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Parental Concerns of Hypersensitivity Reactions to Gelatin, Antibiotics, and Latex in Vaccines

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Parental Concerns of Hypersensitivity Reactions to Gelatin, Antibiotics, and Latex in Vaccines Parental concerns of hypersensitivity reactions to gelatin, antibiotics, and latex in vaccines Julie Sterbank, DO Jonathan M. Horbal, DO Erin C. Toller-Artis, DO Robert Hostoffer, DO accines licensed by the US Food and VDrug Administration (FDA) have been protecting children in the United States for more than 50 years and represent one of the most important health advances of the 20th century. Vaccines are credited with saving more lives and preventing more illnesses than any other medical treatment. June 2012 Pediatric and adolescent vaccines AOA Health Watch 23 he risks of devastating childhood tetanus, diphtheria, and acellular pertussis eating gelatin-containing food products may Tdiseases, such as diphtheria, polio - (Tdap) vaccines. 3 (Most Tdap vaccine also develop serious anaphylactic reactions myelitis, and tetanus, from failure to formulations are now manufactured without to gelatin-containing vaccines. 4,5 vaccinate far outweigh the risks associated gelatin.) It is also a frequent ingredient in In addition to being aware of gelatin in with adverse reactions from vaccines. 1 capsules for oral administration, as the MMR vaccine and the few remaining More than 1 billion doses of vaccines are evidenced by the list of 360 gelatin-contain - gelatin-containing formulations of Tdap administered to infants, children, and adults ing products in the 1998 Physician’s Desk vaccine, clinicians should also be cautious each year in the United States. 2 The FDA Reference (published by Thomson regarding varicella and influenza vaccines. mandates that vaccines be tested in both Corporation). There have been confirmed cases of animal studies and human clinical trials The greatest risk for anaphylaxis from urticaria, with positive results to intradermal prior to licensure. Included in this testing gelatin-containing products would be from testing for gelatin, associated with varicella process is a review of all active ingredients, injection or intravenous administration to a vaccine. 6,7 There have also been cases of as well as additives, in the vaccines in an sensitized individual. 3 Although there has anaphylaxis, with positive results to IgE effort to ensure both safety and effective - been speculation that vaccine schedules immunoblotting, associated with gelatin- ness. After a vaccine is approved, its effec - with administration of an initial gelatin-con - containing influenza vaccine. 8 tiveness and safety are subsequently moni - taining vaccine may sensitize individuals for In cases for which gelatin-free vaccines tored by both the FDA and the Centers for subsequent gelatin-containing vaccines, it is are not available and a gelatin allergy is Disease Control and Prevention (CDC). 2 not entirely clear how susceptible individu - suspected, it is appropriate to refer patients Vaccines have become a frequent topic als become sensitized or which individuals to an allergy-immunology specialist for of conversation between primary care may be predisposed to serious IgE- further evaluation before initiating physicians and their patients—especially mediated reactions. 3 Case reports suggest immunization. 9-12 Keep in mind that parents who express concerns regarding the that individuals who show sensitivity to patients who eat gelatin products are not possibility of their children experiencing hypersensitivity reactions to vaccines. Patients’ safety concerns should be thoroughly addressed before administration of any medication, including vaccines. In the present article, we review the published evidence about hypersensitivity reactions associated with gelatin, antibiotics, and latex in vaccines. Gelatin In the early 1990s, several case reports implicating gelatin in live vaccines to hyper - sensitivity reactions surfaced, particularly in medical literature in Japan. Published in 1993, a single case report in the United States of a documented hypersensitivity reaction to the measles, mumps, and rubella (MMR) vaccine that took place in 1991— with confirmed immunoglobulin E (IgE) antibodies to gelatin—led to further investi - gation into gelatin-mediated vaccine reactions. 3,4 Before that report, egg protein or antibiotics were the suspected culprits in these vaccine reactions and, often in an effort to avoid hypersensitivity events, egg- allergic individuals were appropriately not offered vaccination. 4 Gelatin is a partially hydrolyzed protein derived from animal sources (eg, bovine and porcine hide and bones) that is added to vaccines as a heat stabilizer. It is most commonly added to live vaccines, including the MMR vaccine and—until recently—the 24 AOA Health Watch Pediatric and adolescent vaccines June 2012 tivity to such vaccines or to foods containing gelatin products. Aminoglycoside antibiotics Aminoglycoside antibiotics are used to treat patients who have infections caused by aerobic, gram-negative bacteria. However, because of toxicities effects known to be associated with aminoglycoside antibiotics, their systemic use has been limited to empiric treatment of patients with severe likely to have a gelatin allergy. In addition, patients and by many parents of young infections. These antibiotics are often the CDC provides an online publication patients. These concerns may be partly discontinued once culture results establish a titled Guide to Vaccine Contraindications related to living in a society with heightened narrower spectrum, better-tolerated and Precautions for clinician use awareness and easy accessibility to informa - treatment option. 14 The everyday use of (www.cdc.gov/vaccines/recs/vac- tion regarding other life-threatening hyper - aminoglycosides in clinical practice has admin/downloads/contraindications-guide- sensitivity reactions, such as those shifted primarily to topical preparations, 508.pdf). 13 Included in this guide is an associated with food or stinging insects. 5,9 such as neomycin sulfate ointment, gentam - outline of the Vaccine Adverse Event However, the actual prevalence of icin otic drops, and gentamicin ophthalmic Reporting System (VAERS), a national hypersensitivity to gelatin-containing solution. Neomycin is also used as a preser - vaccine safety program administered by the vaccines appears to be small, and the vative in vaccines. FDA and CDC. Health care professionals, benefit of vaccination against common dev - In the early 20th century, the history of as well as vaccine manufacturers, are astating childhood diseases is great. Thus, vaccine administration in children was required by the National Childhood Vaccine vaccination with gelatin-containing vaccines tarnished by reports of severe and some - Injury Act of 1986 to report specific adverse should be encouraged, except in cases in times fatal bacterial infections resulting events, including hypersensitivity reactions, which patients have a history of hypersensi - from contaminated vaccines. 15 As a result, occurring after the administration of routinely recommended vaccines. 13 The CDC guide also includes Vaccine Figure. Vaccines That Contain Neomycin Sulfate Information Statements (VISs) for Vaccine Proprietary Neomycin commonly used vaccines. These statements Targeted Illness Name (Manufacturer) Amount* should be given to patients and their care - Havrix (GlaxoSmithKline 40 ng/mL givers. Vaccine Information Statements in Hepatitis A р Biologicals, Rixensart, Belgium) Spanish and other languages can be found on the Immunization Action Coalition Influenza Fluvirin (Novartis Vaccines р2.5 ug and Diagnostics Ltd, Liverpool, England) website at www.immunize.org/vis/. According to the Guide to Vaccine Measles, mumps, M-M-R II: Attenuvax, Mumpsvax, ~25 ug Contraindications and Precautions, the rubella Meruvax II, M-R-Vax II, and Biavax II (Merck & Co Inc, Whitehouse Station, NJ) following vaccines should not be administered to individuals with a known Pertussis and Kinrix (GlaxoSmithKline Biologicals, р0.05 ng hypersensitivity to gelatin: MMR, varicella, poliomyelitis Rixensart, Belgium) and yellow fever. 13 These contraindications Poliomyelitis IPOL (Sanofi Pasteur SA, Lyon, France) Ͻ5 ng † are specifically stated on the VISs for those Poliomyelitis Pediarix (GlaxoSmithKline Biologicals, р0.05 ng vaccines. In addition to being given the Rixensart, Belgium) appropriate VISs, patients or their Rabies Imovax (Sanofi Pasteur SA, Ͻ150 ug caregivers should be questioned about Lyon, France) previous reactions to any vaccines or Rabies RabAvert (Novartis Vaccines and р150 ug vaccine components, as well as about any Diagnostics, Marburg, Germany) food hypersensitivities. Such questions will Varivax (Merck & Co Inc, Trace amounts allow clinicians to proactively identify those Varicella Whitehouse Station, NJ) individuals who may be predisposed to hypersensitivity reactions. * Neomycin amount is per dose unless otherwise noted. Given the large number of routinely † IPOL may also contain 200 ng streptomycin. administered vaccines, concerns about possible hypersensitivity reactions to Source: Package inserts from manufacturers, as accessed on John Hopkins Bloomberg vaccines are commonly raised by many School for Public Health. June 2012 Pediatric and adolescent vaccines AOA Health Watch 25 preservatives began to be added to vaccines. sides may also have adverse reactions to cases reviewed of type I hypersensitivity Neomycin is one of several antibiotics used vaccines containing neomycin. This associa - reactions secondary to use of topical amino - in vaccine manufacturing to prevent tion has raised parental concern about the glycosides displayed stereotypical
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