Practice Alert
Immunization update: The latest ACIP recommendations
A third meningococcal vaccine broadens coverage for children at high risk of infection. The 13-valent pneumococcal vaccine is now available for...
John W. Epling, MD, MSEd
Margot L. Savoy, MD, MPH
Jonathan L. Temte, MD, PhD
Bellinda K. Schoof, MHA, CPHQ
Douglas Campos-Outcalt, MD, MPA
State University of New York, Upstate Medical University, Syracuse
(Dr. Epling); Christiana Care Health System, Wilmington, Del
(Dr. Savoy); University
of Wisconsin, Madison (Dr. Temte); American Academy of Family Physicians, Leawood, Kan (Ms. Schoof); Mercy Care Plan, Phoenix, Ariz (Dr. Campos-Outcalt)
eplingj@upstate.edu
The authors produced this work as part of the American Academy of Family Physicians Vaccine Science Fellowship, which was funded by an unrestricted educational grant from Merck, Inc.
Once licensure has been granted, the focus of safety then shifts to the “open system” of usual clinical practice. Vaccine recipients are unselected members of the general population and may have underlying medical conditions, and sometimes—such as with school entry mandates—are less volitional. In this sphere, the responsible parties for safety include the government, manufacturers, and health care systems.
Three ongoing systems function to assure vaccine safety: the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment (CISA) Network.23,24
VAERS serves as an early warning system for coincidental safety signals and can generate hypotheses for further investigation.24,25 It is characterized by high sensitivity but low specificity as it relies on voluntary reporting from health care personnel, parents, and others. This system was instrumental in identifying the initial cases of intussusception attributable to the rotavirus vaccine, RotaShield.26
The VSD is a network of 10 large, geographically diverse and linked health maintenance organizations that cover about 3% of the US population. Within this “real time” network, vaccination (exposure) can be compared with outpatient, emergency department, hospital, and laboratory data (health outcomes), while accounting for demographic variables (confounders).27,28 VSD studies linked the measles, mumps, rubella, and varicella vaccine to febrile seizures29 and showed no relationship between cumulative vaccine antigen exposure and autism.30
The CISA was established in 2001 to investigate the pathophysiologic mechanisms and biologic risks of adverse effects following immunization and to provide evidence-based vaccine safety assessments.
Based on all available evidence, routinely recommended vaccines have attained a very high level of safety. As with other preventive services, immunizations are generally provided to healthy individuals to maintain good health; thus, a low tolerance for significant adverse events exists. Well over 100 million doses of vaccines are given each year, yet the VAERS receives, on average, only 28,000 adverse event reports per year.
These reports comprise mild, moderate, and severe reactions to vaccines, but also adverse events that may not be related in any way other than chronologically to the vaccine’s administration. Despite this relatively low number of real safety concerns, it is still more likely that patients will know someone who has had a vaccine-related adverse event than someone who has had some of the diseases the vaccines prevent.31
Final thoughts
Current anti-vaccine sentiments appear to arise from varying perspectives.To appreciate the benefit of vaccine acceptance, we need only look to Europe, where high levels of vaccine refusal has led to a resurgence of vaccine-preventable diseases such as measles. Some are held by parents of children who have allegedly suffered a severe vaccine related adverse event; others by those opposed to government-mandated school immunization requirements; and some from those who have a dislike of vaccine manufacturers. These sentiments persist in part because of a low level of vaccine preventable diseases: When such illnesses are no longer deemed a threat, those who have concerns about vaccine safety, no matter how invalid, believe their concerns should trump all other considerations.
To appreciate the true benefit of vaccine acceptance, we need only look to Europe, where the anti-vaccine movement has led to high levels of vaccine refusal and a resurgence of vaccine-preventable diseases, such as measles, with their associated morbidity and mortality.32 In advocating for continued acceptance and widespread use of vaccines, family physicians can convey to patients and parents the magnitude of associated health benefits while confidently attesting to the effectiveness and safety of vaccines.
CORRESPONDENCE
John Epling, MD, MSEd, Department of Family Medicine, SUNY Upstate Medical University, 475 Irving Ave, Suite 200, Syracuse, NY 13210; eplingj@upstate.edu
A third meningococcal vaccine broadens coverage for children at high risk of infection. The 13-valent pneumococcal vaccine is now available for...