Introduction
Risk stratification in allergic and asthmatic children
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History of anaphylactic reactions to foods, insects, latex.
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Idiopathic anaphylaxis and exercise-induced anaphylaxis.
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Mastocytosis.COVID-19 vaccination is generally recommended in patients with mastocytosis. Safety measures, including pharmacological pre-medication and post-vaccination observation, should be considered in all patients with mastocytosis, depending on the individual risk and general conditions of every single case [16, 25].Action: In most cases, proceed with routine vaccination in an outpatient setting with emergency awareness and emergency medication available (24). Pre-medication with sedating or non-sedating H1 antihistamine and supervision for 60 minutes after vaccination should be considered.For the high-risk population (previous anaphylaxis, also to a vaccine, known or suspected allergy to excipients, systemic mastocytosis): see red zone.
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Uncontrolled asthma.According to GINA document [26], asthma in children is not controlled if the child (or parents) answers “yes” at least to 3 of these questions: i) Presence of daytime asthma symptoms more than twice/week?; ii) Is there any night waking due to asthma?; iii) Use of Short-Acting Beta-Agonists (SABA) reliever for symptoms more than twice/week?; iv) Is there any activity limitation due to asthma?Action: Try to reach the best possible asthma control and then proceed to vaccination. If asthma is severe or only partially controlled, proceed with vaccination in a hospital setting with an observation of at least 60 minutes [16, 27]. COVID-19 vaccine should be administered 2–7 days after biologic administration in asthmatic patients treated with biologics [18].
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Large local reaction to previous COVID-19 vaccination.Action: some documents [11, 14, 28] include this reaction in the green zone. However, according to other consensus (8), we suggest to perform teleconsulting and eventually specific risk assessment in some cases of immediate reaction, in order to exclude a possible allergy to PEG or another excipient. The general indication is to perform vaccination in an outpatient setting with emergency awareness and emergency medication available. Pre-medication with H1 antihistamine should be considered.
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Immediate allergic reactions to drugs or vaccines.Action: specific risk assessment concerning a possible PEG (or another excipient) allergy is required [14, 16, 29]. If skin tests result negative, vaccination should be performed in a hospital setting with an observation of at least 60 minutes. If skin tests result positive, refer to the red zone.Generally, allergy assessment or teleconsulting are indicated in all above cases, if requested by pediatricians or vaccination centers. According to the allergy assessment or teleconsulting, vaccination should be performed in settings where symptoms of anaphylaxis can be recognized as early as possible and promptly treated with epinephrine and further emergency treatment or in hospital settings where it is possible to continue monitoring/treating of the patient in case of need [13, 16, 17, 27]. The allergy assessment or teleconsulting aims to make a certain diagnosis and give specific indications: modify therapy in case of uncontrolled or partially controlled asthma, or pharmacological pre-medication.
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Positive skin tests to excipients
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Previous allergic reaction to the specific vaccine
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Previous severe allergic reaction to a vaccine component or drugs, including PEG or trometamolAction: perform allergy risk assessment; consider that sensitivity and specificity for a skin test to excipients is unknown, and the diagnostic utility of PEG and polysorbate allergy testing is uncertain [5]. According to skin test results, the patient may be considered ineligible for a further vaccination or eligible for another vaccination containing another excipient negative to the skin test. Vaccination in fractionated doses could be considered in selected cases [14]. In all these cases, vaccination must be carried out under strict control in a hospital setting where emergency medical services for resuscitation are available [9, 16, 28].
Low risk | |
Patient characteristics | Action |
Allergic rhinoconjunctivitis and allergic well-controlled asthma Non-anaphylactic allergic reactions to food, insects, and latex | Proceed with vaccinations as usual, according to local guidelines. No allergic evaluation is needed. Therapies for allergies and/or asthma must be continued as usual. Children treated with allergen immunotherapy (AIT) should withhold administration for few days (see text). |
Medium risk | |
Patient characteristics | Action |
Anaphylactic allergic reactions to food, insects, and latex | Consider referral (or teleconsulting) to an allergist-immunologist to confirm the diagnosis and give proper indications. Reach the best possible asthma control and then proceed to vaccination. If asthma control is suboptimal, proceed to vaccination in a hospital setting with an observation of at least 60 minutes. |
Idiopathic anaphylaxis and exercise-induced anaphylaxis | |
Uncontrolled asthma | |
Mastocytosis | Routine vaccination in an outpatient setting with emergency awareness and emergency medication available. Pre-medication with H1 antihistamine should be considered. For high-risk population (previous anaphylaxis, also to vaccinations, known or suspected allergy to excipients, systemic mastocytosis) see red zone. |
Large local reaction to previous COVID-19 vaccination | Specific risk assessment (or teleconsulting) to exclude a possible allergy to PEG or another excipient. Routine vaccination in an outpatient setting with emergency awareness and emergency medication available. Pre-medication with H1 antihistamine should be considered. If skin tests are positive, see the red zone. |
Immediate systemic allergic reactions to drugs or vaccines | Specific risk allergy assessment concerning a possible PEG (or other excipients) allergy. If skin tests are negative, vaccination should be performed in a hospital setting with an observation of at least 60 minutes. If skin tests are positive, see the red zone. |
High risk | |
Patient characteristics | Action |
- Positive skin tests to excipients - Previous allergic reaction to COVID-19 vaccine - Previous severe allergic reaction to a component of the vaccine or drugs, including PEG or trometamol | According to allergic risk assessment, the patient may be considered ineligible for a further vaccination or eligible for another vaccination, containing another excipient that resulted negative to the skin test. In all these cases, vaccination must be carried out under strict control in a hospital setting where emergency medical procedures for resuscitation are available. |