Tag: hpv vaccine

New Vaccine Bills and Laws in 2019

California passed a new vaccine law, SB 277, in 2015.

With the passage of SB 277, California joined Mississippi and West Virginia as the only states that do not allow either religious or personal belief vaccine exemptions.

A few other states passed new vaccine laws of their own in the following years.

Despite what anti-vaccine folks might think, not one of the new laws means that anyone is forcing kids to get vaccinated though.

New Vaccine Bills and Laws in 2019

The idea of vaccine mandates is a big issue as we continue to see outbreaks of measles around the world.

New vaccine laws being proposed across the United States include:

  • House Bill 2505 in Arizona will change their non-medical exemptions from personal to religious
  • Senate Bill 1201 in Arizona will require schools to post immunization rates on their websites
  • House Bill 7005 in Connecticut would permit ordained, commissioned and licensed members of the clergy to acknowledge parental statements concerning religious objections to vaccinations required for enrollment in public and nonpublic schools, instead of school nurses.
  • Senate Bill 354 in Florida updates their immunization registry
  • Senate Bill 1659 in Illinois adds the HPV vaccine to the list of childhood vaccines that kids receive before starting 6th grade
  • HF 206 in Iowa eliminates the religious vaccine exemption.
  • Senate Bill 133 in Kentucky adds vaccine requirements for college students
  • Legislative Document 798 has been sent to the Committee on Education and Cultural Affairs in Maine and would remove non-medical vaccine exemptions
  • SD 1520 in Massachusetts adds the HPV vaccine to the list of childhood vaccines that kids receive
  • Assembly Bill 3818 in New Jersey clarifies the religious exemption to vaccination, so that a general philosophical or moral objection to getting vaccinated will no longer count as a true religious exemption
  • Senate Bill 298 in New York adds the HPV vaccine to the list of childhood vaccines that kids receive
  • Senate Bill 925 in Oklahoma requires school districts to report exemption rates
  • House Bill 2783 in Oregon requires parents to submit a form signed by a health care practitioner if they are not going to vaccinate their kids and a signed certificate verifying that they completed a vaccine educational module
  • Senate Bill 329 in Texas simply requires schools to post how many kids are claiming vaccine exemptions
  • House Bill 238 in Vermont eliminates religious exemptions
  • House Bill 1638 has already passed a Health Care and Wellness Committee in Washington and will remove personal or philosophical exemptions for the MMR vaccine
  • Senate Bill 5841 in Washington will remove personal or philosophical exemptions for all vaccines

It’s easy to navigate the new laws.

Get educated and get your kids vaccinated. Vaccines are safe, with few risks, vaccines work, and vaccines are necessary.

Be a vaccine advocate and make sure your state legislators know that you support strong vaccine laws that will keep us all protected from vaccine-preventable diseases, as more and more folks try and abuse vaccine exemptions.

What To Know About Vaccine Mandate Laws

Vaccine mandate laws are expanding as we are seeing more outbreaks of vaccine preventable diseases.

More Information on Vaccine Mandate Laws:

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I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Believe it or not, there are some parents who get their kids each and every vaccine, but skip the one that protects them from cancer.

I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Why?

HPV Vaccine is Cancer Prevention.

That’s a good question.

And although they won’t have a good answer, some of their reasons include that:

  • the HPV vaccine is too new – even though Gardasil was first approved in 2006 and the first phase 1 and phase 2 trials began in 1997!
  • they don’t think it is necessary – even though about 4,200 women die of cervical cancer each year (that’s just in the United States), even in this age of routine pap tests
  • it might lead their kids to have early sex or unprotected sex – even though studies show it won’t
  • Michele Bachmann once said it caused mental retardation – even though she had no evidence to support her claim
  • the HPV vaccine is too controversial – any “controversy” about Gardasil and Cervarix is made up by anti-vaccine folks
  • HPV vaccines can cause POTS, ASIA, primary ovarian failure, venous blood clots, behavior problems, or multiple sclerosis, etc. – even though over and over, studies have found HPV vaccines to be safe and to not cause any of the other serious side effects or vaccine induced diseases you read about on the Internet that scare you away from vaccinating and protecting your kids
  • it is banned in Utah – even though that isn’t true
  • it doesn’t provide life-long protection – even though the protection has been found to be long-lasting, as long as we have been giving the vaccine so far
  • it is banned in Japan and France – even though HPV vaccines aren’t banned anywhere and are actually on the immunization schedule in at least 64 countries
  • Katie Couric once did a scary segment on HPV vaccines – well, she did but later apologized… after being called out for pushing anti-vaccine misinformation
  • an HPV vaccine researcher says it’s dangerous – no, the HPV vaccine researcher, Diane Harper, actually says it is a safe vaccine
  • HPV vaccines are just for girls – even though there are around 11,000 cases of HPV induced cancer in men each year, including anal cancer and cancers of the mouth/throat and penis
  • their kids are too young and can get it later, when they are older – even though protection is likely better when they get the vaccine when they are younger, and you don’t want to wait too long, when you increase the chance that they will have had sex and will already be exposed to HPV

So why aren’t you getting your kids vaccinated and protected… against cancer?

Need to do more research? Read the links below and then schedule your kids for their HPV vaccine.

More on HPV Vaccine Safety

Should You Get an Extra Dose of Gardasil9?

Believe it or not, the first human papillomavirus (HPV) vaccine was approved way back in 2006.

HPV Vaccine is Cancer Prevention.

And believe it or not, we are now on our third version of the vaccine, which provides protection against even more strains of HPV.

HPV Vaccine Timeline

So we have gone from:

  • Cervarix – HPV serotypes 16, 18 (2006)
  • Gardasil – HPV serotypes 6, 11, 16, 18 (2006)
  • Gardasil9 – HPV serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58 (2014)

And with each new vaccine, there comes more protection against anal and genital warts and anal, genital, head and neck, and cervical cancers.

Gardasil9, the only HPV vaccine available in the United States, increases the protection level against cervical cancer from 70 to 90%!

Should You Get an Extra Dose of Gardasil9?

Has your child already finished their HPV vaccine series?

With which HPV vaccine?

To be clear, if they have finished the series, then they are considered to be fully vaccinated and protected.

“Persons who have completed a valid series with any HPV vaccine do not need any additional doses.”

National Cancer Institute on Human Papillomavirus (HPV) Vaccines

Remember, the key, high-risk strains that cause most HPV-associated cancer are HPV-16 and 18, which are present in all of the HPV vaccines.

The extra coverage in Gardasil9 to HPV strains 31, 33, 45, 52, and 58 could prevent an additional 10% of invasive HPV associated cancers or about 3,800 cases each year though, mostly in women.

Should you get any extra doses of Gardasil9 for this extra coverage?

“Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.”

Garland et al on Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.

While safe to do and it works, there is no formal recommendation that anyone actually get any extra doses of Gardasil9 at this time.

It is something to consider if you want the extra protection though.

Will we get even more coverage in future HPV vaccines? The future might come in different types of vaccines or even in therapeutic vaccines. There doesn’t seem to be a new version of Gardasil with expanded strain coverage in the immediate pipeline though.

More on Getting an Extra Dose of HPV9

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

Crisis at the Nordic Cochrane Centre

This could be it for the Nordic Cochrane Centre.

“I regret to inform you that I have been expelled from membership in the Cochrane Collaboration by the favourable vote of 6 of the 13 members of the Governing Board. No clear reasoned justification has been given for my expulsion aside from accusing me of causing “disrepute” for the organization.”

Peter Gøtzsche on A moral governance crisis: the growing lack of democratic collaboration and scientific pluralism in Cochrane

Or at least for Peter Gøtzsche and his association with the Cochrane Collaboration, which he co-founded in 1993.

I’m not sure how he thinks that there was no clear justification for his being expelled though.

Crisis at the Nordic Cochrane Centre

Most folks understand why Peter Gøtzsche was expelled from the Cochrane Collaboration…

They remember that he recently published a poorly done analysis in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias that was critical of a Cochrane Review on the HPV vaccine, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.

While Gøtzsche’s analysis prompted the Cochrane Collaboration to initiate an investigation, they concluded that his analysis “substantially overstated its criticisms” and that the allegations were “not warranted and provided an inaccurate and sensationalized report of their analysis.”

Is that it?

Nope.

Many people are also familiar with the Nordic Cochrane Centre because of their involvement in continued complaints about the HPV vaccine. Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!

“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”

Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope

Complaints that had already been investigated and dismissed by the European Medicines Agency and refuted by many other studies.

“This week at its meeting in Edinburgh, Cochrane’s Governing Board considered, as planned, the findings of an independent review and additional complaints related to the conduct of a Member. The Board’s conclusion was communicated to the individual concerned and is part of an ongoing process. The Co-Chairs of the Board will provide further details once this process is complete.

Following this, four Board members (Gerald Gartlehner, David Hammerstein Mintz, Joerg Meerpohl and Nancy Santesso) decided to resign as Cochrane trustees with immediate effect.”

Message from the Governing Board

Unfortunately, Gøtzsche’s being expelled led to others leaving the Cochrane Governing Board, including two appointed trustees who volunteered to step down to to comply with Cochrane’s Articles of Association.

Although they may not have been defending Gøtzsche's opinions or behaviors, four other board members resigned in solidarity.
Although they may not have been defending Gøtzsche’s opinions or behaviors, four other board members resigned in solidarity.

We can hope that this is the end of the matter, as Cochrane will soon have an election for new board members.

Peter Gøtzsche is out at the Cochrane Collaboration.
Peter Gøtzsche is out at the Cochrane Collaboration.

Will he be kept on at the Nordic Cochrane Centre, which he founded? Will the Nordic Cochrane Centre be allowed to keep ‘Cochrane’ in their name?

The Nordic Cochrane Centre is primarily funded by the Danish Government, and what do they get besides all of the anti-HPV vaccine stuff?

“Antidepressant drugs are another major killer that people could do well without.”

Peter C Gøtzsche: Prescription drugs are the third leading cause of death

Peter Gøtzsche seems to be against cancer screening, psychiatric drugs, and thinks that Big Pharma has corrupted health care. Is that the “plurality of opinions, views, and perspectives” that folks want at Cochrane or anywhere else in medicine?

Unfortunately, I bet this isn’t the last that we have heard from him.

More on the Crisis at the Nordic Cochrane Centre

About the Cochrane HPV Controversy

Have you heard about the Cochrane HPV controversy?

What controversy?

Well, yeah, but anti-vaccine folks are crowing about what is essentially a letter that was published in BMJ Evidence-Based Medicine journal.

About the Cochrane HPV Controversy

What’s the controversy?

Seems that the folks at Cochrane Reviews recently published a review, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.

That doesn’t sound controversial…

Well, it seems that some other folks, associated with the Nordic Cochrane Center, disagreed. They published an “analysis” in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias.

So who do we believe when we have Cochrane vs Cohrane?

Who is the Nordic Cochrane Centre?

Some people will be familiar with the Nordic Cochrane Centre because of their involvement in complaints about the HPV vaccine that were investigated by the European Medicines Agency.

Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.
Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.

Complaints that were initially triggered by a case series that was published by Dr. Louise Brinth, when she was head of the Danish Syncope Group, but who is now part of the Nordic Cochrane Centre.

While the Cochrane Collaboration has a very good reputation, you can't really say the same about the Nordic Cochrane Centre.
While the Cochrane Collaboration has a very good reputation, you can’t really say the same about the Nordic Cochrane Centre.

Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!

“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”

Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope

Complaints that had already been investigated and dismissed by the European Medicines Agency.

“In conclusion, in clinical trials conducted in the 9 to 26-year- old age range, vaccination was generally well tolerated with no apparent adverse health impact following completion of the vaccination regimen.”

Block et al Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine.

Complaints that are also refuted by many other studies.

So we don’t actually have Cochrane vs Cochrane…

The Cochrane HPV Review

Once you read the complaint against the Cochrane HPV review, you realize that this isn’t even just about the Cochrane HPV review.

The main faults that the Nordic Cochrane Centre folks found is that the Cochrane review left out a bunch of what they consider to be eligible HPV vaccine trials, even though “twenty-six randomised trials were identified that contained data on vaccine efficacy and/or safety, which all together enrolled 73,428 women.”

But if this was just about a systemic review which didn’t stick to protocol about which studies to include, then why do the Nordic Cochrane Centre folks go on and on about placebos and active comparators?

“The Cochrane authors mistakenly used the term placebo to describe the active comparators.”

Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and
ignored important evidence of bias

Would you be surprised to know that one of Nordic Cochrane Centre’s arguments to the EMA was about placebos?

“In all the vaccine trials apart from a small one, the “placebo” contained aluminium adjuvant, which is suspected of being neurotoxic.”

Cochrane Nordic Complaint to the European Medicines Agency (EMA) over maladministration at the EMA

Why do they talk about placebos?

Most of these folks want pure saline placebos to be used in clinical trials, even though doing so would make it hard to keep the trials blinded.

Placebos don’t have to be inert though. The BMJ and the Nordic Cochrane Centre authors mistakenly corrected the Cochrane authors on their use of the term placebo.

They make plenty of other mistakes too.

“The Cochrane authors did not mention a study from 2017 by the WHO UMC that found serious harms following HPV vaccination overlapping with two syndromes: postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS).”

Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and
ignored important evidence of bias

What study?

Jørgensen cites a commentary that describes “a signal based on both spontaneous reports and published case series that is best characterized as a potential association between HPV vaccination and dysfunction of the autonomic nervous system.”

“There is currently no conclusive evidence to support a causal relationship between the HPV vaccine and POTS. It is of utmost importance to recognize that although temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population inherent to this type of scientific literature. If POTS does develop after receiving the HPV vaccine, it would appear to do so in a small subset of individuals and would be difficult to distinguish from the normal prevalence and incidence of the disorder.”

Butts et al on Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature

So who do you believe?

Researchers who published a systemic review as part of the Cochrane Review Groups that confirms that the HPV works and that it is safe, or a group who seems to have an axe to grind against the HPV vaccines?

Update on the Cochrane HPV Controversy

Apparently, Cochrane has taken the Nordic Cochrane Centre complaints seriously enough to launch an investigation.

“Our current investigations appear to show that there may be a handful of missed but potentially eligible studies, but that this falls substantially below ‘nearly half of the eligible trials’.”

David Tovey, editor-in-chief of the Cochrane Library

And not surprisingly, Tovey stated that “To date, we also have no reason to believe that the main conclusions of the review relating to benefit and serious adverse effects are unsafe.”

And yet, as with their complaints to the EMA, resources get wasted as the attacks are put down.

More on the Nordic Cochrane Centre HPV Attacks

Et Tu, Slate? Flaws with Their Questions About Gardasil

Questioning vaccines doesn’t make someone anti-vaccine.

Something is missing in this article about Gardasil testing in Slate...
Something is missing in this article about Gardasil testing in Slate…

Doing a poor job of it and making folks scared to get vaccinated and protected?

I’ll let you decide what to call them…

Slate Investigates the Gardasil Clinical Trials

So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.

What was the problem?

The way that they recorded possible side effects after folks were vaccinated.

“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”

What made the method convoluted?

“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.

Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”

When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.

And those other quotes?

The EMA does state that:

  • “At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
  • “While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”

So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.

They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”

This case of a subject with POTS was reported as being "well characterized" by the EMA, even though it likely wasn't caused by her Gardasil shots.
This case of a subject with POTS was reported as being “well characterized” by the EMA, even though it likely wasn’t caused by her Gardasil shots.

But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?

I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…

“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”

Not far-fetched at all, which is why studies are done to see if there really is a link.

So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:

  • A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
  • In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
  • A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
  • A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
  • A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
  • A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination

The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.

We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.

And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.

“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”

Li et al on Autoimmune Basis for Postural Tachycardia Syndrome

Lastly, what’s with calling cervical cancer uncommon???

“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”

European Medicines Agency

Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.

The HPV vaccines are safe. They work and they are necessary. Don’t skip them.

What to Know About the Slate Gardasil Investigation

Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.

More on the Slate Gardasil Investigation