Tag: safety

Are Vaccines Tested Together?

If you are on the Fence about vaccines, one issue that might have you scared is that the idea that vaccines aren’t tested together.

So maybe they tested the Prevnar vaccine, but did they test it with the Hib vaccine?

And did they test the Prevnar and Hib vaccine with the Pediarix vaccine?

After all, kids get all of those vaccines at their two, four, and six month well child checkups.

Vaccines Are Tested Together

It is not hard to find evidence that most combinations of vaccines are in fact tested together.

For example (and this is not a complete list):

  • Rotarix was tested with Pediarix (DTaP-HepB-IPV), Prevnar, and Hib
  • Prevnar 13 was tested with DTaP, IPV, hepatitis B and Hib
  • Prevnar 13 was tested with MMR, Varicella, and hepatitis A
  • MenC with DTaP-IPV-HepB-Hib
  • MenC with MMR
  • MMR and Varicella with Hib, Hepatitis B, and DTaP
  • hepatitis A and hepatitis B with either MMR or DTaP-IPV-Hib
  • HPV vaccine for babies
  • Flumist with MMR and Varicella
  • Kinrix (DTaP-IPV) with MMR and Varicella
  • HPV9 with Tdap and Meningococcal vaccines
  • Tdap with influenza vaccine
  • Meningococcal vaccine with influenza vaccine

And even after a vaccine is added to the immunization schedule and it is given together with other vaccines, our post-licensure vaccine safety monitoring systems, from VAERS to the Vaccine Safety Datalink, kick in to make sure that they are indeed safe and effective.

The Myth That Vaccines Aren’t Tested Together

If it is clear that vaccines are in fact tested together, then why do some folks still believe that they aren’t?

Bob Sears appeared on Fox & Friends in 2010 for the segment
Bob Sears appeared on Fox & Friends in 2010 for the segment Vaccines: A Bad Combination?

Hopefully everyone sees the irony in Dr. Bob saying something about vaccines being untested, as he is infamous for pushing his own made up and completely untested alternative vaccine schedule.

“Babies get as many as 6 or 7 vaccines altogether…and the CDC is admitting that they don’t always research them that way.”

Dr. Bob Sears on Fox & Friends Vaccines: A Bad Combination?

When did they admit that???

“We’ve researched the flu vaccine in great detail and it seems safe when it’s given alone, but the CDC has never researched the flu vaccine when you give it in conjunction with all the other infant shots…and that’s what we’re worried about. ”

Dr. Bob Sears on Fox & Friends Vaccines: A Bad Combination?

So, what about the flu vaccine?

A 2013 report from the Institute of Medicine found that there was no evidence that vaccines caused ADHD.
A 2013 report from the Institute of Medicine stated that “Each new vaccine considered for inclusion in the immunization schedule is tested within the context of the existing schedule and reviewed by clinical researchers, who analyze the balance of demonstrated benefits and risks.”

While most kids get their flu vaccine by itself, just before the beginning of flu season, some might get it when they see their pediatrician for a regular checkup, at the same time they are due for other vaccines.

Not surprisingly, Dr. Bob was wrong, and several studies have shown that the flu vaccine can be safely given with other vaccines.

And don’t forget, any problems with co-administration of vaccines would show up in post-licensure vaccine safety testing.

That’s how a very small increased risk of febrile seizures was found during the 2010-11 flu season in toddlers who received either DTaP or Prevnar and a flu shot at the same time.

The very small extra risk doesn’t mean that you still can’t get the vaccines at the same time if your child needs them all though. Remember that febrile seizures “are temporary and do not cause any lasting damage.”

It will be even more reassuring to some parents that another study “examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP)” and found no extra risk for febrile seizures.

“Vaccines can generally be co-administered (i.e. more than one vaccine given at different sites during the same visit). Recommendations that explicitly endorse co-administration are indicated in the table, however, lack of an explicit co-administration recommendation does not imply that the vaccine cannot be co-administered; further, there are no recommendations against co-administration.”

Summary of WHO Position Papers – Recommendations for Routine Immunization

Also remember that “there are no recommendations against co-administration of vaccines,” unless of course, you are getting your advice from Bob Sears…

 

What To Know About Vaccines Being Tested Together

Vaccines are thoroughly tested for both safety and efficacy and they are also tested in many of the different combinations on the routine childhood immunization schedule.

More On Vaccines Being Tested Together

Are You on the Fence About Vaccines?

If you have doubts about vaccinating your kids, but you are still doing research, then you are probably what people like to call a fence sitter.

On the Fence About Vaccines

Folks who are on the fence haven’t made a decision yet and are torn between what they see as two difficult options.

In this case, the two options we are talking about are:

  1. vaccinate your kids
  2. don’t vaccinate your kids

What makes those options difficult?

If you spend a little time on the Internet, those two options get complicated quickly and can turn into:

  1. vaccinate your kids – exposing them to toxins and all kinds of vaccine-induced diseases, from autism to SIDS
  2. don’t vaccinate your kids – risking a deadly disease because they are unvaccinated or the possibility that someone will come and force you to get them vaccinated

How do you figure out the truth to help you make the right decision for your family?

The Truth Behind Your Vaccine Decision

Most parents vaccinate their kids on time and on schedule.

These books about vaccines can help with your research about vaccinating and protecting your family.
These vaccine books can help you make the right decision if you are on the fence about vaccines.

Do they all have a hard time making their decision?

Most don’t.

They understand the risks their children face if they aren’t vaccinated.

“When a well-meaning parent like Jenny McCarthy blames vaccines for her child’s autism, placing the fear of God into every parent who has a baby, it’s not only irresponsible – it’s dangerous. Why? It’s simple math: vaccines are less effective when large numbers of parents opt out. And the more who opt out, the less protected ALL our children are.

Celebrity books come and go . . . but the anxiety they create lives on in pediatricians’ offices across the country. A small, but growing number of parents are even lying about their religious beliefs to avoid having their children vaccinated, thanks in part to the media hysteria created by this book.”

Ari Brown, MD responding to Jenny McCarthy appearing on Oprah

That’s not to say that they don’t think about their decision to vaccinate their kids. Or even think twice about it.

But in the end, they know that:

  • vaccines work – even if they aren’t perfect and waning immunity is an issue with a few vaccines
  • vaccines are safe – even if they do have some side effects, which can rarely be severe
  • vaccines are necessary – without them, we would end up in like it was in the pre-vaccine era, even with modern health care, nutrition, and sanitation, etc.

And they know that their decision might affect others around them.

If your research about vaccines has pushed you off the wrong side of the fence and into your pediatrician’s office with a copy of Dr. Bob’s vaccine book demanding an alternative immunization schedule, then you might want to do a little more research.

Misinformed Consent

Most importantly, parents who choose to vaccinate their kids don’t believe the myths and conspiracy theories that might lead them to skip or delay any recommended vaccines.

“If you see a turtle sitting on top of a fence post, it didn’t get there by accident.”

President Bill Clinton

Ironically, the anti-vaccine “experts” and websites that scare some parents often talk about choice and informed consent.

Understand though, that by exaggerating the risks of vaccines and vaccine injury (no, vaccines are not full of toxins), playing down the risks of vaccine-preventable diseases (no, they are not mild diseases that should be thought of as a rite of passage), and ignoring the benefits of vaccines (yes, vaccines do work), they are violating the basic tenets of informed consent themselves.

And that limits your ability to make the right choice for your family.

Making the Right Decision About Vaccines

There is nothing wrong with asking questions and being skeptical about the answers you get.

No one wants to return to the days when reports of measles epidemics made the front page of the New York Times.
No one wants to return to the days when reports of measles epidemics made the front page of the New York Times.

With all of the things you see and hear about vaccines, there is nothing wrong with being a little scared and wanting to do more research, instead of blindly following the advice of your pediatrician.

But remember that if you are going to be skeptical and are not going to blindly follow the advice of someone you know and maybe trust, then don’t blindly believe everything you read on the Internet that says vaccines are bad.

“My husband and I agreed we would just not have our new baby vaccinated until she was at least 1 year old, which seemed like enough time to continue looking for information. Also, we were not concerned that she was at risk of contracting any serious childhood illnesses.

We were wrong.

A week before our baby girl’s first birthday, she was feverish and listless. When she refused to nurse for 24 hours, I took her to see our pediatrician. She was hurriedly admitted to intensive care with the diagnosis of spinal meningitis caused by Haemophilus influenzae, type B, which is a vaccine-preventable disease.”

Suzanne Walther on A Parent’s Decision on Immunization: Making the Right Choice

Suzanne Walther discovered that “it is easy for parents to be misinformed. It is a real challenge to be well informed.”

What questions did she want answers to?

  • Are vaccines really effective at preventing diseases? – Yes, although they aren’t 100% effective, vaccines do work well at preventing and controlling 16 different vaccine-preventable diseases on our childhood immunization schedule. And yes, vaccines did help eliminate smallpox and herd immunity is real.
  • How are vaccines made? – Vaccines are made in a multi-step process that begins with generating the antigens that will go in the vaccine and then moves to releasing and isolating the antigen from the growth medium, purifying the antigen, strengthening and stabilizing the vaccine, and then combining it all into the final vaccine. Unlike videos you may have seen on the Internet, there is nothing scary about this very scientific process.
  • Are they tested for safety? – Vaccines are extensively tested in Phase I, II, and III trials before they are approved and added to the immunization schedule. This entire vaccine development process may take as long as 10 to 15 years.
  • Are there ongoing clinical trials to rule out the possibility that vaccines cause diseases later in life? – Yes, after vaccines are approved and are added to the immunization schedule, ongoing Phase IV studies continue to monitor their safety and efficacy. In addition, Vaccine Adverse Event Reporting System (VAERS), the Clinical Immunization Safety Assessment (CISA) Project, and the Vaccine Safety Datalink (VSD) help make sure vaccines are safe after they are approved.
  • Have allegations of adverse reactions been studied and confirmed or refuted? – Yes. In addition to several Institute of Medicine Vaccine reports, study after study have shown that vaccines don’t cause autism, SIDS, ASIA, or any of the other vaccine induced diseases “they” come up with.
  • And, last but not least, where can I get truthful, clear answers to my questions? – In addition to your pediatrician, there are plenty of vaccine books, sites, and groups that can help you get educated about vaccines.

Today, she might also have had questions about package inserts, aluminum, MTHFR mutations, shedding, vaccine mandates, the CDC Whistleblower, and the HPV vaccine. These and a hundred more have been answered over and over again.

Suzanne Walther learned about vaccines the hard way – after her infant contracted Hib meningitis, a vaccine-preventable disease. She also discovered that you can sometimes delay or wait too long to vaccinate your child.

What will you do to be well informed and to make sure you are making the right choice?

What to Know If You Are on the Fence About Vaccines

It is easy to be misinformed about vaccines, especially if you are on the fence and aren’t sure what to do. Get educated and and be sure you are making the right decision for your family.

More About One the Fence About Vaccines

National Immunization Awareness Month

This year, we celebrate the 17th annual National Immunization Awareness Month.

History of National Immunization Awareness Month

The National Partnership for Immunization first designated August as National Immunization Awareness Month in 2001.

“NIAM was officially announced to the media and the immunization community with a kickoff event at the National Press Club on August 1, 2001. Key stakeholders, including maternal and child health professionals, immunization advocates and policymakers participated in a press conference and reception in Washington, D.C. to celebrate the initiation of this yearly event.”

Are you up-to-date? Vaccinate! An early theme of National Immunization Awareness Month.
Are you up-to-date? Vaccinate! An early theme of National Immunization Awareness Month.

In addition to giving awards to a few members of Congress, the TV show ER got a media award at the first National Immunization Awareness Month because the show “portrayed the importance of vaccinations using the story of an unvaccinated child who was sent to the emergency room and subsequently died from measles. The episode effectively relayed the important messages that measles still occurs in this country, that the disease can be deadly and that it can be prevented by immunization.”

In 2006, the CDC “took over” National Immunization Awareness Month, continuing NPI’s campaign focused around the theme, “Are You Up to Date? Vaccinate!”

Unfortunately, the CDC didn’t really sponsor the month. They just recognized that it was happening on their website…

“While CDC does not sponsor this month, CDC does support and encourage the efforts of state and local health departments and other immunization partners to celebrate NIAM and use this month to promote back to school immunizations, remind college students to catch up immunizations before they move into dormitories, and remind everyone that the influenza season is only a few months away. It’s a great reminder to our nation that people of all ages require timely immunization to protect their health.”

It wasn’t until 2013 that National Immunization Awareness Month really came back.

That’s when the National Public Health Information Coalition started coordinating NIAM activities, including key messages, sample media materials, social media content, and event ideas to:

  • Encourage parents of young children to get recommended immunizations by age two
  • Help parents make sure older children, preteens, and teens have received all recommended vaccines by the time they go back to school
  • Remind college students to catch up on immunizations before they move into dormitories
  • Educate adults, including healthcare workers, about vaccines and boosters they may need
  • Educate pregnant women about getting vaccinated to protect newborns from diseases like whooping cough (pertussis)
  • Remind everyone that the next flu season is only a few months away

In 2014, NIAM began to also focus on a different stage of the lifespan each week, from infants, children and teens to pregnant women and adults.

National Immunization Awareness Month 2017

What’s going on in #NIAM17?

In addition to adding a ‘Back to School’ category for school age children that lasts throughout the month to make sure kids are ready for school, NAIM17 continues with different themes each week:

  • Vaccines are safe. Vaccines are necessary. Vaccines work. These are good messages to learn in NIAM17.
    Vaccines are safe. Vaccines are necessary. Vaccines work. These are good messages to learn in NIAM17.

    Babies and Young Children: A healthy start begins with on-time vaccinations. (July 31-August 6)

  • Pregnant Women: Protect yourself and pass protection on to your baby. (August 7-13)
  • Adults: Vaccines are not just for kids. (August 14-20)
  • Preteens/Teens: Ensure a healthy future with vaccines. (August 21-27)

Are your kids up-to-date?

National Immunization Awareness Month is a great time to get educated about vaccines and learn that:

  • Vaccines protect against serious diseases.
  • These diseases still exist and outbreaks do occur.
  • Vaccines are recommended throughout our lives.
  • Vaccines are very safe.

It’s also a good time to learn how to avoid getting scared by anti-vaccine talking points and the misinformation pushed by the anti-vaccine movement.

What To Know About National Immunization Awareness Month

National Immunization Awareness Month is a great time to learn why vaccinating and protecting your family is an important and safe decision.

More About National Immunization Awareness Month

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Best Books to Help You Research Vaccines

There are many books to help you get educated about vaccines and avoid getting influenced by vaccine scare stories and anti-vaccine talking points.

Some can even help you understand why you are afraid of vaccines.

Unfortunately, if you simply search Amazon for books about vaccines, you are going to be hit with a list of anti-vaccine books. These are books that push their own made-up, so-called alternative immunization schedules and misinformation about vaccines to scare you away from vaccinating and protecting your kids.

Best Vaccine Books

Which books about vaccines have you read?

Did you even realize you had so many choices?

These books about vaccines can help with your research about vaccinating and protecting your family.
These books about vaccines and vaccine-preventable diseases can help with your research about vaccinating and protecting your family.

Some of my favorite vaccine books that can help you with your research on vaccination and making the right decision for your child include:

  • Autism’s False Prophets. Bad Science, Risky Medicine, and the Search for a Cure
  • Bad Faith: When Religious Belief Undermines Modern Medicine
  • Bad Science: Quacks, Hacks, and Big Pharma Flacks
  • Calling the Shots: Why Parents Reject Vaccines
  • The Cutter Incident: How America’s First Polio Vaccine Led to the Growing Vaccine Crisis
  • Dangerous Pregnancies: Mothers, Disabilities, and Abortion in Modern America
  • Deadly Choices. How the Anti-Vaccine Movement Threatens Us All
  • Do Vaccines Cause That?!
  • Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine
  • Immunity by William E. Paul, MD
  • On Immunity: An Inoculation
  • NeuroTribes: The Legacy of Autism and the Future of Neurodiversity
  • The Panic Virus: A True Story of Medicine, Science, and Fear
  • Panicology: Two Statisticians Explain What’s Worth Worrying About (and What’s Not)
  • Polio. An American Story
  • Polio Wars: Sister Kenny and the Golden Age of American Medicine
  • Pox. An American History
  • Smallpox and the Literary Imagination, 1660-1820
  • Tabloid Medicine: How the Internet is Being Used to Hijack Medical Science for Fear and Profit
  • Twin Voices: A Memoir of Polio, the Forgotten Killer
  • Vaccinated. One Man’s Quest to Defeat the World’s Deadliest Diseases
  • Vaccination: A History from Lady Montagu to Genetic Engineering
  • Vaccine. The Controversial Story of Medicine’s Greatest Lifesaver
  • The Vaccine Race: Science, Politics, and the Human Costs of Defeating Disease
  • Vaccines and Your Child. Separating Fact from Fiction
  • Your Baby’s Best Shot. Why Vaccines Are Safe and Save Lives

How many of these books about vaccines have you read?

What To Know About Vaccine Books

If you were scared away from vaccinating your kids because of a book you read or something you saw on the Internet, consider reading a few of these vaccine books that are based on evidence, not fear.

More Information on Vaccine Books:

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Is the HPV Vaccine a Savior or the Most Dangerous Vaccine Ever Made?

I’m still surprised at the responses some parents have when I mention that it is time for their kids to get their HPV vaccine.

Despite what you might read on the Internet, the HPV vaccines are safe and necessary.
Despite what you might read on the Internet, the HPV vaccines are safe and necessary.

While most say things like, “good, I was wondering when they would start it,” a minority still use arguments that could come straight off of any anti-vaccine website or forum.

Is the HPV Vaccine Dangerous?

The HPV isn’t dangerous, but it is easy to see why some parents still think that it is.

How many myths about the HPV vaccine have you heard?

“I don’t like this vaccine… Heaven help us if we have a generation of kids who get a hepatitis B vaccine and a HPV vaccine and they think that now unprotected sex is okay…

I don’t think it is really clear that this vaccine is really as safe as they say it is and it is certainly not as dangerous as they say it is, but I recommend against it in my practice.”

Dr. Jay Gordon discussing the HPV vaccine on the Ricki Lake Show

You can rest assured that they aren’t true.

Deciding to Get an HPV Vaccine

The HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

Still undecided?

“The manufacturers of Cervarix and Gardasil are following patients in Scandinavia for at least 15 years to verify that protection from both vaccines lasts at least that long.”

National Cancer Institute on HPV Vaccines

Parents who are still hesitant should know that:

  • Gardasil, the first HPV vaccine, was approved by the FDA in 2006. The first phase 1 and phase 2 trials began in 1997. It has been given to over 200,000,000 children, teens, and young adults for over 10 years now all over the world.
  • while fainting might occur after vaccination, it is also not uncommon after other vaccinations and medical procedures, especially in teens. It is not a specific issue caused by the HPV vaccine or any vaccine, for that matter.
  • the HPV vaccine does not cause primary ovarian failure, venous blood clots, behavior problems, multiple sclerosis, autoimmune disorders, or any of the other serious side effects you read on the Internet
  • while the HPV vaccine won’t protect against all forms of HPV, it protects against the forms that are most likely to cause cervical cancer. Just two types of HPV, types 16 and 18, cause 70% of cervical cancers, and another two types, types 6 and 11, cause 90% of genital warts. All are included in the Gardasil vaccine and Cervarix includes the types most likely to cause cervical cancer.
  • HPV is not rare – in fact, it is the most common sexually transmitted infection in the United States. While many infections do go away on their own, spontaneously, others linger and can cause cervical cancer.
  • HPV doesn’t just cause cervical cancer though, it can also cause vaginal, vulvar, penile, and anal, and oropharyngeal cancer, and genital warts
  • the HPV vaccines seem to provide long lasting protection, although, as with any new vaccine, we won’t know just how long the true duration of protection is until the vaccines have been out even longer. So far, Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.
  • boys need the HPV vaccine too, as 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.
  • you want your child to get the HPV vaccine before they are having sex, to prevent them from ever getting infected with HPV, which is why it is routinely recommended when kids are 11 to 12 years old. That they are not sexually active yet is the whole point! As with other vaccines, if you continue to wait, you might eventually wait too long, although you can still get the vaccine if they are already sexually active, even if they are already infected with HPV, as it might protect them against another strain that they don’t have yet.
  • getting the HPV vaccine does not make it more likely that a teen will have sex
  • using condoms will not prevent all HPV infections. HPV can also spread through nonpenetrative sexual contact.
  • cervical cancer is serious, with about 4,200 women dying of cervical cancer each year, even in this age of routine pap tests
  • although you may hear that the HPV vaccine has been banned in some places, it is still offered in Japan, Utah, and other places where they talk about these bans, and since 2014, at least 64 countries have added the HPV vaccine to their immunization schedule

Get educated about vaccines and get your kids their HPV vaccine series. Remember that if you start the series before your kids are 15 years old, they only need two doses of the vaccine. After 15 years, they need 3 doses.

What To Know About Deciding to Get an HPV Vaccine

The HPV vaccines are safe, they work, and are necessary, which are beliefs shared by experts and most parents who decide to get their kids vaccinated and protected against HPV.

More Information on Deciding to Get an HPV Vaccine

 

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Can the Shingles Vaccine Cause Shingles?

Licensed in 2006, it has been recommended that all seniors who are at least 60 years old get Zostavax, the shingles vaccine.

When given as a one time dose, it can help reduce your risk of developing shingles by 51% and risk of developing post-herpetic neuralgia (PHN) by 67%. That protection will last about five years.

Since you can get shingles more than once, you can get the shingles vaccine even if you have already had shingles.

Myths About the Shingles

A lot of people don’t understand shingles (herpes zoster).

Herpes zoster was described as early as 1867, as can be seen in the lithograph from the Atlas der Hautkranheiten, although the connection with chickenpox didn't come until later.
Herpes Zoster was described as early as 1867, as can be seen in the lithograph from the Atlas der Hautkranheiten, although the connection with chicken pox didn’t come until later.

What is shingles? It is a reactivation of the varicella zoster virus, which also causes chicken pox. Although we don’t know why, it is clear that in some people, instead of staying dormant, the chicken pox virus can reactivate from the dorsal root ganglia of a spinal nerve.

Is shingles contagious? Yes, but other people exposed to shingles won’t actually get shingles, instead, they can get chicken pox (if they are not immune).

Can you catch shingles? No, but you can catch chicken pox (if you are not immune) from someone that has shingles.

Can kids get shingles? Yes, you can get shingles at just about any age, but the risk increases as you get older, which is why the elderly are most at risk.

What does herpes zoster have to do with genital herpes? Nothing. Shingles got the name herpes zoster before it was known that it was caused by the chicken pox virus (varicella zoster).

Can you get shingles if you have never had chicken pox? Yes, if you have had the chicken pox vaccine, although the risk is much less than after a natural chicken pox infection with the wild-type chicken pox virus. In fact, so far, it has been shown that vaccinated children have a moderately decreased risk of getting shingles after being vaccinated with the chicken pox vaccine.

Are we seeing more cases of shingles in adults because kids get the chicken pox vaccine now? No. While an interesting theory, it has been shown over and over and over that the chicken pox vaccine is not creating an epidemic of shingles. Studies have shown that shingles cases were rising before we started giving the chicken pox vaccine and they have been rising in countries that don’t even protect children with the chicken pox vaccine. The two are not connected.

Myths About the Shingles Vaccine

A lot of people also don’t understand the shingles vaccine.

They especially don’t seem to understand that it is same live strain of virus that is in the chicken pox vaccine, only with higher virus titers (it is more potent).

Why is it just for seniors who are at least 60 years old? That’s the age that it works best and since the immunity is not life long and it is given as just one dose, experts felt that would be the best time to get it. You can get it later though. You could even get it earlier, as early as age 50 years. Can you get it even earlier? You might consider getting the vaccine off-label at an earlier age if you have already had one or more severe cases of shingles, but it is only routinely recommended for people who are at least 60 years old.

Can you get the shingles vaccine if you have never had chicken pox? No, you should get the chicken pox vaccine instead. But keep in mind that most adults born in the pre-vaccine era, especially if they were born before 1980, are presumed to have had chicken pox already, even if they don’t remember it. Talk to your doctor if you really don’t think you have though.

“If you see a turtle sitting on top of a fence post, it didn’t get there by accident.”

President Bill Clinton

Does the shingles vaccines cause shingles? No. Since it only reduces your risk of developing shingles by 51% and the duration of protection is about 5 years, there is certainly a chance that you could get shingles even after having the vaccine, but the shingles vaccine doesn’t actually cause shingles.

The package insert for the shingles vaccine was updated in 2014.
The package insert for the shingles vaccine was updated in 2014 to add ‘herpes zoster: vaccine strain’ as a possible adverse reaction.

Is it worth getting vaccinated against shingles? It is if you want to try and avoid getting shingles! And even though the vaccine isn’t perfect, it is safe, and “In general, with increasing age at vaccination, the vaccine retained efficacy against severity of zoster better than against zoster itself.” So even if you do get shingles later on, it should be a milder case.

Why do some folks think that the shingles vaccine can cause shingles? In 2014, the package insert for the shingles vaccine was updated to mention that shingles could be a side effect after getting the vaccine. It was added to the Adverse Events section of the package insert, where “these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to the vaccine.”

Vaccines are monitored for safety even after they are approved by the FDA, so it is not a surprise that the package insert would be updated like this.

Have you seen any TV ads for lawsuits against the shingles vaccine?
Have you seen any TV ads for lawsuits against the manufacturers of the shingles vaccine?

Since they reportedly found the vaccine strain of the virus (VZV-Oka), the implications are pretty clear. But that likely just means that they got the shingles vaccine without having any immunity to chicken pox. After all, if they were immune to chicken pox from a past infection, then they would have had wild-type virus (VZV-WT) in their shingles lesions, not vaccine strain virus. And then, just like someone who got the chicken pox vaccine could still get shingles, these folks got shingles.

“The absence of VZV-Oka in samples from cases of HZ in zoster vaccine recipients indicates either that VZV-Oka rarely, if ever, establishes latency in sensory ganglia already latently infected with VZV-WT, or that if VZV-Oka does establish latent neuronal infections in VZV seropositive vaccine recipients, it rarely, if ever, reactivates to cause HZ. ”

Ruth Harbecke, et al on A Real-Time PCR Assay to Identify and Discriminate Among Wild-Type and Vaccine Strains of Varicella-Zoster Virus and Herpes Simplex Virus in Clinical Specimens, and Comparison With the Clinical Diagnoses

That still wouldn’t mean that the shingles vaccine caused shingles though. Remember, we know that “Among vaccine recipients, the attenuated Oka/Merck strain of VZV included in varicella vaccine also can establish a latent infection and clinically reactivate as zoster.” Again, that means you can get shingles after getting the chicken pox vaccine.

So the shingles vaccine could theoretically have caused a latent infection that reactivated = shingles.

But doesn’t that mean that the shingles vaccine caused them to have shingles. Maybe indirectly, but then it also gave them immunity against chicken pox. It has been shown that the shingles vaccine can safely provide immunity to adults who never had chicken pox before.

It’s not an accident that some people think that the shingles vaccine can cause shingles though and are maybe even afraid to get it. Like most anti-vaccine misinformation, this myth is spread on the Internet, this time with the help of personal injury lawyers.

What To Know About the Shingles Vaccine

The shingles vaccine is a safe way to decrease your risk of developing shingles and post-herpetic neuralgia, and it doesn’t directly cause shingles.

For More Information on the Shingles Vaccine:

How to Read a Package Insert for a Vaccine

The highlights of prescribing information of the package insert offers a nice summary of each section, with more details in the full prescribing information section that follows.
The Highlights of Prescribing Information of the package insert offers a nice summary of each section, with more details in the Full Prescribing Information section that follows.

Show me the package insert!

If you are going to ask for a package insert, you should know what’s in it and how it should be read.

Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

He really just found the widely available vaccine package insert that said no such thing.

How to Read a Package Insert for a Vaccine

What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.

Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:

  1. Indications and Usage – what the vaccine is used for
  2. Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
  3. Dosage Forms and Strengths – available dosage forms
  4. Contraindications – all situations when the vaccine should not be given
  5. Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  6. Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
  7. Drug Interactions – any reactions you might expect between the vaccine and other drugs
  8. Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
  9.  Drug abuse and dependence – usually blank
  10.  Overdosage – usually blank
  11. Description – general information about the vaccine, including how it was made and all vaccine ingredients.
  12. Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
  13. Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
  14. Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
  15. References – when necessary, a list of references that are important to decisions about the use of the vaccine
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information – information necessary for patients to use the drug safely and effectively

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

Myths About Package Inserts

Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.

Or what you might be led to believe it says.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

When reading a package insert, don’t be misled into thinking that:

  • you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
  • any vaccine actually causes SIDS or autism
  • pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.

Better yet, just don’t be misled by anti-vaccine misinformation.

“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”

WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines

Vaccines are thoroughly tested for both efficacy and safety before they are approved.

It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.

Why not?

It is because vaccines have a low risk of inducing tumors.

There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.

Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.

What to Know About Reading Vaccine Package Inserts

Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.

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