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

FDA approved Gardasil

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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HPV vaccine efficacy – another study shows long-term immunogenicity

HPV vaccine efficacy

As I’ve mentioned dozens of times, the anti-vaccine religion probably hates the HPV vaccine more than all others put together. They’ve invented numerous myths and tropes about the HPV vaccine, all without any foundation in science. One of these claims is that we don’t know anything about long-term HPV vaccine efficacy.

Of course, the HPV vaccine is a relatively new one, so long-term data requires us to wait for time to pass. Fortunately, we are accumulating a boatload of data that shows us that the long-term HPV vaccine efficacy is pretty strong.

And now, we have a powerful new study from Finland that shows that after 12 years post-vaccination, anti-HPV immunogenicity remains quite high. Let’s take a look. Continue reading “HPV vaccine efficacy – another study shows long-term immunogenicity”

Sexual promiscuity and the HPV vaccine – debunking an ignorant myth

sexual promiscuity and the HPV vaccine

There is a myth pushed by the anti-vaccine religion that the HPV vaccine leads to sexual promiscuity. I’ve debunked this fable previously, using peer-reviewed research, but you know the anti-vaccine zombie tropes – they never really die, and they always come back to life.

Let’s look at a couple of new studies that, once again, debunk the myth that sexual promiscuity is linked to the HPV vaccine. There is no link. Period. Full stop. Continue reading “Sexual promiscuity and the HPV vaccine – debunking an ignorant myth”

Cochrane Nordic kerfuffle – HPV vaccine is still safe and effective

Cochrane Nordic

If you’ve been following the old dinosaur’s articles over the past few weeks,  you’d know the ongoing kerfuffle between the anti-vaccine group located within Cochrane Nordic and the parent Cochrane Collaboration. Cochrane Nordic attacked a well done systematic review, published by Cochrane, of safety and effectiveness of the HPV vaccine without merit.

In case you are unfamiliar with the organization, Cochrane Collaboration is a critically important source of evidence-based medicine and a useful tool in providing analytical evidence that can debunk pseudoscientific beliefs. Cochrane’s goal is to organize research data and publications in a logical way that helps physicians and researchers make appropriate decisions about a proposed new therapy, medication or clinical idea.

According to Cochrane, their mission is:

…to provide accessible, credible information to support informed decision-making has never been more important or useful for improving global health. In the Internet age, people have much greater access to health information, but little way of knowing whether that information is accurate and unbiased. We do not accept commercial or conflicted funding. This is vital for us to generate authoritative and reliable information, working freely, unconstrained by commercial and financial interests.

Mostly, Cochrane produces systematic reviews, which utilizes systematic methods to collect published data, critically analyze research studies, and then synthesize data from numerous published studies in an attempt to eliminate bias and increase the power of the data that includes a larger number of patients than one study alone.

In the hierarchy of biomedical research, systematic reviews rank at the very top. They are, without a doubt, the most powerful pieces of scientific research available in medicine. To be fair, Cochrane is not perfect. They have made egregious errors in systematic reviews of acupuncture quackery in the past. Like all scientific literature, one must examine a systematic review (whether published in Cochrane or any other journal) with a critical eye.

So this whole Cochrane Nordic kerfuffle may seem like an internecine feud of no importance to the world of science. And it would have been, except it has evolved into one of those tropes that the anti-vaccine religion uses to attack the cancer-preventing HPV vaccine.

Let me end this introduction with a simple statement backed by a mountain of science – the HPV vaccine is demonstrably safe and demonstrably effective.

Let’s take a look at this whole Cochrane Nordic nonsense. Continue reading “Cochrane Nordic kerfuffle – HPV vaccine is still safe and effective”

HPV vaccine adverse effects and the European Medicines Agency

HPV vaccine adverse effects

Despite the robust body of evidence supporting HPV vaccine safety and effectiveness, the European Medicines Agency (the European Union’s version of the US FDA) began a review of human papillomavirus (HPV) vaccines “to further clarify aspects of their safety profile,” although the agency also points out that this review did not “question that the benefits of HPV vaccines outweigh their risks.” In other words, the EMA examined the HPV vaccine adverse effects, real or imagined.

After a few months of investigation, the EMA came to a conclusion about HPV vaccine adverse effects – there were no major ones. Let’s take a look at this story.
Continue reading “HPV vaccine adverse effects and the European Medicines Agency”

Cochrane HPV vaccine systematic review – responses to anti-vax criticism

Cochrane HPV vaccine systematic review

In May 2018, I wrote an article about a Cochrane HPV vaccine systematic review that provided solid evidence that the human papillomavirus (HPV) vaccine was safe and effective. I considered the review to be one of the seminal pieces that support the use of the cancer-preventing vaccine. Moreover, most scientists in the biomedical field consider Cochrane systematic reviews (see Note 1) as near the pinnacle of the hierarchy of biomedical research.

Then, in early August 2018, several anti-vaccine, and more particularly vehement anti-HPV vaccine, “researchers” at Cochrane Nordic, a branch of the Cochrane Collaboration, went on the attack against the HPV vaccine. They published a paper in BMJ Evidence Based Medicine that blasted the Cochrane HPV vaccine systematic review.

I thought that this critique was without merit. Moreover, nothing they wrote diminishes the quality of the original Cochrane HPV vaccine systematic review. Once again, that systematic review provided us with solid, high-quality support of the fact that the vaccine is, indeed, safe and effective.

Even though the anti-HPV vaccine group provided some apparently cogent criticisms, it was clear that they had an agenda. Well, there has been more backlash against the anti-vaccine “researchers” in a long post by a scientist who studies and analyzes systematic reviews. And Cochrane itself responded to the criticism. Let’s take a look.  Continue reading “Cochrane HPV vaccine systematic review – responses to anti-vax criticism”

43,000 HPV-associated cancers annually – HPV vaccine can prevent most

HPV-associated cancers

As I’ve written before, there are just a handful of ways to reduce your risk of cancer. Don’t smoke. Stay out of the sun. Keep a healthy weight. Don’t drink alcohol. And get vaccinated with the HPV vaccine to prevent HPV-associated cancers (see Note 1).

Too many people who discuss the HPV vaccine, especially among the anti-vaccine religion, tend to focus on HPV-related cervical cancer. But HPV is linked to several dangerous and deadly cancers, and a new report examines the details of those cancers.  Continue reading “43,000 HPV-associated cancers annually – HPV vaccine can prevent most”

Primary ovarian insufficiency unrelated to HPV vaccine – anti-vaxxers will move goalposts

primary ovarian insufficiency

Primary ovarian insufficiency (POI), previously known as premature ovarian failure, is one of those tropes pushed by the anti-vaccine religion – HPV vaccines cause POF. Although there is no robust epidemiological or clinical evidence of a link between the vaccine and primary ovarian insufficiency, the myth persists.

The overall safety of the HPV vaccine has been shown over and over again in multiple huge epidemiological studies published in top-tier, peer-reviewed journals. And in those studies, which include millions of patients, there have been no safety signals regarding primary ovarian insufficiency. Yet, the myth persists.

We’ve got a new large study, published in a top-ranked journal, that, once again, refutes this myth. Let’s take a look. Continue reading “Primary ovarian insufficiency unrelated to HPV vaccine – anti-vaxxers will move goalposts”

Gardasil effectiveness – yes, HPV vaccine does protect you against cancer

Gardasil effectiveness

Although I have no poll numbers sitting in front of me, and certainly no scientific peer-reviewed research, I just have a feeling that if you scratch the surface of an anti-vaccine activist, you will find that if they could hate one vaccine, it would be Gardasil. And one of the arguments will be all about Gardasil effectiveness – they claim it doesn’t actually prevent cancer.

When you couple their false claims about the dangers of the vaccine with the claims about the lack of Gardasil effectiveness, you’d probably agree with the anti-vaccine crowd. Despite these false claims, HPV vaccine uptake has slowly grown in the US and other countries.

I’ve written nearly 200 articles about the HPV cancer-preventing vaccine, but most of those are focused on debunking myths and confirming the safety of the vaccine. I’m going to focus on a quick primer about Gardasil effectiveness in preventing cancer. Stay tuned for some interesting science. Continue reading “Gardasil effectiveness – yes, HPV vaccine does protect you against cancer”

Cervical cancer rate declines after introduction of HPV vaccine – new evidence

cervical cancer rate

One of the misinformed tropes of the anti-vaccine world is that there is no evidence that the human papillomavirus (HPV) vaccine actually reduces cancer rates. Given that the vaccine was only introduced in the last 10 years, it would take time for researchers to study this issue. But now, we have more evidence that the cervical cancer rate declined after the introduction of the HPV vaccine in the USA.

We have robust evidence that the HPV vaccine actually stops HPV infections, which are linked to several types of cancer. Over the past few years, a number of published articles have provided us with powerful evidence that the HPV vaccine is significantly reducing the cervical cancer rate.

Although there is a myth that the HPV vaccine is just to prevent cervical cancer, I expect, over the next few years, there will be new research that shows reductions in other cancers, in both women and men, as a result of the introduction of the vaccine. Moreover, the effect of the vaccine on males may take longer since the vaccine was recommended for males only a few years after it was introduced.

This year, a solid systematic review, the most powerful research in the hierarchy of biomedical science, along with other studies, have been published that provide strong evidence that the HPV vaccine reduces the cervical cancer rate. Now we have a new study to add to the body of science supporting the effectiveness in preventing cancers of the HPV vaccine. Continue reading “Cervical cancer rate declines after introduction of HPV vaccine – new evidence”