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Alternate vaccine schedules are not safer and should be obsolete


Since the days of Edward Jenner, the father of smallpox vaccine, there have been parents who have been vaccine hesitant, and at times vaccine refusers. After Benjamin Franklin’s son died of smallpox, he lamented the fact that he had prohibited his son from getting the smallpox vaccine due to his concerns over safety.


 DR BRADY is physician-in-chief, Nationwide Children’s Hospital, and professor of pediatrics, The Ohio State University, Columbus.


Since the days of Edward Jenner, the father of smallpox vaccine, there have been parents who have been vaccine hesitant, and at times vaccine refusers. After Benjamin Franklin’s son died of smallpox, he lamented the fact that he had prohibited his son from getting the smallpox vaccine due to his concerns over safety.

Vaccines are no different than any other medical therapy. It is essential that patients or their parents make an informed decision whether to immunize. Fortunately, evidence supports the efficacy and safety of the vaccines currently recommended by the Advisory Committee on Immunization Practices (ACIP)1 and the American Academy of Pediatrics (AAP).2 Immunizations have been noted to be 1 of the 10 great public health achievements in the 20th century.3 But still there are doubts.

The Institute of Medicine (IOM) has been very good at reviewing evidence and providing reports that have markedly enhanced our understanding of how to provide more effective and safer health care. The IOM is an independent, nonprofit organization that works outside the government to provide unbiased and authoritative advice to decision makers and the public.4 In the past, the IOM has reviewed the safety of individual vaccines.5 The 2012 IOM report has clearly delineated adverse events that are causally associated with vaccines. More importantly, IOM has reviewed scientific evidence to identify those adverse events that are not casually related to vaccines, eg, autism and the measles vaccine.

However, as the safety of individual vaccines became more evident, vaccine detractors started to target the vaccine schedule. As the number of vaccines increased over the past 2 decades, concern was raised that the number of vaccines given to children was unsafe, possibly overwhelming the ability of the child’s immune system to manage such an antigen exposure. Despite a lack of biologic plausibility and ample preapproval studies refuting these concerns, vaccine-hesitant families were persuaded that “alternate vaccine schedules” that spaced the vaccines further apart would be better for their children.

IOM took on the task of reviewing the evidence concerning the currently approved vaccine schedule. Its report supporting the safety of the current vaccine schedule was recently released.6 More importantly, IOM believes that it would not be appropriate to conduct studies of alternate schedules to the approved schedule if the alternate schedule delayed any of the vaccines and that any delay in vaccines would increase the period of risk for vaccine-preventable diseases. This increased risk for vaccine-preventable diseases would make these alternate schedules less safe (not safer) than the approved schedule.

The IOM report states that continued evaluation of vaccine safety is necessary to monitor for rare or unanticipated adverse events. IOM believes that the currently available surveillance systems such as the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), and postlicensure studies conducted by vaccine manufacturers have been very valuable in monitoring vaccine adverse events and providing timely information to inform vaccine policy.

Parents choose alternate vaccine schedules because they have concerns about vaccine safety and the increasing number of vaccines that their children receive. The ACIP/AAP recommended immunization schedules were developed following significant research studies assessing their effectiveness and safety. None of the alternate schedules has been evaluated in this manner. Individuals who advise families to utilize alternate schedules capitalize on families’ misperceptions and fears; however, their endorsements fall short in evidence.

The IOM report provides parents with 2 important pieces of information to inform their decision making: (1) Available evidence supports that the current vaccine schedule is safe and (2) any vaccine schedule that delays vaccines is less safe than the approved schedule because it places these children at risk of acquiring vaccine-preventable disease for a longer period of time.

Are alternate vaccine schedules obsolete? With this new report from IOM, they certainly should be.



1. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years-United States, 2013. MMWR Morb Mortal Wkly Rep. 2013;62(Supp 1):2-8.

2. Committee on Infectious Diseases. Recommended childhood and adolescent immunization schedule-United States, 2013. Pediatrics. 2013;131(2):397-398.

3. Centers for Disease Control and Prevention (CDC). Ten great public health achievements in the 20th century. CDC Web site. www.cdc.gov/about/history/tengpha.htm. Last updated March 11, 2013. Accessed May 8, 2013.

4. Institute of Medicine (IOM) Web site. www.iom.edu. Accessed May 8, 2013.

5. Institute of Medicine (IOM). Adverse effects of vaccines: evidence and causality. Washington, DC: National Academies Press; 2012. www.iom.edu/vaccineadverseeffects. Accessed May 8, 2013.

6. Institute of Medicine (IOM). The childhood immunization schedule and safety: stakeholder concerns, scientific evidence, and future studies. Washington, DC: National Academies Press; 2013. www.iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety.aspx. Accessed May 8, 2013.


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