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AIM Vaccine Misinformation Q&A AIM Vaccine Misinformation Q&A 2

Table of Contents

INGREDIENTS 22. Why are most vaccines approved before long-term safety data is released?...... 7 1. What are adjuvants and are they safe to include in vaccines?...... 3 23. Is there sufficient oversight for vaccine testing?. . . 7 2. Why do vaccines contain aluminum and is it safe? . . 3 24. Has the recommended vaccine schedule been sufficiently researched?...... 7 3. Why do vaccines contain mercury/thimerosal and is it safe?...... 3 CONSPIRACY 4. Why do vaccines contain formaldehyde and is it safe?...... 3 25. Are vaccines very profitable for 5. Do vaccines contain aborted fetus cells?...... 3 the pharmaceutical industry?...... 7 6. Are vaccines kosher?...... 4 26. How is the pharmaceutical industry held accountable for vaccine safety?...... 8 7. Are vaccines halal?...... 4 27. Does the U.S. government require safety reporting for vaccines and share research INJURY on adverse reactions?...... 8 8. How do we know that vaccines 28. Are vaccine mandates constitutional?...... 8 do not cause mitochondrial injury?...... 4 29. Are vaccine mandates necessary? ...... 9 9. How do we know that vaccines 30. Should the government mandate do not cause autism? ...... 4 vaccines when there are known risks?...... 9 10. How do we know that vaccines 31. Do any religions prohibit vaccines?...... 9 do not cause SIDS?...... 4 32. How does ACIP ensure its recommendations 11. How do we know that vaccines are not biased by the pharmaceutical industry?. . . .9 do not cause miscarriages?...... 5 33. If vaccines do not cause injury, 12. How do we know that vaccines are why is there the National Vaccine not responsible for the increase in Injury Compensation program? ...... 9 autoimmune issues?...... 5 34. Why is the pharmaceutical industry 13. How do we know that vaccines protected from being sued for vaccine injuries?. . . 10 do not adversely affect gut health?...... 5 35. Are doctors who do not support or RECOMMENDED VACCINE SCHEDULE follow the CDC recommended vaccine schedule punished?...... 10 14. Why are there so many more vaccines 36. If vaccines are not part of a profit recommended for infants and children now?. . . . . 5 scheme, why do doctors get bonuses 15. Aren’t the large number of vaccines for high vaccine rates?...... 10 too much for an infant’s immune system?...... 5 16. Why are we vaccinating for diseases PSEUDO-SCIENCE that are not that serious? ...... 6 37. What is the difference between natural 17. Is it okay to pick and choose which vaccines to get?. .6 and vaccine-acquired immunity?...... 10 18. What’s wrong with an alternative 38. Was the decrease in VPDs caused by schedule that spaces out vaccines for infants?. . . . .6 improved hygiene/sanitation or vaccination?. . . . 10 19. Has there been adequate research on 39. Are disease outbreaks driven by the current vaccine schedule and the vaccine shedding or unvaccinated individuals?. . . .11 multiple vaccines in such a short time frame?. . . . . 6 40. Are immuno-boosting supplements as 20. Are other countries that recommend effective as vaccines in protecting fewer vaccines healthier than the U.S.?...... 6 against disease?...... 11 41. Are vaccine-preventable diseases as VACCINE TESTING serious as they are made out to be?...... 11 21. What is the process for testing vaccines? 42. How do I know if scientific findings How do we know it is sufficient?...... 6 are legitimate?...... 12 43. Is the science around vaccines really settled?. . . . 12 44. Why can’t scientists prove definitely that vaccines do not cause serious harm?...... 12

ASSOCIATION OF IMMUNIZATION MANAGERS AIM Vaccine Misinformation Q&A 3

Ingredients can accumulate in a person’s body and cause harm at high levels. Methylmercury is the type of mercury found in fish 1. What are adjuvants and are they and other animals in our food chain. safe to include in vaccines? Many chemical compounds have complex and unfamiliar Adjuvants are ingredients that help vaccines produce a names that can confuse or concern people. However, stronger immune response so the vaccine works better. thimerosal is actually an organic compound and has been Adjuvants may be added to a vaccine to produce more used in vaccines and other drugs since the 1930s, and is antibodies and longer-lasting immunity which means commonly found in contact lens solutions. Today, there a vaccine can use a smaller amount of the virus or bacteria. are only a few vaccines that use thimerosal because vaccine manufacturers have found cost-effective Adjuvants have been used in vaccines since the 1930s. ways to make single-use vials. Thimerosal has been Millions of American children have safely received rigorously studied in the U.S. and many other countries vaccines with adjuvants for decades. Like all vaccines, but for people who still have concerns about it, there are adjuvanted vaccines are rigorously tested in clinical trials thimerosal-free vaccines available. to ensure they are both safe and effective. Once they are approved in the U.S., adjuvanted vaccines continue to be Key resources to learn more: monitored by the CDC and FDA. ƒ World Health Organization – Key resources to learn more: Thiomersal Questions & Answers ƒ CDC Guide to Adjuvants ƒ Immunization Action Coalition – Thimerosal ƒ Children’s Hospital of Philadelphia Adjuvant Video 4. Why do vaccines contain formaldehyde and is it safe?

2. Why do vaccines contain aluminum and is it safe? Formaldehyde is a naturally occurring compound. In fact, formaldehyde is essential in human metabolism and The reason some vaccines contain aluminum is that it is necessary for synthesizing DNA and amino acids. an effective adjuvant (an ingredient that helps a vaccine All humans have detectable quantities of formaldehyde produce a stronger immune response so the vaccine in their system. works better). Formaldehyde is also used when making vaccines to make Aluminum is naturally found in fruits, vegetables, meats, sure the viruses or bacteria in the vaccine are inactivated and fish – that’s because it’s the 3rd most abundant and don’t cause disease. Most of the formaldehyde is element on earth. The amount of aluminum found in diluted during the process, but a trace amount may still vaccines is well within safe limits. For example, the amount be found in some vaccines. The amount of formaldehyde of aluminum infants receive from vaccines in their first found in vaccines is safe and far less than what is found 6 months is about 4.4 mg. During the same six months, a naturally in the body. An infant naturally has about 1,500 breast-fed baby will typically receive more than twice the times the amount of formaldehyde in their bloodstream amount in a vaccine from their mother’s milk. than what is found a vaccine. Key resources to learn more: Key resources to learn more: ƒ CDC Guide to Adjuvants ƒ Children’s Hospital of Philadelphia – ƒ Children’s Hospital of Philadelphia – Vaccine Vaccine Ingredients Ingredients (Aluminum) ƒ American Chemistry Council Fact Sheet

3. Why do vaccines contain mercury/thimerosal 5. Do vaccines contain aborted fetus cells? and is it safe? No, vaccines do not contain aborted fetus cells but there Some multi-dose vials of vaccines contain a type of mercury are some vaccines that are grown in embryo fibroblast called thimerosal because it prevents dangerous microbes cells. The cells today are cultured in labs, but the first cells from growing in the vials once they are opened. There has came from two terminated pregnancies in the 1960s. been concern about thimerosal because some people have confused it with a type of mercury that, at high levels, can Key resources to learn more: be toxic to people. But not all types of mercury are harmful. ƒ Vaccinate Your Family – Vaccine Ingredients Thimerosal is an ethylmercury, and is safe because it breaks down and is excreted from the body rapidly. It is different than methylmercury, which is the type of mercury that

ASSOCIATION OF IMMUNIZATION MANAGERS AIM Vaccine Misinformation Q&A 4

6. Are vaccines kosher? disease have found no link between the two. However, in 2008 the United States Vaccine Injury Compensation Some Jewish communities have questioned whether Program (VICP) did find that one child who already had vaccine ingredients are kosher. The concern came mitochondrial disease had symptoms that were made worse up because of the gelatin used in some vaccines as a by the vaccines she received. Even though this was the only stabilizer. While this gelatin is porcine-derived (came from such case, the CDC has called for more research on this. pigs), a vaccine is highly purified during manufacturing and is not taken orally. Jewish law has restrictions about non- The mitochondrial disease advocacy group, Mito Action, kosher foods but does not forbid non-kosher products as supports vaccination stating: long as they are not swallowed. Vaccinations are critical in protecting the health of our Most well-known ultra-Orthodox rabbis have stated that children. All children, even those with suspected or known vaccines are kosher, and that immunization is supported mitochondrial diseases, should receive the recommended by the Code of Jewish Law requiring a person to guard his vaccinations. The risks of these communicable illnesses or her own health and avoid danger. outweigh the risk of vaccine-related reactions.

Key resource to learn more: Key resource to learn more: ƒ Chabad.org - What does Jewish law ƒ CDC FAQs on Mitochondrial Disease say about vaccination? 9. How do we know that vaccines do not cause autism? 7. Are vaccines halal? The 1998 study that started this disinformation was Some Muslim communities have questioned whether investigated and found to be fraudulent (meaning that vaccine ingredients are halal. This concern has come up the study was not true). The doctor who led the study with some polio vaccines that are cultured in monkey misrepresented the data and was found guilty of scientific cells. A good way to understand the vaccine process is misconduct. He lost his license to practice medicine and to think of it like a garden. Often gardeners will use cow his paper was retracted from the peer-reviewed journal manure to help their vegetable grow. But when they eat that originally published it. When a study is retracted it the vegetables they have grown, they are only eating the means it is no longer part of the scientific record. vegetable and not the manure. Vaccines are similar to Since then, there have been hundreds of studies vegetables and what they are cultured in is like manure. involving thousands of children in many countries It helps them grow but is not in the vaccine. looking at whether there is a connection between autism Most well-known Islamic religious scholars have issued and vaccines. None of these studies have found any Fatwahs stating that vaccination is part of the Islamic duty connection. Two important studies include: to protect children. ƒ The 1999 Brent Taylor study that compared children Key resource to learn more: with and children without autism. The study found that the percentage of vaccinated children was the same in ƒ Vaccine Article: What the World’s religions teach, as applied to vaccines both groups. ƒ The 1991-1998 Denmark study by Madsen that Injury included 537,303 children for a total of 2,129,864 person-years. The study found the risk of autism was 8. How do we know that vaccines do not cause the same in vaccinated and unvaccinated groups. mitochondrial injury? Here is a summary of studies looking at vaccines and autism that are sponsored or led by the CDC: Mitochondria are the powerhouses of our cells, turning https://www.cdc.gov/vaccinesafety/00_pdf/ sugar and oxygen into energy. Mitochondrial disease is CDCStudiesonVaccinesandAutism.pdf when the mitochondria do not work properly. Every cell in our bodies has mitochondria and so the disease can affect many different parts of the body. This disease is estimated 10. How do we know that vaccines do not cause SIDS? to affect 1 in 4,000 people and can range from someone Ninety percent of SIDS deaths happen before a child is with no symptoms to someone with severe symptoms. six months old. That is the same age when most children The disease usually shows up in toddlers and preschoolers. receive their DTaP series of vaccinations. Because of Because the disease tends to develop at the same time the similar timing, some people think vaccines cause as children are getting vaccines, some parents have been SIDS. However, there is no link between the two. Many concerned that vaccines cause mitochondrial disease. But studies have been conducted over the last 20 years and mitochondrial disease is genetic and believed to be inherited. none of them found a link between SIDS and childhood Studies looking into whether vaccines cause mitochondrial vaccinations. In fact, several studies found children who

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recently received DTaP vaccines were less likely to get malnutrition, infectious disease, or overuse of antibiotics) SIDS. SIDS deaths are often investigated by coroners are not always able to produce as strong an immune who find evidence of asphyxiation, meaning the child response from vaccines. Hepatitis vaccines actually suffocated. The most common cause of SIDS-related prevent some types of hepatitis that can damage the liver asphyxiation is unsafe sleep practices, such as having and affect gut health. blankets and toys in the crib, placing a child on its stomach There have been a number of studies that show that good to sleep, or co-sleeping with a parent. gut health is important in helping vaccines do their job. For a list of research and links to journal publications visit: You can read one study here: https://www.ncbi.nlm.nih. https://www.cdc.gov/vaccinesafety/concerns/sids.html gov/pmc/articles/PMC4635895/

11. How do we know that vaccines do not cause miscarriages? Recommended Vaccine Schedule

There is a large body of research that has looked to see if 14. Why are there so many more vaccines recommended there is any connection between vaccines and miscarriage for infants and children now? and no link has been found. One study looked at flu The reason more vaccines are recommended in infancy seasons from 2012 to 2015 and found no increased risk than any other time in a person’s life is because that is for miscarriage after flu vaccination during pregnancy. the time when children are most at risk of getting sick or Not only are vaccines safe for pregnant women, but dying from preventable diseases. A baby is born with some certain vaccines that pregnant women get can also provide immunity to diseases that it gets from its mother, but that immunity to their newborns. For example, if a woman gets immunity wears off in the first few months of life. This TDaP when she is between 27 and 36 weeks pregnant, leaves a child vulnerable to diseases that are very serious her newborn will have some immunity to whooping cough, for babies such as whooping cough. which is serious and sometimes deadly for babies. Children get more vaccines now than decades ago simply You can read the above referenced study here: because today we are able to prevent more diseases https://www.sciencedirect.com/science/article/pii/ through vaccines. As a result, fewer children become ill or S0264410X19312447 die from these diseases.

12. How do we know that vaccines are not responsible Key resources to learn more: for the increase in autoimmune issues? ƒ Mayo Clinic - Infant and Toddler Health ƒ World Health Organization – Six Common There have been a number of studies conducted to look Misconceptions about Immunizations at whether there is a connection between vaccines and autoimmune disease. While there have been some rare ƒ CHOP Vaccine Q&A examples, the studies generally show that there is no connection between vaccines and autoimmune diseases. 15. Aren’t the large number of vaccines too much for an infant’s immune system? The example that some people point to when arguing that vaccines can cause autoimmune disease is usually the flu No. In fact, a baby’s immune system meets many more vaccine. There have been some studies that show the flu immunological components on a daily basis than what is vaccine was can cause Guillain-Barre Syndrome (GBS). in vaccines. A baby’s immune system is designed to face However, it is important to understand the real risk. The new bacteria, viruses, and other pathogens—that is how studies show that flu vaccine can cause GBS in 1 person out it learns to protect the baby from serious disease. But of 1 million vaccinated. But the flu causes GBS in 17 people sometimes a baby’s system cannot identify a disease and out of 1 million infected. So, the risk of GBS is lower in build protection against it fast enough and the baby can vaccinated people compared to those who get the flu. get very sick or die. Vaccines prevent that. They allow a baby’s immune system to safely recognize a disease and Key resources to learn more: build protection against it without the risk of getting sick. ƒ Lancet - Vaccination and autoimmune disease: what is Science and technology are constantly evolving, so while the evidence? children get more vaccines than they used to they are ƒ Children’s Hospital of Philadelphia – Vaccines and actually getting fewer antigens (a foreign substance that Autoimmune Disease helps the body create an immune response).

Key resources to learn more: 13. How do we know that vaccines do not adversely affect gut health? ƒ CDC – Multiple Vaccines and the Immune System ƒ World Health Organization – Six Common Actually, it is the other way around. Vaccines do not affect Misconceptions about Immunizations gut health, but people with damage to their gut (from

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16. Why are we vaccinating for diseases 19. Has there been adequate research on the current that are not that serious? vaccine schedule and the multiple vaccines in such a short time frame? Every disease we vaccinate against can be very serious and sometimes deadly. For example, one in every ten Both vaccines and the vaccine schedule have been well people who get measles will have complications. Those researched. Vaccine manufacturers have to do careful complications can be serious, such as heart problems, and thorough clinical trials on all vaccines. Then the vision loss, and infection of the membranes that surround FDA reviews all the data from the multiple clinical trials the brain and spinal cord. For pertussis (whooping cough), and decides whether or not to approve a vaccine. Then about 1 in every 400 babies who survive pertussis will each vaccine is tested within the context of the existing have permanent brain damage. Tetanus kills at least schedule and reviewed by clinical researchers and vaccine 10% of victims. experts. Finally, all the data and recommendations are presented to the CDC’s Advisory Committee on Key resource to learn more: Immunization Practices (ACIP) to review and decide ƒ CDC – 14 Diseases You Almost Forgot About whether or not to add the vaccine to the schedule. Once (Thanks to Vaccines) they are added, vaccines continue to be monitored to keep an eye on any safety issues. 17. Is it okay to pick and choose which vaccines to get? To understand more about the childhood schedule and It’s not a good idea to skip vaccines. Vaccines prevent safety you can read this study: https://www.ncbi.nlm.nih. serious and sometimes deadly diseases, and without them, gov/books/NBK206938/ you leave your child vulnerable. Even if your child survives the disease, they can be left with a lifelong disability Key resources to learn more: like heart or brain damage. If you have concerns about ƒ CDC’s Who sets the Immunization Schedule particular vaccines, talk to your doctor or learn the facts from a reputable parent network like Voices for Vaccines 20. Are other countries that recommend fewer vaccines or Vaccinate Your Family. healthier than the U.S.?

Key resources to learn more: No. In fact, the opposite is true. Countries with fewer recommended vaccines see increases in sickness and death ƒ Pediatrics – The Problem with Dr. Bob’s Alternative Vaccine Schedule from those diseases. Japan is a good example. In 1993, the Japanese government stopped recommending the MMR ƒ Children’s Hospital of Philadelphia – Vaccine Schedule: vaccination because of concerns about aseptic meningitis. Altering the Schedule However, aseptic meningitis actually increased among ƒ Reasons to follow CDC’s Immunization Schedule patients who contracted natural mumps (1.24%) compared to those who received the mumps vaccine (0.05%). 18. What’s wrong with an alternative schedule that spaces out vaccines for infants? The World Health Organization states that not only do vaccines reduce disease and death, but they also reduce This biggest problem with an alternative schedule is that inequity. That is because children who are not protected it is difficult to predict if and when a vaccine-preventable from preventable diseases often fall sick and miss school. disease outbreak could occur, which leaves a child Additionally, if a child is permanently disabled from a vulnerable to serious diseases. The vaccine schedule was preventable disease such as polio, it is harder for that child developed to provide children protection when they are to find work as an adult. most at risk of disease. Science backs this up. There have been many clinical Key resource to learn more: trials that show the schedule is safe and offers the best ƒ World Health Organization Bulletin protection for children. Aside from the scientific reasons, the vaccine schedule is also easier on a baby. Studies show that there is less stress on a child’s body from multiple Vaccine Testing vaccines at one than an increased number of well-baby 21. What is the process for testing vaccines? How do we visits. By giving more than one vaccine at a visit, there are know it is sufficient? fewer visits and less stress. Vaccines are some of the most tested medical Key resources to learn more: interventions in the world. They go through a rigorous ƒ Pediatrics – The Problem with Dr. Bob’s Alternative testing process that can take years with several phases of Vaccine Schedule clinical trials and licensure. The process includes: ƒ Children’s Hospital of Philadelphia – ƒ Exploratory Phase: This phase happens in research Vaccine Schedule: Altering the Schedule labs and works to identify potential antigens (a foreign

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substance that helps the body create an immune as part of the ongoing monitoring process. response that might prevent a disease). Key resources to learn more: ƒ Pre-clinical Phase: In this phase, researchers take the antigen(s) they identified in the Exploratory Phase and ƒ American Family Physician – Vaccine Adverse Events – Separating Myth from Reality test them in the lab (not on humans) to see if they work to produce an immune response. ƒ AAP HealthyChildren.org: Vaccine Safety Evidence ƒ Clinical Development 23. Is there sufficient oversight for vaccine testing? – Phase I is a very small study (usually around 100 people) to determine if the vaccine is safe and to learn There is significant oversight for vaccine testing from about what type of response the vaccine produces. many regulatory and government bodies. First, any clinical trial protocol must be approved by one or more – Phase II is a larger study with hundreds of participants Institutional Review Boards (IRBs). An IRB is a group of that looks to learn more about safety, immunogenicity, experts in an organization that has been formally review the immunization schedule, and the dose size. and monitors biomedical research involving human – Phase III is the largest of the phases, usually with subjects. In the U.S., the FDA sets the IRB process. In thousands of participants that continue to measure accordance with FDA regulations, an IRB has the authority the safety (rare side effects may not show up in small to approve, require modifications, or disapprove research. groups) and effectiveness of the vaccine. There may be multiple reviews, for instance, each partner in a study may require its own IRB process and approval. ƒ Regulatory Review and Approval: If a vaccine is found The FDA also needs to approve a study. Additionally, there to be safe and effective during the clinical development is usually an organization that is not a partner in the study phase, then it is reviewed by the FDA for approval. to serve as an independent study monitor. The FDA will look at all the data compiled through the research phases to determine if it will approve the Key resources to learn more: vaccine for use in the U.S. ƒ The History of Vaccines – Vaccines, Development, Key resources to learn more: Testing, and Regulation ƒ CDC Journey of Your Child’s Vaccine ƒ Shot of Prevention – Multiple Vaccine Oversight ƒ Milken Institute School of Public Health: The Complex Development of Vaccines 24. Has the recommended vaccine schedule been sufficiently researched? 22. Why are most vaccines approved before long-term Yes, vaccines and the vaccine schedule are some of the most safety data is released? studied medical interventions – both in the United States and across the world. The ACIP-recommended schedule is Vaccines undergo a rigorous testing process that can developed based on the findings from a number of studies take years, including large Phase III studies that measure as well as ongoing monitoring of vaccines. safety. These trials usually follow participants for six months to a year. The reason this is enough of a time frame Key resources to learn more: for approval is that any allergic reaction or adverse events ƒ The Childhood Immunization Schedule and Safety happen shortly after vaccination. Stakeholder Concerns, Scientific Evidence, Allergic reactions are extremely rare and will happen and Future Studies immediately after vaccination (most occur within 30 to 60 minutes, although very rarely reactions can occur up to four hours after vaccination). Adverse events (something Conspiracy that happens after vaccination and may be a side effect of 25. Are vaccines very profitable for the vaccine) are common, the most common are swelling the pharmaceutical industry? and tenderness at the injection site. Adverse events that are actually related to the vaccine are most likely to occur No. Vaccines are not big profit-makers for pharmaceutical within several days after vaccination. That is why Phase III companies. In fact, most of their profit is from selling drugs clinical trial data is sufficient for vaccine approval. that treat diseases (including those prevented by vaccines). Just like with all medicines, vaccines continue to be Like any business, pharmaceutical companies must make monitored over time, not only in the U.S.,vbut around the enough profit from vaccine sales to justify investing world. Most often, long-term data confirms the findings of the huge amounts of money, effort, and time it takes to the clinical trial safety data. In rare instances, an extremely develop vaccines. Vaccines can take up to 15 years to uncommon adverse event can be identified from long- research and test. It costs a lot to produce and distribute term safety data. If that does happen, the data is evaluated vaccines, but they have limited demand (just a few doses)

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compared to other medicines. They are also heavily eye on vaccine safety and find possible safety problems as regulated. In the past, vaccines were so unprofitable that early as possible. Anyone can access the VAERS data (but some companies stopped making them altogether. no patient information is shared). Once global demand for vaccines began to grow in 2000, The CDC partners with healthcare organizations to run more pharmaceutical companies started making vaccines. the Vaccine Safety Datalink (VSD) program. Together, The current global vaccine market is about $35 billion, they do vaccine safety studies based on questions or which is less than 3% of the over $1.25 trillion global concerns reported to VAERS. The CDC also works with pharmaceutical market. To put this in perspective, the national vaccine safety experts and medical research complementary and alternative medicine market (which centers on the Clinical Immunization Safety Assessment includes mainly untested products and supplements) was (CISA) Project. As part of this project, they do studies to $192 billion in 2018. understand who is more likely to have vaccine reactions and how to prevent them. Key resources to learn more: The CDC Immunization Safety Office regularly reports ƒ Lancet Article: Estimating the Cost on vaccine safety to the Advisory Committee on of Vaccine Development Immunization Practices. These reports are public, and ƒ Atlantic Article: Vaccines Are Profitable, So What? anyone can see them.

26. How is the pharmaceutical industry held accountable for For example, the U.S. government and medical experts were vaccine safety? able to quickly act on reports of adverse reactions to the RotaShield vaccine due to the monitoring systems in place. Pharmaceutical companies must prove that vaccines are This vaccine was licensed for use in the U.S. in August 1998 safe and effective before they can be licensed for use. to prevent rotavirus gastroenteritis. When it was reported There are five phases of research and development that to VAERS that some infants developed intussusception (a vaccines go through before a vaccine can be approved by rare type of bowel obstruction) soon after, the CDC quickly the FDA. This can take up to 15 years. Vaccines are tested recommended that use of the vaccine be suspended and on thousands of people to make sure they are safe and immediately started two emergency investigations to find any common side effects. find out if receiving RotaShield vaccine was causing the After vaccines are licensed, they are monitored by intussusception. Based on the results, the CDC estimated pharmaceutical companies and government agencies for as that the vaccine increased the risk for intussusception by long as they are in use. This is to make sure there are no other one or two cases out of 10,000 infants vaccinated (0.01 side effects that happen when given to even more people. – 0.02%). The ACIP then withdrew its recommendation to vaccinate infants with RotaShield vaccine, and the The U.S. government created the National Vaccine manufacturer voluntarily withdrew it from the market Injury Compensation Program (VICP) to make sure in October 1999. More information about this case is that people have a free and straightforward process to available on the CDC website. get compensated for any serious side effects caused by vaccines (rather than going through the costly and complex Key resource to learn more: legal system). Money for this compensation fund comes ƒ CDC Vaccine Safety Research Reports from an excise tax paid by pharmaceutical companies on each vaccine dose. If someone petitions the VICP but is 28. Are vaccine mandates constitutional? not happy with the decision, they can still file a claim in civil court against the company that made the vaccine. Yes. The U.S. Supreme Court and other courts have found that a community’s need to be protected from infectious Key resources to learn more: diseases justifies requiring vaccination. The U.S. Supreme ƒ CDC Journey of Your Child’s Vaccine Court also recognizes the government’s authority to create ƒ CHOP Making Vaccines: Process policies that protect children’s health and well-being. of Vaccine Development Immunization laws are there to protect communities from ƒ Shot of Prevention: The Facts about the serious diseases. Vaccination mandates apply to community National Vaccine Injury Compensation Program settings with a high risk of diseases being spread, like schools, daycares, and hospitals. All states allow people with 27. Does the U.S. government require safety reporting for valid medical reasons to not get vaccinated (be exempt). vaccines and share research on adverse reactions? And no one is forced to be vaccinated. People can choose Yes. Health care providers are required by law to report not to vaccinate for personal reasons – but they cannot put any adverse reactions that happen after immunization to others at risk for serious diseases in the community settings the Vaccine Adverse Event Reporting System (VAERS). that require vaccination. This system is used by the CDC and the FDA to keep an

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Key resource to learn more: There are some Christian churches that oppose ƒ U.S. Supreme Court Jacobson v Massachusetts (1905) vaccination because they believe only in faith healing: Church of the First Born, End Time Ministries, Faith 29. Are vaccine mandates necessary? Assembly, and Faith Tabernacle.

Yes. Vaccines prevent serious diseases that cause illness, Key resources to learn more: hospitalization, and death. We cannot control diseases and ƒ Vanderbilt University Medical Center: stop deadly outbreaks unless most people in a community Immunizations and Religion have immunity. Diseases spread faster in communities ƒ Vaccine Article: What the World’s religions with higher percentages of unvaccinated people. The more teach, as applied to vaccines people that are vaccinated, the less likely a disease can move from person to person. This is called community or 32. How does the ACIP ensure its recommendations are not herd immunity. Vaccine mandates help maintain community biased by the pharmaceutical industry? immunity and keep serious diseases under control. The Advisory Committee on Immunization Practices Several recent outbreaks of measles, whooping cough, and (ACIP) has 15 voting members who are responsible for chickenpox have been traced to communities with pockets making vaccine recommendations. The Secretary of the of unvaccinated children: https://www.immunize.org/ U.S. Department of Health and Human Services (HHS) catg.d/p2069.pdf selects these members based on a thorough application Vaccine mandates are supported by the Infectious and nomination process. Fourteen members are medical Diseases Society of America, American Medication experts. One member is a consumer representative. Association, American Academy of Pediatrics, and many ACIP also has 38 non-voting members. Eight are ex-officio other medical organizations. members who represent other federal agencies involved in U.S. immunization programs. Thirty are representatives Key resource to learn more: from liaison organizations with immunization expertise ƒ The History of Vaccines: Herd Immunity (like medical associations). There is only one non-voting liaison from the biotechnology industry. 30. Should the government mandate vaccines when there are known risks? All voting members have to file an ethics form and an annual financial disclosure report. At every ACIP meeting, each voting It is reasonable for parents to be concerned about possible member must disclose any conflicts of interest. Members reactions and side effects of vaccines. Like any medicine, with potential conflicts cannot participate in discussions or vaccines can cause some side effects. But serious or long- decisions related to those issues. term harm from a vaccine is rare, as proven by numerous scientific studies: https://www.healthychildren.org/ 33. If vaccines do not cause injury, why is there the National English/safety-prevention/immunizations/Pages/Vaccine- Vaccine Injury Compensation program? Studies-Examine-the-Evidence.aspx The Vaccine Injury Compensation Program (VICP) was Hundreds of medical, health, school, research, and created in 1988 to make sure that, in the rare cases of children’s organizations believe that vaccines are the serious vaccine side effects, there is a way to file a claim safest and most cost-effective way to prevent serious and get compensation without having to go through the diseases: APHA Vaccine Safety Letter. complex and costly legal system. The government created the National Vaccine Injury The VICP has paid out about $4 billion in compensation Compensation Program (VICP) to make sure that, in the over the last 30 years. That might seem like a lot, however rare cases of serious vaccine side effects, there is a way it is a tiny amount compared to the number of vaccines to file a claim and receive compensation without having that have been given since 1988. For every 1 million doses to go through the complex and costly legal system. For of vaccine distributed in the U.S., only about one recipient each 1 million doses of vaccine distributed in the U.S., has been compensated (0.0001 percent). That means approximately one recipient has been compensated. That 99.9999% of vaccines that have been given did not result is an extremely low 0.0001 percent. in serious side effects.

31. Do any religions prohibit vaccines? Key resources to learn more: While there are some religious sects and leaders ƒ What You Need to Know About the National Vaccine who have concerns about vaccination, no major Injury Compensation Program religions prohibit vaccines. ƒ Vaccine Injury Compensation Data

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34. Why is the pharmaceutical industry protected from being sued for vaccine injuries? Pseudo-Science In the 1980s, lawsuits against vaccine manufacturers 37. What is the difference between natural and vaccine- were costing both companies and individuals too much acquired immunity? time, effort, and money. Pharmaceutical companies Natural immunity develops when a person is exposed to were threatening to no longer develop and distribute disease and becomes infected. This may result in better vaccines. There was worry that this would lead to a lack immunity than vaccination, but the risks are much higher of innovation and shortages of current vaccines followed because the disease will likely cause serious illness. In by disease resurgence. People claiming vaccine injuries contrast, the vaccination will likely only cause mild side were also unhappy with the process required to bring effects (like a sore arm) for a few days. cases through the courts to prove injury which was both complicated and costly. Key resource to learn more: That’s why the government passed the 1986 National ƒ CHOP Vaccine Safety: Immune System and Health Childhood Vaccine Injury Act and created the National Vaccine Injury Compensation Program (VICP). This 38. Was the decrease in VPDs caused by improved hygiene/ program balances liability protections for vaccine sanitation or vaccination? manufacturers with a clear and efficient process for Hygiene and sanitation are important for controlling petitioners. Now, any individual can file a petition and disease spread. But looking at the actual rates of disease receive assistance to waive fees if needed. They do not over the years, most vaccine-preventable diseases had a have to provide evidence of vaccine defects. There is a significant drop in cases once vaccines were put into use, much lower bar to prove evidence of injury if that injury is even in modern times. included on what is known as the “table of injuries”. For example, there were ups and downs in measles Money for this compensation fund comes from an excise cases throughout the years, but the permanent drop tax paid by pharmaceutical companies on each vaccine only happened after the wide use of the measles vaccine dose. If someone petitions the VICP but is not happy with beginning in 1963. Measles was declared eliminated in the the decision, they can still file a claim in civil court against U.S. in 2000, but we now have outbreaks again because of the company that made the vaccine. growing numbers of unvaccinated children. Key resource to learn more: Another example is the Hib vaccine, which was introduced ƒ National Vaccine Injury Compensation Program (VICP) in the early 1990s when we had similar sanitation to present day. After we started vaccinating babies with this 35. Are doctors who do not support or follow the CDC vaccine, Hib disease went from affecting about 20,000 recommended vaccine schedule punished? children every year in the U.S. to now almost none. Doctors must share medical advice based on accurate, Finally, we can look at the experiences of developed scientific information and follow evidence-based countries after they allowed their immunization levels standards of care. Immunization is a standard of care to drop. Three countries —Great Britain, Sweden, and supported by decades of scientific research and careful Japan — cut back the use of pertussis (whooping cough) review by thousands of medical experts. Acting against vaccine because of fear about the vaccine. The effect was these standards and sharing vaccine misinformation immediate. In Great Britain, after pertussis vaccination that leads to harm can result in legal charges and be dropped in 1974, there 100,000+ cases of pertussis and investigated by state medical boards. 36 deaths by 1978. In Japan, around the same time, a drop in vaccination rates led to a jump in pertussis from Doctors who have spoken out publicly against vaccines 393 cases and no deaths in 1974 to 13,000 cases and 41 have not faced legal or professional repercussions. They deaths in 1979. In Sweden, the annual rate of pertussis per are protected under the First Amendment. However, 100,000 children aged 0-6 years increased from 700 cases complaints about patient care and record-keeping have in 1981 to 3,200 in 1985. led to investigations. These experiences make it clear that diseases would not be disappearing without vaccines. And, if we were to 36. If vaccines are not part of a profit scheme, why do stop vaccinating, they would come back despite current doctors get bonuses for high vaccine rates? sanitation standards. Insurance companies (not vaccine manufacturers) provide doctors with a Quality of Care bonus for preventive Key resources to learn more: services, including vaccinations, that are proven to reduce ƒ IAC Vaccines Work! illness and hospitalization. ƒ The History of Vaccines Graph of Measles Cases ƒ WHO Six Common Misconceptions about Immunization

ASSOCIATION OF IMMUNIZATION MANAGERS AIM Vaccine Misinformation Q&A 11

39. Are disease outbreaks driven by vaccine shedding or ƒ Flu (influenza) can lead to pneumonia, bronchitis, unvaccinated individuals? and other infections. For people with chronic health problems, it can make their conditions worse. About Several recent outbreaks of measles, whooping cough, and 30,000 Americans die from flu yearly. chickenpox have been traced to pockets of unvaccinated children: https://www.immunize.org/catg.d/p2069.pdf ƒ Pertussis (whooping cough) can lead to pneumonia, seizures, brain damage, and death. Live vaccines have weakened forms of viruses that cannot cause serious disease. They prompt the immune system to recognize the virus and develop immunity. Stories of Families Affected by VPDs Shedding happens when a recently vaccinated person transmits the vaccine’s virus to another person. While AAP Why I Vaccinate Parent Testimonials shedding of virus after vaccination with live vaccines may https://www.healthychildren.org/English/safety- occur, the risk of infecting another person is very low. prevention/immunizations/Pages/Why-I-Vaccinate- The Infectious Disease Society of America recommends Parent-Testimonials.aspx that even people living in the same household as a person with a weakened immune system should receive most recommended live vaccines to better protect the person CHOP Personal Stories of VPDs with weakened immunity. https://www.chop.edu/centers-programs/parents- pack/personal-stories Key resources to learn more: ƒ IAC Personal Belief Exemptions for Vaccination Put FFF Family Stories of Flu People at Risk https://www.familiesfightingflu.org/family-stories/ ƒ 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host IAC Unprotected People Stories

40. Are immuno-boosting supplements as effective as vaccines https://www.immunize.org/reports/ in protecting against disease? IAC Personal Testimonies No. According to Harvard Medical School, there is no https://vaccineinformation.org/personal-testimonies/ scientific evidence that supplements can boost immunity to the point that you are better protected against infection and disease. Boosting the number of immune NFID Real Stories on VPDs cells may not necessarily be a good thing because the https://www.nfid.org/real-stories/ immune system is very complex. Vaccines are proven to protect against the diseases they PKIDS Family Stories of VPDs are created to fight. Even for people who have a lower https://www.youtube.com/user/pkidsorg immunological response, vaccines significantly lower rates of illness and death compared to people with no vaccination. SBS Stories of VPDs http://www.shotbyshot.org/ Key resource to learn more: ƒ Harvard Medical School - how to boost your immune system SOP Personal Stories https://shotofprevention.com/category/testimonials- 41. Are vaccine-preventable diseases as serious as they are personal-stories/ made out to be? VFV Why I Choose to Immunize Yes, all diseases targeted by vaccination carry substantial risks for serious illness and even death, especially for https://www.voicesforvaccines.org/gallery/ young children. There is no way to tell in advance if a person will get a mild or severe case. VYF Why Vaccinate: Personal Stories https://www.vaccinateyourfamily.org/why-vaccinate/ Even diseases that people think are mild can personal-stories/ be very serious: ƒ Chickenpox (varicella) can have serious complications like pneumonia, encephalitis, and bloodstream Key resource to learn more: infections. It can also lead to shingles later in life, which ƒ CDC Vaccines and Preventable Diseases can be very painful and cause long term nerve damage.

ASSOCIATION OF IMMUNIZATION MANAGERS AIM Vaccine Misinformation Q&A 12

42. How do I know if scientific findings Every medical authority in the U.S. recommends are legitimate? immunization as the safest way to prevent disease, including the Centers for Disease Control and Prevention, Food and Legitimate scientific studies are: Drug Administration, American Academy of Pediatrics, Random: A study is randomized when participants are American Academy of Family Practitioners, American separated into control (placebo) and test groups in a College of Obstetricians and Gynecologists, American random way, like by using a formula or software. By not College of Physicians, American Medical Association, choosing which study participants are in the test group, American Nurses Association, American Pharmacists scientists make it less likely that the results are biased. Association, and National Academy of Medicine, plus every Replicable: Study results must be repeatable for them state health department, every city health department, and to be widely accepted. If a researcher tries to replicate a every children’s hospital in the country. study’s findings and fails, there was likely a unique factor in Key resources to learn more: the original study that caused the different findings. Many researchers will look at similar questions in different ways. ƒ APHA & Partners Letter on Vaccine Safety and Efficacy Only when a finding has been reproduced many times in a ƒ IAC Science Supports Our Confidence in Vaccines variety of populations is it widely accepted. ƒ HealthyChildren.org Vaccine Safety Evidence Double-blind: In double-blind studies, both the study participants and the scientists don’t know which 44. Why can’t scientists prove definitely that vaccines do not participants are in the test group. Double-blind studies are cause serious harm? the most reliable because they eliminate the potential for This is one of the most commonly misunderstood concepts bias among both participants and scientists. in science. Scientists are a careful bunch of people – they While double-blind study design is considered the gold want to make sure that they only state things are true (or standard, this may not always be possible or ethical. For untrue) only when they know that to be true (or untrue) example, withholding a proven treatment for a sick person beyond a shadow of a doubt. Because it is impossible to to test a placebo is not ethical. know everything in the world, a good scientist will often use phrases like “no evidence supports this claim” rather Large: Large sample sizes allow researchers to account than say “it’s false.” To a non-scientist, this may sound like for individual differences such as genetics, income, race/ double-speak. But it’s not. ethnicity, and environmental or lifestyle choices. For example, scientists rigorously evaluated the link Some scientific publications may be biased or inaccurate. between vaccines and autism and couldn’t find any link. That is why it is important not to rely on the findings of If you asked how sure a scientist was that vaccines and one study based on the reputation of the scientist who autism are not linked, most would say 99.999% sure. conducted it. Instead, you should look at the study design But even though they are overwhelmingly certain, a real and whether the results are replicable over time. scientist will not say 100% sure. Key resources to learn more: This language is a good way of sifting through real science ƒ CHOP Evaluating Information: and pseudo-science. If a researcher claims to have proof What You Should Know or is 100% certain of something, they are likely not a real ƒ CHOP Logical Fallacies and Vaccines: scientist and their findings will not hold up among other What you should know scientists.

ƒ IAC Reliable Sources of Key resources to learn more: Immunization Information ƒ Psychology Today – Common Misperceptions about Science 43. Is the science around vaccines really settled? Vaccines are one of the most tested and proven medications available. They are studied through double- blind placebo-controlled trials in larger populations than other drugs before being licensed. They are monitored carefully for as long as they are in use. There are hundreds of studies that show they do not cause any harm, including autism. Medical experts across the globe have reviewed the extensive science on vaccines.

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This publication is supported by the Centers for Disease ControlASSOCIATION and Prevention of the OF U.S. IMMUNIZATION Department of Health and MANAGERS Human Services (HHS) as part of a Cooperative Agreement. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by CDC/HHS, or the U.S. Government.