Vaccines: Truths, Myths, & Controversies An annotated bibliography for the study grant prepared by Amy W. Helms, PhD ahelms@collin.edu 972-377-1085 Spring 2015 Vaccines: Truths, Myths, & Controversies To most scientists, doctors, and public health officials, the introduction of vaccinations revolutionized human health and health care and has had a long-lasting impact on the diseases we fight today versus the ones we fought before the advent of the vaccination. But there has been a popular movement amongst some doctors and lay-people to forgo vaccines. These groups believe that vaccines are more harmful than helpful and are recommending simply not vaccinating children at all on one end of the spectrum, and at the very least, radically modifying the vaccination schedule for children. According to some, there are links between vaccinations and autism, other neurological disorders, and autoimmune diseases. While most children today are vaccinated, as the pool of unvaccinated children becomes larger, we lose what is called “herd immunity,” the ability of vaccinated people to prevent widespread outbreaks of serious illnesses and thus protecting the unvaccinated few. We are already seeing outbreaks of previously well controlled infections like whooping cough (Bordetella pertussis), measles and polio viruses. If the anti-vaccine movement continues, these previously rare infections may become common again, and may reveal weaknesses in our current vaccination programs. The aims of this study grant are to understand the history of vaccination and how vaccines are made and delivered, in the past and today in the present. I would like to delve into the basis for the antivaccine movement to better understand the true scientific evidence (if any) for vaccine side effects and injury. Just in my initial research of book titles for this project, most of the popular literature out there is anti-vaccine and filled with pseudoscience and non-scientific conclusions. Because these types of books are omnipresent in bookstores, the public is getting a warped view of the importance of vaccines and are beginning to go against their doctor’s recommendations out of fear. Is this fear unfounded? I would like to understand how the anti-vaccine movement started and how it has gained power and influence over so many. I will study if there is any scientific evidence for vaccine injuries and long lasting side effects. There have been some who have proposed changes to the vaccination schedule for children. I will study if this idea has any merit, scientifically. Finally, I would like to study new advances in vaccine production and administration. Will new advances and scientific evidence alleviate the controversy? Are we headed for the return of many nearly eradicated diseases in the U.S.? I propose to complete this study grant during the Spring 2015 semester. Aim #1 (weeks 1-3) To understand the history of vaccination and its impact on public health. Allen, A. (2007). Vaccine: The controversial story of medicine's greatest lifesaver. New York, NY: W.W. Norton & Company. Arthur Allen provides a sweeping history of both the early origins of vaccination, its “golden age” during the mid-to-late 20th century, and the more recent controversies that surround vaccine safety. Allen, a former AP foreign correspondent, focuses keenly on the political nature of the controversy. This is a good starting place for the reader who wants a comprehensive look at the history of vaccination and the controversy tied together. Bazin, H. (2000). The Eradication of Smallpox: Edward Jenner and the First and Only Eradication of a Human Infectious Disease. London, England: Academic Press. Herve Bazin covers the history of smallpox from its origins to present day. For centuries, smallpox has ravaged the earth, killing and disfiguring millions of people. While Edward Jenner was not the first to vaccinate, he is the scientist most commonly credited with developing the first large scale vaccination program for smallpox in the late 1700’s. Fastforward to the 20th century, and smallpox is the only human infectious disease on earth that is believed to have been eradicated. Bazin also brings forward the ethical dilemma of the last remaining smallpox viral stocks—should they be destroyed? Could they get into the hands of bioterrorists? Bookchin, D., & Schumacher, J. (2004). The Virus and the Vaccine: Contaminated vaccine, deadly cancers, and government neglect. New York, NY: St Martin's Griffin. This book was a good historical reference about the polio vaccine and the controversies that have surrounded it. Unfortunately, there is a dark side to the polio vaccine story. In the early days of polio vaccination, a vaccine contaminated with a monkey virus (SV40) was administered to millions in the U.S. The SV40 virus was known to be carcinogenic to monkeys at the time and it was unknown if this would also be true for humans. This piece chronicles the way this mistake was handled by the government and how it may have caused the distrust that has led to the current anti-vaccination movement. Centers for Disease Control. (2015). Retrieved from http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html The Centers for Disease Control (CDC) maintains this website with current information about vaccines and vaccine safety. This site links to documents about the licensing procedures for vaccines, safety monitoring and the VAERS event reporting system and the National Childhood Vaccine Injury Act College of Physicians of Philadelphia. (2015). Retrieved from http://www.historyofvaccines.org/content/timelines/diseases-and-vaccines I found this site and its contents to be invaluable in putting together a working timeline of events related to vaccination history. The timeline in this site is fully “clickable” for more information on almost every entry. This resource helped me to see the big picture in this project. Jenner, Edward. The Three Original Publications on Vaccination Against Smallpox. Vol. XXXVIII, Part 4. The Harvard Classics. New York: P.F. Collier & Son, 1909–14; Bartleby.com, 2001. www.bartleby.com/38/4/. It is not very often that we, as scientists, can get access to full length original scientific literature from the 18th century. Bartleby.com provides free full text access to Jenner’s 3 original, seminal articles: An Inquiry Into the Causes and Effects of the Variolæ Vaccinæ, Or Cow-Pox. 1798, Further Observations on the Variolæ Vaccinæ, or Cow–pox. 1799, and A Continuation of Facts and Observations Relative to the Variolæ Vaccinæ, or Cow–pox. 1800. Jenner’s ideas were not accepted at first, and met with vehement rebuttal. I find it amazing that Jenner was able to gain the insight into the disease process without being able to see a virus with a microscope and without understanding the intricacies of the human immune system. He was definitely before his time. Aim #2 (weeks 4-6) To better understand how different types of vaccines are produced today, their scheduling and the rationale behind it, and to update my knowledge of how the different types of vaccines work on the immune system Bloom, B. R., & Lambert, P. (2003). The Vaccine Book. San Diego, CA: Academic Press. I found this book (albeit older than I would have liked) to be a pretty comprehensive reference for almost all things related to immunization. From an overview of the immune system and microbial pathogenesis, to trial design, to ethics and future challenges, this book was nice to go to for basic information and was friendly even for the lay public. Centers for Disease Control. (2015). Immunization Schedules. Retrieved from http://www.cdc.gov/vaccines/schedules/index.html?s_cid=ostltsdyk_govd_406 The CDC website provides information on the proposed vaccination schedules for infants, children, adolescents, and adults, as well as information for “catch-up” schedules for persons who have not been fully immunized. This site is a great reference for both health care professionals and for the lay public. Kimberlin, MD, D. W., Brady, MD, M. T., Jackson, MD, M. A., & Long, S. S. (2015). Red Book 2015. Elk Grove, IL: Red Book Online. Retrieved from http://redbook.solutions.aap.org/book.aspx?bookid=1484 The American Academy for Pediatrics publishes an incredibly comprehensive document online for pediatricians called the Red Book. Because it is published online, it is updated frequently. The information on this website gives background on immunity as well as information to help pediatricians talk to parents about their concerns with vaccines. This is definitely my favorite “go-to” reference for all things vaccines. Marshall, MD, G. S. (2012). The Vaccine Handbook: A Practical Guide for Clinicians. West Islip, NY: Professional Communications, Inc. This book is meant as a desk reference/pocket edition for physicians similar to the Red Book. It is meant to be nearby as a ready reference for doctors. Information is cataloged by pathogen, with basic clinical information about the pathogen, the diseases it causes, vaccines (and their sources), short summaries of the efficacy of the vaccine and information to help parents understand the vaccine. Whyte, J. (2013). Child, Adolescent, and Adult Immunization Schedules. N.p.: CME Resource/NetCE. Again, this book is a continuing education (CE) “course” for physicians on vaccine schedules. Like the Red Book and the Handbook described above, it has comprehensive information about vaccination schedules and is freely available. Of all the comprehensive summaries available, the Red Book seems the most comprehensive and up to date, with this document coming in second. The Red Book is preferred as it is the most continuously updated. Aim #3 (weeks 7-9) To understand the history of the anti-vaccination movement and the principles behind it by looking at the popular literature. How much pseudoscience is driving this movement and where is it coming from? Is there any evidence in the scientific (not popular) literature for vaccine injury or side-effects? Conis, E. (2015). Vaccine Nation: America's Changing Relationship with Immunization. Chicago, IL: University of Chicago Press. This was probably one of the most unbiased books I read regarding how the current antivaccination movement began. Conis asks the following questions about the history of the movement. How did we come to place such importance on the mass vaccination of children over the last 50 years? Why has it become so contentious in the 21 st century? Conis is able to discuss the issues without showing a clear bias in one direction or the other, something that the majority of the books I read could not do. Habakus, MA, L. K., Holland, JD, M., & Rosenberg, JD, K. M. (2012). Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children. New York, NY: Skyhorse Publishing. This book was very hard to read and take seriously. The authors are not scientists or physicians (two are lawyers), and the book’s cover is designed to look almost identical to another book that I read (Deadly Choices: How the anti-vaccination movement threatens us all, by Paul Offit), as if it is trying to gain some legitimacy by looking as “official” as the Offit book. As a scientist, I am very particular about my sources. I had a hard time getting my head around that I was supposed to be reading this for research because all I wanted to do was to put it as far away as possible! I found it to be manipulative and full of propaganda but also eye-opening. It disturbs me to think that there are lay people out there who can’t sort out the propaganda from the truth. Humphries, MD, S., & Bystrianyk, R. (2013). Dissolving Illusions: Disease, Vaccines, and the Forgotten History. N.p.: Create Space Independent Publishing Platform. Humphries and Bystrianyk first and foremost, try to paint a picture that we have been misled by scientists, doctors, and the government about the efficacy of vaccines. They spend a fair amount of time manipulating data to conform to their idea that vaccines are not effective and infectious disease was already in severe decline by the time vaccines were introduced. In his introduction, Bystrianyk narrates a drama-filled story trying to connect all his children’s adverse health events to vaccination. Like Habakus, et al, Humphries and Bystrianyk are spin doctors and master manipulators of data. James, W. (1995). Immunization: the reality behind the myth. Westport, CT: Bergin and Garvey. You could consider this one of the earlier books promoting the current anti-vaccination movement. James is an activist and proponent of alternative medicine and did not have her children vaccinated in a time where that was not the norm. More recently, she and her daughter have fought in court against compulsory vaccination laws. In this edition of the book, James wants her readers to wake up and challenge the “tyranny of what everyone knows.” Again, I could not take this book seriously as there was a whole chapter devoted to de-bunking the germ theory of infectious disease. James puts forth the ideas of a scientist named Antoine Bechamp, a contemporary of Louis Pasteur, who was a germ theory denialist. Mnookin, S. (2011). The Panic Virus: A true story of Medicine, Science, and Fear. New York, NY: Simon & Schuster Seth Mnookin explores the roots of the controversy surrounding the MMR vaccine and the supposed link to autism. Mnookin summarizes the anti-vaccination movement and questions why the public continues to believe that there is a relationship between vaccines and autism. This is a good source for scientists and non-scientists alike who want to understand the current anti-vaccine climate. Wakefield, MB, BS, FRCS, A. (2010). Callous Disregard: Autism and Vaccines--The Truth Behind a Tragedy. New York, NY: Skyhorse Publishing. This book was not on my original list of readings, but it should have been. This book, published in 2010, almost 12 years after the original Lancet paper was published in 1998, is Andrew Wakefield’s rebuttal to all of the claims that have been made against him and his research. As with all of the anti-vaccination literature I read, I found Dr. Wakefield himself to be guilty of manipulation and “smoke and mirrors” in this book, much like the others I read. Aim #4 (weeks 10-12) How has the anti-vaccination movement already changed the spread of disease, if at all? Centers for Disease Control. (2013). Global Control and Regional Elimination of Measles 20002011. Atlanta, GA: Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6202a3.htm For this aim, I wanted to look at some historical data about some of the diseases that are said to be “coming back” due to decreased vaccination rates. The CDC has published worldwide data on the incidence of measles for the first part of the 20 th century (20002011). Even though the data were only through 2011, starting in 2010-2011 there was an increase in the incidence of measles and large outbreaks in multiple countries. DeBold, T., & Friedman, D. (2015). Battling Infectious Diseases in the 20th Century: The Impact of Vaccines. New York, NY: Wall Street Journal. Retrieved from http://graphics.wsj.com/infectious-diseases-and-vaccines/ I’ve included this site because I found it to be a great visual to “see” the incidence of many vaccine preventable diseases over a number of years by producing a “heat map.” Lower rates are green and blue and higher rates are yellow, orange, and red. This makes it easy to see that the incidence of many diseases has gone up in recent times. Offit, MD, P. A. (2011). Deadly Choices: How the anti-vaccine movement threatens us all. New York, NY: Basic Books. This was the most well written and engaging book on the subject of the anti-vaccine movement. Dr. Paul Offit appears to be the resident expert on the pro-vaccination side of the movement, the author of several books for different audiences. Offit explains the problem in a simple way, for anyone to read. In addition to the book by Mnookin, I would highly recommend this book to scientists and non-scientists alike. Offit, MD, P. A., & Moser, C. A. (2011). Vaccines and Your Child: Separating Fact from Fiction. New York, NY: Columbia University Press. Another book by Offit, this book is directed most definitely at lay-people, trying to help people understand the mass amount of literature out there about vaccines. Dr. Offit and Moser explain all using a Q&A method. I would recommend this book for confused parents and for people who would find it hard to comprehend something more detailed. Sears, R. W. (2011). The Vaccine Book: Making the Right Decision for your Child. New York, NY: Little, Brown & Company. For many, Sears is the “new” Dr. Spock when it comes to all things pediatric. The book is written for lay people in a Q&A style similar to the book by Dr. Offit. One notable difference is that Dr. Sears promotes the idea of alternate and delayed vaccine schedules for childhood vaccinations. Aim #5 (weeks 12-15) What are the latest advances in vaccine administration? Is alternate scheduling a viable option? What new delivery methods are being used? How are scientists and medical professionals addressing the anti-vaccination movement? Gregory, A. E., Titball, R., & Williamson, D. (2013). Vaccine delivery using nanoparticles. Frontiers in Cellular and Infection Microbiology, 3, 13. http://doi.org/10.3389/fcimb.2013.00013 Saroja, C., Lakshmi, P., & Bhaskaran, S. (2011). Recent trends in vaccine delivery systems: A review. International Journal of Pharmaceutical Investigation, 1(2), 64–74. http://doi.org/10.4103/2230-973X.82384 Shim, B.-S., Choi, Y., Cheon, I. S., & Song, M. K. (2013). Sublingual Delivery of Vaccines for the Induction of Mucosal Immunity. Immune Network, 13(3), 81–85. http://doi.org/10.4110/in.2013.13.3.81 Suh, H., Shin, J., & Kim, Y.-C. (2014). Microneedle patches for vaccine delivery. Clinical and Experimental Vaccine Research, 3(1), 42–49. http://doi.org/10.7774/cevr.2014.3.1.42 Villarreal, D. O., Talbott, K. T., Choo, D. K., Shedlock, D. J., & Weiner, D. B. (2013). Synthetic DNA vaccine strategies against persistent viral infections.Expert Review of Vaccines, 12(5), 537–554. http://doi.org/10.1586/erv.13.33 These literature reviews discuss the use of novel methods for vaccine delivery. Nanoscale size materials (e. g. virus-like particles, liposomes, non-degradable nanospheres), microneedle patches and sublingual delivery are just some of the methods outlined. Nanoparticles are of interest because they may stabilize the antigens as well as simultaneously acting as adjuvants. Interestingly, these nanoparticles are able to enter cells to modulate the immune response. DNA vaccines are another novel approach to vaccine delivery.