Continuing Education| Volume 11, ISSUE 1, P1-10, January 2015

Promoting Childhood Immunizations

DOI:https://doi.org/10.1016/j.nurpra.2014.10.016
Promoting Childhood Immunizations
Next ArticleThe Journal for Nurse Practitioners Continuing Education Credit Application

      Highlights

      • •
        Describes vaccine-hesitant or -resistant parents
      • •
        Offers detailed information about:
        • ○
          The CDC/FDA reporting systems for vaccine adverse events
        • ○
          The FDA regulatory process for vaccine approval and postmarketing surveillance
      • •
        Review common concern and questions patients may have about vaccination and offers answers and background information.

      Abstract

      Immunization was perhaps the single most beneficial public health measure of the 20th century. Vaccine manufacturers work in tandem with government, academic, and nongovernmental agencies to develop safe and effective vaccines that decrease health costs and improve compliance. Despite overwhelming evidence of vaccine safety, suspicion and misconception continues in small groups of hesitant or resistant parents, often leading to outbreaks of vaccine-preventable infections. On the front lines of vaccination, nurse practitioners can improve vaccination rates by developing a trusting relationship with parents and being armed with information based on sound clinical evidence.

      Keywords

      This CE learning activity is designed to augment the knowledge, skills, and attitudes of nurse practitioners and assist in their understanding of immunizations and their impact on humans.
      At the conclusion of this activity, the participant will be able to:
      • A. Describe the characteristics of a hesitant vs resistant parent
      • B. Address parental concerns by explaining major immunization concepts
      • C. Use current evidence to clarify the relationship between vaccines and autism
      The author, reviewers, editors, and nurse planners all report no financial relationships that would pose a conflict of interest.
      The author does not present any off-label or non-FDA-approved recommendations for treatment.
      This activity has been awarded 1.0 contact hours for nurses and advanced practice nurses and 1.0 contact hours of pharmacology credit. The activity is valid for CE credit until February 1, 2017.
      Readers may receive the 1.0 CE credit free by reading the article and answering each question online at www.npjournal.org, or they may mail the test answers and evaluation, along with a processing fee check for $10 made out to Elsevier, to PO Box 786, East Amherst, NY 14051. Required minimum passing score is 70%.
      This educational activity is provided by Nurse Practitioner Alternatives™.
      NPA™ is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
      Accreditation does not imply endorsement by the provider, Elsevier, or ANCC of recommendations or any commercial products displayed or discussed in conjunction with the educational activity.

      Introduction

      Immunization is perhaps the single most important public health measure of the 20th century. Infectious diseases were once the leading cause of death in the early 1900s, but, since the advent of vaccines, they currently rank eighth.

      Centers for Disease and Control and Prevention. National health statistics, leading cause of deaths 1900-1998. http://www.cdc.gov/nchs/data/dvs/lead1900_98.pdf/. Accessed June 15, 2014.

      Vaccination is also responsible for improving substantially the number of children who reach their first birthday.

      Centers for Disease and Control and Prevention. National health statistics, leading cause of deaths 1900-1998. http://www.cdc.gov/nchs/data/dvs/lead1900_98.pdf/. Accessed June 15, 2014.

      At the turn of the 20th century, 100 of 1,000 babies born in the United States died before their first birthday, and today that rate has decreased dramatically to 7 in 1,000 babies.
      Centers for Disease and Control and Prevention
      Achievements in public health, 1900-1999. Impact of vaccines universally recommended for children, United States, 1990-1998.
      MMWR Morb Mortal Wkly Rep. 1999; 48
      Table 1 demonstrates that introduction of vaccines has led to dramatic declines vaccine-preventable diseases (VPDs).

      Centers for Disease and Control and Prevention. Reported cases and deaths from vaccine preventable diseases, United States, 1950-2011. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/G/Gcases-deaths.pdf/. Accessed September 1, 2014.

      Table 1Rates of Vaccine Preventable Diseases and Deaths
      Table adapted from reference 3
      Diptheria
      YearCases ReportedDeaths
      19505796410
      20110NA
      Tetanus
      YearCases ReportedDeaths
      1950486336
      20119NA
      Pertussis
      YearCases ReportedDeaths
      1950120,7181,118
      201115,2160
      Polio
      YearCases ReportedDeaths
      195033,3001,904
      20110NA
      Measles
      YearCases ReportedDeaths
      1950319,124468
      2011212NA
      Rubella
      YearCases ReportedDeaths
      196646,97512
      20114NA
      Mumps
      YearCases ReportedDeaths
      1968152,20925
      20113700
      Varicella
      YearCases ReportedDeaths
      1972164,114122
      201112,041NA
      Haemophilus
      YearCases ReportedDeaths
      1991276417
      20113184NA
      Hepatitis A
      YearCases ReportedDeaths
      196632859N/A
      20111139N/A
      Hepatitis B
      A rapid rise in the number of cases was reported after 1966, following separation of Hepatitis B from all cases of Hepatitis and a peak of cases in 1986 of 26,107 is followed by a post vaccine fall in cases to 2,495 by 2011.
      YearCases ReportedDeaths
      19661497N/A
      20112495N/A
      CDC= Center for Disease Control and Prevention
      NA= Not available
      a Table adapted from reference 3
      b A rapid rise in the number of cases was reported after 1966, following separation of Hepatitis B from all cases of Hepatitis and a peak of cases in 1986 of 26,107 is followed by a post vaccine fall in cases to 2,495 by 2011.
      Despite clear benefit, many parents choose not to vaccinate their children, most often citing the fear of the unknown as their motive. In a time when the incidence of VPDs is very low to nonexistent, it is easy to see why parents would become distracted by stories of severe reactions to vaccination. Vaccination scares propagated by the media and self-serving clinicians have led many parents to choose the risk of infection over the risk of vaccination. This year, 592 cases of measles and 4 college campus mumps outbreaks have been reported across the nation, with the majority of these occurring in patients who were unvaccinated.

      Centers for Disease and Control and Prevention. Measles (Rubeola). http://www.cdc.gov/measles/index.html/. Accessed September 5, 2014.

      , 

      Centers for Disease and Control and Prevention. Mumps cases and outbreaks. September 2014. http://www.cdc.gov/mumps/outbreaks.html . Accessed September 5, 2014.

      Endemic in the US, pertussis cases still range from 20,000 to 40,000 cases yearly. However, these numbers are dwarfed by the prevaccine rates of 100,000 to 200,000 cases per year.

      Centers for Disease and Control and Prevention. Pertussis (whooping cough outbreaks). http://www.cdc.gov/pertussis/outbreaks/index.html/. Accessed September 5, 2014.

      Other than smallpox, vaccine-preventable diseases remain active across the globe. When an outbreak of a VPD occurs it is frequently due to one unvaccinated person. Exposure to infections is an inevitable consequence of our global economy, thus stressing the importance of vaccinations domestically and worldwide.
      Understanding the fear some parents have as they contemplate vaccinating their child and addressing specific concerns for their child with scientific data is a reasonable approach to improve immunization rates in this subgroup. This article aims to characterize the vaccine-hesitant or -resistant parent and assess the current research about the relevant perspectives and practices. Potential answers are presented for common questions or concerns parents have about vaccination. The nurse practitioner (NP) can support long-term efforts to monitor vaccine safety by reporting (AEs) promptly to the Vaccine Adverse Event Reporting System (VAERS) of the Center for Disease Control and Prevention (CDC). The data are evaluated with an aim to enhance overall postmarketing surveillance and improve vaccine safety.

      Who Is the Vaccine-Hesitant/Resistant Parent?

      The sequelae of VPDs, like iron lungs, braces, paralysis, blindness, deafness, infertility, and death, are a distant memory for most parents and grandparents in the US. Many parents are terrorized by fears fueled by notable celebrities and unscrupulous medical researchers who indict vaccines as the cause of autism, diabetes, arthritis, and a variety of autoimmune diseases. These loving, but misinformed parents, eager to protect their children, become hesitant to vaccinate and some are even resistant. This behavior has led to intermittent and serious outbreaks of VPDs across the country.
      About 1% to 2% of parents nationwide absolutely refuse vaccinations for their children and an additional 11% to 19% are hesitant or elect to delay vaccines.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      A number of factors influence these the decision to vaccinate including: information/knowledge about the vaccine; past personal or close family and friend experiences with vaccinations; perception of vaccine importance; perception of vaccine risk, including trust in vaccines, research and development, and regulation; social pressure/responsibility; and religious and moral convictions.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      , 
      • Dubé E.
      • Laberge C.
      • Guay M.
      • Bramadat P.
      • Roy R.
      • Bettinger J.
      Vaccine hesitancy an overview.
      Hum Vaccine Immunother. 2013; 9: 1763-1773
      Parental acceptance of vaccination ranges from vaccine-acceptor to vaccine-hesitant to vaccine-rejector.

      Centers for Disease and Control and Prevention. Pertussis (whooping cough outbreaks). http://www.cdc.gov/pertussis/outbreaks/index.html/. Accessed September 5, 2014.

      Accepting parents have a high trust in health-care providers, have their children fully immunized, and do not offer many concerns about vaccination.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      Hesitant parents may choose alternate vaccination schedules or refuse specific vaccines. These parents tend to cite concerns that their child’s immune system will become overwhelmed with too many vaccines or that the side effects, such as pain or fever, are too great of a risk. They may worry about severe, very uncommon side effects, such as Guillain-Barré syndrome, encephalitis, or unsubstantiated adverse effects, such as autism or autoimmune diseases like type 1 diabetes. These parents often predict that their child will recover easily from a vaccine-preventable disease, even if exposed, which they feel is unlikely because the rate of VPDs remains low in the US. Some parents actually consider it beneficial for their child to contract a VPD, so they will develop a “safer” natural immunity.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      , 
      • Dubé E.
      • Laberge C.
      • Guay M.
      • Bramadat P.
      • Roy R.
      • Bettinger J.
      Vaccine hesitancy an overview.
      Hum Vaccine Immunother. 2013; 9: 1763-1773
      Parents who chose not to vaccinate (refusal) at all are hesitant parents on the extreme end of the spectrum. These parents’ refusal may be entirely based on religious reasoning as currently seen among the Amish in the US. Resistant parents may severely distrust the federal government, specifically regulatory agencies or the health-care structure.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      They fear vaccines because they distrust pharmaceutical companies.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      They trust homeopathic or naturopathic practitioners more than classically trained physicians and nurses.
      • Larson H.
      Negotiating vaccine acceptance in an era of reluctance.
      Hum Vaccine Immunother. 2013; 9: 779-1781
      They may have misinformation about adverse reactions to a vaccine, such as death or seizure. They may even have had personal experience with a vaccine side effect that was unacceptable or extreme.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      , 
      • Dubé E.
      • Laberge C.
      • Guay M.
      • Bramadat P.
      • Roy R.
      • Bettinger J.
      Vaccine hesitancy an overview.
      Hum Vaccine Immunother. 2013; 9: 1763-1773
      , 
      • Larson H.
      Negotiating vaccine acceptance in an era of reluctance.
      Hum Vaccine Immunother. 2013; 9: 779-1781
      Often these parents’ convictions to not vaccinate are insurmountable.
      Research supports the concept that primary-care providers can promote acceptance of vaccination in most hesitant parents. A commonly cited intervention is to build a trustworthy relationship and to be as transparent as possible with information.
      • Gowda C.
      • Dempsey A.
      The rise (and fall?) of parental vaccine hesitancy.
      Hum Vaccine Immunother. 2013; 9: 1755-1762
      , 
      • Dubé E.
      • Laberge C.
      • Guay M.
      • Bramadat P.
      • Roy R.
      • Bettinger J.
      Vaccine hesitancy an overview.
      Hum Vaccine Immunother. 2013; 9: 1763-1773
      , 
      • Larson H.
      Negotiating vaccine acceptance in an era of reluctance.
      Hum Vaccine Immunother. 2013; 9: 779-1781
      A trustworthy relationship is built with supportive open communication that allows hesitant parents an opportunity to verbalize their specific concerns in a nonjudgmental environment.
      Some health-care providers are also vaccine-hesitant or -resistant. Like parents, they perceive a greater risk of vaccines over benefits. Many believe that vaccinating children denies that child free choice, whereas others feel that vaccination unnaturally creates antibody formation, affecting normal self versus non-self recognition of the immune system; most all agree that the risks of natural infection are minimal due to advances in medicine and today’s US health-care system.

      Answering the Difficult Questions

      Because they are the face on the vaccination campaign on a daily basis, NPs need to be able to discuss VPDs; current vaccines available; vaccine scheduling, including spacing strategies; and any known common and adverse side effects. In what follows are common questions or concerns and answers that can be tailored to meet the needs of parents. Links to education tools and further reading are also provided.

      Question: Are Vaccines Tested and Monitored for Safety?

      Answer: Yes, every vaccine undergoes stringent review before licensing. The total process from vaccine concept to licensing can take up to 10 years and, during this time, the Food and Drug Administration (FDA) monitors its development every step of the way. Even after licensing, vaccine safety continues to be monitored with periodic safety reports and inspections of vaccine manufacturing sites.

      Background About Vaccine Development, the US Regulatory Process, Vaccine Adverse-event Reporting, and Data Analysis

      Food and Drug Administration Regulatory Process

      In 1902, Congress passed the Biologics Control Act, or Virus-Toxin Law, that directed the FDA to regulate biologics, which was followed in part from the tragic death of 13 children who inadvertently received diphtheria antitoxin contaminated with tetanus spores.
      • Larson H.
      Negotiating vaccine acceptance in an era of reluctance.
      Hum Vaccine Immunother. 2013; 9: 779-1781
      Under the guidelines of this Act, the FDA has authority to inspect manufacturing facilities and batch certification guidelines.
      • Larson H.
      Negotiating vaccine acceptance in an era of reluctance.
      Hum Vaccine Immunother. 2013; 9: 779-1781
      The US Public Service Act of 1944 mandated that the federal government issue licenses for biologic products, including vaccines.

      US Food and Drug Administration. History, FDA’s origin & functions. http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/default.htm/. Accessed July 20, 2014.

      The pathway to vaccine licensure is spelled out in the federal code as the Investigation New Drug (IND) process. In brief, a prospective clinical study to evaluate a new drug or biologic is submitted to the FDA.

      US Food and Drug Administration. Vaccines, blood and biologics. http://www.fda.gov/BiologicsBloodVaccines/default.htm/. Accessed June 20, 2014.

      The IND process begins with a sponsor’s intention to investigate a substance for the prevention or treatment of human disease. An IND submission package must include information on all investigators, background on the drug or biologic, preclinical data (must have evaluable data of this substance in appropriate preclinical [animal/primate] model), the clinical study design, proposed data collection and analysis, chemical and manufacturing information for the substance, known safety data in humans, the clinical protocol, and informed consent/assent. The clinical protocol should be performed under the review and approval of an internal or external review board as well as a data safety and monitoring board.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      The IND “package” is submitted to the appropriate FDA area for review, which, in the case of vaccines, is the Center for Biologics Evaluation and Research (CBER) and the Division of Vaccine Research and Review (DVRR).
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      The IND review team is assembled based on the content and complexity of the proposed clinical trial and vaccine.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      , 

      US Food and Drug Administration. Investigational new drug application. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm/. Accessed June 20, 2014.

      Once the IND is received, the team has 30 days to make its comments and to meet with the sponsor.

      US Food and Drug Administration. Investigational new drug application. http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm/. Accessed June 20, 2014.

      The IND team either allows the study to continue, or places it on “hold,” with stipulations. “Hold” issues are generally related primarily to concerns for patient safety.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      INDs usually start with a Phase I clinical study design, primarily to address safety and tolerability of a vaccine. The IND can be amended to include Phase II studies evaluating the immunogenicity of the vaccine and giving an estimate of rates of adverse effects. A Phase III study, critical to licensure, generally enrolls large numbers of subjects to evaluate risks/benefits of the proposed vaccine.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      In Phase III, manufacturing reproducibility is evaluated by checking multiple lots of vaccine for consistent levels of antigen.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      Beyond licensure, manufacturers are required to provide ongoing reports of safety for licensed vaccines. These reports may influence current labeling and use. Another post-licensure safety measure is manufacturer facility inspection and lot testing. Except for influenza vaccine, with manufacturing facilities that are inspected yearly, all other vaccine manufacturing sites are inspected every 2 years. Vaccine lot testing is ongoing and includes evaluating the sterility, purity, and potency of the vaccine.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30

      Postmarketing Vaccine Safety Tools

      After licensure, the FDA can request postmarketing studies (Phase IV) to evaluate the vaccine further.
      • Marshall V.
      • Baylor N.
      Food and Drug Administration regulation and evaluation of vaccines.
      Pediatrics. 2011; 127: S23-S30
      To help capture postmarketing data in general, the CDC and FDA established the VAERS in 1990.

      Centers for Disease Control and Prevention. About the VAERS program. https://vaers.hhs.gov/about/index/. Accessed May 13, 2014.

      Unlike directed postmarketing studies, VAERS is a voluntary system and reporting is open to anyone (patient, parent-guardian, or clinician) who suspects that they or someone else has had a vaccine-related AE.
      Any post-vaccination medical concern that the patient, or his or her family, may have is considered an AE and is reportable to VAERS.

      Centers for Disease Control and Prevention. About the VAERS program. https://vaers.hhs.gov/about/index/. Accessed May 13, 2014.

      Under the National Childhood Vaccine Injury Act, health-care workers are mandated by law to report serious AEs (death, hospitalization, prolonged hospitalization, disability, or birth defect), as listed in the VAERS’s “Table of Reportable Events” on the CDC website (http://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf).
      Another CDC-sponsored safety surveillance tool was also launched in 1990, the Vaccine Safety Datalink (VSD).

      Centers for Disease Control and Prevention. Vaccine safety datalink. http://www.cdc.gov/vaccinesafety/activities/vsd.html. Accessed June 1, 2014.

      The VSD collects data from nine different sites across the US on vaccination, and other relevant clinical information to observe the safety of vaccines. Data from the VSD are correlated with pre–product-release safety data and ongoing VAERS reporting, and can be rapidly dispersed to the public.

      Centers for Disease Control and Prevention. Vaccine safety datalink. http://www.cdc.gov/vaccinesafety/activities/vsd.html. Accessed June 1, 2014.

      More information about this complicated process, as just simplified, can be accessed at the FDA website (http://www.fda.gov), the VSD page (http://www.cdc.gov/vaccinesafety/activities/vsd.html), or the VAERS webpage (http://vaers.hhs.gov/resources/VAERS_Brochure.pdf).

      Questions

      • 1.
        What are adjuvants and why are they needed in vaccines?
      • 2.
        Why does my child’s vaccine contain formaldehyde or mercury?
      Answers to 1 and 2: Vaccines produce an immune response to induce immunity to the intended virus or bacteria. Inactivated vaccines often require a substance to help bolster the immune response, called an adjuvant.

      Food and Drug Administration. Complete list of vaccines licensed for immunization and distribution in the U.S. http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm/. Accessed June 12, 2014.

      Aluminum in many chemical forms, when combined with the attenuated virus, produces a better immune response than the vaccine does alone.

      Food and Drug Administration. Complete list of vaccines licensed for immunization and distribution in the U.S. http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm/. Accessed June 12, 2014.

      , 
      • Plotkin S.A.
      • Plotkin S.L.
      The development of vaccines: how the past led to the future.
      Nature Rev. 2011; 9: 882-893
      Aluminum is used, in some form, in vaccines against human papilloma virus influenza, hepatitis A, hepatitis B, diphtheria-tetanus-pertussis (DTaP or Tdap), Hemophilus influenzae type B, and pneumococcal infection.

      Food and Drug Administration. Complete list of vaccines licensed for immunization and distribution in the U.S. http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm/. Accessed June 12, 2014.

      , 
      • Plotkin S.A.
      • Plotkin S.L.
      The development of vaccines: how the past led to the future.
      Nature Rev. 2011; 9: 882-893
      There are 60 years of experience with aluminum as an adjuvant and, to date, there is no evidence to support a safety concern with its use.

      Food and Drug Administration. Complete list of vaccines licensed for immunization and distribution in the U.S. http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm093833.htm/. Accessed June 12, 2014.

      , 
      • Plotkin S.A.
      • Plotkin S.L.
      The development of vaccines: how the past led to the future.
      Nature Rev. 2011; 9: 882-893
      Attenuating or weakening a virus or bacterial toxin involves products like formalin or formaldehyde. Formaldehyde is a naturally occurring substance in our body and in our environment.

      Centers for Disease Control and Prevention. Common ingredients in vaccines. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm/. Accessed May 1, 2014.

      The amount of formaldehyde that can be left in a vaccine after the many dilutions is still infinitesimal.
      It is estimated that a newborn has 50 to 70 times more formaldehyde naturally in their bodies than is contained in a single dose of vaccine.

      Centers for Disease Control and Prevention. Common ingredients in vaccines. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm/. Accessed May 1, 2014.

      Thimerasol is a mercury-based preservative used to prevent contamination of vaccines.

      Food and Drug Administration. Thimerasol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm/. Accessed July 14, 2014.

      Based on concerns that this preservative may contribute to neurologic disorders such as autism, since 2001 it has been removed entirely or is found in minute amounts in multiple-dose influenza vaccines.

      Food and Drug Administration. Thimerasol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm/. Accessed July 14, 2014.

      Are There Ingredients in Vaccines I Should Worry About?

      Answer: Many ingredients are involved in the end product of a vaccine, although, per dose, the volumes are exceedingly small. If a child has had a severe, life-threatening allergic response to a type of food, such as eggs, gelatin, or yeast, or an antibiotic, such as neomycin, or latex, the child may not be eligible for some vaccines.

      Background

      Preservative

      Thimerasol is an organomercurial and has been used as a preservative in vaccines since the 1930s.

      Food and Drug Administration. Thimerasol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm/. Accessed July 14, 2014.

      It came under scrutiny in 2001 in an article suggesting that mercury-poisoned individuals exhibited the same symptoms as autistic children.
      • Barnard S.
      • Enayati A.
      • Redwood L.
      • Roger H.
      • Binstock T.
      Autism: a novel form of mercury poisoning.
      J Med Hypotheses. 2001; 56: 462-471
      The Institute of Medicine (IOM) first studied ethyl mercury in 2001 but could neither accept nor reject a causal relationship between thimerasol and pervasive developmental disorders.

      Food and Drug Administration. Thimerasol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm/. Accessed July 14, 2014.

      The committee recommended thimerasol be removed from all childhood vaccines, although further studies did not support a causal relationship between thimerasol and autism.

      Food and Drug Administration. Thimerasol in vaccines. http://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228.htm/. Accessed July 14, 2014.

      There is no evidence that thimerasol leads to pervasive developmental delay or autism.

      Adjuvants

      Adjuvants historically have been used to increase the immunogenicity of a vaccine. Aluminum in salt form (aluminum hydroxide, aluminum phosphate, alum [potassium aluminum sulfate], or mixed aluminum salts) is the only FDA adjuvant in licensed vaccines.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719

      Antibiotics

      An antibiotic is added to a vaccine to prevent bacterial contamination.

      Centers for Disease Control and Prevention. Common ingredients in vaccines. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm/. Accessed May 1, 2014.

      The worry is that adding antibiotics to a vaccine may increase the risk of an allergic reaction or anaphylaxis. Antibiotics associated with severe allergic reactions include sulfonamides, penicillins, and cephalosporins, and for that reason the most common antibiotics used in vaccines are polymyxin B, neomycin, streptomycin, and gentamycin.

      Centers for Disease Control and Prevention. Common ingredients in vaccines. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm/. Accessed May 1, 2014.

      Vaccine schedule questions:
      • 1.
        Why are vaccines combined?
      • 2.
        Will combined vaccines cancel each other out?
      • 3.
        Will they overwhelm my baby’s immune system?
      • 4.
        Can they be given individually or spaced apart somehow?
      Answers to 1-4: Vaccines are combined to ensure that the child is protected as quickly as possible from vaccine-related infections. Combination vaccines have been available since the 1940s and are developed to limit the number of needle injections a baby will be given, to ensure protection as soon as possible, and to overall reduce the cost and inconvenience of vaccines. Combination vaccines are safe. All combination vaccines undergo clinical testing for efficacy and safety before licensing by the FDA. Furthermore, the FDA often mandates that vaccines be monitored for safety after licensing and that there is also a VAERS to help monitor safety.
      Babies are exposed to immunologic challenges immediately at birth. As babies pass through the birth canal and breathe, they are immediately colonized with trillions of bacteria, and thus they carry the bacteria in their bodies but are not infected by them. A healthy baby’s immune cells are busy making antibodies and will not tire or get overworked by vaccines. Despite their size, they have very robust immune systems that can handle and process many vaccines. In fact, exposure to vaccines produces less of an immune response the older we get, meaning that sometimes older people need “stronger” vaccines than the young.
      If one delays or chooses to limit vaccinations for their child, that child’s risk for acquiring an infection is increased. The spacing of vaccines has to do with how the immune system works. Some vaccines require boosters for full protection. These vaccines are primarily the ones given very early in life, but also include the vaccine for measles mumps and rubella. Once the full series is completed, the child will be protected for life. The one vaccine that requires updates throughout life is tetanus and influenza.

      Background

      Overview of Vaccines

      Vaccines are biologics that mimic the infection they are aimed to prevent and therefore have both expected and unintended side effects. Today there are vaccines available to treat 25 viral and bacterial infections.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719
      , 
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      These vaccines range from single-antigen to combination-antigen products. There are two types of vaccines: live attenuated and inactivated.
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      The majority of live attenuated vaccines are for viruses. These vaccines are manufactured by modifying a disease-producing organism to produce antigen to stimulate the formation of antibody, without causing the disease.
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      Generally, these vaccines create a vigorous immune response and are dosed once. They include measles, mumps, rubella (MMR), vaccinia (smallpox/monkeypox), varicella zoster, yellow fever, bacillus Calmette-Guerin (BCG), oral polio, cholera, rotavirus, typhoid, and intranasal influenza (BCG, cholera, and oral polio are not available in the US).
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      Inactivated vaccines use a part of an organism for the immune system to recognize.
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      These vaccines can be whole cell or fractional. They require multiple vaccinations to achieve adequate immunity. Whole cell vaccines, such as inactivated polio, hepatitis A, rabies, and influenza, are inactivated (unable to replicate) by treatment with heat or formalin.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719
      , 
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      Fractional vaccines are inactivated and then purified further to contain only the elements desired. These vaccines are subdivided into subunit, toxoid, and polysaccharide vaccines.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719
      , 
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      Subunit vaccines (hepatitis B, influenza, acellular pertussis, human papillomavirus, and anthrax) use a part of the viral protein, and there is no chance for a natural reversion to disease.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719
      , 
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13
      Toxoid vaccines (diphtheria and tetanus) use the toxins produced by the putative bacteria after treatment with formalin and are then adsorbed onto an adjuvant such as alum.
      Stratton C. Ford A. Rush E. Clayton E.W. Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press, Washington, DC2011
      Conjugating a bacterial protein with a complex sugar (polysaccharide) has produced improved vaccines for Hemophilus, pneumococcus, and meningococcus.
      • Plotkin S.A.
      Vaccines: the fourth century.
      Clin Vaccine Immunol. 2009; 16: 1709-1719
      , 
      • Moser M.
      • Leo O.
      Key concepts in immunology.
      Vaccine. 2010; 28: C2-C13

      Autism Questions

      • 1.
        Could my child develop autism from a vaccine?
      • 2.
        I remember a scientific study about autism and vaccines, was it true?
      • 3.
        Did the courts pay a family whose child had autism from a vaccine?
      Answer to question 1: No. There is no study supporting the idea that autism is associated with vaccination. The IOM has reviewed extensively all published reports about autism and has concluded that there is no convincing evidence to support that any vaccine causes autism.
      Answer to question 2: A study published in The Lancet reported a link between the MMR vaccine and development of an irritable bowel disease and autism (see next section). Unfortunately, it was later found that the lead author fabricated information about his study patients and did so to gain financially. The author’s motives and unethical behavior came to light several years after the report was published and he lost his medical license.
      Answer to question 3: Yes, in one case, a family was compensated when their daughter, who had an underlying genetic disease, received a vaccine and developed a form of autism. After multiple vaccinations she developed high fevers and brain injury. Because no one could be certain that she developed autism due to her genetic disease and not vaccines; the court decided that vaccination could have aggravated her genetic disease and that her family should receive compensation.

      Background

      In February 1998, The Lancet published an article written by Andrew Wakefield and colleagues that was the result of a now disputed critical examination of 12 pediatric/adolescent subjects who were reported to have developed enterocolitis and regressive autism after MMR vaccination.
      • Wakefield A.J.
      • Murch S.H.
      • Anthony A.
      • et al.
      Ileal lymphoid nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.
      Lancet. 1998; 351 ([retracted]): 637-641
      The fallout of this article and Wakefield’s press conferences thereafter, was catastrophic. Vaccination rates plummeted and cases of autism associated with the MMR were increasingly brought before federal and state agencies. Calls for Wakefield to replicate his study in larger numbers were unanswered.
      • Deer B.
      How the case against the MMR vaccine was fixed.
      BMJ. 2011; : 342-347
      , 
      • Deer B.
      How the vaccine crisis was meant to make money.
      BMJ. 2011; 342: c5258
      Investigations into the findings noted discrepancies from onset of symptoms and receipt of the MMR and claims that these children had colitis, when in fact they did not. Moreover, evidence showed he had an unethical relationship with a lawyer planning to sue the pharmaceutical companies while he was studying these children and had created plans to develop alternative vaccines and genetic tests before his results were published. In 2004, 10 of his coauthors retracted the conclusions of his study and, after 12 years of mounting evidence of criminal and ethical fraud, The Lancet retracted the article entirely.
      • Deer B.
      How the case against the MMR vaccine was fixed.
      BMJ. 2011; : 342-347
      The damage was done. Wakefield, whose singular motive was to make money by cooperating in lawsuits against vaccine makers and by being an entrepreneur in genetic studies laboratories, had stoked the anti-vaccination pyre, which drove vaccination rates down and measles outbreaks up.

      Vaccines Risk and Review of the 2011 IOM Report

      Research, development, and manufacture of vaccines do not net major profits for the pharmaceutical industry. Thus, the federal government and academia work closely with the pharmaceutical industry to promote early-phase development of vaccines. Vaccine development was threatened in the 1970s and early 1980s by an overwhelming number of lawsuits especially related to the DTaP, which forced many vaccine manufacturers out of the vaccine business.
      • Mariner W.K.
      The national vaccine injury compensation.
      Health Affairs. 1992; 11: 255-265
      The US Government, in response, created a compensatory court, the National Vaccine Injury Compensation Program, to mediate claims of harm.
      • Mariner W.K.
      The national vaccine injury compensation.
      Health Affairs. 1992; 11: 255-265
      The program is funded by a small tax on vaccines.
      Diagnosis of autism often occurs around age 2 years and, coincidentally, the MMR vaccine is given at around 12 to 18 months. In the absence of a cause of autism, the search for the origins of sometimes severely disabling neurodevelopmental disorder led scientists and lay people alike to consider vaccines. In 2002, a special Omnibus Autism Proceeding (OAP), housed within the US Court of Federal Claims Office of Special Masters, was created due to of the thousands of claims of autism in relation to the MMR.

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      The OAP consolidated all the cases into theory test cases to test: (1) autism’s relation to the MMR with vaccines containing the preservative thimerasol (an ethyl mercury); or (2) vaccines with thimerasol.

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      The OAP concluded that autism was not associated with thimerasol-containing vaccines or the MMR; however, vaccine manufacturers have since voluntarily removed thimerasol from their products.

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      In 2009, in response to the anti-vaccination environment, the Health and Resources Services Administration (HRSA) contracted with the IOM to rigorously review AEs commonly cited for 8 of the 12 covered vaccines in VAERS (MMR, DTaP, hepatitis B, meningococcal conjugate virus, varicella, human papillomavirus, and influenza).

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      The IOM reviewed 158 AEs reported to be associated with vaccines.

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      The IOM reviewers mined published studies of the vaccine, assessing them for scientific rigor and methodology.

      Department of Health Resources and Service Administration. About the Omnibus Autism Proceedings. http://www.hrsa.gov/vaccinecompensation/omnibusautism.html/. Accessed July 11, 2014.

      They also reviewed case studies, animal and in vitro studies, as well as the natural history of the diseases.
      The IOM reviewers were unable to attribute causality to a large number of AEs associated with the vaccines they evaluated. The AEs found to have a convincing relationship or a favorable acceptance for relationships are listed in Table 2.
      Table 2IOM conclusions of AE's and Vaccine Causality
      Table adapted IOM report of Adverse Events of Vaccines: Evidence and Causality.28
      VaccineData Convincingly Support a Causal Relationship of Adverse Event to VaccineData Favor Acceptance of a Causal Relationship of Adverse Event to Vaccine
      MMRInclusion-body encephalitis, anaphylaxis,

      febrile seizure      		Transient arthralgia in women and children
      Hepatitis BAnaphylaxis
      InfluenzaAnaphylaxis
      DT-, TT-, and aP-containing vaccinesAnaphylaxis (TT only)
      MeningococcusAnaphylaxis
      Any injected vaccineDeltoid bursitis, syncope
      Human papillomavirusAnaphylaxis
      InfluenzaOculorespiratory syndrome
      aP = acellular pertussis; DT = diphtheria toxin; MMR = measles, mumps, rubella; TT = tetanus toxin.
      a Table adapted IOM report of Adverse Events of Vaccines: Evidence and Causality.
      Stratton C. Ford A. Rush E. Clayton E.W. Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press, Washington, DC2011
      Most importantly, the IOM provided clear evidence that: (1) autism was not associated with the MMR; (2) type 1 diabetes was not associated with the MMR or the DTaP; and (3) inactivated influenza vaccine was not related to Bell’s palsy or exacerbation of asthma or reactive airway disease in adults or children.
      Stratton C. Ford A. Rush E. Clayton E.W. Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality. National Academies Press, Washington, DC2011
      A subsequent review 67 journal articles published after the IOM review included vaccines not reviewed by the IOM: conjugated pneumococcal vaccine 13; rotavirus vaccines; hepatitis A; Hemophilus influenzae B; and the inactivated polio vaccine. The review supported the IOM’s findings of no causal relationship between the MMR and autism, or type 1 diabetes and DTaP; however, they did favor a relationship between disseminating varicella disease in immunocompromised children.
      • Maglione M.A.
      • Das L.
      • Raaen L.
      • et al.
      Safety of vaccines used for routine immunization of US children: a systematic review.
      Pediatrics. 2014; 134: 325-337
      With regard to the vaccines not evaluated in the IOM 2011 report, the review identified a moderate potential relationship between the MMR, DTaP, varicella, and hepatitis A and the development of thrombocytopenic purpura and moderate risk of intussusception in all the rotavirus vaccines.
      • Maglione M.A.
      • Das L.
      • Raaen L.
      • et al.
      Safety of vaccines used for routine immunization of US children: a systematic review.
      Pediatrics. 2014; 134: 325-337

      The Autism Case With Financial Compensation

      In 2008, the federal government awarded the parents of Hannah Poling $20 million over her lifetime as compensation due to vaccine-related injuries.
      • Offit P.
      Vaccines and autism revisited: the Hannah Poling case.
      N Engl J Med. 2008; 358: 2089-2091
      Hannah was described as a normal interactive, communicative child, who was vaccinated with nine vaccines and soon developed rashes, high fevers, and swiftly regressed developmentally.
      • Offit P.
      Vaccines and autism revisited: the Hannah Poling case.
      N Engl J Med. 2008; 358: 2089-2091
      She was diagnosed with a mitochondrial disorder.
      • Offit P.
      Vaccines and autism revisited: the Hannah Poling case.
      N Engl J Med. 2008; 358: 2089-2091
      Her parents would later bring their daughter’s case to the Vaccine Injury Compensation Program for compensation. The court ruled that vaccines “aggravated” Hannah’s undiagnosed mitochondrial disorder and may have led to the development of her symptoms.
      • Offit P.
      Vaccines and autism revisited: the Hannah Poling case.
      N Engl J Med. 2008; 358: 2089-2091
      At no point did they indicate that vaccines were the direct cause of her autism. Studies of children with autism spectrum disorders have concluded that some may have mitochondrial disorders, and that the regressive developmental deterioration seen in children with autism is identical to that in patients with mitochondrial diseases.
      • Maglione M.A.
      • Das L.
      • Raaen L.
      • et al.
      Safety of vaccines used for routine immunization of US children: a systematic review.
      Pediatrics. 2014; 134: 325-337

      Question Natural and Herd Immunity

      • 1.
        Isn’t it better for my child to get the disease?
      • 2.
        Could I just rely on herd immunity to protect my child?
      Answer to question 1: Although it is true that recovering from a vaccine-preventable disease will provide lifelong immunity, the child could suffer and may develop serious complications, such as brain damage, infections, sterility, or paralysis.
      Answer to question 2: Herd immunity only works when everyone gets immunized. Outbreaks of infections occur because of introduction of an infection to an unvaccinated person, who then spreads it to other unvaccinated people. Recent significant outbreaks of measles in 15 states have been attributed to unvaccinated persons.

      Centers for Disease and Control and Prevention. Measles (Rubeola). http://www.cdc.gov/measles/index.html/. Accessed September 5, 2014.

      Background

      Disease Versus Vaccination

      Although the debate may continue about what adverse effect is truly attributable to a vaccine, the evidence is very clear when it comes to the sequelae of natural infection. Before the conjugate pneumococcal vaccine became a part of the schedule in 2000, over 17,000 cases of invasive pneumococcal infections occurred each year in children under age 5.
      • Offit P.A.
      • Moser C.A.
      The problem with Dr. Bob’s alternative vaccine schedule.
      Pediatrics. 2009; 123: e164-e169
      Meningitis occurred in 700 patients, and at least 200 would die from complications.
      • Offit P.
      Vaccines and autism revisited: the Hannah Poling case.
      N Engl J Med. 2008; 358: 2089-2091
      Chickenpox, often treated as an innocuous disease by anti-vaccination proponents who encourage chickenpox parties, resulted in 100 deaths per year before vaccination. Polio resulted in flaccid paralysis in 1% of its victims and 5% to 10% of these patients died.
      • Offit P.A.
      • Moser C.A.
      The problem with Dr. Bob’s alternative vaccine schedule.
      Pediatrics. 2009; 123: e164-e169
      The eradication of smallpox was due to herd immunity. A herd requires a substantial number of immune persons, in this case via vaccination, to reduce the likelihood that an infected person would come in contact with a susceptible (nonimmune/unvaccinated) person(s). The smallpox vaccination campaign by the World Health Organization began in 1967.

      Center for Global Development. Case study: eradicating smallpox. http://www.cgdev.org/page/case-1-eradicating-smallpox/. Accessed September 5, 2014.

      The campaign began in endemic countries in Africa, South America, and Asia, aided by US funding, a freeze-dried vaccine, and a new bifurcated needle system. Strategies to vaccinate masses changed to vaccinating all contacts of an index case. Impeded by local wars, civil unrest, refugees, and other political and social blocks, the campaign ended 10 years later in Somalia as the last case was seen.

      Center for Global Development. Case study: eradicating smallpox. http://www.cgdev.org/page/case-1-eradicating-smallpox/. Accessed September 5, 2014.

      , 

      Centers for Disease Control and Prevention. Connects: smallpox eradication: memories and milestones. globalhealthchronicles.org/archive/files/869774faa96420dc6f1a1628e3fa7127.pdf.

      Smallpox was officially declared eradicated at the 33rd conference of the World Health Organization in 1980.

      World Health Organization. Smallpox. http://www.who.int/biologicals/vaccines/smallpox/en/. Accessed September 6, 2014.

      Conclusions

      Vaccination accounts for healthier, longer, lives for all, but especially among infants and children. We as a society have enjoyed what generations before us could not—the comfort that we will not be afflicted by the same childhood diseases that they feared. There are no substantial data suggesting the AEs that rarely occur with vaccination outweigh the remarkable benefits of vaccines. Federal and nonfederal agencies support vaccination and make every effort to ensure a safe and efficacious vaccine supply. Clinicians should continue to make every effort to ensure proper immunization for their patients at every visit, and to report known or suspected AEs to the CDC.

      Author’s Note

      I have a 16-year-old son with autism. His diagnosis came late at age 12, well after he had completed all necessary vaccinations. In researching this study, I gave myself comfort validating what I believed all along—that vaccinations did not cause my son harm.

      Links for Resources

      Common ingredients in US vaccines:
      Thimerasol questions and answers:
      Disease questions and answers from the Immunization Action Coalition:
      Link to government, nongovernment, and consumer sites about vaccines:
      Links to educational resources:

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      Biography

      Victoria L. Anderson, MSN, CRNP, is a Family Nurse Practitioner at the Clinical Center, Department of Radiology and Center for Interventional Oncology, National Institutes of Health in Bethesda, MD. She can be reached at .

      Article info

      Footnotes

      This study was supported by the Intramural Research Program of the National Institutes of Health, Clinical Center, Department of Radiology, National Cancer Institute, Center for Interventional Oncology, and the Mark Hatfield Clinical Research Center. In compliance with national ethical standards, the author reports no relationships with business or industry that would pose a conflict of interest.

      Identification

      DOI: https://doi.org/10.1016/j.nurpra.2014.10.016

      Copyright

      © 2015 Elsevier Inc. Published by Elsevier Inc. All rights reserved.

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      Linked Article

      • Erratum
        The Journal for Nurse PractitionersVol. 11Issue 4
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          Thimerosal was incorrectly spelled in the article “Promoting Childhood Immunizations” in the January 2015 issue.
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      • Letter to the Editor
        The Journal for Nurse PractitionersVol. 11Issue 4
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          I want to thank you for including the article “Promoting Childhood Immunizations,” written by Victoria Lynn Anderson, MSN, in the most recent journal (January 2015). I am a family nurse practitioner, but I am also a mother and grandmother. I have many friends who are among those convinced that the measles, mumps, rubella (MMR) vaccine causes autism. A very good friend of mine has 3 sons, 2 of whom are autistic. This friend, who is an intelligent and reasonable person, is also a critical care RN.
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