First-Dose mRNA COVID-19 Vaccine Allergic Reactions: Limited Role for Excipient Skin Testing

Wolfson, Anna R.; Robinson, Lacey B.; Li, Lily; McMahon, Aubree E.; Cogan, Amelia S.; Fu, Xiaoqing; Wickner, Paige G.; Samarakoon, Upeka; Saff, Rebecca R.; Blumenthal, Kimberly G.; Banerji, Aleena

doi:10.1016/j.jaip.2021.06.010

Cited by 117 publications

(152 citation statements)

References 28 publications

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“…A careful allergology personal history appears the most important moment, which should not be limited to the evaluation of known vaccine excipient sensitization. Skin testing before vaccine dose two administration was not predictive in a recent study, with negative skin tests in patients who developed reactions to their 388 mRNA COVID-19 vaccine second dose [5]. In our experience, the personal allergy history was positive for penicillin and other drug reactions, instead of the allergens considered related to the messenger RNA (mRNA) vaccine, such as polyethylene glycol, polyoxyl castor oil, or polysorbate.…”

Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 99%

“…However, the Centers for Disease Control and Prevention (CDC) recommends to avoid a second dose if a severe or immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine has occurred [ 4 ]. Assessment with excipient skin testing in 80 patients reporting an allergic reaction to mRNA COVID-19 vaccine dose one, a sensitization to PEG ( n = 5) and/or polysorbate 80 ( n = 12) was documented in a minority of patients, and most of the patients received the second dose safely [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

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Skin Adverse Reactions to Novel Messenger RNA Coronavirus Vaccination: A Case Series

Peigottu¹,

Ferreli

Atzori³

et al. 2021

Diseases

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Vaccines are actually the most effective strategy to control the COVID-19 spread and reduce mortality, but adverse reactions can occur. Skin involvement with novel messenger RNA coronavirus vaccines seems frequent but is not completely characterized. A real-world experience in the recent vaccination campaign among health care workers in Sardinia (Italy) is reported. In over a total of 1577 persons vaccinated, 9 cases of skin adverse reactions were observed (0.5%). All reactions have been reported to the Italian Pharmacovigilance Authority. Eight occurred in women (mean age 46 years), and five were physicians and four nurses. All patients had a significant allergology history but not for the known vaccine excipients. After dose one, no injection site reactions were observed, but widespread pruritus (n = 3), mild facial erythema (n = 1), and maculopapular rash (n = 3) occurred in the following 24–48 h in three patients. These three patients were excluded from the second dose. Of the remaining six patients, one developed mild anaphylaxis within the observation period at the vaccination hub and five delayed facial erythematous edema and maculopapular lesions, requiring antihistamines and short-course corticosteroid treatment. Spontaneous reporting is paramount to adjourning vaccination guidance and preventive measures in order to contribute to the development of a safe vaccine strategy. Dermatologist’ expertise might provide better characterization, treatment, and screening of individuals at high risk of skin adverse reactions.

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Section: Discussionmentioning

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Skin Adverse Reactions to Novel Messenger RNA Coronavirus Vaccination: A Case Series

Peigottu¹,

Ferreli

Atzori³

et al. 2021

Diseases

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show abstract

“…However, many cases of successful revaccination of the second dose with the same platform after experiencing an immediate hypersensitivity reaction to the first dose have been reported. [17][18][19][20][21] We provide the recommendation for individuals with anaphylactic reactions to the CoronaVac COVID19 vaccine, summarized in Figure 2.…”

Section: Discussionmentioning

confidence: 99%

CoronaVac COVID-19 Vaccine-Induced Anaphylaxis: Clinical Characteristics and Revaccination Outcomes

Laisuan¹,

Wongsa²,

Chiewchalermsri³

et al. 2021

JAA

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“…Two academic allergy groups have begun evaluation of the Boston HCW who reported allergic symptoms within 3 days of vaccination for evidence of allergic sensitization. Wolfson et al [ 40 ] have reported the results of testing the first 80 individuals for HMW PEG allergy by skin testing and reported outcomes of repeat vaccine dosing. Skin testing to PEG 3350 was used as a surrogate for the PEG 2000 incorporated into the LNP of the mRNA vaccines.…”

Section: Allergy Testing and Repeat Vaccination In Adults Suffering Immediate Allergic Reactions (<4 Hours) After Covid-19 Mrna Vaccinatimentioning

confidence: 99%

COVID-19 mRNA vaccine allergy

Risma

2021

Current Opinion in Pediatrics

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Purpose of review A known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is the only contraindication to coronavirus disease 2019 (COVID-19) mRNA vaccination. It is important for pediatricians to understand the likelihood of an allergic reaction to COVID-19 mRNA vaccines, including its excipients. Recent findings Episodes concerning for anaphylaxis were immediately reported following early administration of COVID-19 mRNA vaccines to adults. Although allergic type symptoms were reported equally in recipients of placebos and test vaccines in phase 3 clinical trials, post-authorization prospective studies state that 0.2–2% of vaccine recipients have experienced allergic reactions. Subsequent allergy testing of affected individuals has focused largely on evaluation of allergic sensitization to a novel vaccine excipient, polyethylene glycol (PEG). PEG is a polymer incorporated in numerous pharmaceutical products because of its favorable, inert properties. The results of allergy testing in adults to date indicate that IgE mediated anaphylaxis to PEG allergy is rarely identified after COVID-19 mRNA vaccine reactions. Numerous individuals with presumed anaphylaxis have tolerated a second vaccine after evaluation and testing by an allergist, suggesting either misdiagnosis or a novel immune mechanism. Summary Confirmed anaphylactic reactions to COVID-19 mRNA vaccines are rare, likely due to a lack of preexisting IgE against the vaccine components, including PEG.

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First-Dose mRNA COVID-19 Vaccine Allergic Reactions: Limited Role for Excipient Skin Testing

Cited by 117 publications

References 28 publications

Skin Adverse Reactions to Novel Messenger RNA Coronavirus Vaccination: A Case Series

Skin Adverse Reactions to Novel Messenger RNA Coronavirus Vaccination: A Case Series

CoronaVac COVID-19 Vaccine-Induced Anaphylaxis: Clinical Characteristics and Revaccination Outcomes

COVID-19 mRNA vaccine allergy

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