Understanding risk is difficult; explaining risk may be even more so. Yet for healthcare providers this is a regular place in which you likely find yourself. How do you convince patients and their families of the risks associated with vaccine-preventable diseases (VPD) especially VPD that they — and even you — may not have seen?
New technologies may make the job of relaying the realities and risks associated with vaccine-preventable diseases easier and more timely. Whether keeping yourself up to date or looking for new ways to share information with parents and families, we think you will be glad to know about the following innovative projects:
Find out more about the app or download it, visit http://vaccine.chop.edu/mobileapp. Providers can get free copies of a poster with QR code to distribute or display in the office. Please complete and submit this form to request your free copies.
Editor’s Note: For additional information about communicating risk, read On the Bookshelf.
A recent MMWR (11/1/13, 62(43);858-61) highlighted global vaccination coverage. While it may seem as though these data are unimportant in the scheme of things, some attention may be warranted. We have all heard and many of us have probably even said, “Continuing to get vaccines is important because vaccine-preventable diseases are only a plane ride away.” Indeed, the data in this report provide evidence for that statement:
Indeed, 83 percent of children having had three doses of diphtheria, tetanus, pertussis-containing vaccine may seem pretty good; however, this means almost 23 million children throughout the world did not receive three doses.
Importantly, the communication discusses the caveats associated with data collection methods and highlights the goals for global vaccination coverage. The report also briefly discusses geographic differences among regions.
Reports such as this may be useful to share with your patients, particularly those who are preparing to travel.
Editor’s note: David Rubin, MD, MSCE and Kathleen Noonan, JD, the co-directors of the PolicyLab at The Children's Hospital of Philadelphia presented Grand Rounds for CHOP staff in January 2014. PolicyLab is a center of emphasis at CHOP focused on health services and health policy research with a mission of “evidence to action.” This article is based on notes taken during the Grand Rounds presentation.
As we begin 2014, several critical components of the Affordable Care Act (ACA) will go into effect raising questions about which changes are taking place and how the landscape of healthcare will change over time. In 2010, when the ACA passed, approximately 50 million people in the United States were uninsured. Most of these people were adults; in fact, at the time of passage, about 90 percent of children had medical coverage, but only about 78 percent of adults did. Further, a large group of uninsured adults were between the ages of 18 and 35 years of age.
According to the Congressional Budget Office, the costs associated with the uninsured were about $43 billion in unreimbursed healthcare charges. In addition, the healthcare industry spent approximately $90 billion dollars in administrative costs associated with underwriting who was eligible for coverage. By 2010, healthcare costs represented about 16 percent of our gross domestic product (GDP) and were increasing.
A main goal of the ACA was to increase coverage thereby decreasing the costs associated with the uninsured, allowing for redirection of funds being spent by insurers and slowing the rate of increase to the GDP.
As written, the ACA would have allowed 32 of the 50 million uninsured persons to enter the insurance marketplace. This would have been accomplished by the implementation of individual mandates, abolition of pre-existing conditions policies, addition of employer penalties for non-coverage of employees and expansion of Medicaid. Two of these have been challenged legally – individual mandates and expansion of Medicaid:
The result of the difference between ACA as written and as implemented after the Supreme Court decision is unintended coverage gaps:
Like any new legislation, implementation of the ACA will not be without hurdles, and modifications to the law are likely. The ACA is, nonetheless, unprecedented in its intention to close the health insurance coverage gap in the United States. Further, the law makes it imperative that healthcare providers focus on providing high-quality, affordable care in a standardized, evidence-based environment. Finally, the law expands the importance of prevention and overall population health and requires providers to plan and provide care through this lens.
Dorit Rubenstein Reiss recently published a paper in the Cornell Journal of Law and Public Policy (Vol. 23, No. 3, 2014; UC Hastings Research Paper No. 61) titled, “Compensating the victims of failure to vaccinate: What are the options?” The central premise of this piece is that parents who choose not to vaccinate may be liable through a tort system when their choice compromises the health of others in the community.
Likening the dangers of infectious diseases to drunken driving and unshoveled sidewalks, Reiss suggests that families should similarly be compensated for the costs incurred from an illness transmitted by someone who was not vaccinated. With that backdrop, the reader is provided with background information highlighting the known risks of infectious diseases and the proven success and safety of vaccines.
The essence of the article is contained in the second section, which outlines the requirements needed to win a case of negligence, such as duty to act, lack of action, proof of harm and probable link between the inaction and the harm, and concludes with a discussion of the potential for compensation.
Two additional sections of the article offer a proposal for the text of such a law and additional concerns that might arise, such as religious beliefs and situations that might be used to argue against this approach.
Editor’s Note: We’d love to hear your thoughts on this concept. Do you agree or disagree with the approach? Do you think it would strengthen or weaken the vaccine program? Do you think it would make your job of giving vaccines easier or more difficult?
Please email us at email@example.com after you’ve considered the approach suggested by the author. Feedback may be shared with the author, but identifying information will be removed unless otherwise indicated by the author of the email.
Historically, the Institute of Medicine (IOM) has convened groups to review a variety of vaccine-related issues, including vaccine safety concerns. In each case a committee of experts was charged with offering “independent, objective, evidence-based advice” meant to inform the direction of policy and provide a viewpoint based on the compendium of existing information for the public and private sectors. Most recently, the IOM turned its attention to concerns about the safety of the childhood immunization schedule. The resulting report, “The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies,” was released on January 16, 2013.
The 14-member committee was charged with:
To compile the report, committee members participated in three information-gathering sessions and five committee meetings, completed an extensive literature review, commissioned a paper about study designs, and reviewed approximately 900 public comments.
The resulting approximately 200-page report provides background information about both the study and the immunization schedule (chapters 1 and 2), reviews existing systems for data collection and existing literature (chapters 3 and 5), discusses stakeholder concerns (chapter 4), and reviews methodological approach options as well as feasibility, ethical issues, and priorities as they relate to questions about the current schedule (chapter 6). The final chapter (chapter 7), a report summary and an abstract outline the conclusions of the committee.
Conclusions were based on three primary sources of information including the current scientific literature, online comments and public testimony. A subset of parents was found to be the stakeholder group with the most concerns about the safety of the immunization schedule. Their concerns focused on overloading the child’s immune system, lack of data in the literature, specifically regarding individual susceptibilities that may make a child more likely to experience negative outcomes, and communication of existing data in response to these fears. Outside influences were also identified, particularly in the online comments and the public testimony, suggesting that parental decisions are also affected by skepticism relating to the quality of research and untoward influence by pharmaceutical companies and governmental groups that oversee research.
Concerns related to effectively communicating vaccine safety among stakeholders were indicated by a larger subgroup that included not only parents, but also providers and public health officials. In addition, while the latter groups did not indicate concerns about the safety of the immunization schedule, providers did indicate a need for more information related to vaccine delivery and communication surrounding the schedule.
The committee determined the scientific literature to be lacking in three areas:
The committee felt that standardizing definitions related to these areas would improve the quality of future studies.
Four broad research questions relating to concerns about the safety of the immunization schedule were defined:
A variety of methodological approaches were reviewed for the appropriateness of answering these questions including randomized controlled trials, observational studies, secondary analysis of existing databases, and animal models. While randomized controlled trials were considered the gold standard, the report discussed reasons they were not an appropriate approach for the aforementioned questions. The Vaccine Safety Datalink (VSD) was described as one of the current best systems for gathering information via a secondary analysis, and enhancements were suggested to make this a more robust option.
After review of presentations, sources of data, the commissioned report and the literature, the committee suggested an approach in which concerns of stakeholders are identified and decisions to begin studies are then based upon the following:
The committee also commented on the oft-suggested “vaccinated versus unvaccinated” study recommending against such a study based on factors that included:
The conclusions of the report described a lack of evidence to support the safety concerns purported by stakeholders, but a realization that perceptions must also be addressed. In this light, the committee called for future studies to address the full scope of the schedule as well as the commencement of studies to better understand perceptions and how they are formed. Further, while concerns of stakeholders should be acknowledged and serve as a potential source for scientific questions, existing evidence and biological plausibility should inform the decision to begin scientific studies. The committee further concluded that evidence does not suggest that the current immunization schedule is unsafe.
The IOM report can serve as evidence that parents’ concerns related to the immunization schedule are being addressed, and that when an extensive review was completed, the conclusion was that the current schedule is safe. Further, while the committee pointed to the fact that evidence looking at the elements of the schedule is not as plentiful as we may wish, the reality is that this indicates even less knowledge about the effects of altering the schedule.
The framework suggested by the committee can also provide a basis for discussions about how the scientific community addresses parental concerns about vaccine safety. That is to say, if a concern is brought about, the existing evidence and biological plausibility should be assessed and if appropriate, sound scientific studies should follow.
Finally, the discussion of the “vaccinated versus unvaccinated” study provided in this report should provide support when discussing this notion with parents who deem such a study plausible.
In January 2012, researchers from the Centers for Disease Control and Prevention (CDC) published a study evaluating the relationship between receipt of human papillomavirus (HPV) vaccine and sexual activity (Liddon NC, Leichliter JS, Markowitz, LE. "Human Papillomavirus Vaccine and Sexual Behavior Among Adolescent and Young Women," Am J Prev Med. 2012 Jan;42(1):44-5.
To put this study in perspective, following licensure of HPV vaccine in 2006, several concerns were raised. The media carried stories claiming that HPV vaccine caused chronic fatigue syndrome as well as blood clots with consequent strokes and heart attacks. However, post-licensure studies have exonerated HPV vaccine as a cause of any of these severe adverse reactions. Another question that was raised was whether receipt of HPV vaccine would cause adolescents and young women to increase sexual activity. To answer this question, CDC researchers surveyed 1,243 women between 15 and 24 years of age. Not surprisingly, they found "no association between HPV vaccination and risky sexual behavior."
In truth, the concern about increased sexual activity following vaccination never made much sense. First, no vaccine is 100 percent effective. Second, the HPV vaccine doesn’t prevent all types of HPV. Third, the HPV vaccine doesn’t prevent other sexually transmitted diseases, such as Chlamydia, herpes, gonorrhea, or syphilis. Still, the concern persisted.
The HPV vaccine has been recommended for routine use in 11- to 13-year-old girls for about five years. Unfortunately, uptake has been poor. Only about one-third of those for whom the vaccine is recommended get it. With this latest study, clinicians can offer further reassurance about this much-needed vaccine.
Charlotte A. Moser, Assistant Director, and Paul A. Offit, Director, Vaccine Education Center at The Children’s Hospital of Philadelphia
We often get questions about the use of cell lines from aborted fetuses in vaccines. In this article, we will address the issues and provide information about the resources available to share with parents.
The only vaccines that are made in human cells are:
The viruses were grown in cells obtained from elective terminations of pregnancies which occurred in the early 1960s. Since that time, the cell lines have been maintained in the laboratory. No further sources of fetal cells are necessary.
The questions about use of fetal tissues generally fall into one of three categories:
Christian Science does not believe in using any vaccines; however, when outbreaks have occurred in communities with Christian Scientists, some have agreed to be vaccinated. Their concerns are not related to the use of fetal tissue, but rather to the use of modern medical interventions.
Given the position of the Catholic Church on abortion, some concerns have revolved around the use of cell lines from aborted fetuses. However, reviews by both the Vatican’s Pontifical Academy for Life and the National Catholic Bioethics Center have determined that vaccines grown in these cell lines do not defy the religion’s doctrine:
The concern about DNA is that it can cause changes in the vaccine recipient’s DNA. This is unlikely for two reasons:
The concern about contamination of vaccines with human proteins seems to be relatively new. Because viruses are purified during vaccine production, it is unlikely that proteins from the human cells used to grow them would survive intact or in quantities sufficient to cause harm.
Paul A. Offit, Director, Vaccine Education Center at The Children’s Hospital of Philadelphia , Dec. 2010
Many of today’s consumers crave organic, all-natural, or free-range products. Willing to pay more and drive further to get these products, they believe they are keeping their families healthy. Some of these same people forego vaccines claiming that they are not natural.
According to the Merriam-Webster dictionary, natural means “being in accordance with or determined by nature.” Viruses and bacteria are natural; diseases caused by them are natural.
Because vaccines are made using parts of the viruses and bacteria that cause disease, the ingredient that is the active component of the vaccine that induces immunity is natural. However, critics point to other ingredients in vaccines or the route of administration as being unnatural.
“Green our vaccines” is a common mantra of those who believe that the ingredients in vaccines are harmful—and unnatural. However, vaccine vials contain well-characterized ingredients in known quantities.
Vaccines contain three types of ingredients other than the virus or bacterium of interest:
Some wonder about the amount of different additives in vaccines or the cumulative effect from several vaccines. This is a valid concern; in fact, the Swiss chemist Paracelsus coined the phrase, “the dose makes the poison.” However, the good news is that the quantities of ingredients in vaccines are determined to be the lowest amounts necessary and when vaccines are given together, they must be studied together. So the quantities of ingredients in vaccines have been determined to be safe.
Viruses and bacteria typically enter the body through our noses or mouths. With the exceptions of the oral rotavirus and intranasal influenza vaccines, most vaccines are given as a shot. While at first glance the injections appear to be different or “unnatural,” they are not when you consider what happens in each case.
When viruses or bacteria enter the body through the nose or mouth, they are detected by cells of the immune system which line the surfaces of these areas of entry. These “foreign invaders” are ingested by immune cells and processed in lymph nodes in the region of the infection. The immune response has two aspects, local and systemic. The immune cells are produced near the site of the infection, but they are dispersed throughout the body via the bloodstream. After the infection has been resolved, a small number of immune memory cells continue circulating to monitor for future infections. Because these memory responses are specific, subsequent exposures to the same virus or bacterium generate a quicker and stronger immune response that completely prevents or significantly lessens the effects and duration of illness.
Vaccines are no different. Although common belief is that vaccines are injected directly into the bloodstream, they are actually administered into muscle or the layer of skin below the dermis where immune cells are produced and circulate as occurs following natural infection.
The active ingredients in vaccines are the parts of the viruses or bacteria to which we make an immune response. The additional ingredients are determined to be the lowest plausible quantities and are studied as part of the vaccine during safety testing. The immune system responds in the same way it would to the virus or bacteria following unexpected introduction. So while not natural in that they are given at specified times, vaccines offer a controlled way to protect ourselves from the viruses or bacteria that cause illness.
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