Vaccination of persons allergic to latex: a review of safety data in the Vaccine Adverse Event Reporting System (VAERS)

doi:10.1016/j.vaccine.2004.06.042

Vaccine

Volume 23, Issue 5, 16 December 2004, Pages 664-667

https://doi.org/10.1016/j.vaccine.2004.06.042 Get rights and content

Abstract

Vaccine products currently licensed in the US and other countries are marketed in vials and syringes that may contain natural latex allergens. Little scientific information exists regarding the safety of vaccination of latex-allergic individuals. A review of data within the Vaccine Adverse Event Reporting System (VAERS), a large registry of reported possible vaccine adverse reactions was conducted. A search of the database, which contains >160,000 vaccine adverse event reports, revealed only 28 cases of possible immediate-type hypersensitivity reactions in vaccine recipients with a history of allergy to latex. Given the large number of immunizations administered every year in the US, the reported risk of allergic reactions possibly due to latex contamination of vaccines appears to be very small.

Introduction

Natural latex is a milky fluid obtained from the H. brasiliensis (rubber tree). It contains cis-1,4-polyisoprene in a colloidal suspension, as well as some proteins. Latex is used to manufacture a large number of consumer and medical products. Latex can be processed in two different ways. One process yields dipped products such as medical gloves. These products are referred to as natural rubber latex (NRL). The other process yields molded products such as medication vial stoppers and syringe plungers (including the ones used for vaccines). These products are referred to as dry natural rubber (DNR). It is more difficult to extract latex protein allergens from DNR products that from NRL products [1]. Nonetheless, it is theoretically possible that latex allergen contamination of vaccine solutions that contact DNR vial stoppers or syringe plungers could occur and cause allergic reactions when the vaccines are administered to latex-allergic individuals. It should also be noted that many vial stoppers and syringe plungers are made from synthetic rubber. Such products contain no natural latex and pose no risk to latex-allergic individuals. The National Immunization Program of the United States Centers for Disease Control and Prevention occasionally receives requests for guidance on immunization of persons allergic to latex. Package inserts for many vaccines used in the US indicate that the vaccine packaging contains DNR and include cautionary statements regarding possible risks for latex-allergic vaccine recipients. To respond to such inquiries the Advisory Committee on Immunization Practices (ACIP) in the US developed the following recommendations: “If a person reports a severe (anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain natural rubber should not be administered, unless the benefit of vaccination outweighs the risk of an allergic reaction to the vaccine. For latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex can be administered” [2]. These recommendations were partially based on an unpublished review of safety data in the Vaccine Adverse Event Reporting System (VAERS). In this letter, we present details of that review.

Section snippets

Methods

VAERS is a large national spontaneous reporting system for adverse events following immunization. Since November 1990, it has received >160,000 reports. Among persons who submit notifications to VAERS are vaccine providers, other health care workers, vaccine recipients and their parents. Detailed descriptions of the system are presented elsewhere [3]. VAERS reports submitted from 1 January 1991 to 15 October 2003 were queried using a text string search on “latex” and “rubber”. The reports were

Results

As on 15 October 2003, VAERS received 167,233 notifications. Of these, 147 (0.1%) reports mentioned a history of latex allergy in the vaccine recipient. Of the 147, 28 (19%) developed a possible allergic adverse event (Table 1). Two patients required hospitalization for 1 day, with both reporting a complete recovery. The majority of patients were female (N = 24, 86%). Ages ranged from 1 to 54 years. Onset of first symptoms ranged from 5 min to 3.5 h after injection. Eleven cases (39%) received

Discussion

The direct scientific evidence that vaccines which come into contact with DNR products present a problem in clinical settings is limited. There are various views expressed in the literature regarding the potential of latex proteins in vial stoppers and syringe plungers to elicit allergic reactions in latex-allergic individuals [4], [5], [6], [7], [8]. Two reports provide strong circumstantial evidence for the association [9], [10]. These describe two diabetic patients who developed local

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Unlike respiratory allergies, food allergies and hymenopteran venoms which involve protein allergens, the management of drug allergies rarely requires the use of laboratory tests to obtain evidence of an IgE-dependent allergic mechanism. A very small number of drug specific IgE assays are available because drugs are mostly haptens. The rational use of the biological tools available according to updated scientific data can guarantee diagnostic efficiency. The misuse of the biology of allergy and/or their misinterpretation may lead to inappropriate or even dangerous therapeutic attitudes. Aware of this issue, the French Society of Allergology (SFA) has set up a multidisciplinary task force to update allergy biology recommendations, the previous recommendations drawn up in 2005 by the High Authority for Health (HAS) having become partly obsolete due to the evolution of techniques and concepts. The methodology used is that of the recommendations for clinical practice (RPC) developed by the HAS, even if the text has not been labeled by that institution. The working group drafted 11 graded recommendations for the management of drug allergy. Although not exhaustive, these 11 questions respond to the most common concerns of prescribers whether or not they are allergists for the management of patients with suspected drug allergy, while taking into account the French regulatory context.
Evaluation of Adverse Reactions to Vaccines
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The development and widespread use of vaccination over the past centuries has been the single most impactful intervention in public health, by effectively preventing morbidity and mortality from infectious diseases. Vaccination is generally well tolerated in the vast majority of the population, and the benefits of vaccination largely outweigh the risk of severe adverse events in the majority of patients. Vaccine hesitancy can be a significant concern and lead to infectious disease outbreaks. All health care providers play an important role in maintaining public confidence in vaccines because their attitude and knowledge is often critical in facilitating acceptance of a vaccine. The purpose of this review is to first, provide an understanding of the basic concepts that are relevant to vaccine pharmacovigilance, and secondly, to provide an overview and discuss management of both immune and nonimmune adverse events after vaccination.
Latex content in the anthrax vaccine absorbed
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Las vacunas son altamente efectivas en prevenir enfermedades infecciosas a través del desarrollo en el individuo de una respuesta inmune protectora, sin desarrollar la enfermedad. Los distintos tipos de vacunas producen diferentes tipos de respuestas inmunes y variadas estrategias se han desarrollado para mejorar esta respuesta. El sistema inmune sufre cambios con la edad y esta inmunosenecencia altera la capacidad de responder frente a ellas. Por otro lado, si bien el sistema inmune puede reconocer elementos presentes en las vacunas y montar respuestas de hipersensibilidad ante ellos, las alergias a las vacunas son raras, teniendo que distinguirlas adecuadamente de otro tipo de reacciones. En caso que un paciente presente una reacción compatible con alergia, es importante conocer todos los componentes de la vacuna para realizar un estudio adecuado.
Vaccines are highly effective in preventing infectious diseases through the development in the individual a protective immune response, without developing the disease. Different types of vaccines produce different types of immune responses, and varied strategies have been developed to improve this response. The immune system undergoes changes with age, and this inmunosenescence alters the ability to respond to them. On the other hand, although the immune system can recognize elements present in vaccines and establish hypersensitivity responses to them, vaccine allergies are rare, having to properly distinguish them from other types of reactions. In the event that a patient has an allergy-compatible reaction, it is important to know all the components of the vaccine to conduct a proper study.
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Anaphylactic reactions are rare and estimated to occur at a rate of 1 per million doses.132 IgE-mediated reactions to vaccines have been reported as the result of additives and residual vaccine components, such as gelatin, yeast, latex, neomycin, thimerosal, and casein.133-137 In some reactions the gelatin stabilizer in the MMR and Japanese encephalitis vaccines was thought to be the culprit.138-141
Providers caring for patients with mastocytosis are tasked with the decision to consider therapeutic options. This can come with some trepidation because information available in the public domain lists numerous mast cell (MC) activators based on data that do not discriminate between primates, rodents, and MC lines; do not consider dosage; and do not take into account previous exposure and resultant clinical findings. This being said, there is support in the literature for an enhanced MC response in some patients with mastocytosis and in cases in which there is a greater incidence of adverse reactions associated with certain antigens, such as venoms and drugs. Thus this report provides a comprehensive guide for those providers who must decide on therapeutic options in the management of patients with clonal MC disease.
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Natural latex is also present in the rubber stoppers of some vaccine vials and on the plungers in some prefilled syringes. There are rare reports of acute-onset hypersensitivity reactions in this situation, but in most instances specific studies to determine that latex was the cause of the reaction have not been performed.39 Nevertheless, patients with severe latex allergy should avoid vaccines packaged with latex-containing stoppers and syringe plungers, if possible.36
Vaccine-associated hypersensitivity reactions are not infrequent; however, serious acute-onset, presumably IgE-mediated or IgG and complement-mediated anaphylactic or serious delayed-onset T cell–mediated systemic reactions are considered extremely rare. Hypersensitivity can occur because of either the active vaccine component (antigen) or one of the other components. Postvaccination acute-onset hypersensitivity reactions include self-limited localized adverse events and, rarely, systemic reactions ranging from urticaria/angioedema to full-blown anaphylaxis with multisystem involvement. Risk of anaphylaxis after all vaccines is estimated to be 1.31 (95% CI, 0.90-1.84) per million vaccine doses, respectively. Serious hypersensitivity reactions after influenza vaccines are particularly important because of the large number of persons vaccinated annually. Influenza vaccines are unique in requiring annual changes in the vaccines’ antigenic composition to match the predicted circulating influenza strains. Recently, novel influenza vaccine types were introduced in the United States (recombinant vaccines, some with higher antigen content and a new adjuvanted vaccine). Providers should be aware of changing recommendations on the basis of recent published evidence for persons with a history of egg allergy to receive annual influenza vaccination. Further research is needed to elucidate the pathophysiology and risk factors for reported vaccine-associated adverse events. Further research is also needed to determine whether repeated annual inactivated influenza vaccination, the number of vaccine antigens administered at the same time, and the current timing of routine infant vaccinations are optimal for overall population well-being.

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Published by Elsevier Ltd.

Vaccination of persons allergic to latex: a review of safety data in the Vaccine Adverse Event Reporting System (VAERS)

Abstract

Introduction

Section snippets

Methods

Results

Discussion

Vaccine

J Allergy Clin Immunol

Lancet

J Allergy Clin Immunol

J Allergy Clin Immunol

Vaccine

The “non-allergenicity” of NR dry rubber products with reference to type I protein allergy

Rubber Technol

General recommendations on immunization recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP)

MMWR Recomm Rep

Latex allergy and plastic syringes

Anesth. Analg

Risk of latex allergy from medication vial closures

Ann Pharmacother

Lack of latex allergen contamination of solutions withdrawn from vials with natural rubber stoppers

Am J Health Syst Pharm