ABSTRACT
Background: The diagnosis of drug allergy requires a previous medical history suggestive of a Drug Hypersensitivity Reaction (DHR). DHRs caused by vaccines are rare (< 1/100.000 doses) and are mainly due to excipients. At the beginning of the COVID-19 vaccination, occasional cases of severe reactions were reported in patients with allergy history. This warning led to an increased demand for allergy testing to evaluate pre-vaccination risk assessment, especially due to the refusal of allergic patients to receive the vaccine. Method(s): Twenty patients were evaluated between May to July 2021, referred for allergology study prior to receiving the vaccine against COVID-19. All patients tested had allergy history. Skin tests were performed with the available excipients of the COVID-19 vaccine: polyethylene glycol (PEG-1500, 10% prick ROXALL), polysorbate 80 (tween 80 prick 0.04 -ID 0.004 mg/ml), and trometamol (prick 1 -ID 0.1 mg/ml). A telephone follow-up was subsequently performed to assess tolerance to the vaccine. Result(s): The median age of the patients was 54.5 years and ninety percent were female. (Table 1) The most frequent allergy history was adverse drug reactions (ADRs) in 18 patients (90%), followed by bronchial asthma (35%), rhinitis (25%), food allergy (25%), and dermatitis (15%). 12 patients (60%) had multiple allergic diseases. The drugs implicated in these ADRs were beta-lactam antibiotics (40%), NSAIDs (20%), radiographic contrast media (15%), and vaccines (15%). Skin tests with the excipients studied were negative in all cases. Subsequently, the COVID-19 vaccine was administered in 16 patients (80%). Six patients (30%) reported side effects expected from the vaccine and no DHRs were described. Although vaccination was recommended to all patients after the study, 4 patients (20%) refused the administration. Conclusion(s): Patients with atopic history do not require an allergology study prior to the administration of the COVID-19 vaccine. Exceptionally, it may be necessary if the patient has a history of suspected DHRs to the excipients involved. The previous allergology assessment did not prevent refusal of vaccination in 20% of the patients. (Table Presented).
ABSTRACT
Background: Trometamol is an excipient present in radiological contrast media, antibiotic drugs such as fosfomycin, and some NSAIDs formulations (namely ketorolac and desketoprofen). Patients with previous hypersensitivity reactions to these drugs could be at a higher risk after the administration of a SARS-CoV- 2 vaccine formulation including trometamol (SARS/Trometamol vaccine) Method: Patients with a previous history of hypersensitivity reactions to drugs including trometamol as excipient, were sent to our Department for assessment, before receiving a SARS/Trometamol vaccine from December 2021 to January 2022 Allergic study included prick-tests with SARS/Trometamol vaccine and trometamol. According to skin-tests results, a controlled administration of SARS/ Trometamol vaccine was performed. Result(s): A total of 59 patients, 42 women (71.2%) and 17 men (28.8%), were included in our study, with a mean age of 57.3 years. Nineteen patients (32.2%) reported a previous history of hypersensitivity reactions to radiological contrast media, thirty-five patients (59.3%) had reacted to NSAIDS, and five patients had suffered reactions to both drug groups (8.5%) None of the studied patients showed a positive skin-test to neither SARS/Trometamol vaccine nor trometamol. Corresponding SARS/Trometamol vaccine doses were administered to all the patients, and no hypersensitivity reactions were observed. Conclusion(s): According to our results, a previous history of hypersensitivity reactions to drugs including trometamol does not seem to increase the allergic risk after the administration of a SARS-CoV- 2 vaccine formulation containing trometamol. Thus, it would not be necessary to perform an allergic study routinely previous to the vaccination of this kind of patients. However, since trometamol allergy is rather rare, more patients should be studied before this conclusion can be generalized.
ABSTRACT
Background: Adverse reaction's reported after COVID 19 vaccination had a negative impact on public opinion. These adverse reactions may be or may be not be mediated by hypersensibility reactions. The proper assesment and the manegament of adverse reactions are crucial in order to offer a safer inmunitation and also to reduce the misinformation and the growing rejection to COVID 19 vaccination. Objective(s): To describe clinical characteristics and the allergological study done in different patients who had an adverse event right after COVID 19 vaccine administration Method: Descriptive study in patients who have experienced an adverse event after one single dose of the SARS CoV2's vaccine. Sex, age, atopy, drug allergies, anaphylaxis reaction (according to EEACI), syntoms, timing, vaccine and dose are described on this study. Skin test were done in every patient (Prick-Test and intradermo reaction) with ARN vaccine samples (Pfizer and Moderna), Adenovirus vaccine extract (Astrazeneca) and a battery of excipients (Polietilenglicol, Polisorbato80 and Trometamol). Result(s): The study included 44 patients with an average of 48,76 +/- 12,23 years, (93% women-29% atopic). 29% of the patients reported to be allergic to other drugs (AINES especially). The most frequent reaction according to EEACI anaphilaxy's classification was Grade 1 with a 61%. Grade 2: 18%, Grade 3: 21%. Urticaria and/or angioedema were the most frequent syntoms (60%) followed by disnea (20%) and being late syntoms (50%) the most usual ones. Pfizer was the most implicated vaccine (64%) with the first dose (84%). Skin tests with Polietilenglicol, Trometamol and Polisorbato80 at different concentrations were negative in all patients but two, one positive to Polisorbato80 0.004mg/ml with a previous sensitization to Prontosan (contains Polisorbato) and another one positive to Trometamol 0.1mg/ml. Conclusion(s): Allergists play a main role to offer the maximum befenits to their patients and to improve the vaccine's safety. Skin tests were the most efective tool to diagnose hypersensibility reactions. The 93,17% of the patients with a negative test result tolerated the second dose. The others did not get the second dose due to their own will. Avoiding the COVID 19 vaccine was recommended in those patients with a hypersensibility to the vaccine components diagnose.
ABSTRACT
Background: Polyethylene glycol (PEG) and polysorbate are two commonly used excipients in cosmetics, therapeutics, and processed foods. They are used not just to stabilize and preserve but also to influence the pharmacokinetics and bioavailability of the active ingredients of these products. Numerous reports have described patients with recurrent urticaria self-reporting multiple unrelated products hypersensitivities. We aim to describe a case series of sensitization to PEG in patients with recurrent urticaria and its implications to the currently available COVID-19 vaccines in Malaysia. Method(s): Data of all patients during the peak vaccination period (March 2021 -May 2021) who had positive intradermal test to surrogate PEG and polysorbate 80 were retrieved and analyzed. They were tested with PEG 4000 (macrogol), PEG 400 (Systane Ultra eye drop) and polysorbate 80 (Tween 80). Result(s): A total of eight patients were skin test positive to PEG and/ or polysorbate 80. The mean age was 35.1 +/- 10.5 years. Only one patient was male. Everyone reported history of multiple product reactions with recurrent urticaria as the major symptom. Majority (75%) had multiple unrelated products hypersensitivities. Four of them had urticarial reactions after the first dose of mRNA vaccine. Two patients were skin test negative to the lower molecular weight PEG 400. Cross sensitization between PEG 4000 and polysorbate 80 was 100%. All patients were subsequently inoculated with two doses of inactivated virus COVID-19 vaccine without any serious sequalae. Conclusion(s): The validity of skin testing towards PEG is not yet clear. Nonetheless it is a promising tool in diagnosing PEG sensitization in selected patients reporting recurrent urticaria with multiple unrelated products. Pretesting of this select group may be considered before the inoculation of PEG-containing COVID-19 vaccine.
ABSTRACT
Background: As we progress with mass vaccination against SARs-CoV- 2, there are key questions about immunogenicity of Covid vaccines that still are not answered. One of the reasons for this is the lack of suitable cellular immune methods that are easy to perform in large amount of vaccinated individuals. Conventional methods of measuring cellular and humoral immunity are complex and expensive in a pandemic situation. Here we present data about in vivo Delayed Type Hypersensitivity (DTH) results on the long-term follow-up of vaccinated immunocompetent health care workers showing that DTH is a suitable and affordable method to understand immunigenicity elicited by Covid-vaccines. This tool could be used to modify vaccine administration to optimize responses obtained in the vaccinated individuals. Method(s): Forty healthy healthcare workers accepted to participate during the vaccination schedule with a mRNA vaccine against SARS-CoV- 2. We measure the DTH cutaneous response after intradermal test of protein S of SARS-CoV- 2 at day 35 and day 200. At the same time, we perform specific anti-RBD IgG using a classic ELISA before vaccination and on days 35 and 200. Result(s): All forty individuals had a positive DTH skin response al day 35, whereas thirty-nine participants had a positive skin test at day 200 (Figure 1). Moreover, although all 40 individuals showed a humoral response of specific IgG against spike protein at day 35 considered positive, most of them have significant lower levels at day 200. Conclusion(s): DTH responsiveness has been shown to be an ideal and easy method to predict cellular immunity response to mRNA vaccines 200 days after starting immunization schaedule with mRNA vaccine for Covid-19. (Figure Presented).
ABSTRACT
Case report Background: Association of chronic spontaneous urticaria (CSU) with malignancies and worsening of urticaria during COVID-19 have been reported. The efficacy of treatment of CSU with omalizumab in the context of malignancies or COVID-19 is not well established. Method(s): Case report of a patient followed for 9 years with CSU. Data collected from Medical Records and interviews during consultations. Result(s): Female, 29 years-old, came to clinic in 2013 for investigation, diagnosed with CSU. She also presented mild asthma, allergic rhinitis and history of urticaria after taking amoxicillin. She had a positive autologous serum skin test, and positive skin tests to dust mite, cat, cockroach, peanut and milk. Her total IgE was 227IU/ mL. Anti-nuclear and anti-thyroid antibodies were negative;ERS 13mm, blood eosinophils 300/mm3, and stool exam negative for parasites. She showed no response to second generation antihistamines up to fourfold doses, with UCT < 6 and CU-QoL = 89. After 6 months, omalizumab was added at 300 mg subcutaneously, every 4 weeks. The patient showed immediate reactions after the two applications of omalizumab: first, diffuse pruritus and throat tightness;second, worsening of urticaria and pruritus, requiring iv medications. Treatment with omalizumab was stopped, she was kept on fourfold dose of bilastine with partial control of symptoms. In 2016, she presented worsening of urticaria (UCT = 1), weight loss of 6kg/2 months, daily fever and enlarged cervical lymph nodes, and was diagnosed with diffuse large B-cell non-Hodgkin's lymphoma. Following chemotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone and rituximab, she presented complete resolution of urticaria. Two years after remission of the lymphoma, in 2019, she presented recurrence of urticaria, and treatment with fourfold dose of bilastine was reinitiated with control of symptoms (UCT = 16). Investigation ruled out recurrence of lymphoma. In May 2021, she was diagnosed with SARS-CoV- 2 infection. Symptoms of COVID-19 were runny nose and low grade fever, however urticaria got worse and no longer responsive to bilastine. Treatment with omalizumab was attempted, with no reactions and good efficacy after the first dose, with an UCT = 15, and urticaria remains controlled on treatment with omalizumab to present. Conclusion(s): In this report, we highlight the efficacy and safety of using omalizumab in a patient with refractory CSU associated with neoplasia and SARS-CoV- 2 infection.
ABSTRACT
Background: Covid 19 is a global epidemic. One of the most important steps in the fight against this epidemic is vaccination. mRNA vaccines are used in vaccination in our country. Among the additives in the vaccine, the substance with the highest allergenic risk is polyethylene glucose (PEG). There are different molecular weights of PEG. Another additive that has a high risk of cross-reaction with PEG as an additive is POLISORBAT 80. Skin tests with drugs containing PEG and POLISORBAT 80 and, if available, tests with vaccines are instructive. Among the drugs containing PEG: Moxifloxacin tablet, ciprofloxacin tablet, Amoxicillin clavulanic acid tablet;Medicines containing polysorbate include: Omalizumab vaccine, Mepolizumab vaccine. The results of the skin test with PEG-containing methylprednisolone (DEPO-MEDROL) and POLYSORBAT-containing triamcinolone (KENACORT-A) in order to be evaluated in terms of vaccine in our 2 patients who had multiple drug sensitivities before were shared. Method(s): Case 1: 33 y, F *There are diagnoses of urticaria and angioedema. Urticaria 30 minutes after taking aspirin, levofloxacin, cefdinir tablet;5 minutes after taking ciprofloxacin tablets, he has anaphylaxis. *Applies before Biontec vaccine. *The patient had a history of anaphylaxis with PEG-containing ciprofloxacin. In the skin tests performed with DEPO-MEDROL and KENACORT-A, 1/100 intradermal test was positive. *The patient for whom Biontec vaccine was not recommended received Synovac vaccine without any problems. Case 2: 52 years, F * He has a diagnosis of urticaria. 5 minutes after general anesthesia and local anesthesia;The patient who had cardiac arrest 3 times was evaluated. The patient, who had Synovac for 2 times without any problems, wanted to have the 3rd dose of Biontec vaccine. *Tested with general -local anesthetic agents. *Ciprofloxacin skin tests are negative;Urticaria plaques developed after 30 minutes of 1/4 tb in oral provocation. In the skin tests performed with DEPO-MEDROL and KENACORT-A, 1/100 intradermal test was positive. *Biontec vaccine is not recommended. Result(s): A safer vaccination is ensured by testing with additives in Covid 19 vaccines. Conclusion(s): Drug additives should also be kept in mind in patients with multiple drug allergies.
ABSTRACT
Background: Since the introduction of COVID-19 vaccines, many reports have focused on adverse reactions. However, there is no global agreement on how to manage those patients. We aim to assess the management of adverse reactions by an immunoallergology department and its outcomes. Method(s): Retrospective analysis of the patients sent to our centre from January to October 2021 for adverse reactions to a COVID-19 vaccine, and who were considered ineligible for a 2nd dose by general practitioners. We collected data on the reported reactions, allergological study and outcomes. Result(s): 123 patients with adverse reactions were included (77% women, n = 95), mean age 55 years-old (min 12;max 92). Pfizer/ BioNTech Vaccine was inoculated in 64 patients (52%);Moderna in 15 (12%);AstraZeneca in 44 (36%). 65 patients (53%) presented symptoms compatible with allergic reactions: 86% (n = 56) with mucocutaneous symptoms, mainly urticaria-like lesions and/or angioedema;17% (n = 11) with suspected anaphylaxis and 5% (n = 3) with Steven-Johnson Syndrome. 19 patients performed skin testing with: PEG2000 (n = 17);polysorbate 80 (n = 15);COVID-19 vaccines (n = 21). Four patients had at least one positive test. 58 patients (47%) presented with non-allergic reactions. They showed great variability of symptoms. Most mild: 47% reported non-specific symptoms (such as malaise, headache, myalgia, fever, or fatigue) and 26% reported local reactions on the inoculation site. Some severe: 6 with deep vein or pulmonary thrombosis, 4 with myocarditis, 2 with stroke or myocardial infarction, and 1 with VITT. Patients with positive skin tests or severe previous reactions (n = 36, 29%) were referred for an alternative vaccine. Those with suspected allergic reaction but negative skin tests were premedicated with antihistamines before the 2nd dose. Follow-up showed: of the 81 patients (66%) who received an additional dose, 25% (n = 20) reported an adverse reaction, which was mild, and no case of anaphylaxis was reported. 16 (13%) refused a 2nd dose, and for 26 (21%) the information could not be obtained. Conclusion(s): The intervention of an allergologist had a significant positive impact on vaccination rates, with 2/3 of patients being reclassified as eligible for a 2nd dose. Allergological study and intervention identified vaccine-allergic patients and guided the decision on vaccine change and premedication, which resulted in a considerably lower number of adverse reactions to the 2nd dose, or at least its severity.
ABSTRACT
Background: Allergic reactions to COVID-19 vaccines have raised concerns, particularly as repeated doses are required. Skin tests with vaccines excipient were found to be of low value whereas the utility of skin tests with the whole vaccine is yet to be determined. Objective(s): we set to evaluate a panel of skin tests and outcomes of subsequent doses of immunization among subjects that suffered an immediate allergic reaction to the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Method(s): In a prospective cohort study during December 27th-2020 to February 22nd-2021 Individuals with allergies who applied to the COVID 19 vaccine referral center at the Sheba Medical Center in israel, underwent risk assessment using an algorithm that included a detailed questionnaire department. Patients were considered to be at high risk for allergic reactions if thery either had: (1) prior anaphylactic reaction to any drug or vaccine, (2) multiple drug allergies, (3) multiplemallergies, or (4) mast cell disorders, as were patients who were deferred by their GP or local allergist or the immunization team from vaccination in the regular setting because of concerns about allergic. reactions. This high-risk group was referred to be immunized with 2 hours of observation by a dedicated allergy team. Result(s): Of the 429/8102 individuals who applied to the COVID-19 referral center and were defined as "highly allergic", 304 (70.8%) were female, mean age was 52 +/- 16 years. This "highly allergic" group was referred to immunization under medical supervision. Following the 1st dose of the BNT162b2, 420/429 (98%) had no immediate allergic event, 6/429 (1.4%) developed minor responses and 3/429 (0.7%) had anaphylactic reactions. During the study period, 218/429 "highly allergic" patients received the 2nd dose, of which 214/218 (98.1%) had no allergic reactions while 4 patients had minor allergic reactions. Other immediate and late reactions were comparable to the general population except for delayed itch and rash that were more common among allergic patients. Conclusion(s): The rate of allergic reactions to BNT162b2 vaccine, is higher among allergic patients, particularly in a sub-group with high-risk history. In this study we showed that the vast majority of patients with a history of allergic diseases and particularly "highly allergic" patients can be safely immunized. Utilizing an algorithm that can be implemented in different medical facilities and include a referral center, a risk assessment questionnaire and a setting for immunization under medical supervision of "highly allergic" patients. Further studies are required to define more specific risk factors for allergic reactions to BNT162b2 vaccine.
ABSTRACT
Background: Vaccination plays an essential role in controlling SARS-CoV- 2 pandemics. Due to initial concerns about hypersensitivity reactions (HR) to these new vaccines, our department, in articulation with Primary Healthcare Services (PHS) has developed several strategies to support COVID-19 vaccination. This work aims to describe those strategies and report the results. Method(s): The strategies developed for COVID-19 vaccination, from March to December 2021, included: 1) telephone support for health professionals (TS for HP) from the Vaccination Centres (VC), 2) priority appointments (PA) of patients classified as a higher risk for HR, 3) hospital vaccination of high-risk patients as defined by the national health authority. A retrospective and descriptive analysis of the support activity developed and from the data of patients vaccinated at the hospital in the same period were performed. Result(s): During the considered period, our department screened 1618 patients: 420 (26%) through telephone support for HP (TS for HP) from VC and 1198 (74%) at priority appointments (PA). After TS for HP, community vaccination (CV) was recommended in 87% (n = 364) of cases and a PA was advised in 13% (n = 56). Of the patients evaluated in PA, 80% were recommended CV, with restriction of the vaccine to administer in 28% of them. We always found an option to vaccine all. At the hospital were vaccinated 178 patients, 83% (n = 147) women, median age (P25-75) 61 (46-76) years. Hospital vaccination criteria were: past history of multiple drug HR (n = 93;52%), HR to vaccines (n = 46;26%), HR to the 1st dose of anti-SARS- CoV- 2 vaccine (n = 30;17%), idiopathic anaphylaxis (n = 10;6%) and systemic mastocytosis (n = 2;1%). 15% of patients (n = 26) performed skin tests with vaccines, which were negative in 25 and inconclusive in 1 case. 145 (82%) were first shots, 32 (18%) second shots, and one booster shot. Only one patient had a mild immediate reaction (2nd booster vaccination), promptly treated with antihistamine and corticosteroid. Conclusion(s): The collaboration strategies adopted by our department allowed the vaccination of 1618 patients and avoided vaccination delays in most of the VC contacts. In our sample, hospital vaccination of patients at higher risk for HR was safe.
ABSTRACT
Background: Sars-CoV- 2 infections are hazardous, especially to the elderly and patients with comorbidities. With no efficient treatment available, newly developed vaccines are the only way to change the course of the pandemic. However, reports of allergic reactions resulted in some patients and practising physicians being concerned about the safety of vaccine administration, particularly in people with severe anaphylactic reactions to multiple or unknown factors in their medical history. This study aimed to develop an allergic workup protocol based on skin prick tests (SPT), intradermal testing (IDT) and intramuscular provocations, and desensitization which may contribute to diagnosis and management of anti-COVID- 19 vaccine allergy. Method(s): 285 patients were enrolled. 205 of them entered the study based on severe anaphylactic reaction to unknown or multiple factors in their medical history which disqualified them for standard treatment. Another 80 patients were enrolled after developing an allergic reaction to the first dose of one such vaccine. In all subjects, SPT and IDT were performed with one of 4 available vaccines. Result(s): 277 patients with negative tests were given a vaccine without complications. Six patients with positive skin tests received desensitization with a reasonable tolerance. One patient did not consent to desensitization and one patient resigned despite negative tests. All in all, 283 (99%) patients were vaccinated using this newly developed protocol. Patients with adverse reactions to the first dose of the vaccine before the study had a significantly lower basal serum tryptase concentration (p = 0.001). Conclusion(s): Skin tests with anti-COVID- 19 vaccines are a useful tool in the vaccination protocol. This protocol enables safe immunization of high-allergy- risk patients even cases of positive skin tests.
ABSTRACT
Globally, tuberculosis (TB) was the leading cause of death from a single infectious agent until the coronavirus (COVID-19) pandemic. In 2020, an estimated 10 million people fell ill with TB and a total of 1.5 million people died from the disease. About one-quarter of the global population, almost two billion people, is estimated to be latently infected with Mycobacterium tuberculosis (MTB). Although latent TB infection (LTBI) is asymptomatic and noncontagious, about 5–10% of LTBI patients have a lifetime risk of progression to active TB. The diagnosis and treatment of active cases are extremely vital for TB control programs. However, achieving the End TB goal of 2035 without the ability to identify and treat the pool of latently infected individuals will be a big challenge. To do so, improved technology to provide more accurate diagnostic tools and accessibility are crucial. Therefore, this chapter covers the current WHO-endorsed tests and advances in diagnostic and screening tests for active and latent TB. © 2023
ABSTRACT
Background: Public concern has risen regarding the risk of hypersensitivity reactions (HSR) due to vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) in the general allergic population, especially in those with a history of anaphylaxis. Moreover, the associated alarm that patients diagnosed with allergies to polyethylene glycol (PEG) could suffer from an allergic reaction to vaccines against SARS-CoV- 2 has become a limitation during the mass immunization campaign. Method(s): Objective: 1. To describe the management implemented between allergology and primary care physicians (PCP) in our territory during the first mass immunization campaign in order to safely reach the largest number of people immunized. 2. To only asses patients at risk of having an HSR to the components of the SARS-CoV- 2 vaccine according to the algorithm implemented in primary care centers. Method(s): A retrospective study was performed including patients referred to the allergist by PCP due to the potential risk of presenting HSR to SARS-COV- 2 vaccines between March and September 2021. An algorithm was created, to assess the potential risk of presenting HSR to SARS-COV- 2 vaccine in allergic population. Patients were visited firstly by PCP, who applied the algorithm proceeding with virtual consultation with the allergist if needed. Risk assessment performed by the allergist determined if vaccination could continue at their assigned place or if an allergological diagnosis approach was needed. The rate of virtual and physical consultations with the allergist as well as the results of skin test and drug provocation tests were recorded. Result(s): A total of 181 patients were assessed virtually. A total of 147 (81%) patients were immunized at their assigned vaccination point after virtual consultation without incidences. On the other hand, 19% of the patients were assessed by the allergist physically and only 12 (6.6%) patients underwent skin tests and drug provocation test with negative results and good tolerance to the vaccine in all cases. Conclusion(s): A careful allergological risk assessment protocol significantly reduced the number of patients who would have avoided vaccination due to a history of allergies or apparent HSR to the first doses of SARS-CoV- 2, demonstrating the low incidence of true allergy to SARS-COV- 2 vaccines in our territory.
ABSTRACT
Background: Vaccination has proven to be the best viable tool for preventing the spread of SarsCov2 infection. The fear of adverse events represents one of the limits of this vaccination campaign. As Allergists, we had a fundamental role evaluating the allergological risks and performing specific tests. The only absolute contraindication to SARS-CoV- 2 vaccination is hypersensitivity to its components. When an individual is allergic to an indispensable medication, it is possible to resort to desensitization. Given the lack of a standardized scheme, the aim of our study is to propose a desensitization protocol for anti-SARS- CoV- 2 vaccines. Method(s): The desensitization protocol we developed consists in the fractioned administration of the entire vaccine dose into 5 separate injections of increasing quantity, through a 2-hour period. Premedication with antihistamines and chromones was administrated. Between January 2021 and January 2022, 23 patients referred to our Unit were deemed with a high risk of hypersensitivity reactions to the vaccines and underwent the desensitization protocol. We here describe 23 consecutive cases of patients who underwent desensitization to anti-SARS- CoV- 2 vaccine. Result(s): 4/23 had positive allergy skin test to Polysorbate and underwent desensitization for their entire vaccination cycle. 19/23 had a previous hypersensitivity reaction to an anti-SARS- CoV- 2 vaccine (18 after the first dose and 1 after the second one). Among 4 patients with sensitization to Polysorbate none developed hypersensitivity reactions after fractionated administration of BNT162b2 vaccine. Among 19 patients that underwent desensitization because of hypersensitivity reactions after I or II dose of vaccine, 15 experienced a reaction following vaccination with BNT162b2, 4 with mRNA-1273 and 4 with ChAdOx1-S recombinant. Furthermore, we categorized their reactions according to WAO score per systemic reactions: 15/19 (79%) grade1, 2/19 (10.5%) grade2, 2/19 (10.5%) grade3. No severe late hypersensitivity reactions were observed. All but one of this 19 patients had no hypersensitivity reactions after vaccination through the desensitization protocol. 1 patient experienced anaphylaxis during desensitization with BNT162b2 vaccine (WAO grade4). No late hypersensitivity reactions were observed. Overall, 22/23 (95.6%) patients that underwent anti-SARS- CoV- 2 vaccination through the desensitization protocol did not experience hypersensitivity reactions. Conclusion(s): Our results suggest that desensitization can be implemented to extend the vaccination to currently ineligible individuals. Larger studies are needed to prove the safety and efficacy of this approach.
ABSTRACT
Background: Most of adverse reactions (ARs) caused by COVID-19 vaccines are self-limited and benign, such as localized cutaneous injection-site reactions, fatigue, headache. However, IgE-mediated hypersensitivity reactions (HSR) to COVID-19 vaccines are considered extremely rare. These HSR are either attributed to the vaccine itself or its excipients. Method(s): We carried out a retrospective study including all cases of suspected immediate HSR induced by COVID-19 vaccination and notified to the pharmacovigilance department of Monastir (Tunisia). Skin tests (Prick and intradermal tests (IDR)) to vaccines and their respective excipients were performed. Result(s): Among 339 ARs following COVID-19 vaccination, only 10 cases were related to suspected immediate HSR (7 females/3 males) with an average age of 46 years old. Clinical manifestations were urticaria in 7 cases, anaphylactic reaction grade 3 in 2 cases and grade 2 in one case. The median delay to the onset of symptoms was 3 hours (few seconds to 24 hours). All immediate HSR were secondary to the first dose of vaccine administration. Suspected Covid-19 vaccines were Vaxzevria in 6 cases, Moderna in 2 cases, COMIRNATY and CoronaVac in one case, each of them. Skin tests (Prick test/ IDR10-1/ undiluted IDR) were performed for all patients. Only 2 patients, who presented urticaria and anaphylactic 0.0shock, had a positive result to the culprit vaccine Vaxzevria. Skin test (Prick test/IDR10-1) to the excipient (Polysorbate 80) was negative. Among patients with negative skin tests (n = 8), six underwent vaccination with the same vaccine with antihistaminic premedication, without recurrence of the HSR. In the two remaining patients, culprit vaccines were contraindicated in view of the severity of the reaction Conclusion(s): Hypersensitivity reactions to COVID-19 vaccines are unpredictable and can vary from a localized reaction to life-threatening anaphylaxis. Skin tests can be helpful in the diagnosis of authentic IgE mediated HSR. However, their sensitivity remains to be determined in a large scale population.
ABSTRACT
Case report Background: P olyethylene g lycol ( PEG) a llergy i s g enerally c onsidered a contraindication to COVID-19 mRNA vaccines as they are formulated in lipid nanoparticles that contain a PEGylated lipid. However, there is an uncertain risk of allergy to mRNA vaccines in PEG-allergic patients and sensitivity of skin testing in the diagnosis of PEG allergy is poor. Our patient presented to Allergy and Immunology Clinic with a history of systemic reaction to PEG (in bowel prep), now requiring a mRNA booster. The patient had tolerated two doses of the AstraZeneca vaccine prior but this vaccine was no longer available in our health region due to safety concerns. Method(s): The chart was reviewed, skin prick testing to polyethylene glycol (PEG) 3350 (Restoralax diluted in water) was negative. Intradermal testing to the Pfizer-BioNTech vaccine at a dilution of 1:100 was positive at 11mm. Histamine and saline controls were appropriate. Result(s): Graded administration of the Pfizer-BioNTech vaccine was offered and consent was obtained. The patient tolerated administration of the vaccine in four divided doses (0.03cc, 0.06cc, 0.09cc, and 0.12cc). The patient was observed for 20 minutes between doses and an hour after the last dose with no reaction. Conclusion(s): We found that skin test reactivity to the Pfizer-BioNTech COVID-19 vaccine, at a nonirritating concentration (1:100), does not reliably predict reactivity on vaccine inoculation. This case highlights that it is possible to safely administer COVID-19 mRNA vaccines to patients with positive intradermal testing to the vaccine and a high suspicion for PEG allergy.
ABSTRACT
Background: During the initial rollout of COVID-19 vaccination in Singapore, the Ministry of Health (MOH) issued recommendations that patients with a history of any previous vaccine allergy be referred to an allergist for further review on suitability to proceed with mRNA-based COVID-19 vaccines. We review the evaluation of these patients with suspected vaccine allergies prior to receiving mRNA-based COVID-19 vaccines. Method(s): Between 8 April and 22 September 2021, 304 patients were evaluated prior to receiving the COVID-19 vaccinations. Of these, 63 (20.7%) patients with suspected immediate hypersensitivity reactions to non-COVID polysorbate-containing vaccines proceeded to have skin prick test (SPT) and Intradermal test (IDT) to polyethylene glycol (PEG)-3350, polysorbate 80 and polysorbate 20 containing products. Another 62 (20.4%) who reported delayed hypersensitivity reactions to polysorbate-containing vaccines proceeded to have direct inoculation (DI) of the Pfizer BNT162b2 vaccine under the supervision of an allergist. The remaining 242 (76.6%) finally assessed not allergic polysorbate-or tolerated previous non-polysorbate- containing vaccines were recommended to proceed with COVID-19 vaccinations at the community vaccination sites. 99 patients in the SPT/IDT and DI group completed a questionnaire-based survey to report any post vaccination reactions. (Figure 1) Results: Of 63 patients who underwent SPT/IDT, 2 (3.2%) with equivocal IDT tolerated both doses of the BNT162b2 vaccine without major allergic reactions. 61 (6.8%) patients with negative SPT/IDT and 62 (100%) in the DI group completed both doses of BNT162b2 vaccination without major reactions. Among those who completed the questionnaire survey, 13 (13%) reported reactions including non-specific rashes and mild urticaria/angioedema post first dose vaccine. All subsequently completed the second dose of the BNT162b2 vaccine following allergist review;with 8 (61.5%) reporting similar mild skin reactions. Conclusion(s): Majority of those with suspected reactions to polysorbate containing vaccines are able to tolerate the BNT162n2 vaccine which contains PEG-2000. Skin tests prior to mRNA COVID-19 vaccination is unnecessary. Those who report mild potentially allergic reactions after the first dose are able to tolerate the second dose of the BNT162b2 vaccine.
ABSTRACT
Background: National guidelines recommend that patients with high risk of allergic reactions to COVID-19 vaccinations must undergo allergological evaluation before authorizing vaccination. To date, allergological testing to COVID-19 vaccines and its excipients is not standardized. There is a need to provide more data on skin testing (ST) to COVID-19 vaccines. In this study, we aimed to evaluate the performance of skin testing with SARS-CoV- 2 vaccines and their excipients in our cohort of adult and pediatric patients. Method(s): All patients evaluated for a suspicion of allergy to any of the vaccine components (polyethylene glycols (PEGs) and polysorbate (PS)), or with a history of immediate or delayed reaction to a first injection of an mRNA vaccine were included. Evaluated patients received the following ST: *PEG 400 and 4000 (100 mg/ml), prick (PT) 1:1 and intradermal tests (IDR) 1:100,000, 1:10,000, 1:1000, 1:100, 1:10. *PS80 (0.4 mg/ml), PT 1:1, IDR 1:1000, 1:100, 1:10. *Tozinameran (Comirnaty) vaccine (30 mug/0.3 ml), PT 1:1 and IDR 1:10. ST readings were performed after 20 minutes for immediate reaction and 24 hours for delayed reaction. Patients were systematically contacted by phone after vaccination to assess side effects including anaphylaxis. Result(s): Between February 1st and October 31st 2021, 83 patients underwent allergological testing, with a majority of female (83.1%). Age (mean +/- SD) was 51 +/- 18 years old (yo) (range: 12-91 yo). Among those patients, 35 were tested following a reaction to the SARS-CoV- 2 vaccine and 48 for a suspected allergy to an excipient. No patients reported anaphylactic reaction after a COVID vaccine. Among them, 13 had positive ST (1 patient to PS80 IDR, 1 patient to PS80 PT and vaccine IDR, 11 patients to vaccine: 5 delayed IDR, 5 immediate IDR, 1 doubtful IDR). Eleven patients were vaccinated, well tolerated. We have no information about COVID vaccination for 2 patients. Out of the 70 patients with negative ST, 5 chose not to be vaccinated and 54 (77.1%) got vaccinated (11 (15.7%) did not respond to the phone call). No anaphylactic reactions were reported. Conclusion(s): In our cohort, vaccinations do not lead to hypersensitivity reactions, regardless of test results. We did not find real IgE mediated allergy. Vaccine IDR seemed too irritating and did not contribute to the diagnosis of vaccine hypersensitivity. The clinical context and skin tests results are helpful in authorizing vaccination.
ABSTRACT
Background: Use of ultrasound contrast agent spread increasingly in worldwide. Although few side effects are published, number of increase anaphylactic reaction is reported. A recent cautionary remark was published about polyethylene glycol (PEG) as culprit for some ultrasound contrast agent hypersensitivity (Krantz et al. JACIP. Avril 2020). A 22 years-old woman was referred for a severe anaphylaxis after a second injection of Sulphur Hexafluoride (SonoVue, Bracco, Milan, Italy). The investigation was performed to explore hepatic multinods. She already had presented with uncomfortable feeling, generalized pruritus and nausea few minutes after the first injection of Sonovue, 10 months earlier. Three months before, she has recieved also a first injection of SPIKEVAX without any reaction. As Sonovue and SPIKEVAX contain PEG, we looked for a hypersensitivity to PEG and RNAm COVID-19 vaccine. Method(s): Skin tests and basophil activation test (BAT) with expression of CD63 were performed for SonoVue, PEG 3350 and 4000 and COMIRNATY. Result(s): Skin tests were negative for all products except the undiluted IDT to COMIRNATY. BAT to PEG and SonoVue were negative but positive to COMIRNATY. Despite a fractioned administration of COMIRNATY, the patient presented with an acute urticaria few minutes after the last injection Conclusion(s): The relationship between PEG, RNAm vaccine, and hypersensitivity to SonoVue is once again highlighted by this new report. (Soni et al. J Am Soc Echocardiogr, Oct 2021).
ABSTRACT
Background: Polyethylene glycol (PEG) is being used for the first time as an excipient in mRNA vaccines against SARS-CoV- 2 containing PEG 2000, highlighting it as a potential cause of anaphylaxis. We aim to report clinical cases of severe allergy to PEG and furthermore to assess the usefulness of skin tests (ST) performed with the commercial extract PEG 1500 for the allergy work-up of patients with suspected allergy to SARS-CoV- 2 vaccines. Method(s): We evaluated 126 patients with moderate to high risk of allergy to SARS-CoV- 2 vaccination referred to our Allergy Department from March to December 2021. ST were performed with extract PEG 1500 (Roxall), using the following methodology: prick tests with 0.1%, 1% and 10% concentrations, with readings at 30 minutes (according to manufacturer's instructions);if negative, intradermal tests (IDT) were performed with the 1/10 dilution (0.01%), except in cases of anaphylaxis, where dilutions 1/1000 and 1/100 were used (adapted from previous publication using PEG 20000). Immediate IDT readings were made at 30 minutes and delayed readings at 24 hours. The same protocol was applied to 5 healthy controls who received PEGylated vaccines. Result(s): We present 6 cases of severe PEG allergy: one near-fatal anaphylaxis after glucocorticoid injection containing PEG 3350 and five systemic allergic reactions after mRNA vaccine containing PEG 2000 (Pfizer-BioNTech or Moderna). All patients had positive immediate IDT using PEG 1500 allowing the diagnosis and the selection of vaccine without PEG. All of them were negative to polysorbate 80. One patient developed anaphylaxis following IDT 0.01%. In the remaining 120 patients, the ST using PEG 1500 were negative in immediate and delayed reading of IDT. Seven patients were positive to polysorbate 80. All healthy controls had negative ST using PEG 1500. Conclusion(s): To our knowledge this is the first case series describing the allergy work-up testing with commercial extract PEG 1500 in the scope of SARS-CoV- 2 vaccination. ST using extract PEG 1500 revealed to be a useful tool for the diagnosis of PEG allergy, since it allowed confirming six cases of severe PEG allergy, contraindicating the further administration of PEGylated vaccines. It also allowed allergy exclusion in one hundred cases that took afterwards SARS-CoV- 2 vaccines containing PEG 2000. Moreover, healthy controls had negative IDT demonstrating the reliability of the proposed procedure. Investigation should only be conducted in a specialized drug allergy centre.