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.
ABSTRACT
Summary: Background. Polyethylene glycol (PEG) is being used for first time as an excipient for mRNA anti-SARS-CoV-2 vaccines containing-PEG2000, highlighting it as a potential cause of anaphylaxis. Objective. To assess the usefulness of skin tests using PEG1500 extract in patients with suspected allergy to SARS-CoV-2 vaccines. Methods. We evaluated 126 patients with moderate-high risk of allergy to SARS-CoV-2 vaccines referred to our department from March-December 2021. Skin tests were performed with PEG1500 extract (Roxall), using a stepwise approach, with readings at 30 minutes: prick tests with 0.1%, 1% and 10% concentrations; if negative, intradermal tests with 0.0001%, 0.001% and 0.01% concentrations. The same protocol was applied to 5 healthy controls. Results. Six patients had positive immediate intradermal tests with PEG1500, all with severe PEG allergy: one with a near-fatal anaphylaxis after glucocorticoid injection containing-PEG3350 and five with systemic allergic reactions after mRNA vaccines containing-PEG2000 (Pfizer-BioNTech or Moderna). One patient developed anaphylaxis during intradermal test. These six patients were negative to polysorbate 80. The remaining 120 patients had negative tests to PEG1500; seven had positive tests to polysorbate 80. All controls had negative tests. Conclusions. To our knowledge this is the first study describing the allergy work-up testing with PEG1500 commercial extract in the scope of SARS-CoV-2 vaccination. The algorithm designed for skin tests revealed to be a useful tool. Severe PEG allergy was diagnosed in 5% of patients, contraindicating PEG-containing vaccines. PEG allergy was excluded in one hundred patients that afterwards took SARS-CoV-2 vaccines containing-PEG2000. Investigation should be conducted in specialized drug allergy centres.
ABSTRACT
Background: COVID-19 vaccines are being administered all over the world, but information is lacking about the frequency and type of allergic reactions associated to these new vaccines. Method: Retrospective study of health care professionals (HCP) from our hospital who received COVID 19 vaccine Comirnaty, between 29/12/2020 and 20/2/2021. We reviewed clinical data, particularly the immediate reactions after the administration (<6h), skin tests (ST) and graded vaccine administration. Following national guidelines, all HCP with previous history of food, drug or hymenoptera venom allergy or idiopathic anaphylaxis (IA) were first evaluated by an allergist. Vaccination was postponed if HCP had previous history of IA and/or recurrent anaphylaxis (RA), severe allergic reactions to vaccines and mast cell activation syndromes. ST to the vaccine (prick and intradermal) were performed in HCP with IA and/ or RA, severe allergic reactions to vaccines and HCP with immediate reactions to the 1st dose. Graded administration of the vaccine (0.1+0.2cc after 30') was performed in the postponed HCP and the ones with immediate reactions to the 1st dose. Results: From 3073 HCP who received the vaccine, 74.2% were female, mean age 40.2 years-old ± 13.4, 316 (10.3%) were evaluated by an allergist and 4 (1.3%) postponed the administration and performed allergy investigation. 2955 HCP (97%) were able to receive the 2 doses of the vaccine. 118 employees received only one dose: 98 had COVID-19 meanwhile, 7 got pregnant, 13 due to other conditions. Adverse reactions to the vaccine with possible hypersensitivity mechanisms, occurred in 17 (0.6%) HCP, 12 on the 1st dose and 5 on the 2nd dose. Observed reactions were 6 (0.2%) urticaria, 5 (0.16%) pruritus with or without flushing, 2 (0.07%) anaphylaxis (mild), 2 (0.07%) flushing and hoarseness, 1 (0.03%) flushing and nausea and 1 (0.03%) asthma exacerbation. ST with the vaccine were performed in 4 HCP, all negative in the immediate reading and 1 positive in non-immediate reading. 7 HCP undertook the graded administration with the vaccine: 6 tolerated, but one reproduced the immediate urticaria with 0.1cc of the vaccine (0.03% vaccine allergy). Conclusion: In the evaluated sample, suspicious allergic reactions to COVID19 vaccine Commirnaty were rare and allergy was only confirmed in one HCP. The allergist initial evaluation was essential for a safe risk stratification and permitted the non-exclusion of a considerable number of HCP from the vaccination program.
ABSTRACT
The relationship between asthma and COVID-19 is not completely understood yet. We here review the publications on the interplay between these two diseases, as available on the article submission day. The preliminary results did not find a conclusive association between asthma and an increased risk for SARS-CoV-2 infection or severe COVID -19. However, important differences have been found between studies performed in various locations. SARS-CoV-2 infection does not seem to cause asthma exacerbations, and certain typical asthma signs like wheezing were not described in COVID -19 patient series. The susceptibility and risk for COVID -19 in asthma patients may vary according to the patients’ age, asthma severity, asthma control, phenotypes/endotypes, or current treatment. Studies analysing COVID--19 specifically in asthma patients will be required to evaluate the real impact of COVID--19 in asthma.