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Influenza vaccination in individuals with egg allergy

Influenza vaccination in individuals with egg allergy. Authors John M Kelso, MD Julie Wang, MD Section Editor Scott H Sicherer, MD, FAAAAI Deputy Editor Elizabeth TePas, MD, MS Last literature review version 19.1: January 2011 | This topic last updated: February 9, 2011 (More). INTRODUCTION .

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Influenza vaccination in individuals with egg allergy

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  1. Influenza vaccination in individuals with egg allergy AuthorsJohn M Kelso, MDJulie Wang, MD Section EditorScott H Sicherer, MD, FAAAAI Deputy EditorElizabeth TePas, MD, MS Last literature review version 19.1: January 2011 | This topic last updated: February 9, 2011 (More)

  2. INTRODUCTION  • Both the intramuscular inactivated and intranasal live-attenuated influenza vaccines are cultured on fluid from chicken embryos. As a result, there is a small amount of egg protein in these vaccines. Thus, there is a potential risk of inducing an allergic reaction when administering the influenza vaccine to an individual with egg allergy.

  3. INTRODUCTION  • However, many of these same patients are also at higher risk of an adverse outcome due to influenza infection (eg, age <2 years, history of asthma) and would therefore benefit from vaccination.

  4. INTRODUCTION • This topic reviews the risks and benefits of administration of the influenza vaccine in patients with egg allergy and discusses several possible approaches. • The measles, mumps, and rubella (MMR) vaccine is not contraindicated in egg allergic patients.

  5. RISKS ASSOCIATED WITH INFLUENZA INFECTION • Both seasonal and pandemic influenza infection can lead to severe infection and death, particularly in certain high risk groups. Seasonal influenza results in higher mortality rates among patients with certain chronic medical conditions (eg, asthma), pregnant women, and those at the extremes of age.

  6. RISKS ASSOCIATED WITH INFLUENZA INFECTION • The 2009 H1N1 influenza pandemic also led to higher rates of severe infection and/or death among patients with underlying conditions and pregnantwomen, - but elderly individuals had a lower rate of infection and death, and younger individuals a higher rate, compared with what has been observed during seasonal influenza epidemics. • Both seasonal influenza and pandemic H1N1 influenza result in high rates of infection in children.

  7. Influenza vaccination is recommended for all individuals six months of age and older and is particularly important in those at increased risk of complications.

  8. RISK OF ANAPHYLAXIS TO VACCINE • Allergic reactions to a vaccine may be caused by the immunizing agent itself or to other proteins/haptens that are introduced into the vaccine during the production process. • These may include residual animal proteins, antibiotics, preservatives, stabilizers, virus-inactivating compounds, and latex . • Thus, not all episodes of anaphylaxis caused by the influenza vaccine are due to egg allergy.

  9. RISK OF ANAPHYLAXIS TO VACCINE  • Overall, anaphylaxis induced by influenza vaccine is a rare event. However, it is possible that anaphylaxis to influenza vaccine is a rare event in patients with egg allergy because many of these patients do not receive the vaccine. In addition, rates may be lower now than in years past because overall the vaccines contain lower amounts of egg protein.

  10. RISK OF ANAPHYLAXIS TO VACCINE  • A nationwide surveillance of reactions to the influenza vaccine in the United States during the 1976-77 epidemic found only 11 cases of anaphylaxis out of 48,161,019 persons immunized. A known history of egg allergy was not reported in any of these cases.

  11. RISK OF ANAPHYLAXIS TO VACCINE  • A survey of children and adolescents enrolled at four health maintenance organizations from 1991-97 revealed no episodes of anaphylaxis to influenza vaccine out of 197,964 doses administered during this time period

  12. RISK OF ANAPHYLAXIS TO VACCINE  • Several cases of anaphylaxis to the intranasal influenza vaccine have been reported, although these cases were not directly linked to egg allergy. • No studies have directly compared the rate of anaphylactic reactions between the intranasal live-attenuated vaccine and the injectable trivalent inactivated vaccine.

  13. Fatal anaphylaxis • There is a single anecdotal report from 1969 of fatal anaphylaxis after administration of influenza vaccine to a child with egg allergy

  14. Fatal anaphylaxis • A review of reports to the Vaccine Adverse Event Reporting System over a 15-year period from 1990 to 2005, during which 747 million doses of influenza vaccine were administered in the United States, revealed four reports of death shortly after influenza vaccination that identified anaphylaxis as the cause . No information on egg allergy was provided nor was any evaluation performed to determine whether these were allergic reactions.

  15. VACCINE EGG PROTEIN CONTENT • In the past, influenza vaccine manufacturers did not state the egg protein content of the vaccines. • Independent research laboratories found that the levels of ovalbumin were as high as 42 mcg/mL. • Now most manufacturers of these vaccines provide this information in the package inserts.

  16. VACCINE EGG PROTEIN CONTENT • The vaccine ovalbumin content is typically expressed in micrograms per dose . • The 2010-2011 seasonal trivalent influenza vaccines all contain the H1N1 strain used in the 2009-2010 monovalent pandemic vaccine.

  17. VACCINE EGG PROTEIN CONTENT • Those manufactured by CSL Biotherapies, Inc (King of Prussia, PA), GlaxoSmithKline (Research Triangle Park, NC), MedImmune, LLC (Gaithersburg, MD), and Novartis Vaccines and Diagnostics, Inc (Cambridge, MA) all are reported to contain ≤1 mcg per dose. • The influenza vaccines manufactured by Sanofi Pasteur, Inc (Swiftwater, PA) are reported by personal communication to contain ≤5 mcg per dose .

  18. VACCINE EGG PROTEIN CONTENT • Independent investigators assayed several brands and lots of the 2009-2010 seasonal and H1N1 influenza vaccines and found that the actual ovalbumin content of the vaccines was one or two orders of magnitude lower than the manufacturers' claimed maximum levels.

  19. Safety of low egg protein vaccines in patients with egg allergy  • The lowest observed adverse-effect level (LOAEL, the lowest dose reported to cause harmful effects) for egg white triggering a reaction upon ingestion was estimated to be around 130 mcg for egg-white proteins and 2 mg for raw egg white (equivalent to 200 mcg of proteins).

  20. Safety of low egg protein vaccines in patients with egg allergy  • The no observed adverse-effect level (NOAEL, the greatest level of exposure that causes no detectable adverse effects) is not known. • The LOAEL and NOAEL for egg in a product given by injection or intranasally are not clearly defined.

  21. Safety of low egg protein vaccines in patients with egg allergy  • Safe administration of injectable influenza vaccine containing up to 1.2 mcg egg protein/mL to egg-allergic recipients was reported in a multicenter trial that evaluated the administration of influenza vaccine to • 83 people with histories of allergic reactions to egg

  22. Safety of low egg protein vaccines in patients with egg allergy  • including 27 patients with a history of anaphylaxis to egg, in whom skin testing or oral challenge with egg was positive, • and to 124 control patients. • Skin prick test with the vaccine was positive in four egg-allergic patients and one control patient. • All egg-allergic patients were given the influenza vaccine in two doses, 30 minutes apart. The first dose was one-tenth, and the second dose was nine-tenths of the total volume. There were no allergic reactions in any of the 83 egg-allergic subjects.

  23. Safety of low egg protein vaccines in patients with egg allergy  • No cases of anaphylaxis were reported in a series of 830 children with confirmed egg allergy who were given an adjuvanted pandemic H1N1 vaccine that contained <0.015 mcg/mL of ovalbumin [15].

  24. Safety of higher egg protein vaccines in patients with egg allergy • The current higher egg protein vaccines still have significantly lower levels than in the past. However, the ovalbumin content may be 5- to 100-fold higher (per stated content) in these vaccine compared with the low egg protein vaccine.

  25. Safety of higher egg protein vaccines in patients with egg allergy • In a retrospective series, none of the 64 patient with egg allergy (positive skin or blood test results and a clinical history of a reaction or no history of egg consumption) who were vaccinated with higher ovalbumin content seasonal and H1N1 vaccines during the 2009 to 2010 season had anaphylaxis

  26. Safety of higher egg protein vaccines in patients with egg allergy • Three patients had mild cutaneous symptoms (urticaria or erythema) with the 1/10 dose, and one patient reacted with the 9/10 dose. Three of the four patients who had these mild reaction tolerated egg in baked goods.

  27. ALTERNATIVE TO VACCINATION  • An alternative to vaccination is chemoprophylaxis after exposure to the influenza virus. However, there is increasing emergence of resistance of the influenza virus to the available antiviral agents.

  28. ALTERNATIVE METHODS OF VACCINE PRODUCTION  • The influenza vaccine is produced in fluid from embryonated eggs. Alternative methods of influenza virus propagation are under investigation. These methods do not use embryonated hen's eggs, and therefore would not be contraindicated in patients with egg allergy.

  29. OPTIONS FOR TESTING AND ADMINISTRATION • A history of allergy to the ingestion of egg, raw or cooked, should be sought prior to the administration of any egg-containing vaccine. People who react to raw egg, but tolerate cooked egg, may still experience allergic reactions to egg-containing vaccines [23]. Such patients may not be easily detected, since they may not think of themselves as "egg-allergic."

  30. OPTIONS FOR TESTING AND ADMINISTRATION • In a prospective series, 2 percent (2/105) of those with egg allergy and 5 percent (1/19) without egg allergy reacted to the H1N1 vaccine on skin prick testing and 39 percent (40/105) with egg allergy and 5 percent (1/19) without egg allergy reacted to intradermal testing. All patients, including 25 with a history of egg anaphylaxis, received the H1N1 vaccine without significant allergic reactions (those with “positive” skin tests received the vaccine via a two-step protocol and those with negative skin tests received the vaccine in a single dose; all booster doses were given as a single dose).

  31. OPTIONS FOR TESTING AND ADMINISTRATION • In another prospective series of children with egg allergy (but no history of reaction to vaccines), some with positive prick skin tests to influenza vaccine were given the vaccine uneventfully with a two-dose protocol [14]. • Five out of six children with chronic severe asthma, egg allergy, and negative prick skin tests, but positive intradermal tests to influenza vaccine, tolerated immunization by a multidose protocol [25]. One child developed mild wheezing after the first dose of influenza vaccine, but did not react four weeks later to the second dose.

  32. OPTIONS FOR TESTING AND ADMINISTRATION • Likewise, some healthy adults with positive intradermal skin tests to influenza vaccine diluted 1:100 have been given the vaccine uneventfully [26]. • The rate of serious adverse reactions to the vaccine was the same whether vaccine skin testing was performed prior to a two-step administration protocol or not (5 versus 3 percent, respectively) [27].

  33. OPTIONS FOR TESTING AND ADMINISTRATION • Prick and intradermal skin testing — Clinically irrelevant positive skin tests are possible, as with skin testing to any allergen. • => • Thus, the presence of a positive skin test to influenza vaccine is not necessarily predictive of a subsequent reaction.

  34. Irritant reactions False positive irritant skin test reactions are also possible, particularly with intradermal testing at concentrations of 1:10 or undiluted. One study of 20 healthy adult volunteers without histories of vaccine reactions evaluated rates of false positive results in response to prick and intradermal skin testing with 10 common vaccines [28]. False positives were not seen with prick testing, but false positive rates of 15, 55, and 65 percent were seen on intradermal testing with 1:100, 1:10, and undiluted concentrations of influenza vaccine, respectively.

  35. Administration protocols The administration of influenza vaccine to an egg-allergic patient is a relatively common clinical dilemma. The risk of a serious allergic reaction to the vaccine needs to be weighed against the risks of severe illness and death due to influenza infection and secondary complications.

  36. Administration protocols • The American Academy of Pediatrics (AAP), the United States Centers for Disease Control and Prevention, and the National Institute of Allergy and Infectious Diseases (NIAID) in the United States note the relative contraindication to administration of the influenza vaccine in patients with severe egg allergy or anaphylaxis, but acknowledge that vaccination may be indicated in certain individuals in whom the benefits outweigh the risks

  37. Two-step protocol •  The two-step protocol is considered a graded challenge. This procedure should be administered only under close observation by personnel prepared to recognize and treat anaphylaxis. • Administer one-tenth of the inactivated vaccine dose intramuscularly followed by a 30 minute observation period. • If no reaction is noted, then administer the remaining nine-tenths dose intramuscularly followed by an observation period of at least 30 minutes.

  38. SUMMARY AND RECOMMENDATIONS • The large majority of patients with egg allergy are young children, although this allergy can persist into adulthood. Many patients with egg allergy are at increased risk of influenza complications, including young children and those with a history of asthma or wheezing.

  39. SUMMARY AND RECOMMENDATIONS • Both the intramuscular inactivated and intranasal live-attenuated influenza vaccines contain a small amount of egg protein. Safe administration of injectable influenza vaccine containing ≤1.2 mcg ovalbumin/mL to egg-allergic recipients has been reported.

  40. SUMMARY AND RECOMMENDATIONS • The risk of a serious allergic reaction to the vaccine needs to be weighed against the risks of severe illness and death due to influenza infection and secondary complications.

  41. SUMMARY AND RECOMMENDATIONS • For the patient who is six months of age or older and has known egg allergy of any severity, we suggest administration of an age-appropriate, approved vaccine that contains the lowest ovalbumin per dose without prior vaccine skin testing, followed by a 30 minute observation period in a facility prepared to recognize and treat anaphylaxis (Grade 2C)

  42. SUMMARY AND RECOMMENDATIONS • Vaccine options are shown in the table (table 3). For most patients, we suggest administration of the vaccine as a single dose (Grade 2C). However, a two-step protocol is a reasonable alternative, especially for patients with a history of anaphylaxis to egg or when a low ovalbumin vaccine is not available.

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