Practical handling of allergic reactions to COVID-19 vaccines
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   A position paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and ÖGAI

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Summary

Background

For the preventive treatment of the 2019 coronavirus disease (COVID-19) an unprecedented global research effort studied the safety and efficacy of new vaccine platforms that have not been previously used in humans. Less than one year after the discovery of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral sequence, these vaccines were approved for use in the European Union (EU) as well as in numerous other countries and mass vaccination efforts began. The so far in the EU approved mRNA vaccines BNT162b2 and mRNA-1273 are based on similar lipid-based nanoparticle carrier technologies; however, the lipid components differ. Severe allergic reactions and anaphylaxis after COVID-19 vaccination are very rare adverse events but have drawn attention due to potentially lethal outcomes and have triggered a high degree of uncertainty.

Methods

Current knowledge on anaphylactic reactions to vaccines and specifically the new mRNA COVID-19 vaccines was compiled using a literature search in Medline, PubMed, as well as the national and international study and guideline registries, the Cochrane Library, and the Internet, with special reference to official websites of the World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), Robert Koch Institute (RKI), and Paul Ehrlich Institute (PEI).

Results

Based on the international literature and previous experience, recommendations for prophylaxis, diagnosis and therapy of these allergic reactions are given by a panel of experts.

Conclusion

Allergy testing is not necessary for the vast majority of allergic patients prior to COVID-19 vaccination with currently licensed vaccines. In case of allergic/anaphylactic reactions after vaccination, allergy workup is recommended, as it is for a small potential risk population prior to the first vaccination. Evaluation and approval of diagnostic tests should be done for this purpose.

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Most cited references 71

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

Lisa A Jackson, Evan J Anderson, Nadine G Rouphael … (2020)

Abstract Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein. Methods We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. Results After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events. Conclusions The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).

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Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

Edward E Walsh, Robert W Frenck, Ann Falsey … (2021)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States. Methods In an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor–binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose. Results A total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2–neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples. Conclusions The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Author and article information

Contributors

Karl-Christian Bergmann: karl-christian.bergmann@charite.de

Journal

Journal ID (nlm-ta): Allergo J Int

Journal ID (iso-abbrev): Allergo J Int

Title: Allergo Journal International

Publisher: Springer Medizin (Heidelberg )

ISSN (Electronic): 2197-0378

Publication date (Electronic): 19 April 2021

Publication date PMC-release: 19 April 2021

Pages: 1-17

Affiliations

[1 ]Center for Rhinology and Allergology, Wiesbaden, Germany

[2 ]GRID grid.6363.0, ISNI 0000 0001 2218 4662, Clinic for Dermatology, Venereology and Allergy, , Charité—University Medicine Berlin, ; Charitéplatz 1, 10117 Berlin, Germany

[3 ]GRID grid.6363.0, ISNI 0000 0001 2218 4662, Berlin Institute of Health, , Charité—Medical University Berlin, ; Berlin, Germany

[4 ]GRID grid.16149.3b, ISNI 0000 0004 0551 4246, Outpatient Clinic for Allergology, Occupational Dermatology and Environmental Medicine, General Dermatology and Venereology, Department of Skin Diseases, , Münster University Hospital, ; Münster, Germany

[5 ]GRID grid.10253.35, ISNI 0000 0004 1936 9756, Department of Dermatology and Allergology, University Hospital Marburg, UKGM, , Philipps University Marburg, ; Marburg, Germany

[6 ]GRID grid.6612.3, ISNI 0000 0004 1937 0642, Department of Dermatology and Allergology, University Hospital Basel, , University of Basel, ; Basel, Switzerland

[7 ]GRID grid.8664.c, ISNI 0000 0001 2165 8627, Department of Dermatology and Allergology, Giessen University Hospital, UKGM, , Justus Liebig University Giessen, ; Giessen, Germany

[8 ]GRID grid.15090.3d, ISNI 0000 0000 8786 803X, Clinic and Polyclinic for Dermatology and Allergology, , University Hospital Bonn, ; Bonn, Germany

[9 ]GRID grid.6936.a, ISNI 0000000123222966, Clinic and Polyclinic for Dermatology and Allergology at Biederstein, , Technical University of Munich, ; Munich, Germany

[10 ]GRID grid.412301.5, ISNI 0000 0000 8653 1507, Department of Dermatology and Allergology, , RWTH Aachen University Hospital, ; Aachen, Germany

[11 ]GRID grid.7491.b, ISNI 0000 0001 0944 9128, Pediatric and Adolescent Medicine, Bethel Children’s Center, OWL University Hospital, , Bielefeld University, ; Bielefeld, Germany

[12 ]Clinic for Pediatric and Adolescent Medicine, Municipal Hospital Kiel GmbH, Kiel, Germany

[13 ]GRID grid.5603.0, Center for Pediatric and Adolescent Medicine, Clinic and Polyclinic for Pediatric and Adolescent Medicine, , University Medicine Greifswald, ; Greifswald, Germany

[14 ]GRID grid.22937.3d, ISNI 0000 0000 9259 8492, Institute for Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, , Medical University of Vienna, ; Vienna, Austria

[15 ]GRID grid.473675.4, Clinic for Dermatology and Venereology, Allergy Center, , Kepler University Hospital GmbH, ; Linz, Austria

[16 ]GRID grid.22937.3d, ISNI 0000 0000 9259 8492, Institute for Pathophysiology and Allergy Research, Center for Pathophysiology, Infectiology and Immunology, , Medical University of Vienna, ; Vienna, Austria

[17 ]Inter-university Messerli Research Institute Vienna, Vienna, Austria

[18 ]GRID grid.425396.f, ISNI 0000 0001 1019 0926, Paul-Ehrlich-Institute, ; Langen, Germany

[19 ]GRID grid.6363.0, ISNI 0000 0001 2218 4662, Allergology and Immunology, Department of Dermatology, Venereology and Allergology, , Charité—University Medicine Berlin, ; Berlin, Germany

Article

Publisher ID: 165

DOI: 10.1007/s40629-021-00165-7

PMC ID: 8054127

PubMed ID: 33898162

SO-VID: bc46fb5c-8b18-4343-8d43-60870fe2bbee

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 21 January 2021

Date accepted : 25 January 2021

Funding

Funded by: Charité (3093)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

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Practical handling of allergic reactions to COVID-19 vaccines : A position paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and ÖGAI

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Summary

Background

Methods

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Conclusion

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Novel Coronavirus Disease COVID-19

Most cited references 71

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

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