Tag: HPV vaccines

Have Over 75,000 Adverse Reactions to the HPV Vaccine Been Reported?

Why do some people think that over 75,000 adverse reactions to the HPV vaccine have been reported?

The adverse reactions to the HPV vaccine they are talking about are reports to VAERS and are almost all non-serious, including injection site reactions.
I fixed this anti-vax sign to make it less misleading… The adverse reactions they are talking about are reports to VAERS and are almost all non-serious, including injection site reactions.

Oh, the anti-vax sign folks…

Have Over 75,000 Adverse Reactions to the HPV Vaccine Been Reported?

So is it true?

Actually, it probably is.

After all, the first HPV vaccine was approved in 2006 and over 110,000,000 doses have been distributed to children, teens, and young adults in the United States alone.

And the adverse reactions they are talking about are reports to VAERS, which means that they are not actually known to be causally linked to the vaccine.

“During June 2006–March 2014, the Vaccine Adverse Event Reporting System (VAERS) received a total of 25,176 adverse event reports after HPV vaccination in the United States. Among these, HPV4 was cited in 99% of reports (22,867 and 2,196 reports among females and males, respectively); 92.4% of the HPV4 reports were classified as nonserious. Since October 2009, when HPV4 was licensed for males, the most commonly reported symptoms among males were similar to those among females, including injection site reactions, dizziness, syncope, nausea, and headache. Overall, reporting of adverse events to VAERS is consistent with prelicensure clinical trial data and consistent with the 2009 published summary of the first 2.5 years of postlicensure reporting to VAERS.”

Human Papillomavirus Vaccination Coverage Among Adolescents, 2007–2013, and Postlicensure Vaccine Safety Monitoring, 2006–2014 — United States

Anyway, the overwhelming majority of the HPV vaccine reports to VAERS haven’t been serious.

And those that are classified as serious weren’t to the point of being severe or anything…

“Among the 7.9% of HPV4-related VAERS reports classified as serious, headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness were the most frequently reported symptoms.”

Human Papillomavirus Vaccination Coverage Among Adolescent Girls, 2007–2012, and Postlicensure Vaccine Safety Monitoring, 2006–2013 — United States

Study after study have shown that HPV vaccines are safe, with few risks.

“After 2 years of near real-time surveillance of 9vHPV and several prespecified adverse events, no new safety concerns were identified.”

Donahue et al on Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine.

Also remember that HPV vaccines prevent cancer!

The next time you see one of these anti-vax propaganda signs, think about why they are trying to scare parents away from vaccinating and protecting their kids, risking their getting life-threatening vaccine-preventable diseases and cancer.

More on Adverse Reactions to the HPV Vaccine

Will a NY Law Make the HPV Vaccine Mandatory for Daycare?

Why do some folks think that a proposed bill in New York will make the HPV vaccine mandatory for kids in daycare?

A NY law will not make the HPV vaccine mandatory for kids in daycare.
Kids in daycare will not need to get the HPV vaccine if S298 passes in New York.

Unfortunately, this time the misinformation isn’t just coming from the usual sources. Local news stations are getting in on the action too.

Will a NY Law Make the HPV Vaccine Mandatory for Daycare?

While Senate Bill S298A does “Provides for the immunization of all children born after January 1, 2008 against the human papillomavirus (HPV),” it doesn’t say anything about a mandate for kids in daycare.

“Section one amends the section heading and subdivisions 2; 3, 5, 6, 7, and 8 of section 2164 of the public health law, as amended by chapter 401 of the laws of 2015, by adding human papillomavirus (HPV) to the list of required immunizing agents, such as those against poliomyelitis, mumps and measles, to be administered to children in this state. Section one also adds the HPV vaccine to the list of vaccines for which a booster is required;”

Senate Bill S298A 2019-2020 Legislative Session

When would they get it?

“Every person in parental relation to a child in this state shall have administered to such child an adequate dose or doses of an immunizing agent against poliomyelitis, mumps, measles, diphtheria, rubella,varicella, HUMAN PAPILLOMAVIRUS (HPV), Haemophilus influenzae type b (Hib), pertussis, tetanus, pneumococcal disease, and hepatitis B, which meets the standards approved by the United States public health service for such biological products, and which is approved by the department under such conditions as may be specified by the public health council.”

Senate Bill S298A 2019-2020 Legislative Session

Like the other vaccines, they would almost certainly get it at the standard age, when they are 11 or 12 years old.

“Every person in parental relation to a child in this state born on or after January first, nineteen hundred ninety-four and entering sixth grade or a comparable age level special education program with an unassigned grade on or after September first, two thousand seven, shall have administered to such child a booster immunization containing diphtheria and tetanus toxoids, [and] an acellular pertussis vaccine, AND A HUMAN PAPILLOMAVIRUS (HPV) VACCINE, which meets the standards approved by the United States public health service for such biological products, and which is approved by the department under such conditions as may be specified by the public health council.”

Senate Bill S298A 2019-2020 Legislative Session

And they would get their second booster dose in the sixth grade.

So why do some folks think the bill includes a mandate for daycare?

“The term “school” means and includes any public, private or parochial child caring center, day nursery, day care agency, nursery school, kindergarten, elementary, intermediate or secondary school.”

Senate Bill S298A 2019-2020 Legislative Session

The term day care is used in the definitions list at the beginning of the bill…

“The term “child” shall mean and include any person between the ages of two months and eighteen years.”

Senate Bill S298A 2019-2020 Legislative Session

While that might be a little confusing, it really isn’t if you read the whole bill.

“This bill will leave to the department of health to determine the age at which children will be required to be vaccinated in light of ACIP recommendations.”

Senate Bill S298A 2019-2020 Legislative Session

After all, what are the ACIP recommendations?

“Routine vaccination at age 11 or 12 years has been recommended by the Advisory Committee on Immunization Practices (ACIP) since 2006 for females and since 2011 for males.”

Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices

Since there is nothing in the ACIP recommendations about kids in day care getting a dose of HPV vaccine, it should be very clear that S298A is not a mandate for day care, preschool, or kindergarten, etc.

It is a mandate for kids to get vaccinated and protected in middle school.

And New York, if this bill is enacted, would join Hawaii, Rhode Island, Virginia, and District of Columbia, which already have HPV vaccine school entry mandates.

More on HPV Vaccine School Entry Mandates

Has Gardasil Really Eliminated Cervical Cancer in Australia?

Why do some folks think that Gardasil hasn’t eliminated cervical cancer in Australia yet?

“New research from Cancer Council NSW, being presented this week at the International Papilloma Virus Conference (IPVC 2018) in Sydney and published in The Lancet Public Health, has shown that if vaccination and screening coverage are maintained at their current rates, cervical cancer is likely to be eliminated as a public health issue within 20 years.

The new research predicts that cervical cancer rates will drop to less than 6 in 100,000 by 2022 – meaning that it will soon be considered a rare cancer. Rates will continue to drop further, dropping below 4 in 100,000 by 2035. These findings indicate that Australia is on-track to be the first country in the world to eliminate cervical cancer by successfully implementing a combined approach to vaccination and screening.”

Australia set to eliminate cervical cancer by 2035

Maybe it is because Gardasil really hasn’t yet eliminated cervical cancer in Australia…

Has Gardasil Really Eliminated Cervical Cancer in Australia?

Wait, so why is anyone trying to say that something that hasn’t happened yet isn’t true?

Is Bobby Kennedy trying to get in the way of work to eliminate cervical cancer?
Who is Dr. Robert Reichert?

Perhaps “Dr. Reichert” just misspoke and did say that Australia had already eliminated cervical cancer instead of that they were on their way to eliminating cervical cancer

It is true, after all. Australia is really on their way to eliminating cervical cancer thanks to the HPV vaccine!

What about all of the slides and tables that Bobby Kennedy included with his post?

Does Slide 1 really show a terrifying increased risk of cervical cancer?

Anti-vax folks like to misrepresent the results of this study.
Anti-vax folks like to misrepresent the results of this study.

Of course not.

It actually shows how thoroughly vaccines are tested before they are approved!

In this case, they were evaluating “the potential of Gardasil to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.”

And although Bobby Kennedy is claiming that is what they found, the women in the Gardasil group (6.5%) were much more likely to have a Pap test with HSIL (high grade squamous intraepithelial lesion) as those in the placebo group (3.7%) at the start of the trial! That’s before they were vaccinated and that’s why they were more likely to have cervical cancer. Remember, the HPV vaccines prevent cervical cancer. They do not treat cervical cancer.

Bobby Kennedy left this out, but during these trials, when they looked at other subgroups, they “did not raise a concern about enhancement of cervical disease due to HPV.”

And Bobby Kennedy‘s other slides?

In Slide 2, just after telling you to look at the vaccine insert, he claims that “nearly half of all women have had prior exposure to HPV – with 38% being exposed before age 10.”

Is that in the vaccine insert?

Nope, it comes from a small study he found, Genital HPV in Children and Adolescents: Does Sexual Activity Make a Difference?, which says that “sexual activity was associated with increased risk for genital high-risk HPV infection.”

Most studies find that prepubertal girls are negative for HPV.
Most studies find that prepubertal girls are negative for HPV.

Surprisingly, the study did find that some girls somehow had exposure to HPV even though they were not sexually active and some, even while they were prepubertal.

“The finding of asymptomatic HPV DNA in children, and correlation with live virus, infectivity, or disease is unclear.”

Jayasinghe et al on Genital warts in children: what do they mean?

Again, Bobby Kennedy leaves out the fact that almost all other studies have found that prepubertal kids and those who are not sexually active are negative for HPV.

And Bobby Kennedy‘s other slides?

The UK doesn't have vaccine mandates and rates of stage II or worse cancers were lower than ever.
The UK doesn’t have vaccine mandates and rates of stage II or worse cancers were lower than ever.

Did rates of cervical cancer increase “in the vaccinated group (20-24)” just after the start of a school vaccination campaign?

“Screening from age 20 yrs, rather than from age 25 yrs, would not prevent any more cancers from spreading beyond the cervix (stage II or worse) by age 27 yrs. The substantial increase in stage I cervical cancers in 24 and 25 year old women, corresponds to changes whereby a high proportion of women are now screened for the first time between ages 24.5 and 25.5 yrs. Previously some of these early stage screen detected cancers would have been prevented by treatment of high-grade cervical intraepithelial neoplasia following earlier screening and a few would have been screen-detected later – at age 26 or 27 yrs. Others may be slow-growing cancers, some of which could be argued to be over-diagnosed.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

It kind of did, but only in the lowest grades and because they changed the ages for when these women were screened!

“Reassuringly no increase in stage II or worse cancers was observed in women under age 27 yrs. In fact, numbers of stage II or worse cancers diagnosed at age 24.5–25.0 yrs in 2014 are lower than in any other year since 2007.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

And that’s not all they found!

Wait, Bobby Kennedy doesn’t mention that rates of cervical cancer are getting lower since 2007…

“Amidst these changes HPV vaccination was introduced in 2008 for girls aged 12–13 with catch-up for those aged 14–18.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

What else happened since 2007?

That’s right. That’s about when we started vaccinating girls with the HPV vaccine.

A vaccine that has been very well studied since to see it’s effects on cervical cancer, including a large meta-analysis of 65 studies in 14 countries.

“More than 10 years have elapsed since human papillomavirus (HPV) vaccination was implemented. We did a systematic review and meta-analysis of the population-level impact of vaccinating girls and women against human papillomavirus on HPV infections, anogenital wart diagnoses, and cervical intraepithelial neoplasia grade 2+ (CIN2+) to summarise the most recent evidence about the effectiveness of HPV vaccines in real-world settings and to quantify the impact of multiple age-cohort vaccination.”

Brisson et al on Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis.

What did they find?

They found “compelling evidence of the substantial impact of HPV vaccination programmes on HPV infections and CIN2+ among girls and women, and on anogenital warts diagnoses among girls, women, boys, and men.”

“In countries like the UK, Australia, and Canada there has been dramatic reduction in HPV related infections and diseases, while in countries with very low coverage there has been very little impact.”

Marc Brisson on HPV vaccine: high coverage could eradicate cervical cancer within decades, say researchers

HPV vaccines are safe and effective and they prevent cancer!

Why are some folks still trying to scare parents away from vaccinating and protecting their kids with these necessary vaccines?

More on Gardasil Eliminating Cervical Cancer in Australia

Do Anti-Vaccine Pediatricians Lose Millions Not Vaccinating Kids?

Paul Thomas is upset…

He thinks that Willamette Week, an alternative weekly newspaper in Portland, is trying to discredit him.

How are they using their platform “to try to discredit an ethical top Pediatrician in the community?”

An “ethical top pediatrician” who made up his own immunization schedule???

Paul Thomas was barred from the Vaccines for Children Program.
Paul Thomas was barred from the Vaccines for Children Program.

Willamette Week published a story about how Paul Thomas was kicked out of the Vaccines for Children Program.

“VFC (Vaccines for Children) does not provide any funding (no real dollars) just free vaccines for the underprivileged. What I lost was the ability to provide this free federal program to my patients who qualify for this program. This is simply a major inconvenience to those affected. Financially it is neutral to me.

My clinic had actually stocked the vaccines Rachel mentions – we just didn’t comply in a timely manner, so you got this part right “I didn’t jump through their hoops fast enough.”

Paul Thomas

To make a long story short, he got kicked out of the Vaccines for Children Program because he didn’t follow the rules of the program.

What about the idea that he “just didn’t comply in a timely manner?”

This all started over two and a half years ago???

Although Paul Thomas says in his post that his “clinic had actually stocked the vaccines Rachel mentions,” the order kicking him out of the VFC program says otherwise.

“Dr. Thomas submitted a Declaration signed under penalty of perjury stating his office does not keep stock of HPV vaccines and instead sends patients to pharmacies.”

Default Order Terminating Integrative Pediatrics from VFC

He also did not have any rotavirus vaccine in his office.

Not exercising medical judgement in accordance with accepted medical practice? Where is the Oregon Medical Board???

To get to the point of being terminated and which Paul Thomas characterizes as “I didn’t jump through their hoops fast enough,” actually involved:

  • ignoring an offer for a probationary agreement (August 2018)
  • asking for a contested case hearing (October 2018) which was scheduled for July 12, 2019
  • withdrawing his request for a contested case hearing on July 10, 2019

I’m surprised they gave him that much time!

Did he lose Medicaid funding?

I’m not sure he even takes Medicaid, but he did lose the ability to give his patients vaccines that he didn’t have to pay for.

“One huge misconception, and I see the comments on this, is that pediatricians don’t make money on vaccines or that they are not financially incentivized to vaccinate. There are profits from vaccine mark-ups and huge profits from vaccine administration fees. The average admin fee is about $35 per vaccine. For the 715 patients born into my practice who have refused to give any vaccines (each child would have had 28 vaccines by age 2 and over 60 vaccines in their childhood) amounting to income of $700,000 for the 2 years and $1.5 million over their childhood. Those are real dollars lost for Integrative Pediatrics. The money lost when considering that we serve over 15,000 patients, with most being selective about how they vaccinate would have driven most practices out of business.

There are also built in incentives in many contracts with health plans. Vaccines are a quality measure (if your practice does not reach a bench mark in numbers vaccinated) you loose a % on all services provided to patients under that insurance contract.

Is it any wonder most of my peers discharge patients from their practices who won’t follow the CDC schedule? Often these patients are told to call Dr. Thomas (Integrative Pediatrics).

Let us be clear. It is not a good business decision to allow families not to vaccinate or to permit selective vaccination.”

Paul Thomas

Let us be clear. He certainly doesn’t understand vaccine administration fees…

Some things he gets wrong?

  • pediatricians might charge $35 as an admin fee, but they are lucky if insurance companies pay them 1/3 or 1/2 that or even less. Your average vaccine administration fee is only going to be $35 if you don’t take insurance and can set your own fees!
  • you get a lower vaccine administration fee for the second vaccine component given (you use a different CPT code – 90461) vs the first (90460), and it pays less, so doctors make less when they give multiple vaccines at the same visit. Is that why many vaccine friendly doctors recommend giving one vaccine at a time?

And he misses the whole point behind vaccine administration fees.

It costs pediatricians money to order, stock, monitor, and give vaccines!

“This study shows that the variable costs of vaccine administration exceeded reimbursement from some insurers and healthplans.”

Glazner et al on Cost of Vaccine Administration Among Pediatric Practices

Do they make any money?

Hopefully they do, as health care is a business in the United States, but they certainly aren’t making millions in net profit as Paul Thomas suggests. And if they aren’t very careful, after considering all of the factors that go into giving a vaccine, it is very easy to lose money.

How Do Anti-Vaccine Pediatricians Make Money?

Which brings us back to the business decision of being a pediatrician who scares parents away from vaccinating and protecting their kids.

Is there any money in that?

Paul Thomas doesn't mention that he gets a big cut of the sales for a "free" summit that costs $197 as he promotes his anti-vaccine lecture.
Paul Thomas doesn’t mention that he gets a big cut of the sales for a “free” summit that costs $197 as he promotes his anti-vaccine lecture.

Books, seminars, supplements, essential oils – there are lots of things to sell parents who don’t vaccinate their kids.

Compared to these pediatricians in California, Paul Thomas is a bargain at just $295/year.

Don’t forget the annual membership fees that many of these pediatricians charge for the privilege of skipping or delaying vaccines and at extra risk to get a vaccine-preventable disease.

And the vaccine exemptions that some of them sell…

More on Do Anti-Vaccine Pediatricians Lose Millions Not Vaccinating Kids?