Tag: safety

How Many People Die in the USA Every Year from Being Vaccinated?

We know that vaccines work to save lives from vaccine-preventable disease.

If you are at all hesitant about vaccines and are doing your research, you have likely come across the myth that vaccines are more dangerous than the diseases they protect us against though.

This is only because most people don’t remember the pre-vaccine era when measles, polio, small pox, and diphtheria, etc., were big killers. So even though vaccine side effects are about the same as they always have been, they can become a much bigger focus for some people because they don’t see any of the mortality or morbidity from the diseases that the vaccines have gotten so good at preventing.

immunization-program-stages
As more people are vaccinated and diseases disappear, they forget how bad those diseases are, skip or delay getting their vaccines, and trigger outbreaks. Photo by WHO

It is at this crossover point that anti-vaccine folks are able to get away with pushing myths, such as like more people die from the MMR vaccine than from measles.

They don’t.

How Many People Die in the USA Every Year from Being Vaccinated?

Although vaccines are not perfectly safe, it is extremely rare for a vaccine reaction to be deadly.

“As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.”

WHO on Six common misconceptions about immunization

So why do anti-vaccine folks think that they are more common than they really are?

That’s an easy question to answer.

“Differentiation between coincidence and causality is of utmost importance in this respect. This is not always easy, especially when an event is rare and background rates are not available.”

Heininger on A risk-benefit analysis of vaccination

They often believe than anything and everything that happens after someone is vaccinated, even if it is weeks or months later, must have been caused by the vaccine. This discounts that fact that most people have a basic risk, often called the background rate, for developing these conditions that can coincide with getting vaccinated. It also explains why they believe in so many so-called vaccine induced diseases.

Another reason is that they also misuse VAERS reports when talking about vaccine deaths.

“In a review of reports of death following vaccination submitted to the Vaccine Adverse Event Reporting System (VAERS) from the early 1990s, the Institute of Medicine concluded that most were coincidental, not causally associated.”

Moro et al on Deaths Reported to the Vaccine Adverse Event Reporting System, United States, 1997–2013

Not surprisingly though, studies have shown that most of the deaths in VAERS are not actually related to vaccines.

In fact, most of the things that anti-vaccine folks blame on vaccines, including things you see in many of their vaccine-injury stories, are not related to vaccines.

How Many People Die in the USA Every Year from Vaccine-Preventable Diseases?

Fortunately, most people are vaccinated, and deaths from  vaccine preventable diseases are tremendously below what they were in the pre-vaccine era.

Most people will be surprised to know that they aren’t zero though.

People do still get vaccine-preventable diseases in the United States.

And tragically, people do still die of vaccine-preventable diseases in the United States.

For example, in 2015:

  • there were at least 37 cases of perinatal hepatitis B infections
  • five infants and children less than age 5 years died of rotavirus disease
  • a 14-month-old died of Hib meningitis
  • an infant died of pneumococcal meningitis
  • a 3-year-old with congenital rubella syndrome died
  • at least two teens died of meningococcal meningitis
  • a woman in Washington died of measles – the immunosuppressed women was exposed to an outbreak in Clallam County that mostly included intentionally unvaccinated kids
  • 85 kids died of the flu

Of course, worldwide, especially in developing countries, the number of deaths are much higher, which is a good reminder of what would happen if more of us stopped vaccinating!

And it is an even better reminder that you have to look at the number of deaths from vaccine-preventable diseases today in the context that most people are vaccinated and protected.

If you are truly looking at a risk vs benefit analysis of whether or not to get vaccinated, it is still the great benefit of avoiding vaccine preventable diseases vs the very small risks of getting vaccinated that you should think about.

“I also warn them not to share their fears with their neighbors, because if too many people avoid the MMR, we’ll likely see the diseases increase significantly.”

Dr. Bob Sears in The Vaccine Book

It is also the small risks of getting vaccinated vs the much greater risk of going back to the pre-vaccine era if you decided to skip or delay any vaccines.

It is not that you have been scared into thinking that the risks of  vaccines outweigh their benefits.

“Millions of vaccinations are given to children and adults in the United States each year. Serious adverse reactions are rare. However, because of the high volume of use, coincidental adverse events including deaths, that are temporally associated with vaccination, do occur. When death occurs shortly following vaccination, loved ones and others might naturally question whether it was related to vaccination. A large body of evidence supports the safety of vaccines, and multiple studies and scientific reviews have found no association between vaccination and deaths except in rare cases.”

Miller et al on Deaths following vaccination: What does the evidence show?

It is not that the risk of getting a vaccine preventable disease is low because you might be able to get away with hiding in the herd.

It is not that the risk of getting a vaccine preventable disease is low because you are counting on everyone else in the world to get vaccinated and eliminate or eradicate the disease and your risk.

If too many parents who are on the fence start believing that their kids have zero risk of getting polio and other vaccine-preventable diseases and continue to skip or delay vaccines, then boom, we are back to the days when outbreaks would close schools and kids would suffer from the devastating effects of these diseases.

Even the schools were closed in San Antonio when polio came to Texas in 1946.
Even the schools were closed in San Antonio when polio came to Texas in 1946.

While anti-vaccine folks won’t have such an easy time convincing people that these diseases are mild anymore, none of us want to wait for more outbreaks to occur before folks get the message that vaccines are safe and necessary.

What to Know About Vaccine Deaths

Despite what anti-vaccine folks would have you believe as they try to scare you away from vaccinating and protecting your kids, vaccines are safe and necessary and vaccine deaths are very rare.

More on Vaccine Deaths

Vaccines Are Made in China!

It shouldn’t be a secret that vaccines are made in China.

There are over 1.3 billion people in China, and no, they don’t import all of their vaccines from the United States.

Neither does India, for all of their 1.2 billion people.

For example, the Serum Institute of India Pvt. Ltd. makes many vaccines, including:

  • GeneVac-B – hepatitis B
  • Quadrovax – DTP-Hib combo
  • Pentavac – DTP-HepB-Hib combo
  • Tresivac – MMR
  • Poliovac – polio
  • Triple Antigen – DTP
  • MenAfriVac – meningococcal group A
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.
At least 34 manufacturers make vaccines for use in China, like this Hib vaccine.

And there are over 34 vaccine manufacturers in China, including:

  • Chengdu Institute of Biological Products Co., Ltd
  • Hualan Biolgical Bacterin Co., Ltd
  • Jilin Brother Biotech Co., Ltd
  • Wuhan Institute of Biological Products
  • Lanzhouz Institute of Biological Products

These vaccine manufacturers in China, a mix of state run, private, and international joint ventures, help produce the vaccines used in China’s immunization program.

Some US vaccine companies even have vaccine manufacturing plants in China and other countries, but they make vaccines that are used in nearby parts of the world.

For example, Merck recently opened a new vaccine plant in Hangzhou, China to make vaccines to be used in the Asia Pacific region.

Should We Be Concerned About Vaccines Made in China?

If you are getting vaccinated in China, then you likely want to know more about where and how your vaccines are made. Everyone else should probably be wondering why anti-vaccine folks make such a fuss about this.

In addition to implying that vaccines are made under unsafe conditions, much of this anti-vaccine propaganda includes racist themes.

Parents who are concerned should understand that the United States doesn’t get any vaccines from China or India, or from Brazil, Cuba, Indonesia, or Russia for that matter.

The concern, of course, would be that it might be hard to test and verify these vaccines if they were.

“Following approval, FDA also carefully monitors the quality of vaccines—all manufactured lots must pass tests before they can be used. And as with all manufacturers of medical products, vaccine manufacturers must follow strict manufacturing standards. In addition, FDA conducts routine inspections of manufacturing sites.”

FDA on How does FDA assess the safety of vaccines?

Instead, vaccines that are used in the United States are made by:

  • Emergent Biosolutions – USA – Anthrax vaccine
  • ID Biomedical Corp – Canada – Fluvaval
  • GSK Vaccines – based in Belgium, but vaccines are made in Belgium (Boostrix, Cervarix, Energix-B, Havrix, Hiberix, Infanrix, MenHibrix, Kinrix, Pediarix, Rotarix), Germany (Boostrix, Fluarix, Infanrix, Kinrix, Pediarix, Rabavert), and Italy (Bexsero, Menveo)
  • MedImmune – USA – FluMist
  • Merck – USA – BCG, Gardasil9, MMRII, PedvaxHIB, PneumoVax23, ProQuad, RecombivaxHB, RotaTeq, Vaqta, Varivax, Zostavax are made at Merck’s vaccine manufacturing plants in West Point, Pennsylvania, Elkton, Virginia, and Durham, North Carolina
  • PaxVax – USA – their Vivotif typhoid vaccine is made in Thörishaus, Switzerland
  • Pfizer – USA – (Prevnar, Trumenba)
  • Protein Sciences Corporation – USA – Flublok
  • Sanofi Pasteur – Canada (Adacel, Daptacel, Pentacel), France (IPOL, Pentacel), USA (Menactra, YF-Vax, ),
  • Seqirus – USA – Afluria, Flucelvax, Fluvirin
  • Valneva (Intercell USA) -their  Japanese encephalitis vaccine (IXIARO) is made in Livingston, Scotland, UK
  • Valneva Sweden AB – their Dukoral cholera vaccine is made in Solna, Sweden

A little competition in the vaccine industry wouldn’t be a horrible thing though.

Vaccines are expensive

They are safe, but expensive. Necessary too.

What to Know About Vaccines Made in China

Although plenty of vaccines are made in China, the vaccines that are used in the United States are not, although anti-vaccine folks use this as a talking point to scare parents away from vaccinating and protecting their kids.

For More Information on Vaccine Manufacturer Sites:

Expert Statements on Vaccines

The AAP published their first recommendations on vaccines in 1938.
The AAP published their first recommendations on vaccines in 1938.

Some parents are still confused about who they should listen to for advice about vaccines.

Is there really a controversy or a real debate going on about whether or not getting vaccinated is a good decision?

What do the experts say?

They say that:

And no, it’s not just one or two of them…

“Vaccines protect the health of children and adults and save lives. They prevent life – threatening diseases, including forms of cancer. Vaccines have been part of the fabric of our society for decades and are one of the most significant medical innovations of our time.”

More than 350 medical, professional and advocacy organizations in a 2017 letter to President Trump

It is the hundreds of thousands of experts at every major health organization around the world!

American Academy of Pediatrics

The American Academy of Pediatrics, an organization of 66,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists, has long advocated for the health and safety of our children.

“Vaccines are safe. Vaccines are effective. Vaccines save lives.

Claims that vaccines are linked to autism, or are unsafe when administered according to the recommended schedule, have been disproven by a robust body of medical literature. Delaying vaccines only leaves a child at risk of disease. Vaccines keep communities healthy, and protect some of the most vulnerable in our society, including the elderly, and children who are too young to be vaccinated or have compromised immune systems.”

Fernando Stein, MD, FAAP, President and Karen Remley, MD, MBA, MPH, FAAP, CEO/Executive Vice President, American Academy of Pediatrics

Vaccine friendly pediatricians who are pushing non-standard, parent-selected, delayed protection vaccine schedules are leaving kids at risk for vaccine-preventable diseases.

“Pediatricians who routinely recommend limiting the numbers of vaccines administered at a single visit such that vaccines are administered late are providing care that deviates from the standard evidence-based schedule recommended by these bodies.”

AAP on Countering Vaccine Hesitancy

Vaccines are necessary.

“Because rare medically recognized contraindications for specific individuals to receive specific vaccines exist, legitimate medical exemptions to immunization requirements are important to observe. However, nonmedical exemptions to immunization requirements are problematic because of medical, public health, and ethical reasons and create unnecessary risk to both individual people and communities.”

AAP on Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance

Society of Pediatric Nurses

“Immunizations are safe and effective in promoting health and preventing disease.”

SPN Position Statement on Immunizations

National Association of Pediatric Nurse Practitioners

Established in 1973, with more than 8,500 members, the National Association of Pediatric Nurse Practitioners (NAPNAP) is the professional association for pediatric nurse practitioners (PNPs) and all pediatric-focused advanced practice registered nurses (APRNs).

“NAPNAP supports the prioritization of immunization education for parents, guardians and other caregivers of infants, children, and adolescents. This education must include the most current scientific evidence related to vaccine safety, risk, benefits and current resources available to ensure that parents and caregivers receive adequate information about immunizations. This includes, when necessary, relaying the risk of not immunizing their child and potential devastation that can occur when a child is infected with a vaccine-preventable disease. It is incumbent that a PNP also be aware of misinformation in the public domain and provides the correct information to the public as well as the health care community.”

NAPNAP Position Statement on Immunizations

American College of Preventive Medicine

“Vaccine-preventable diseases were a major cause of mortality and morbidity in the United States in the 20th century. With the advent of immunizations, there have been dramatic rates of decline in these diseases. Clinical studies have shown vaccines to be efficacious and cost effective.  ”

ACPM on Childhood Immunizations

American College of Obstetricians and Gynecologists

Founded in 1951, the American College of Obstetricians and Gynecologists (The College) represents more than 58,000 members.

“Health care providers and patients should be aware that the reassuring safety data for use of the aforementioned vaccines in pregnancy are compelling, and there is no link to vaccine administration and miscarriage. An added benefit to immunizing during pregnancy is the potential for disease prevention in newborns by way of passive antibody transfer to the fetus. Hence, offering pregnant patients influenza and Tdap vaccines is an avenue to protect newborn infants at a critically vulnerable time and before neonates can be vaccinated.”

ACOG on Immunization for Pregnant Women

American Public Health Association

The American Public Health Association was founded in 1872, the APHA represents over 25,000 public health professionals.

“And further noting that the Institute of Medicine has recently released a report10 describing the U.S. immunization system as “a national treasure that is too often taken for granted” and calling for substantial increases in federal and state allocation of funds to support immunization infrastructure; therefore

Reaffirms its support for immunization as one of the most cost-effective means of preventing infectious diseases;”

APHA on The Need for Continued and Strengthened Support for Immunization Programs

American Medical Association

The American Medical Association, which was founded in 1847, has just over 240,000 members.

“The AMA fully supports the overwhelming body of evidence and rigorous scientific process used by the Advisory Committee on Immunization Practices which demonstrate vaccines are among the most effective and safest interventions to both prevent individual illness and protect the health of the public.”

William E. Kobler, MD, member of the AMA Board of Trustees.

Immune Deficiency Foundation

“The development of immunizations for common bacterial and viral infections has represented a major advance in the battle against microbial organisms that constantly threaten the welfare of humankind and particularly the pediatric population. However, the alarming increase in nonimmunized persons could lead to a return of the epidemics seen in the past.

…critical need for maintenance of herd immunity in the population at large. It is particularly important for family members of patients with defective T and B lymphocyte–mediated immunity to receive all of the available standard immunizations (excluding live poliovirus).”

Medical Advisory Committee of the Immune Deficiency Foundation on Recommendations for live viral and bacterial vaccines in immunodeficient patients and their close contacts

American Nurses Association

The American Nurses Association (ANA), founded in 1896, represents “the interests of the nation’s 3.6 million registered nurses.”

“To protect the health of the public, all individuals should be immunized against vaccine-preventable diseases according to the best and most current evidence outlined by the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP). All health care personnel (HCP), including registered nurses (RNs), should be vaccinated according to current recommendations for immunization of HCP by the CDC and Association for Professionals in Infection Control and Epidemiology (APIC).

As stated in the Code of Ethics for Nurses (ANA, 2015, p. 19), RNs have an ethical responsibility to “model the same health maintenance and health promotion measures that they teach and research…,” which includes immunization against vaccine-preventable diseases.”

ANA Position Statement on Immunizations

Autism Science Foundation

“Multiple studies have been completed which investigated the measles, mumps and rubella vaccination in relation to autism. Researchers have also studied thimerosal, a mercury-based preservative, to see if it had any relation to autism. The results of studies are very clear; the data show no relationship between vaccines and autism.”

Autism Science Foundation on Vaccines and Autism

The American Association of Immunologists

The American Association of Immunologists (AAI) is the largest professional association of immunologists in the world, representing more than 7,600 basic and clinical immunologists.

“Recent outbreaks have brought increased attention to vaccine- preventable diseases and have highlighted the need for robust and timely immunization to reduce preventable sicknesses and deaths. AAI strongly urges full adherence to recommended vaccination schedules and views vaccines as efficacious for individuals and crucial to public health.

Research has repeatedly confirmed that vaccinations are safe and highly effective for all healthy children and adults, and any suggestions to the contrary have been discredited. Ongoing vaccine research continually reaffirms its safety and efficacy, including the number of vaccines administered at any one time and the recommended vaccination schedule.”

The American Association of Immunologists Statement on Vaccines

American Osteopathic Association

“The American Osteopathic Association supports the Centers for Disease Control and Prevention in its efforts to achieve a high compliance rate among infants, children and adults by encouraging osteopathic physicians to immunize patients of all ages when appropriate ; supports the HHS National Vaccine Implementation Plan; and encourages third- party payers to reimburse for vaccines and their administration.”

AOA on Immunizations

National Association of School Nurses

#TodaysSchoolNurse is “grounded in ethical and evidence-based practice, are the leaders who bridge health care and education, provide care coordination, advocate for quality student-centered care, and collaborate to design systems that allow individuals and communities to develop their full potential.”

“It is the position of the National Association of School Nurses (NASN) that immunizations are essential to primary prevention of disease from infancy through adulthood.

The school nurse is well-poised to create awareness and influence action to increase the uptake of mandated and recommended immunizations. The school nurse should use evidence-based immunization strategies, such as school-located vaccination clinics, reminders about vaccine schedules, state immunization information systems (IIS), strong vaccination recommendations, and vaccine education for students, staff, and families.”

NASN Immunizations Policy Statement

American Academy of Family Practice

“With the exception of policies which allow for refusal due to a documented allergy or medical contraindication, the AAFP does not support immunization exemption policies.”

AAFP Immunization Policy Statement

American Academy of Allergy, Asthma & Immunology

The American Academy of Allergy, Asthma & Immunology (AAAAI) is a professional organization with over 7,000 members, including allergists/ immunologists, in the United States and 73 other countries.

“Immunization is perhaps the greatest public health achievement of all time, having significantly reduced the morbidity and mortality of many infectious diseases. Routine immunization of children, adolescents, and adults provides substantial protection from a large number of infectious diseases…

Patients who have experienced adverse reactions to vaccines might unnecessarily be advised to avoid subsequent immunization, which could have important adverse personal and population health consequences. Although there are some adverse reactions to vaccines that constitute absolute contraindications to administration of future doses, most such reactions do not preclude subsequent immunization. Patients who have experienced an apparent allergic or other serious adverse reaction after receiving a vaccine warrant evaluation by an allergist/immunologist. Also, patients with preexisting health conditions that might predispose to adverse reactions to vaccines could benefit from such an evaluation. In most cases, a risk-benefit analysis will favor subsequent immunization.”

AAAAI Practice Paramater on Adverse Reactions to Vaccines

CJ First Candle

“There seems to be a common misconception that vaccines are somehow associated with SIDS deaths. This is not true! Experts warn that the risk of leaving your baby unprotected is 1,000 times greater than any increased risk for SIDS. Because infants receive many immunizations during the critical development period from two to six months of age, and 90 percent of SIDS deaths occur within this time frame, it is only logical that many SIDS victims have recently received vaccines. This does not mean that the immunization had anything to do with the infant’s subsequent sudden and unexpected death. The cause and effect of immunizations and SIDS has been comprehensively studied for more than two decades. In fact, in countries where immunization schedules are different from those in the United States, the peak incidence of SIDS is still between two to four months.”

CJ First Candle on Immunizations

Infectious Disease Society of America

Founded in 1963, the Infectious Diseases Society of America (IDSA), with over 9,000 members, represents physicians, scientists and other health care professionals who specialize in infectious diseases.

“The Infectious Diseases Society of America (IDSA) recognizes the great benefits that vaccines provide for the public health. Substantial scientific evidence demonstrates vaccines’ enormous value in protecting individuals and populations from serious and life-threatening infections. Scientific evidence also demonstrates the overall safety of vaccines. Communities are most effectively protected when all are immunized.

Studies demonstrate that the easier it is to receive an exemption, the higher the rate of exemptions in a particular state. As the number of exemptions increases, the risk of vaccine – preventable disease increases. Therefore, states must make every effort to minimize the number of its citizens exempted from immunization mandates. Such exemptions make the state legislatures who grant them, as well as the individuals who receive them, responsible for placing the remaining state population at greater risk of acquiring potentially fatal infections.”

IDSA Policy Statement on State Immunization Mandates

The Arc of the United States

“Prior to widespread immunization in the United States, infectious diseases killed or disabled thousands of children each year. The near elimination of intellectual disability due to measles encephalitis, congenital rubella syndrome, and Haemophilus influenzae type b meningitis or Hib can be contributed to vaccines.”

The Arc Facts About Childhood Immunizations

American College Health Association

“The American College Health Association (ACHA) strongly supports the use of vaccines to protect the health of our individual students and our campus communities. In recognition of the vital role that vaccine coverage plays in community immunity (herd immunity), ACHA discourages use of nonmedical exemptions to required vaccines.”

ACHA on Immunization Recommendations for College Students

What to Know About Expert Statements on Vaccines

Over the years, hundreds of organizations representing millions of families, health care providers, researchers, patients, and consumers,  have repeatedly expressed their unequivocal support for vaccines, because they understand that vaccines work and that they are safe and necessary.

More on Expert Statements on Vaccines

Myths About Your Baby’s Immature Immune System

Newborns and infants have immature immune systems, at least as compared to older children and adults.

Premature babies can usually get all vaccines on schedule - at their chronological age, not an adjusted age based on being a preemie.
Premature babies can usually get all vaccines on schedule – at their chronological age, not an adjusted age based on being a preemie. Photo by Vincent Iannelli, MD

That doesn’t mean that their immune system is so immature they they can’t fight off many infections or that they shouldn’t be vaccinated. Even premature babies should usually be vaccinated on time.

Your Baby’s Immature Immune System

So just how immature is their immune system?

“A picture emerges of a child born with an immature, innate and adaptive immune system, which matures and acquires memory as he or she grows.”

Simon et al on Evolution of the immune system in humans from infancy to old age

It is immature enough that the protection that they get from passive immunity and transplacental transfer of antibodies before they are born is considered critical to protect them from many infections.

“After birth, the sudden enormous exposure to environmental antigens, many of them derived from intestinal commensal bacteria, calls for a rapid change to make distinct immune responses appropriate for early life.”

Simon et al on Evolution of the immune system in humans from infancy to old age

Fortunately, their immune system quickly matures and develops, so that as their maternal protection begins to fade, they are “better armed with the maturing innate and adaptive immune systems.”

“The risks are now much reduced by vaccinations, which stimulate protective immune responses in the maturing immune system.”

Simon et al on Evolution of the immune system in humans from infancy to old age

Getting fully vaccinated  on time helps too.

Myths About Your Baby’s Immune Response to Vaccines

Getting vaccinated?

With an immature immune system?

How does that work?

It will likely come as a surprise to some folks, but it actually works quite well!

“Although infants can generate all functional T-cells (ie, Th1, Th2, and cytotoxic T-cells), infant B-cell responses are deficient when compared with older children and adults. Infants respond well to antigens (such as proteins) that require T-cell help for development. However, until about 2 years of age, the B-cell response to T-cell-independent antigens (such as polysaccharides) is considerably less than that found in adults.”

Offit et al on Addressing Parents’ Concerns: Do Multiple Vaccines Overwhelm or Weaken the Infant’s Immune System?

In fact, we know that:

  • newborns respond well to the birth dose of the hepatitis B vaccine
  • the birth dose of BCG vaccine is effective at preventing severe TB disease
  • infants respond well to the vaccines in the primary series that they get at 2, 4, and 6 months
  • while infants respond well to most vaccines, to “circumvent the infant’s inability to mount T-cell-independent B-cell responses,” we use some conjugate vaccines when necessary, like Hib and Prevnar. This is especially important because their immature immune system puts them at extra risk for Hib and pneumococcal disease. Why? These are “bacteria that are coated with polysaccharides.”
  • older infants and toddlers respond to other vaccines, including MMR and the chicken pox vaccine, once maternal antibodies began to fade and can no longer cause interference.

So vaccines work in babies and young infants, just like they do for older children, teens, and adults.

But that makes you wonder, if anti-vaccine folks don’t think that vaccines work in these younger children and that their immune system is so immature, then how can these vaccines overstimulate their immune system???

They don’t.

Both the immunogencity and safety of vaccines for infants are well studied.

What to Know About Your Baby’s Immature Immune System

Vaccines work well to help protect newborns and infants as their immune system continues to develop and mature.

More About Your Baby’s Immature Immune System

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

Spend much time on anti-vaccine websites or forums and you will soon be warned that vaccines are not evaluated for mutagenicity, carcinogenicity or impairment of fertility.

Actually, you can often read that simply by reading a vaccine’s package insert.

Mutagenicity, Carcinogenicity and Impairment of Fertility

What are these term exactly?

  • mutagenicity – being known or suspected of causing mutations in our DNA, which can lead to cancer
  • carcinogenicity – being known or suspected of being able to cause cancer
  • impairment of fertility

And why are they listed in Section 13 of a vaccine’s package insert?

The Section 13 Vaccine Conspiracy?

More importantly, why do some folks talk about Section 13.1 of a vaccine’s package insert like it is Area 51 or Agenda 21?

“13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the “Warnings and Precautions” section, must not be included in this subsection of the labeling.”

CFR – Code of Federal Regulations Title 21

So no material for a vaccine conspiracy?

Just information on studies in animals?

“The goals of the nonclinical safety evaluation generally include a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. This information is used to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects. The nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.”

FDA on Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

It still sounds important though…

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

As important as vaccines are, no one wants them to mutate our children, cause cancer, or keep them from having babies.

Fortunately, they don’t!

“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

And that’s because vaccines are safe and well tested.

Then why do anti-vaccine folks scare parents into thinking that vaccines are missing necessary testing when the package insert states that they are “not evaluated for mutagenicity, carcinogenicity or impairment of fertility?”

Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.
“Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.”

Probably because it sounds scarier than saying that vaccines have a low risk of inducing tumors and that there are very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

That means that if  a package insert says that it has “not been evaluated,” it is simply because it was not necessary or appropriate. It is not because they just didn’t want to do it and left those tests out.

That doesn’t sound as scary though.

All necessary pre-clinical or nonclinical testing is done on vaccines and their components. You just don’t see long term testing that would be listed in the package insert unless the initial tests found a problem.

Also remember that vaccines are monitored through several passive and active safety systems that would detect issues with mutagenicity, carcinogenicity, and impairment of fertility.

And several vaccines actually prevent cancer!

What to Know About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

Vaccines are appropriately evaluated for mutagenicity, carcinogenicity and impairment of fertility, when necessary, as a part of pre-clinical or nonclinical studies that occur even before the first phase one studies on people.

More About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

 

Vaccines are Safe

Vaccines have side effects.

Fortunately, they are usually very mild.

And understanding that vaccines are safe, makes getting their kids vaccinated an easy decision for most parents, as they understand that the many benefits of vaccines far outweigh any possible risks.

How Do We Know Vaccines Are Safe?

If you are on the fence about vaccines, simply saying they are safe might not be enough for you.

“​Over the previous 40 years the IOM has conducted over 60 vaccine safety studies, including this comprehensive review of the immunization schedule. The IOM committee did not find any evidence of major safety concerns related to receiving on-time vaccinations according to the Recommended Immunization Schedule for children. They concluded that this should help to reassure stakeholders. Further, they noted that while the receiving on-time vaccines was not harmful, it was strongly associated with reducing vaccine-preventable diseases. ​”

American Academy of Pediatrics on Vaccine Safety: Examine the Evidence

How do we really know vaccines are safe?

A 2013 report about vaccines from the Institute of Medicine uncovered no evidence of major safety concerns.
A 2013 report about vaccines from the Institute of Medicine uncovered no evidence of major safety concerns.
  • vaccines go through a long period of pre-licensure testing and evaluation when being developed to make sure they are safe and that they work before they are approved
  • vaccines are tested together
  • vaccines are continually monitored after they are made, to make sure they maintain their potency, are kept at the proper temperature, and other quality testing
  • several post-licensure vaccine safety systems monitor for safety issues, including VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Project and other global vaccine safety systems
  • 40 years of safety reports from the Institute of Medicine (IOM)
  • reports from the Global Advisory Committee on Vaccine Safety, which has reviewed and commented on everything from aluminum adjuvants and the potential for immunogenic overload (too many too soon) to the safety of HPV vaccines

And it is important to know that much of the information that you hear and read that is trying to scare you about vaccines and vaccine ingredients is simply not true and easily debunked.

What to Know About Vaccine Safety

From years and years of pre-licensure vaccine safety testing to continual post-licensure vaccine safety monitoring, we can be confident that vaccines are safe.

More on Knowing Vaccines are Safe

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Global Vaccine Side Effect Reporting Systems

Has your child had a bad reaction to a vaccine or what you think is a vaccine injury?

Did you or your pediatrician report it?

Reporting Side Effects to VAERS

The CDC advises that “all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.”

But VAERS isn’t for everyone.

VAERS is for anyone who gives or receives a licensed vaccine in the United States.

Global Vaccine Side Effect Reporting Systems

What to folks do outside the United States?

In Canada, Adverse Events following Immunization (AEFI) forms are submitted to the Canadian Adverse Events Following Immunization Surveillance System.
In Canada, Adverse Events following Immunization (AEFI) forms are submitted to the Canadian Adverse Events Following Immunization Surveillance System.

Not surprisingly, most countries have a reporting system for possible adverse events to vaccines that is similar to VAERS, including, but not limited to:

You can also report possible side effects directly to vaccine manufacturers.

And like our Vaccine Safety Datalink, in addition to having a passive reporting system, like VAERS, many countries have an active vaccine safety surveillance system to make sure that their vaccines are safe:

  • Australia – AusVaxSafety monitors 156 surveillance sites
  • Canada – IMPACT or Canada’s Immunization Monitoring Program ACTive that actively monitors “12 Canadian centres, which represent about 90% of all tertiary care pediatric beds in Canada” for “adverse events following immunization, vaccine failures and selected infectious diseases that are, or will be, vaccine preventable.”
  • UK – the Clinical Practice Research Datalink (CPRD)

A lot of this work is also done as part of the World Health Organization’s Global Vaccine Safety Initiative (GVSI). In fact, many (about 110) WHO member countries report to the VigiBase system that is actively monitored by the WHO’s Uppsala Monitoring Centre.

What to Know About Global Vaccine Side Effect Reporting Systems

Passive and active vaccine side effect reporting systems in countries around the world help to make sure that our vaccines are safe.

More on Global Vaccine Side Effect Reporting Systems

 

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