The following question, which deals with a potential contraindication to Hepatitis B vaccination, was submitted to the CBBS e-network expert panel for consideration.

The question deals with a blood bank that has a new employee who is not immune to HBV and who will be working in areas with possible blood exposure (hospital services). The new employee is allergic to yeast. This allergy is sufficiently severe that the new employee cannot eat many baked products, has had allergic reactions to oral drugs that contain yeast, and was told by an MD that yeast allergy was the reason for all. Since allergy to yeast is considered a contraindication to using Heptovax what would be an appropriate course of action? 
 

The following ideas have been submitted in response to the posed question. These opinions are paraphrased and are being presented without attribution. They do not represent an official opinion or position of the CBBS.

One panelist responded that a review of the package insert and a phone call to a "Product Specialist" at the pharmaceutical company that makes one of the vaccines on the market (Engerix-B Hepatitis B Vaccine (Recombinant) -- Smith Kline Beecham Pharmaceuticals, Philadelphia, PA, 1-800-366-8900) resulted in the following information and advice. The package insert states under "Contraindications": Hypersensitivity to yeast or any other component of the vaccine is a contraindication for use of the vaccine. Patients experiencing hypersensitivity after an Engerix-B [(Hepatitis B Vaccine (Recombinant)] injection should not receive further injections of Engerix-B." There apparently is at least one published report of a significant but not life-threatening report of an allergic reaction to the vaccine in a patient who was allergic to "molds." Anaphylactic reactions have been reported to the company but the panelist was given no information about whether or not the patients had a history of allergy to yeast. Since the package insert states that vaccination is contraindicated in patients with yeast allergy, the lack of reports of reactions in yeast-sensitive individuals may be due to the fact that yeast-sensitive individuals don't receive the vaccine. The panelist added that there are currently no yeast-free hepatitis B vaccines being manufactured, and that the amount of yeast in the vaccine is less than 10 picograms of yeast DNA/dose. The yeast is Saccharomyces cerevisiae. Thus, an allergist might be able to determine whether Saccharomyces cerevisiae is a yeast to which the employee is sensitive.

Another product on the market is Recombivax HB which is also a recombinant vaccine against hepatitis B produced in the same species of yeast cells. It is produced by Merck and Co., Inc., West Point, VA 19486. The package insert states that hypersensitivity to yeast or any component of the vaccine is a contraindication to its use. This panelist could not find "Heptovax" listed in the 1997 edition of the Physicians' Desk Reference (PDR). 

A second panelist commented that one should not take a chance on vaccinating this new employee. Rather, the new employees job was really at low risk so nothing need be done. If ever the new employee is exposed to blood, e.g., a needle stick from a person with HBV, the panelist would prescribe HBIG immediately, and again in a one month. This worked well for years before a vaccine was available. The panelist also suggested that a check could be performed to see if any company has any of the original HBV vaccine made from HBsAg positive plasma. The panelist suggested checking with Merck to see if they have any stashed away, or if Merck had any other suggestions.

A third panelist added that their institution uses a refusal form for any employee who does not (for any reason) choose to take the vaccination. 

Entered: Feb. 25, 1999