The most recent recommendation is that all children should get the flu vaccine regardless of egg sensitivity or egg allergy. Skin testing to the vaccine and the use of split doses is no longer recommended. If the history is egg anaphylaxis, the vaccination should be performed in the allergist’s office.

Details from the recommendations written by Drs. Kelso, Li, and Greenhawt are available.

FEL

12-1-2011

Our Indianapolis Star posted a story from Shari Roan. Ms Roan is reporter for the Los Angeles Times. The title of the article in the Star was ‘You may be allergic to a food . . . or not’ . The original article by Ms. Roan had a slightly different title.

The article coincided with the announcement of the publications of the ‘New Guidelines for the Diagnosis and Management of Food Allergy’. This document represented the efforts of a group of food allergy experts working with the National Institute of Allergy and Infectious Diseases. In one of my earlier posts I commented on a draft of this document. The final product is now available.

What struck me after reading the article was the need for us to undo what has been done. There are  many children out there who have had extensive food allergy testing performed and struggle with numerous positive food allergy test results. Are they all truly allergic to all those foods? Are they being deprived of adequate nutrition? Can we help them and their families?

‘A lot of physicians order large numbers of blood tests of various foods, and when they find small amounts of antibody present, they indicate to the patient  that they are allergic to this food and should not ingest it,’ according to Dr. Hugh Sampson- an internationally recognized expert in food allergy. The article goes to state that many children are placed on highly restricted diets that are probably not necessary.

It is also important to point out that the same consequence can be seen with the results of skin testing.

The New Guidelines state that oral food challenges will be needed to sort out the relevance of the positive food allergy test. The oral food challenge is required to make an accurate diagnosis. These guidelines point out that a positive test result only shows sensitization. The test result must be used together with a history for a correct diagnosis of food allergy.

Stated a bit more firmly, these New Guidelines advise against making the diagnosis of food allergy solely based on the results of skin prick tests or blood tests.

 I foresee pediatric allergy practices becoming more involved with doing food challenges. A child presents with an array of positive food allergy tests, restrictive dietary advice, and accompanied by scared and frustrated parents. All too often many of the foods they have been told to avoid had been eaten with impunity- there was absolutely no observed reactions with ingestion, but there was a positive allergy test. This is very confusing.

In  pediatric allergy we sort through the history of exposure and the appearance of reactions that are IgE-mediated (the antibody detected by food allergy testing). We look for that constancy of cause/effective relationships with the food. We also need a sense of the timing between exposure and reaction. From that history, the proper selection of food allergy tests is then made.

So now we need to verify clinical reactivity to food allergy test results that revealed sensitization. For some foods we have been given guidance regarding the chance of having a reaction. For many other foods we do not have that information. Many of these challenges will be adventures in uncharted waters. In our practice we have done many challenges for milk, egg, soy, wheat, and peanut. We have also challenged to beef.  For the other foods we can put together a protocol for the safe introduction of a ‘challenge’ food.

Take a look at these New Guidelines for the Diagnosis and Management of Food Allergy.

FEL

In the past, influenza vaccination was a concern in a child who had an egg allergy. In this situation, the vaccine was either not given or the child underwent a desensitization procedure in the allergist’s office. Current research has caused a re-thinking of the previous guidelines. Now it is not just having an egg allergy that would preclude the vaccination, it is the nature of that allergic response to egg that guides the decision for vaccination.

The influenza vaccination does contain egg products. The amount of egg in the vaccine may vary depending upon the manufacturer and even within distributed lots of the vaccine from the same manufacturer. Once upon a time we thought that if food which contained egg was tolerated, but egg was not, then the vaccine could be given. A few years ago that adage was proven to be incorrect. The nature of the egg protein in the vaccine may differ from the egg in a ‘heated egg’ food product.

Our allergy clinic at Riley has received many calls from worried families and from primary care offices regarding egg allergy and the influenza vaccine.

My partner, Dr. Girish Vitalpur spoke at our recent ’2010 Pediatric Pulmonary Update: Today’s Challenges’ on this very topic of egg allergy and the flu vaccine. The entire conference was dedicated to specific management problems that primary caretakers face: the issue of egg allergy and the vaccine was a notable concern.

Girish and I thought it may be of service to those who could not attend the meeting to post the recommendations and the approach to influenza vaccine in the child with egg allergy.

First a few fact that he shared (all were referenced)

• 1969- one death reported due to anaphylaxis to the vaccine in someone with egg allergy
• 1976- one case of anaphlyaxis per 4.4 million vaccinations with none occurring in an egg allergy individual
• 1990-2005- 747 million influenza vaccine doses given with 4 cases of fatal anaphylaxis

Balance these facts with 540,000 deaths due to influenza during the same time interval.

Flu vaccine recommendations are dependent upon the type or severity of a reaction to egg. The following sorts out considerations for egg allergy severity.

Mild Egg Allergy

• Hives around the mouth/face
• Mild itching
• Nausea
• Itchy mouth

Severe Egg Allergy

• Respiratory changes
• Cardiac changes
• Oral swelling or throat tightness
• Systemic hives
• Multiple organ reactions-hives with vomiting, hives and respiratory symptoms for example

Note- just having a positive test for egg and no history of a reaction is not listed here as a severity consideration.

Current Guidelines (6 months to 18 years of age)

No egg anaphylaxis- may receive the vaccine in a two dose graded manner (graded challenge).

INFLUENZA VACCINE ADMINISTRATION WITH EGG ALLERGY:  MANAGEMENT

• Office must be prepared for anaphylaxis
• Informed consent needed
• Approaches

1.  Administration of vaccine as a single dose

2. Graded Challenge

                  Give 10% of vaccine.  Wait 30 minutes.  Give rest of vaccine.  Monitor for 30-60 minutes (30 minutes usually- 60 minutes depending upon the history).

 3.  Desensitization (for cases of egg anaphylaxis and/ or adverse reaction to the vaccine)

       Administer vaccine in 4-5 incremental doses, at 15-minute intervals

 Zeiger, 2002;Greenhawt, 2010

The desensitization for anaphylaxis should be performed in the allergist’s office.

The graded challenge has been done in primary care offices- it fulfills that gray zone when there are no clear answers and there is anxiety on behalf of the family and the primary caretaker.

Hopefully this posting will help to answer questions about giving the vaccination in someone with an egg allergy. My thanks to my colleague, Dr. Girish Vitalpur for putting this together.

FEL

It is that time of the year again when you need to make plans for your child to get a flu shot. The influenza vaccine is available. Concurrent with the flu vaccine season are all those questions regarding how to handle the child with egg allergy and the need for a vaccination. The vaccines, both the injected and ‘up the nose’ versions are grown in egg. Because of this we have to be careful with the egg allergic child.  However, just having the label of being ‘egg allergic’ may not and should not exclude a child from getting the vaccine and the protection it offers against the flu. A child with an egg allergy can get the influenza vaccine, we just need to spend some time in sorting out the story and the options available. This was a hot topic last influenza season with a few posts on this website regarding this topic; 1. Food Allergy Testing, Egg Sensitivity, and Flu Shots, and Egg Allergy and Influenza Vaccine.

If you have a positive allergy test to egg, how do you handle the flu shot?

In the past the approach was that an egg allergic individual should not get a flu shot. Over time this recommendation has gone through a number of changes in part due to Vaccine Adverse Event Reporting System (VAERS) analyses and knowing the amounts of egg in the vaccines. In past years if foods that contained egg were ingested without any problems, then the egg-containing vaccine could be safely given.

Evidence now shows that the amount of egg in the flu vaccines can vary per manufacturer and even between lots of vaccine made by one source. We therefore no longer abide by the ‘ingestion- okay’ approach.

Last year’s urgency on behalf of the emergence of the H1N1 strain and the need for a second vaccination stimulated a closer look at the population of egg allergic children. Last year the AAP and the CDC stated that caution was needed when the egg reaction was serious. The key word here is ‘serious’ and how it is/was defined.

Current AAP recommendations

The ‘Red Book’ (downloaded from the AAP website) has the following statement:

Given a ‘History of nonspecific allergies or relatives with allergies, including history of a non-anaphylactic allergy to a vaccine component (such as egg)- Only anaphylactic allergy to a vaccine component (such as egg) is a true contraindication to immunization.’  

Update: 2010-2011 Influenza Statement and Guidance

This appeared in the journal Pediatrics this year.

‘Influenza Vaccine Trivalent inactivated influenza vaccine (TIV) and live-attenuated influenza vaccine (LAIV) are multivalent vaccines containing 3 virus strains (one each of A [H3N2], A [H1N1], and B). Typically, 1 or more strains are changed each year in anticipation of the predominant influenza strains expected to circulate in the United States in the upcoming influenza season.

Because viruses for both vaccines are grown in eggs, neither should be administered to anyone with known severe allergic reactions (eg, hives, angioedema, allergic asthma, and systemic anaphylaxis) to chicken, egg proteins, or any other component of the vaccines. Less severe or local manifestations of allergy to egg or feathers are not contraindications to administration of influenza vaccine’.

When there is a serious egg allergy-

The flu vaccinations can be given through a desensitization procedure in the allergist’s office. The procedure involves the administration of gradually increasing doses of the vaccine in a controlled clinical environment.

When the egg allergy issue is nebulous/uncertain, or unknown-

There is a compromise procedure- This one is done when the reaction clearly was not anaphylaxis/serious but there is concern or the specifics of the history are not known. We have labeled it a vaccine challenge (different from a desensitization). In this example, we give 10% of the vaccine, watch and if everything and everyone is stable, we follow-up with the remaining 90% and continue to observe.

Charging ahead with the full vaccination-

This is the administration of the full dose. In this instance, if there is any question about eggs, the child could be kept in the office/waiting room for a period of observation. Significant reactions usually happen within two hours of the exposure.

The algorithm-an approach to consider (click on this to link to Google data which has the slide of the algorithm- also posted below)

Decision Tree for Egg and Giving the Influenza Vaccine

Of course there are many gray zones regarding egg allergy and the influenza vaccination. This is how we approach this problem in our clinic.

The hardest issue is the ‘unknown’ history or exposure or reaction. The child has had a positive test to egg and there was absolutely no egg exposure at all. The allergy test did not predict an egg allergy, it revealed sensitization to egg which may or may not be clinically relevant. The three approaches to vaccination can be considered and the final decision is dependent upon the comfort level of the physician and that of the family. Many primary caretakers have a comfort level as they approach this situation. They have seen vaccine reactions, they know the history of the child,  and the office is geared-up to handle a reaction should one occur. Others may seek the help of an allergist in sorting out these egg allergy issues.

FEL

I was able to get this supply for my population of children who have life-threatening reactions to egg. Remember- in accordance with the recommendations from the Centers for Disease Control the contraindication to the vaccine is a life-threatening reaction. Just having a positive allergy test to egg is not a contraindication nor is having a minor reaction to egg.

Those children with a serious reaction to egg can’t stand in line at school for this vaccination. We need to make special arrangements to take care of them.  In an effort to offer them protection against H1N1 we secured vaccine and we will be scheduling those children for the desensitization protocol.

I would love to be able to offer vaccine for all, however this limited supply was given to me for the use in children with serious reactions to egg only.

I picked this up yesterday and Ms. Meyer has been going through our list of children for whom we have done the desensitization procedure for seasonal influenza. I promised a number of my families that I would post this announcement.

See you in clinic,

Cover that cough and season’s greetings,
Fred Leickly

There are two excellent sources to look to for advice. The Academy of Pediatrics (AAP) has issued a policy statement  regarding influenza vaccination. Both the TIV and LAIV (the injection and the nasal spray) “should not be given to children who have a history of hypersensitivity, including anaphylaxis to egg, to any previous influenza vaccine or to any of the vaccine components”.

The Centers for Disease Control state that the TIV is “contraindicated when there is anaphylactic hypersensitivity to egg or other components of the vaccine unless the recipient has been desensitized” (taken from the CDC Statement). For the LAIV, the statement is a little different and reflects the AAP statement; “the LAIV is contraindicated in persons with a history of hypersensitivity, including anaphylaxis, to any of the components of LAIV or to eggs”.

In our specialty clinic at Riley Children’s Hospital we offer the TIV (the injection) and not the LAIV (nasal spray). This is because the vast majority of children who we see in both Allergy and Pulmonology have asthma. The intranasal vaccination is not indicated in the child who has asthma.

The CDC statement identifies only anaphylaxis- a serious life threatening reaction to egg as a contraindication to the TIV vaccination. With this guideline, a child with only a positive allergy test (skin prick test or specific IgE blood test), contact hives, diffuse hives, atopic dermatitis, eosinophilic esophagitis, and vomiting could get the immunization without any further discussion.

It is important to point out that both the AAP and the CDC state that it is a history of hypersensitivity to egg. This is an important point to make. It is the history of a reaction that dictates the approach. Allergy tests for foods have a high degree of false positivity. The history of a reaction and a test to verify the IgE (allergy) mechanism is required for the diagnosis of allergy. A test shows sensitization. A positive test alone to egg without any clinical correlates (history) is not the same as a history of an anaphylactic reaction to egg.

So how can we help? We found some guidance from an article by Robert A. Wood ( Pediatrics 122, Number 3, September 2008 e771-e777) . The article dealt with immunizations in general and it has some specifics on the influenza vaccination.

This is a summary of our approach to this problem;

1. Is there a history of an egg or vaccine reaction?

          a. If no, give the immunization

          b. If yes, ask if the reaction was anaphylaxis

          c. If unknown due to no known exposure to egg (see below)

2. If the reaction was anaphylaxis- a desensitization procedure is indicated.

3. If the reaction was not serious, not life threatening to egg

          a. Give the vaccine- watch 60 minutes OR

          b. Give the 10% of the vaccine wait 30 minutes

             then give the remaining 90% of the vaccine

             and watch 60 minutes Or

          c. Do the diagnostics- skin testing for reactivity to the vaccine-

            this includes a few intra-dermal tests all done in our allergy office.

4. If there has been no exposure to egg, but there is a positive allergy test to egg-

    This is one of the more difficult areas. There are a few choices here and they all depend upon the comfort level of the family and the physician-

          a. Give the full vaccine and watch OR

          b. Give 10% of the dose and watch for 30 minutes

            followed by the remaining 90% and

           watch for an additional 60 minutes

            OR

          c. Do the diagnostics in the allergy office (see 3c above)

Clearly the safest route is to do the desensitization. The desensitization takes about 3 hours and involves a number of injections (around five). However, there are a number of other approaches to look at. The use of these alternatives needs to consider the comfort level of the family and the primary caretaker in giving the vaccination.

Please note that this procedure applies for both the standard influenza vaccination (seasonal) and for the new H1N1 vaccine.

I do recommend getting the influenza vaccinations.

FEL

A young African-American girl of 11 months presented upon the recommendation of her pulmonologist. The pulmonologist saw the need for a flu shot however there was some concern about a positive allergy test to egg. This little girl had a ‘Phadia Specific IgE’ set of food allergy panels performed for about 31 foods (the bill to the mother was >$800). The test was performed because of a concern for a constant runny nose. The child was tested to the usual suspects for food allergy in young children. The test array went significantly further. As I have talked about previously, because of the marketing of these allergy blood tests to include extra items (at more expense) these are in most cases irrelevent. Many of the foods tested are not part of a young child’s diet. The test included foods that this young lady of 11 months has never ingested; lobster, shrimp, tree nuts, shrimp, and clams to name a few. So in the end mother was at risk to pay for information that was not relevent to the child’s situation or exposures. There is also the argument within this case regarding the pursuit of a food allergy for the complaint of a runny nose in an 11 month old child.

The test for egg was 0.51 kU/L. The cutoff for a negative response is <0.35 kU/L. When you look at the literature for critical cut-off levels for doing an egg challenge, this value would indicate that the child will have a high probability of a negative and successful egg challenge.

Now the real kicker. As we all know there is no better test for a food allergy than the challenge; give the food and see what happens. We do have to be careful depending upon the history of previous reactions for those challenges. In this baby’s history she had been eating scrambled eggs without any problems. There was no history of a cause/effect relationship with egg exposure.

Now let us add in the variable of the flu shot. The flu shot contains egg protein. The recommendations from the CDC and the AAP are to not give the flu shot if there is a history of a severe reaction. This pertains to what happened when egg was ingested. It does not pertain to the presence or size of an allery test for egg. In this case, cooked eggs have been ingested without any reactions. So in my opinion, the history of egg exposure and having no serious reactions with that exposure should clear the way for the flu immunization. For those children who have serious reactions to egg but can eat heated egg products, there is a need for considering a desensitization for the fluogen. The egg in the vaccine is more like cooked egg (scrambled, hard boiled, over easy etc) than heated egg (cakes, cookies, muffins, and waffles). The history of eating products with heated egg should not be considered a ‘safe’ for those with serious egg reactions.

The children need to be immunized for this upcoming flu season.

My humble opinion,

Fred Leickly