FDA approved Gardasil vaccine for 45 year olds – preventing more cancers

Sometimes we get good news about vaccines, and this week, we definitely got good news. The FDA approved Gardasil for 27 through 45-year-olds, greatly expanding the age indications for the vaccine. Consequently, more people are protected against dangerous and deadly cancers.

I always thought that the age cutoff, 26 years, was rather arbitrary and that the vaccine would be safe and effective for a 27-year-old as much as it is for a 26-year-old. The FDA can be very conservative with indications for all medications, including vaccines, so they probably awaited more data before moving the approved age for the vaccine up to 45 years. But it’s better late than never that the FDA approved Gardasil for “older” individuals.

The importance of the vaccine is because genital, anal, and oral human papillomavirus (HPV) infections are the most common sexually transmitted infections (STI) in the USA.  HPV is generally transmitted from personal contact during vaginal, anal or oral sex.

HPV is believed to cause nearly 5% of all new cancers across the world, making it almost as dangerous as tobacco in that respect. According to the CDC, roughly 79 million Americans are infected with HPV – approximately 14 million Americans contract a new HPV every year. Most individuals don’t even know they have the infection until the onset of cancer. The CDC also states that over 43,000 HPV-related cancers are diagnosed in the USA every year. It may be several times that amount worldwide.

Although the early symptoms of HPV infections aren’t serious and many HPV infections resolve themselves without long-term harm, HPV infections are causally linked to many types of cancers in men and women. According to current medical research, here are some of the cancers that are linked to HPV:

In addition, there is some evidence that HPV infections are causally linked to skin and prostate cancers. The link to skin cancer is still preliminary, but there is much stronger evidence that HPV is linked to many prostate cancers.

Merck manufactures Gardasil, along with Gardasil 9, approved by the FDA in 2014, which a 9-valent vaccine, protecting against HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It targets the four HPV strains found in the quadrivalent version, along with five additional ones that are linked to cervical and other HPV-related cancers. Both versions of Gardasil are prophylactic, meant to be given to females or males before they become exposed to possible HPV infection through intimate contact.

Currently, in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV.

In the press release, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said:

Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range.

The Centers for Disease Control and Prevention [CDC] 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% of these cancers from ever developing.

Also, the FDA stated:

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

I know that some may claim that anyone who is 45 years old may have already contracted an infection from one or two HPV types. However, since the current Gardasil9 protects against 9 different HPV types, it’s very possible that the vaccine can provide protection against other HPV types.

As I have written over 100 times, Gardasil is demonstrably effective and incredibly safe. And now that the FDA approved Gardasil for up to 45-year-old men and women means more people can be protected against deadly cancers.

Why shouldn’t anyone up to the age of 45 get this vaccine? Of course, I think that 45 is still arbitrary, and if you can convince your healthcare plan (most will agree) or can afford the vaccine, I don’t think it matters if you’re 50, 55 or 60, especially if you’re sexually active, to get the HPV vaccine.



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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!