KEYWORD1:
Natural rubber latex allergy, Vaccination, Vial closure systems

BACKGROUND:
Prevalence studies have estimated that 6-12 percent of the general population is latex sensitive individuals (LSI), with higher rates occurring among health care workers. In 1998, the FDA required labeling of all medical packaging containing natural rubber latex (NRL). Several vaccine package inserts contain warnings regarding vaccination of LSI, but leave clinicians to weigh the risks and benefits of vaccination. The Advisory Committee on Immunization Practices recommends that “for latex allergies other than anaphylactic allergies, vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex can be administered”. However, data to support this recommendation are limited.

OBJECTIVE:
To estimate the reported clinical outcome associated with vaccination of LSIs in the United States.

METHOD:
We reviewed the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system containing over 130,000 reports. All VAERS reports from 1991-2002 were queried using a text string search on “latex” and “rubber”. Reports were then 1) manually reviewed for histories of latex allergy and 2) classified as a possible hypersensitivity allergic reaction based on appropriate symptoms and same day onset.

RESULT:
A total of 115 VAERS reports contained a documented (n=107) or suspected history (n=8) of latex allergy; 53 reports were suggestive of a hypersensitivity allergic reaction. Only three cases were serious and required hospitalization. Among the 53 cases, 13 different vaccines were administered, with influenza and hepatitis B occurring most frequently. Since these vaccines contain other allergens, it is impossible to implicate latex as the only cause of these reactions.

CONCLUSION:
Our review of VAERS data over an 11 year period suggests that the likelihood of passive reporting of serious allergic reactions following vaccination in LSI is minimal. Nevertheless, this risk of a LSI developing an adverse event can be eliminated by substituting synthetic latex in vaccine vial closures. Until that occurs, special protocols for vaccinating LSIs are needed.
LEARNINGOBJECTIVES:
To understand the risks associated with vaccination of LSIs.