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Greater Mekong Subregion Special Article GMSMJ Medical Journal

Vaccinating against COVID-19 in Allergic Patients Pisuttikan Rangkakulnuwat, M.D.1 1Department of Pediatrics, School of Medicine, Mae Fah Luang University, Chiang Rai 57100, Thailand Received 2 June 2021 • Revised 14 June 2021 • Accepted 30 June 2021 • Published online 1 September 2021

Abstract: It is over a year since the outbreak of coronavirus (COVID-19) and we are still facing an ongoing pandemic. Whilst the number of infected patients and death rates are increasing everyday, newly developed are the main hope for humanity to end this misery. From December 2020, emergency authorized vaccines had been distributed to many parts of the world. Studies of the have confirmed effectiveness with only very rare severe adverse reactions. There are no absolute contraindications for use of the vaccines in people with a history of and preexisting allergic diseases. However, risk assessment and stratification are crucial to ensure ongoing safety for vaccine injection services. The precautions in place for use of the COVID-19 vaccines within high-risk populations include patients with a history of anaphylaxis to previous , severe/uncontrolled asthma, and underlying mast cell disorders. These patients should have their vaccine injections under healthcare provider supervision. A consultation with an expert will provide deeper evaluation and shared decision-making for use of the appropriate vaccine. The observation period for the patients with risks of allergic reactions should be at least 15-30 minutes. If anaphylaxis occurs, prompt treatment improves the survival outcomes. Anaphylaxis is a treatable condition without long-term effects. Taking all of this into account, we encourage everybody to join the campaign. Do not let the fear of the reactions outweigh the advantages of being vaccinated.

Keywords: COVID-19, Vaccine, Anaphylaxis, Allergy

Introduction from asymptomatic or mild illness cases, Since the outbreak of coronavirus to critical respiratory failure and shock2, 3. (COVID-19) and emerging of SARS-CoV-2 For over a year, people around the world variants, over 170 million confirmed cases are now living in a “New Normal” lifestyle, and 3.5 million deaths have been reported under strict social restrictions, to prevent globally, according to the World Health viral transmission. Despite this a rising Organization (WHO) as of June 20211. number of cases and death rates are still The disease has affected people differently, occurring everyday. To end this ongoing

Corresponding author: Pisuttikan Rangkakulnuwat, M.D. GMSMJ 2021; 1 (3): 125-138 Department of Pediatrics, School of Medicine, Mae Fah Luang University, Chiang Rai 57100, Thailand Email: [email protected] @2021 GMSMJ. Hosting by Mae Fah Luang University. All rights reserved

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pandemic, vaccination is an effective such as pain and swelling at the site of intervention to provide protective immunity injection or a systemic reaction, such against the virus and significantly reduce as fever. Minor reactions resolved spon- morbidity and mortality among large taneously after a short period. The severe populations4-6. From December 2020, more reaction may cause patients disability for than 1.5 billion doses of vaccines have been a definite of time but not results in long- administered, with good efficacy and low term morbidities, such as seizure or allergic rates of serious adverse events7. In Thailand, reactions to vaccines. Rarely, a severe 3.7 million doses of vaccines have already reaction results in death. Subjects with been given and currently a plan on mass underlying conditions are likely to have distribution of vaccines is due to start on severe adverse events after vaccination11. June 7, 2021. Although the vast majority of To monitor medication safety, authorities people are willing to get vaccinated, some in each country have set up surveillance people may refuse to join the immunization systems of suspected adverse events on program due to multiple factors. Concerns vaccines, such as the Vaccine Adverse about unknown future effects and misinfor- Event System (VAERS) in the United mation are known to lead to vaccine hesi- States [VAERS - Report an Adverse Event tancy. This situation might delay success in (hhs.gov)], the European medicines agency the control of the pandemic8,9. This article (EMA) in Europe [European Medicines aims to review adverse events following Agency (europa.eu)], (MHRA) in the UK COVID-19 immunization, in which the and the Active surveillance system for author will focus on allergic reactions to COVID-19 Vaccine (App-Based Monitoring vaccines and immunization in allergic or Hospital-Based Safety Monitoring) at patients. The aim is to encourage and build https://co-vaccine.moph.go.th in Thailand. confidence in vaccination among the general The causality assessment or determi- population and healthcare providers. nation of a relationship between the two events is a tool for healthcare providers Adverse event following to find potential causes of AEFI, based (AEFIs) on evidence studies to avoid bias and An adverse event following immuni- confounders. Several factors may precipitate zation (AEFI) is “…Any untoward medical unwanted events. However, if the link to occurrence which follows immunization the vaccines is suspected, the events must and which does not necessarily have a occur only after the injections. Other causal relationship with the usage of the considerations that could alternate the vaccine…”10. The adverse events can be causes of the events including, preexist- any unintentionally noxious signs and ing diseases, and newly acquired illness, symptoms or abnormal laboratory results. exposure to drugs or toxins, and The reactions may range from minor or preceding the vaccinations.12 Classification local reactions to severe reactions. Minor of AEFIs, definitions and examples are reactions are mild unfavorable symptoms shown in table 1.

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Table 1 Classifications, definitions, examples and cluster characteristics of AEFIs (Adapted from World Health Organization. (‎2014)‎. Global manual on surveillance of adverse events following immunization, 2016 update. Available from https://apps.who.int/ iris/handle/10665/206144)13

Classification of Definition Example Cluster characteristics AEFI • Vaccine An AEFI that is caused - Biological - Cases received the product-related or precipitated by a plausibility of same vaccine or lot reaction vaccine due to one or the vaccine - No similar cases in more of the inherent products the community properties of the - Individual’s - Increased frequency vaccine product reactions to the reported from multiple properties of settings to known vaccines such as vaccine reactions allergic reactions to vaccines, aseptic meningitis following • Vaccine quality An AEFI that is - Insufficient defect-related caused or precipitated inactivation of reaction by a vaccine due to wild-type vaccine one or more quality agent defects of the vaccine - Contamination product, including during manufac- the administration turing process device, as provided by the manufacturer. • Immunization An AEFI that - Error in vaccine - Cases received error-related is caused by preparation by vaccines from the reaction inappropriate health care workers same healthcare vaccine handling, - Contamination worker or facility prescribing or during preparation, and there are no administration and transportation, other cases that thus, by its or storage nature - Defect in and transportation - Error in administration techniques - Identification error

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Classification of Definition Example Cluster characteristics AEFI • Immunization An AEFI arising - Not related to - Cases of symptoms anxiety-related from anxiety about properties of after immunization reaction the immunization the vaccines are well-recognized - Individual’s as anxiety-related psychological reactions during reactions immunization - Top four frequent programs targeting reactions (faint, adolescent girls hyperventilation, vomiting, convulsions) • Coincidental An AEFI that is - Not related to - Cases in the event caused by something properties of unvaccinated other than the the vaccines population are vaccine product, - Inevitable events occurring at about the immunization error could occur same rate/proportion as or immunization especially during among the vaccinated anxiety the mass campaign from the same area in - Example: death of the same age group the infant following - Calculating the days after DTP expected rate of vaccination (could an adverse event be from the vaccine may be helpful for or a coincidental investigators. death at a normal death rate of the infancy period)

Cases selection for causality assess- Assessing reactions to vaccines ment is crucial. Serious AEFIs that result in Currently (June 2021), there are seven death, hospitalization, significant disability vaccines in use worldwide, of these five or congenital anomaly, the events that are verified for use by WHO and available happened at an unusual rate or severity for use in Thailand. These emergency and clusters that largely impacted public authorized COVID-19 vaccines, the health policy are the main focus for causality recommended schedules of administration, assessment.12 and frequent reported adverse reactions, are shown in table 2. The majority of the cases report only mild symptoms, usually self-limited and not requiring additional treatment.

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Table 2 Authorized COVID-19 vaccines, recommended schedules of administration, and frequent adverse reactions.14-20

Platform Developer/ Dose schedule and Common side effects Vaccine name administration RNA-based BioNTech–Pfizer Two doses Injection site: pain, vaccine (BNT162b2) (day 0, day 21) swelling, redness Intramuscular Systemic: fatigue, headache, muscle pain, chills, fever, joint pain Moderna Two doses Injection site: pain, (mRNA-1273) (day 0, day 28) swelling, redness Intramuscular Systemic: fatigue, headache, muscle pain, chills, fever, nausea, joint pain Adenovirus AstraZeneca and One (day 0) or Injection site: pain vector University of two (day 0, day 28 Systemic: fatigue, (Nonreplicating) Oxford or 8-12 weeks) doses headache, muscle pain, (AZD1222) Intramuscular nausea, fever, joint pain Janssen One (day 0) or Injection site: pain, (Johnson & Johnson) two (day 0, day 56) redness, swelling doses Intramuscular Systemic: fatigue, headache, muscle pain, nausea, fever Inactivated BBIBP-CorV Two doses Injection site: pain, (Sinopharm) (day 0, day 21-28) swelling Intramuscular Systemic: fatigue, headache, muscle pain, nausea, fever, diarrhea CoronaVac (Sinovac) Two doses Injection site: pain, (day 0, day 14-28) redness, swelling intramuscular Systemic: fatigue, headache, muscle pain, nausea, fever, diarrhea

Hypersensitivity reactions to COVID-19 a rate of 11.1 per million doses of BioNTech– vaccines Pfizer vaccines, 71% of the onsets were Despite safety profiles of vaccine phase within 15 minutes after injection, over 95% 3 trials, hypersensitivity reaction is the issue have been discharged home without any that raises the public fear of vaccination. deaths.21 Clinical recognition of anaphylaxis Nevertheless, at the date of the VAERS is very important to ensure provision of early report, confirmed anaphylaxis occurred at essential initial treatments, before taking

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of a thorough history, physical exam, and previously used term “Anaphylactoid” other investigations. Mechanisms of imme- represents reactions that resemble anaphy- diate reactions are divided into three main laxis without evidence of IgE. These clinical categories, Immunoglobulin E (IgE) mediat- features may result from direct mast cell ed reaction, Non-IgE mediated reaction, and and basophil activation, activation of non-immune reaction (vasovagal reaction). complement pathways, and many other For IgE-mediated reaction, the symptoms pathways. In this case, serum for tryptase can be mild, such as urticaria and pruritus, will be of benefit to distinguish between the to presenting with a severe multi-systemic two conditions.22 Comparison of anaphylaxis reaction, known as anaphylaxis. The and vasovagal features are shown in table 3.

Table 3 Comparison of anaphylaxis and vasovagal features (Adapted from Banerji et al)23

Characteristics Anaphylaxis Vasovagal reactions Onset after vaccination 15-30 minutes Within 15 minutes Signs and symptoms Consciousness Anxiety, may progress to Fainting sensation, dizziness, unconsciousness loss of consciousness in some cases Pulse Rapid, weak, and irregular Slow, weak but regular Blood pressure Hypotension (SBP<90) Variable; may have In children: hypotension, or bradycardia SBP <70 mmHg +2 x age during syncope event (year) in 1-10 years old Respiratory Difficulty breathing; Variable; if accompanied by coughing, sneezing, anxiety, may have an elevated wheezing, stridor respiratory rate Cutaneous - Warm skin, progressing - pallor, diaphoresis, to clammy and pallor clammy skin sensation, - pruritus urticaria in >90% facial warmth of cases - angioedema Gastrointestinal Nausea, vomiting, abdominal Nausea, vomiting pain, diarrhea

Patients at risk for COVID-19 vaccines components, previous drug allergy, atopic anaphylaxis history (especially asthma), and drugs or For newly developed vaccines, it is substance use/ activities before vaccination always a challenging question of who is at must be obtained. Currently, proposed risk risk of anaphylaxis. Ongoing research is factors for COVID-19 vaccines anaphylaxis needed to identify specific risk factors. A are as followed 24 detailed history, including allergy to vaccine

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• Patients with previous anaphylactic Investigation of the culprit agents episode to vaccines responsible for the patient’s reaction, allergic • Patients with mastocytosis and testing (skin prick test, intradermal skin test, other mast cell disorders and blood testing), and allergist consultation • Patients with severe/uncontrolled are crucial to lowering the risks of future asthma. vaccination.

Table 4 Current emergency approved COVID-19 vaccines and excipients27

Vaccines Excipients BioNTech–Pfizer (4-hydroxybutyl) azanediyl) bis (hexane-6,1-diyl) bis (BNT162b2) (2-hexyldecanoate)] (ALC-0315), 2-[()- 2000]-N,N ditetradecylacetamide (ALC-0159),1,2- distearoyl-sn-glycero-3-phosphocholine cholesterol, potassium chloride, potassium dihydrogen phosphate, chloride, disodium phosphate dihydrate, sucrose, water for injection Moderna Lipids (SM-102, 1,2-dimyristoyl-rac-glycero3-methoxy- (mRNA-1273) polyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose AstraZeneca and L-Histidine, L-Histidine hydrochloride monohydrate, University of Oxford Magnesium chloride hexahydrate, polysorbate 80, (AZD1222) , Sucrose, , Disodium edetate dihydrate, Water for injection Janssen Sodium chloride, citric acid monohydrate, polysorbate 80, (Johnson & Johnson) 2 hydroxypropyl-B-cyclodextrin (HBCD), ethanol (absolute), BBIBP-CorV Aluminum hydroxide, disodium hydrogen phosphate, (Sinopharm) sodium dihydrogen phosphate, sodium chloride, sodium hydroxide, sodium bicarbonate, M199 CoronaVac (Sinovac) Aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride

Frequently, the immediate allergic A list of excipients in the vaccine is shown reaction is due to excipients components in table 4 (Inactive ingredients in the vaccine that helps For the mRNA vaccines, Polyethylene formulate the product, to increase stability, glycol (PEG, also known as macrogol) and efficacy, and sterility, such as egg protein, polysorbate, the additives used to improve gelatin, formaldehyde, thiomersal, etc.)25,26 water solubility in the vaccines, are the

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key components that contribute to IgE- COVID-19 Vaccination in patients with mediated reactions.28 PEG is contained in preceding allergic diseases35 many household and cosmetic products, The allergy, asthma and immunology such as toothpaste and skin creams. Association of Thailand (AAIAT) recom- A variety of medications e.g., laxative mend that there is no absolute contraindica- agent for bowel preparation in colonoscopy, tion for COVID-19 vaccine in patients with Methylprednisolone acetate (Depo-Medrol), preceding allergic diseases. The details for Medroxyprogesterone acetate (Depo- each allergic disorders are as followed, Provera) contain PEG 3350. Hence, this specific formulation of PEG in the mRNA Patients with asthma vaccine is designed to stabilize the liposome Patients with asthma can be vaccinated portion, and is in use for the first time for with COVID-19 vaccines. Patients with vaccination purposes. Polysorbates, on the controlled asthma should continue their other hand, are extensively used in common controller medications even on the day of injectable medications and vaccines, vaccination. For uncontrolled asthma and including (Fluarix quad, severe asthma patients, however, there are Flulaval Quad), DTaP (Infanrix), and precautions for these groups, especially Rotavirus (RotaTeq). Polysorbate 80 is used those who are using the systemic steroid in AstraZeneca and Johnson & Johnson. for controlling symptoms at the time of These two chemicals have potential cross- vaccination. Patients who are not well- reactivity due to their structural similarity. controlled asthma should consult with their Though to the substances are physician before getting vaccinated. For the rare, sensitization in the prior exposure to patients who currently receiving biologic polysorbate 80 had been reported before therapy, such as omalizumab, benralizumab, the first dose of vaccination 23,28,29 or dupilumab, at least 7 days intervals Aluminum is a strong adjuvant that after the last dose of biologic medication is enhances immunogenicity in classical recommended before vaccination. inactivated vaccines. Several vaccines, for instance, and vaccines, Patients with food allergy within controlled injectable limits, have Patients with any food allergy can go on used this adsorbed compound, with a good vaccinating with covid-19 vaccine without safety profile, for decades. The aluminum special precautions. itself can cause local reactions, such as granuloma formation and skin rash, and Patients with drug allergy anaphylaxis can occur.30,31 In phase 3 and Patients with a history of drug allergy phase1/2 study of inactivated COVID-19 including antibiotics (i.e. penicillin, sulfa), vaccines, no anaphylaxis had been Non-steroidal anti-inflammatory drugs observed.19,32 Though all of these reactions (i.e. ibuprofen, naproxen, aspirin), anti- are rare, to date (June 2021), in the real convulsants, gout treatment, and radiocon- world, 17 per million anaphylaxis episodes trast media allergy can be vaccinated with were reported in Chile and Thailand.33,34 COVID-19 vaccine. However, a 30-minute Further research and monitoring of the observation period under health care reactions are ongoing. provider supervision is recommended.

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Patient with history of vaccine allergy Asthma, and Immunology (ACAAI) recom- Patients who previously had severe mend a list of questions for physicians and allergic reactions to other vaccines and other providers to ask patients, to screen for who previously had severe reactions or the risks of allergic reactions. The example urticarial rash after the first dose of of the questions are as following, COVID-19 vaccine should consult their • Do you have a history of severe physician before getting COVID-19 allergic reaction to an injectable medication? vaccines. • Do you have a history of severe allergic reaction to a previous vaccine? Vaccination safety measures and precau- • Do you have a history of a severe tions allergic reaction to polyethylene glycol According to the CDC, “…people (PEG), a polysorbate, or polyoxyl 35 castor should get vaccinated even if they have a oil (e.g., paclitaxel)? history of severe allergic reactions not related • Do you suffer from allergies or to vaccines or injectable medications….” allergy-like diseases? (e.g., mast cell Since the benefits of COVID-19 vaccinations disorder) greatly exceed the risks of allergy, everyone These questions triage the patient should be encouraged to join the campaign. whether to proceed with the vaccination, referral for further evaluations, or using The first dose of COVID-19 vaccination other alternative vaccines. In addition, Before the first dose of COVID-19 people with higher risks should be monitored vaccination, The European Academy of for a longer period. Schematic for screening Allergy and Clinical Immunology (EAACI) question and risk stratification is shown in and The American College of Allergy, figure 1.27,36,37

Figure 1 Schematic for screening question and risk stratification. (Adapted from Turner P et al.) 27

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(Detailed in red box is newly arranged) vaccines. This risk stratification ensure § British Thoracic Society (BTS) and Global safety for all patients for current and future initiative for asthma (GINA) recommend vaccination. that Patients with asthma who currently During the observation period, on biological therapy should not receive healthcare providers should obtain the COVID-19 vaccine on the same day, a 7- day patient’s vital signs and look for any interval is advisable (recommendation as of abnormal clinical symptoms. Emergency Mar 2021)38, 39 Supplies and medications should be readily Ŧ No clear evidence on pretreatment of prepared. In the case of anaphylaxis, antihistamine with COVID-19 vaccine, the early recognition and appropriate initial medication may mask initial symptoms or management improve the outcomes. In reactions some situations, patients might not fulfill In figure 1, the green box, yellow box all the diagnostic criteria. However, from the and red box represent the low, medium expert panel discussion, whenever severe and high risk for severe allergic reactions allergic features are in doubt, epinephrine following the first dose of COVID-19 is the treatment of choice40. For all patients vaccination, respectively. Patient with with suspected allergic reactions, a detailed previous allergies, mild or local reaction to history, physical examination, and initial previous other vaccines, patients currently blood sampling (e.g., tryptase) is recom- on immunotherapy and patients with mended. Consider referral for allergist for controlled asthma can proceed to COVID-19 further evaluation. vaccination safely. A routine 15- to 30- minute For local reactions, a self-treatment observation is generally recommended. by cold compression at the side of injection, Patients with a history of anaphylaxis to exercising the arms, over-the-counter multiple drugs or previous vaccination are pain-reliever medications, and drinking at medium risk. These patients may need plenty of water can reduce the symptomatic detailed evaluation before getting vaccinated. discomfort. Some people might experience A premedication with antihistamine (e.g. delayed localized hypersensitivity reac- cetirizine, fexofenadine) may reduce mild tions. Magaret et al. reported a case series discomforting symptoms such as mild rash or of 16 patients who received mRNA vaccine itching. However, this may delay early signs (Moderna) with erythematous rash, pruritus, of anaphylaxis and may delay treatments, induration, and tenderness at the site of which could lead to morbidity and mortality. injection, in which the median onset was Since the anaphylaxis episodes usually 7 days after the first dose and 5 days after occur at 15 to 30 minutes after injection, the second dose. The lesions may persist for therefore at least 30 minutes of observation up to 21 days. All the skin lesions resolved after vaccination is needed. Health care spontaneously and so are not considered as providers should consult expert or allergist contraindications for the second dose of the before giving the vaccines to the high risk vaccine 41. patients who had history of anaphylaxis to any component of COVID-19 vaccines. For Second dose of COVID-19 vaccination mRNA vaccine, skin test with polysorbate It is crucial to follow up on patients’ 20 and 80 is important to confirm diagnosis clinical symptoms after the first dose of of PEG allergy. If possible, patients with vaccinations. According to the CDC recom- positive skin test should be injected with mendation as of Mar 202142, “...if a person other alternative types of COVID-19

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has received the first dose uneventfully, outcomes and will ensure patient’s safety, then they can proceed to the second dose and vaccine confidence, as part of the in the same manner...” vaccination service. If the patients experience mild allergic reactions, likewise, only pruritus or urticaria, References a second dose can be given with precautions. 1. World Health Organization. WHO Pretreatment with fexofenadine or cetirizine Coronavirus (Covid19) Dashboard. 1-2 hours before the injection might reduce Available from: http://covid19.who.int. the discomforting symptoms. A 30-minute Access June 2, 2021 observation period is required to ensure 2. National Institutes of Health. Clinical patient safety. However, once a person Spectrum of SARS-CoV-2 . has severe allergic reactions, healthcare Available from: https://www.covid19 providers should consider further evaluation treatmentguidelines.nih.gov/overview/ and shared decision-making, related to the clinical-spectrum/. Access May 28, risks and benefits of receiving the vaccine, 2021 with the patient and an allergist. Even 3. Zeng H, Ma Y, Zhou Z, Liu W, though the non-irritating concentration of Huang P, Jiang M, et al. Spectrum the vaccine’s component had not been and Clinical Characteristics of Symp- standardized, skin testing may be utilized tomatic and Asymptomatic Corona- to identify the potential component-related virus Disease 2019 (COVID-19) With symptoms. For re-challenging of the and Without Pneumonia. Front Med COVID-19 vaccines, there is a lack of (Lausanne) 2021; 8: 645651. evidence of efficacy of this23. Also the 4. Khoury DS, Cromer D, Reynaldi A, American Academy of Allergy Asthma& Schlub TE, Wheatley AK, Juno JA, Immunology COVID-19 response task et al. Neutralizing levels are force states that in the present situation, highly predictive of immune protection with often limited vaccine resource, it would from symptomatic SARS-CoV-2 be more beneficial for the vaccine to be used infection. Nat Med 2021; 27 (7): 1205-11. for vaccination rather than for evaluation of 5. Haas EJ, Angulo FJ, McLaughlin JM, the reactions.43 Anis E, Singer SR, Khan F, et al. Impact and effectiveness of mRNA Conclusion BNT162b2 vaccine against SARS- In the battle against COVID-19, CoV-2 infections and COVID-19 cases, vaccination is the prime key to success. hospitalizations, and deaths following There are no absolute contraindications for a nationwide vaccination campaign in COVID-19 vaccine use in any patients with Israel: an observational study using pre-existing allergic conditions and diseases. national surveillance data. Lancet While the benefits of vaccination are clear 2021; 397 (10287): 1819-29. and the risks of severe adverse events are 6. Vasileiou E, Simpson CR, Shi T, Kerr S, rare, fear of adverse reactions must be Agrawal U, Akbari A, et al. Interim addressed. Healthcare providers have a role findings from first-dose mass in promoting the COVID-19 immunizing COVID-19 vaccination roll-out and campaign. Well-prepared and prompt COVID-19 hospital admissions in treatment of any emergency conditions, at Scotland: a national prospective cohort the time of vaccination, helps improve the study. Lancet 2021; 397 (10285):1646-57.

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