Answer:
Thank you for your inquiry.
Before speaking to the issue of rotavirus vaccine in particular, I would like to share with you the general approach to evaluating allergic reactions to vaccines. There are a number of articles which are helpful in this regard and discuss the principles of this type of evaluation.
Perhaps the most notable of these is by Robert Wood and colleagues. I have copied the abstract from the Journal of Pediatrics, 2008, for you below. This article presents an algorithm to assist you in approaching each vaccine.
Two other articles by Dr. Wood and associates, both from The Journal of Allergy and Clinical Immunology, will also be helpful to you. They list the non-irritant skin test concentrations for several vaccines (1, 2).
Another document which would be helpful to you is the Practice Parameter entitled “Adverse Reactions to Vaccines” by Drs. Kelso and Li. This was published in the J Allergy Clin Immunol, July 2012.
The Parameters gives you a prototype for a suggested graded challenge to vaccines when they must be administered cautiously. I would suggest if skin tests are negative that you approach the vaccines separately by using this type of graded challenge.
There are other entries on our website regarding previous questions about allergic reactions to vaccines which may be of help to you in gathering a perspective in regards to the approach to your patient. For your interest, these entries can be obtained by clicking here and typing “allergy to vaccines” or “vaccine allergy” in the search box.
In summary, the evaluation of potential vaccine allergy when multiple vaccines have been given simultaneously is unfortunately tedious and time-consuming. There are no large series or multi-tested protocols for each drug, and therefore the utilization of general principles based on empiric criteria and previous case reports are all we have to use to establish an approach. The most standard way of which I am aware to deal with such patients is to skin test separately, and do provocative challenges when skin tests are negative and the vaccine is needed. These need to be done individually and on different days.
Fortunately there are for most vaccines skin test concentrations that are non-irritating, and there is a generalized but very helpful protocol to perform these procedures in the references cited above.
Pediatrics. 2008 Sep;122(3):e771-7.
An algorithm for treatment of patients with hypersensitivity reactions after vaccines.
Wood RA, Berger M, Dreskin SC, Setse R, Engler RJ, Dekker CL, Halsey NA; Hypersensitivity Working Group of the Clinical Immunization Safety Assessment (CISA) Network.
Collaborators (10)
Source
Johns Hopkins Hospital, CMSC 1102, 600 N Wolfe St, Baltimore, MD 21287, USA.
Abstract
Concerns about possible allergic reactions to immunizations are raised frequently by both patients/parents and primary care providers. Estimates of true allergic, or immediate hypersensitivity, reactions to routine vaccines range from 1 per 50000 doses for diphtheria-tetanus-pertussis to approximately 1 per 500000 to 1000000 doses for most other vaccines. In a large study from New Zealand, data were collected during a 5-year period on 15 marketed vaccines and revealed an estimated rate of 1 immediate hypersensitivity reaction per 450000 doses of vaccine administered. Another large study, conducted within the Vaccine Safety Data link, described a range of reaction rates to >7.5 million doses. Depending on the study design and the time after the immunization event, reaction rates varied from 0.65 cases per million doses to 1.53 cases per million doses when additional allergy codes were included. For some vaccines, particularly when allergens such as gelatin are part of the formulation (eg, Japanese encephalitis), higher rates of serious allergic reactions may occur. Although these per-dose estimates suggest that true hypersensitivity reactions are quite rare, the large number of doses that are administered, especially for the commonly used vaccines, makes this a relatively common clinical problem. In this review, we present background information on vaccine hypersensitivity, followed by a detailed algorithm that provides a rational and organized approach for the evaluation and treatment of patients with suspected hypersensitivity. We then include 3 cases of suspected allergic reactions to vaccines that have been referred to the Clinical Immunization Safety Assessment network to demonstrate the practical application of the algorithm.
1. Wood RA, et al. Irritant skin test reactions to common vaccines. J Allergy Clin Immunol 2007 (August); 120(2):478-481.
2. Wood RA, et al. Assessment of irritant skin test reactions to common vaccines. J Allergy Clin Immunol 2007; 119(1):S271.
I think that these will be helpful to you once the rotavirus vaccine issue has been dealt with.
My advice to you would be to proceed with administration of ROTA vaccine at this time. The reason for this is that reactions to rotavirus must be extremely rare. I could not find an urticarial or anaphylactic reaction to rotavirus vaccine with a literature search, and when one looks at the package insert of Rotarix, neither anaphylaxis nor urticaria is listed as a side effect. On the other hand, there is a mention of urticaria (but not anaphylaxis) in the package insert for RotaTeq. In addition, since this is a live vaccine, if the virus itself had been responsible for the urticarial reaction, you would think it would have continued for quite a long period of time. Of course, an excipient could have been responsible, but again, it would be extremely rare for this to be the case.
So, in summary, I would proceed as you mentioned with giving the rotavirus vaccine, and you might empirically switch to Rotarix since the previous reaction was to RotaTeq. And when you decide to evaluate the other vaccines, the information mentioned above will be helpful to you in establishing a strategy of testing and oral challenge.
Thank you again for your inquiry and we hope this response is helpful to you.
Sincerely,
Phil Lieberman, M.D.