News and Views About Vaccine
- Travel notices May 2013
- Measles and congenital rubella syndrome reports in MMWR April 2013
- Healthcare, science and the sequestration March 2013
- IOM reviews safety of childhood vaccine schedule Feb. 2013
- Thimerosal Update: Why It’s in the News . . . Again Jan. 2013
Travel notices
If you have watched the news lately, you have probably heard about disease outbreaks in other parts of the world. The United Kingdom (UK) continues to grapple with measles outbreaks and the latest strain of influenza, H7N9, sickening people in China continues to worry public health officials. These examples are making international headlines; however, the Centers for Disease Control and Prevention (CDC) has recently updated other travel notices as well. Here’s what you should know:
Measles in the UK
The UK continues efforts to reach the large number of unvaccinated adolescents and teens in an effort to protect them and curb the current spread of measles in that country. While immunization rates in younger children are at sufficient levels, gaps in the immunization coverage of adolescents and young teens, resulting from unfounded concerns about the safety of the MMR vaccine in the late 1990s and early 2000s, have fueled the spread of measles. While the CDC has not posted any travel updates related to this outbreak, several news outlets have carried stories, particularly as that country publicly debates whether mandates should be employed.
Read more:
- Vaccine-related news on the VEC website»
- Measles Outbreak: Number of cases rises 121 in a week
- Dr. Offit speaks on British newscast regarding mandates
Even as this outbreak continues, the Measles & Rubella Initiative Annual Report was released and cited progress in the strategic priorities related to the global efforts to immunize every child against measles and rubella. Containing photos by Sophie Blackwell, the report highlights successes and outlines necessary efforts that must continue, pointing out that approximately 430 deaths occur each day as a result of measles infections and more than 100,000 children are still born each year affected by congenital rubella syndrome. Read more about the Measles and Rubella Initiative»
H7N9 influenza in China
Public health officials continue to monitor the cases of influenza caused by H7N9 in China. To date, travel restrictions have not been made; however, travelers are recommended to practice good hand hygiene and food safety practices as well as avoid contact with animals.
Read more about H7N9 influenza»
The Vaccine Education Center has posted information on the Vaccine-related news section of its website.
Other recent travel notices
Cholera – Updates regarding cholera outbreaks in Haiti and the Dominican Republic were posted in mid-April. In addition to information about how travelers can protect themselves, the Haiti notice also includes information for healthcare providers regarding travelers arriving to this country from Haiti.
Malaria – Information for travelers to Greece has been updated due to the emergence of malaria in areas not previously reporting cases. Information about decreasing risk for travelers and clinician information for suspected infections is provided in the update.
Novel coronavirus - A novel strain of coronavirus has been identified as the cause of respiratory illness in Saudi Arabia, Qatar, Jordan and the UK. As of May, 27 people were infected, 16 of whom subsequently died. Limited evidence of person-to-person transmission has been suggested by a cluster of cases in a family in the UK. Travelers are recommended to practice precautions such as frequent hand washing, avoiding touching eyes, nose and mouth, covering coughs and sneezes and avoiding close contact with people who are ill. Guidance for healthcare providers is also included in the travel notice.
Polio – Travelers to several countries are recommended to be up to date on the polio vaccine. The list includes common travel destinations such as India, China and several African nations.
Get travel updates regularly
Interested individuals can get travel health notices from the CDC via email or can regularly view them on the CDC’s travel website.
Measles and congenital rubella syndrome reports in MMWR
The March 29, 2013 issue of Morbidity and Mortality Weekly Report (MMWR) contained articles related to cases of vaccine-preventable diseases in the United States:
- Measles outbreaks – Two measles outbreaks occurred in Utah during 2011 and both were related to importations of the disease following international travel. A total of 13 cases were confirmed. In addition, approximately 13,000 contacts had to be notified, 8,700 medical records of exposed persons reviewed, 253 laboratory tests conducted, 484 vaccines administered and 28 prophylactic treatments given.
An accompanying editorial note reinforced the importance of vaccination and the necessary vigilance on the front lines when considering potential diagnoses of febrile rash illnesses. - Cases of congenital rubella syndrome (CRS) – Although rubella has been eliminated from the U.S., the disease continues to occur elsewhere throughout the world. In 2012, three babies were born with CRS following maternal infection during pregnancy; in all three cases, the mom had traveled to the U.S. from other countries in which rubella vaccination is not routine. One of the three babies died.
The accompanying editorial note pointed out that of the six cases of CRS in the U.S. since 2004, five were related to travelers; therefore, healthcare providers should consider the potential for CRS in infants born with compatible congenital defects if the mother traveled to an area where rubella infections were circulating during her pregnancy. Any suspected case of CRS is required to be reported to local health department officials.
Despite the fact that many vaccine-preventable diseases (VPD) are no longer common in the U.S., considering the possibility that a patient with symptoms suggestive of a VPD may be infected is of the utmost importance. In addition, because many of these diseases can easily spread in communities, handling of suspected cases should include conversations with local public health officials.
Read the MMWR reports discussed in this story»
Read a story from a public health official following a measles outbreak in her community»
Healthcare, science and the sequestration
The looming deadline for the sequestration has come and gone and it may seem as though not much has changed. In fact, in the short term, it is likely that not much will change, but without any congressional votes to undo the required budget cuts, change will come. The sequestration means that almost all federally funded agencies and programs will need to implement spending cuts to the tune of 5.3 to 7.9 percent. While some programs are shielded from these cuts, most are not. Agencies such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) will be required to adhere to these measures. Because the cuts are discretionary within programs, we cannot know for sure what each agency will decide to cut in order to meet the requirements. However, we have gotten a chance to see what they could mean with the White House’s state-by-state analysis.
What does the sequester mean for healthcare providers?
Public health stands to take a severe hit with these cuts because for the most part, public health agencies are already operating on tight budgets. While health departments operate at the state level, most of them receive a significant amount of federal funding. For example federal funds from the 317 program often help provide immunizations and program support in areas that Vaccines for Children (VFC) programs do not cover; both programs are expected to endure cuts. Other areas such as disease surveillance, emergency preparedness and food safety are also supported by federal funds, so while cuts hopefully will not end these programs, they may alter the number of staff who can attend to them. In terms of community health, these types of cuts — lower vaccine coverage, less surveillance and decreased emergency preparedness — could set the stage for disease outbreaks and widespread transmission. For healthcare providers, it means less of a safety net in the community and a need for greater vigilance when it comes to diagnosis and treatment of infectious diseases.
To review areas of public health expected to be affected, see the FY2014 Programmatic Funding Priorities document prepared by the National Association of County & City Health Officials (NACCHO).
Additional information can be found on the website of the Association of State and Territorial Health Officials (ASTHO).
Read Shot of Prevention’s blog “Sequestration and its impact on public health.”
What does the sequester mean for your patients?
Families that rely on programs such as Head Start, military tuition assistance, nutrition assistance, and unemployment benefits may lose access to these and other programs. Jobs are expected to be lost in areas such as the military, education and law enforcement. In some cases, these losses will make already fragile living situations virtually unmanageable. A logical assumption is that these developments are likely to lead to stress-induced illnesses and mental health-related conditions in a setting in which support programs are less available.
Read more about projected cuts related to the following:
- Head Start
- Education (from the National Education Association)
- Effects on the unemployed
- Nutrition assistance
What does the sequester mean for science?
Federally funded agencies including the NIH, National Science Foundation (NSF), National Aeronautics and Space Administration (NASA), National Oceanic and Atmospheric Agency (NOAA), Environmental Protection Agency (EPA) and U.S. Geological Survey will all experience cuts. These agencies will be forced to trim in areas of grants, programs, staff and facilities. Unfortunately, the effects are not likely to be seen before the damage to scientific progress is irreversible. Grants often fund research at institutions such as universities, hospitals and other research centers, so ripple effects are expected.
To hear more about the expected effects on the sciences, listen to Science Friday on NPR, aired on March 1, 2013.
To stay abreast of budget developments related to the sciences, visit the American Academy for the Advancement of Science (AAAS) budget page.
IOM reviews safety of childhood vaccine schedule
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 committee and its charge
The 14-member committee was charged with:
- Reviewing existing literature and stakeholder’s concerns related to the safety of the recommended immunization schedule
- Identifying appropriate methodological approaches for determining the safety of said schedule
- Issuing a summary report
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.
Stakeholder concerns
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.
Existing literature related to the schedule
The committee determined the scientific literature to be lacking in three areas:
- Elements of the immunization schedule, such as number, frequency, timing, order and age at receipt
- Health outcomes related to vaccine safety (i.e., the “completeness” of the list of conditions studied)
- Outcomes specific to particular subpopulations
The committee felt that standardizing definitions related to these areas would improve the quality of future studies.
Methodological approaches
Four broad research questions relating to concerns about the safety of the immunization schedule were defined:
- “How do child health outcomes compare between those who receive no vaccinations and those who receive the full currently recommended immunization schedule?”
- “How do child health outcomes compare between (a) those who receive the full currently recommended immunization schedule and (b) those who omit specific vaccines?”
- “For children who receive the currently recommended immunization schedule, do short- or long-term health outcomes differ for those who receive fewer immunizations per visit (e.g., when immunizations are spread out over multiple occasions)?”
- “Do potentially susceptible subpopulations (for example, children from families with a history of allergies or autoimmune diseases) who may experience adverse health consequences in association with immunization with the currently recommended immunization schedule exist?”
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:
- Epidemiological evidence for an association of the concern with elements of the immunization schedule
- Biological plausibility of the concern
The committee also commented on the oft-suggested “vaccinated versus unvaccinated” study recommending against such a study based on factors that included:
- The large study size needed to aptly power the findings of such rare events would be difficult to obtain.
- Any study based on naturally occurring unimmunized populations (e.g., religious groups) would be fraught with confounding variables.
- Randomly assigning children to be members of the “unimmunized” group would be unethical.
Conclusions of the committee
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.
Potential for applications in practice
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.
More information
- Access the report in its entirety (free)
- Dr. Offit’s Medscape Video about the IOM report
- Recommended Immunization Schedule: What you should know
- Additional information about the immunization schedule
Thimerosal Update: Why It’s in the News . . . Again
If you’ve heard renewed interest related to thimerosal in vaccines, it is likely because of the United Nations Environment Program’s (UNEP) recent investigation of exposure to mercury. Much human exposure is through the consumption of the more harmful form of mercury, known as methylmercury, commonly found in fish and other marine organisms. Despite vocal activists who believe that thimerosal, the more efficiently degraded ethylmercury found in some vaccines, is harmful the UNEP ruled that the mercury in vaccines was exempt from the proposed ban on mercury.
Although thimerosal at preservative levels is not contained in childhood vaccines used in the United States, with the exception of multi-dose vials of some influenza vaccines, many other countries continue to use vaccines that contain thimerosal and a ban would have been detrimental to the immunization programs and the children they aim to protect. The important points include:
- Thimerosal contained in vaccines has been studied as it relates to mercury toxicity or the development of autism or neurologic disorders and no evidence of a causal association was found. For additional information about the existing science, review the Vaccine Education Center’s informational sheet, “Thimerosal: What you should know.”
- The original call for removal of thimerosal (in 1999) was described as an act of caution and was made by the American Academy of Pediatrics (AAP) and the United States Public Health Service. The reasons for this decision were recently described in an editorial in Pediatrics (2013;131:152-153) by Louis Z. Cooper and Samuel L. Katz, both of whom were involved in the decision-making at that time. Read “Ban on Thimerosal in Draft Treaty on Mercury: Why the AAP’s Position in 2012 Is So Important.”
- As a result of the overwhelming amount of evidence that thimerosal does not cause harm in the quantities used in vaccines and the potential crippling effect of a ban on its use in vaccine programs throughout the world, the AAP no longer supports the removal of thimerosal from all vaccines.
- Because thimerosal in vaccines allows for multi-dose vials that are less expensive and more easily transported and stored, especially to remote places around the globe, banning thimerosal in vaccines would be detrimental to many vaccine programs. To read more about the technical and ethical aspects of this decision, check out two additional editorials also published in Pediatrics (2013; 131):
- Global Vaccination Recommendations and Thimerosal by Walter A. Orenstein, Jerome A Paulson, Michael T. Brady, Louis Z. Cooper and Katherine Seib
- Global Justice and the Proposed Ban on Thimerosal-Containing Vaccines by Katherine King, Megan Paterson and Shane K. Green
- Additional information from the UNEP:
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