still suggest that people over 26 do not need to worry about the vaccine. (On Monday afternoon, the HPV page of ACS was updated to reflect the change in approval, but its evaluation of its usefulness remained consistent: "The Gardasil 9 vaccine is approved for women and men up to age 45, although this is no longer recommended after age 26. Although the vaccine is safe, it is unlikely that it will provide a significant, if any, benefit with aging. Population. ")
Some insurers I've called have stated that HPV immunization East covered as preventative care and have no specific age listed in their systems. But another company told my colleague that she would not cover it unless the CDC changes its recommendation. At present, the agency recommends the vaccine only until the age of 26 years. The American Cancer Society states that insurance plans generally cover vaccination if it is administered "in accordance with national guidelines". But there is good news: The New York Times reports that the CDC's Advisory Committee on Immunization Practices has reviewed the data and will likely make a recommendation soon, hoping to strengthen the coverage guarantee. .
Uninsured young people can access the vaccine in different ways, although it is unclear whether it will be extended to those over 26 years of age. The Vaccines for Children program, often referred to as an affordability option, will not be implemented, nor will the Merck Vaccine Patient Assistance Program; in the current state, the people eligible for assistance from the manufacturer of the drug must be between 19 and 26 years old. However, as a customer service representative told me, if you are under 27 for the first dose, they will keep it. to come up. (Merck has updated its product information sheet based on the new age range, but not its eligibility for the Patient Assistance Program.) It has not been in able to answer questions regarding the extension of the assistance program in time for this article.) Medicaid covers the vaccine for those under 20 years old and young people from 21 to 27 years old in some states, while some family planning health centers, university medical clinics and local health departments are also able to offer the vaccine for free. But with limited resources, will family planning services and local health services be able to help those for whom the vaccine is, as the American Cancer Society puts it, "unlikely to provide a benefit, if at all? that there is one "?
It seems that those who missed the protection against HPV because they were too old to be considered worthy to be immunized when the drug was young are about to be doubly manipulated – and potentially several hundred dollars in pocket if they want the vaccine. America is riddled with HPV and, unless the CDC or insurers decide that adults also need this vaccine, it will probably stay that way for now.
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