Vaccination of persons allergic to latex: a review of safety data in the Vaccine Adverse Event Reporting System (VAERS)
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 These recommendations were partially based on an unpublished review of safety data in the Vaccine Adverse Event Reporting System (VAERS).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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2018, Journal of Allergy and Clinical ImmunologyCitation Excerpt :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