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Immediate-Type Systemic Hypersensitivity Reactions After the Inactivated SARS-CoV-2 Vaccine in Healthcare Workers

Year 2022, Volume: 44 Issue: 1, 53 - 60, 14.01.2022
https://doi.org/10.20515/otd.948570

Abstract

The vaccines developed for Coronavirus disease 2019 (COVID-19) not only brought hope to the struggle against the pandemic but also raised questions about hypersensitivity reactions that might occur. Although some studies regarding these concerns with mRNA COVID-19 vaccines have been published, these data on inactivated Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccine are not available. The objective of this study was to determine the safety of the inactivated SARS-CoV-2 vaccine manufactured by Sinovac by evaluating the reported systemic immediate hypersensitivity reactions (IHRs) after the administration of the vaccine to healthcare workers (HCWs). This was a retrospective analysis of inactivated SARS-CoV-2 vaccine recipients in all HCWs vaccinated at our center. Relevant data of all patients who received the vaccine were collected from the electronic medical records available at our center’s database. A statistical analysis of subjects who reported acute adverse reactions was conducted. Of the 3354 HCWs vaccinated with the first dose (female 59.9%, pre-existing allergic disorder 2.4%), four acute adverse reactions (0.12%) met the definition of a systemic IHRs were reported, and only one was confirmed to be anaphylaxis. One out of these four cases received her second dose through graded administration. For the second dose, no systemic reaction was reported in our study population. Inactivated SARS-CoV-2 vaccine appears to be well tolerated in HCWs without any pre-existing allergic disorders.

Supporting Institution

N/A

Thanks

We express our sincere gratitude to all the doctors, nurses, and personnel of Eskisehir City Hospital involved in vaccination for doing their duties devotedly. We also thank Muzaffer Bilgin, Ph.D., for statistical analyses, Resat Kendirlinan, MD, for graphic presentations, and Sevim Bavbek, Prof. MD, for her gracious review of our manuscript.

References

  • Turkish Ministry of Health COVID-19 Information Page: Turkish Ministry of Health; 2021 [Available from: https://covid19.saglik.gov.tr/EN-69532/general-coronavirus-table.html.
  • Nilsson L, Brockow K, Alm J, et al. Vaccination and allergy: EAACI position paper, practical aspects. Pediatric Allergy and Immunology. 2017;28(7):628-40.
  • McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018;141(2):463-72.
  • McNeil MM, Weintraub ES, Duffy J, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016;137(3):868-78.
  • Control CfD, Prevention. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Available et: https://www.cdc. gov/vaccines/covid-19/info-by-product/clinical-Med. 2020.
  • Shimabukuro T. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine - United States, December 14-23, 2020. Am J Transplant. 2021;21(3):1332-7.
  • Team CC-R, Food, Drug A. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine - United States, December 21, 2020-January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(4):125-9.
  • Banerji A, Wickner PG, Saff R, et al. mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J Allergy Clin Immunol Pract. 2021;9(4):1423-37.
  • Cabanillas B, Akdis C, Novak N. Allergic reactions to the first COVID‐19 vaccine: a potential role of Polyethylene glycol? : Wiley Online Library; 2020. Advance online publication.
  • Zhang Y, Zeng G, Pan H, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181-92.
  • Palacios R, Patino EG, de Oliveira Piorelli R, et al. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020;21(1):853.
  • Wu Z, Hu Y, Xu M, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(6):803-12.
  • Cardona V, Ansotegui IJ, Ebisawa M, et al. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020;13(10):100472.
  • World Health Organization. Regional Office for the Western P. Immunization safety surveillance : guidelines for immunization programme managers on surveillance of adverse events following immunization. 3rd ed. Manila : WHO Regional Office for the Western Pacific; 2016.
  • Marshall JS, Warrington R, Watson W, et al. An introduction to immunology and immunopathology. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):49.
  • Ruggeberg JU, Gold MS, Bayas JM, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-84.
  • Caubet JC, Ponvert C. Vaccine allergy. Immunol Allergy Clin North Am. 2014;34(3):597-613, ix.
  • Russell M, Pool V, Kelso JM, et al. Vaccination of persons allergic to latex: a review of safety data in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2004;23(5):664-7.
  • Chung EY, Huang L, Schneider L. Safety of influenza vaccine administration in egg-allergic patients. Pediatrics. 2010;125(5):e1024-e30.
  • Greenhawt MJ, Li JT, Bernstein DI, et al. Administering influenza vaccine to egg allergic recipients: a focused practice parameter update. Ann Allergy Asthma Immunol. 2011;106(1):11-6.
  • Kelso JM, Greenhawt MJ, Li JT, et al. Adverse reactions to vaccines practice parameter 2012 update. J Allergy Clin Immunol. 2012;130(1):25-43.
  • Turner PJ, Fleming L, Saglani S, et al. Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma. Journal of Allergy and Clinical Immunology. 2020;145(4):1157-64. e6.
  • Darsow U, Sbornik M, Rombold S, et al. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. J Eur Acad Dermatol Venereol. 2016;30(11):1971-7.
  • Davenport J, Gomez R, Smith D. Latex content in adult vaccines. Mil Med. 2020;185(3-4):354-5.
  • Prince BT, Mikhail I, Stukus DR. Underuse of epinephrine for the treatment of anaphylaxis: missed opportunities. J Asthma Allergy. 2018;11:143-51.
  • Greenhawt M, Abrams EM, Oppenheimer J, et al. The COVID-19 Pandemic in 2021: Avoiding Overdiagnosis of Anaphylaxis Risk While Safely Vaccinating the World. J Allergy Clin Immunol Pract. 2021;9(4):1438-41.
  • Mustafa SS, Ramsey A, Staicu ML. Administration of a Second Dose of the Moderna COVID-19 Vaccine After an Immediate Hypersensitivity Reaction With the First Dose: Two Case Reports. Ann Intern Med. 2021(L21):0104.

Sağlık Çalışanlarında İnaktive SARS-CoV-2 Aşısı Sonrası Gelişen Ani Tip Sistemik Aşırı Duyarlılık Reaksiyonları

Year 2022, Volume: 44 Issue: 1, 53 - 60, 14.01.2022
https://doi.org/10.20515/otd.948570

Abstract

Koronavirüs hastalığı 2019 (COVID-19) için geliştirilen aşılar, pandemi ile mücadelede umut ışığı sağlarken bir yandan da oluşabilecek aşırı duyarlılık reaksiyonları hakkında soru işaretlerini de beraberinde getirmiştir. Yeni mRNA COVID-19 aşıları ile ilgili bu endişelere ilişkin bazı çalışmalar yayınlanmış olsa da inaktive Şiddetli Akut Solunum Yolu Sendromu Koronavirüs 2 (SARS-CoV-2) aşıları ile ilgili veriler yaygın değildir. Bu çalışmanın amacı, aşının sağlık çalışanlarına uygulanmasından sonra bildirilen sistemik ani aşırı duyarlılık reaksiyonlarını (ADR'ler) değerlendirerek Sinovac tarafından üretilen inaktive SARS-CoV-2 aşısının güvenliğini belirlemektir. Merkezimizde inaktive SARS-CoV-2 aşısı ile aşılanan tüm sağlık çalışanlarını retrospektif olarak inceledik. Aşı yapılan tüm hastaların ilgili verileri merkezimizin veri tabanında bulunan elektronik tıbbi kayıtlardan toplanmıştır. Akut advers reaksiyonlar bildiren deneklerin istatistiksel bir analizi yapılmıştır. İlk dozla aşılanan 3354 sağlık çalışanından (kadın %59,9, önceden var olan alerjik durum %2,4), sistemik ani tip aşırı duyarlılık reaksiyonu tanımını karşılayan dört akut advers reaksiyon (%0,12) bildirilmiştir. Sadece birinin anafilaksi olduğu doğrulanmıştır. Bu dört vakadan biri ikinci dozunu dereceli uygulama yoluyla almıştır. İkinci doz için, çalışma popülasyonumuzda herhangi bir sistemik reaksiyon bildirilmemiştir. İnaktive edilmiş SARS-CoV-2 aşısı, önceden herhangi bir alerjik hastalığı olmayan sağlık çalışanlarında iyi tolere edilmiş gibi görünmektedir.

References

  • Turkish Ministry of Health COVID-19 Information Page: Turkish Ministry of Health; 2021 [Available from: https://covid19.saglik.gov.tr/EN-69532/general-coronavirus-table.html.
  • Nilsson L, Brockow K, Alm J, et al. Vaccination and allergy: EAACI position paper, practical aspects. Pediatric Allergy and Immunology. 2017;28(7):628-40.
  • McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018;141(2):463-72.
  • McNeil MM, Weintraub ES, Duffy J, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016;137(3):868-78.
  • Control CfD, Prevention. Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Available et: https://www.cdc. gov/vaccines/covid-19/info-by-product/clinical-Med. 2020.
  • Shimabukuro T. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine - United States, December 14-23, 2020. Am J Transplant. 2021;21(3):1332-7.
  • Team CC-R, Food, Drug A. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine - United States, December 21, 2020-January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(4):125-9.
  • Banerji A, Wickner PG, Saff R, et al. mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach. J Allergy Clin Immunol Pract. 2021;9(4):1423-37.
  • Cabanillas B, Akdis C, Novak N. Allergic reactions to the first COVID‐19 vaccine: a potential role of Polyethylene glycol? : Wiley Online Library; 2020. Advance online publication.
  • Zhang Y, Zeng G, Pan H, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(2):181-92.
  • Palacios R, Patino EG, de Oliveira Piorelli R, et al. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020;21(1):853.
  • Wu Z, Hu Y, Xu M, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21(6):803-12.
  • Cardona V, Ansotegui IJ, Ebisawa M, et al. World allergy organization anaphylaxis guidance 2020. World Allergy Organ J. 2020;13(10):100472.
  • World Health Organization. Regional Office for the Western P. Immunization safety surveillance : guidelines for immunization programme managers on surveillance of adverse events following immunization. 3rd ed. Manila : WHO Regional Office for the Western Pacific; 2016.
  • Marshall JS, Warrington R, Watson W, et al. An introduction to immunology and immunopathology. Allergy Asthma Clin Immunol. 2018;14(Suppl 2):49.
  • Ruggeberg JU, Gold MS, Bayas JM, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007;25(31):5675-84.
  • Caubet JC, Ponvert C. Vaccine allergy. Immunol Allergy Clin North Am. 2014;34(3):597-613, ix.
  • Russell M, Pool V, Kelso JM, et al. Vaccination of persons allergic to latex: a review of safety data in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2004;23(5):664-7.
  • Chung EY, Huang L, Schneider L. Safety of influenza vaccine administration in egg-allergic patients. Pediatrics. 2010;125(5):e1024-e30.
  • Greenhawt MJ, Li JT, Bernstein DI, et al. Administering influenza vaccine to egg allergic recipients: a focused practice parameter update. Ann Allergy Asthma Immunol. 2011;106(1):11-6.
  • Kelso JM, Greenhawt MJ, Li JT, et al. Adverse reactions to vaccines practice parameter 2012 update. J Allergy Clin Immunol. 2012;130(1):25-43.
  • Turner PJ, Fleming L, Saglani S, et al. Safety of live attenuated influenza vaccine (LAIV) in children with moderate to severe asthma. Journal of Allergy and Clinical Immunology. 2020;145(4):1157-64. e6.
  • Darsow U, Sbornik M, Rombold S, et al. Long-term safety of replication-defective smallpox vaccine (MVA-BN) in atopic eczema and allergic rhinitis. J Eur Acad Dermatol Venereol. 2016;30(11):1971-7.
  • Davenport J, Gomez R, Smith D. Latex content in adult vaccines. Mil Med. 2020;185(3-4):354-5.
  • Prince BT, Mikhail I, Stukus DR. Underuse of epinephrine for the treatment of anaphylaxis: missed opportunities. J Asthma Allergy. 2018;11:143-51.
  • Greenhawt M, Abrams EM, Oppenheimer J, et al. The COVID-19 Pandemic in 2021: Avoiding Overdiagnosis of Anaphylaxis Risk While Safely Vaccinating the World. J Allergy Clin Immunol Pract. 2021;9(4):1438-41.
  • Mustafa SS, Ramsey A, Staicu ML. Administration of a Second Dose of the Moderna COVID-19 Vaccine After an Immediate Hypersensitivity Reaction With the First Dose: Two Case Reports. Ann Intern Med. 2021(L21):0104.
There are 27 citations in total.

Details

Primary Language English
Subjects Health Care Administration
Journal Section ORİJİNAL MAKALE
Authors

Pamir Çerçi 0000-0002-0844-6352

Anıl Uçan 0000-0001-8771-6121

Publication Date January 14, 2022
Published in Issue Year 2022 Volume: 44 Issue: 1

Cite

Vancouver Çerçi P, Uçan A. Immediate-Type Systemic Hypersensitivity Reactions After the Inactivated SARS-CoV-2 Vaccine in Healthcare Workers. Osmangazi Tıp Dergisi. 2022;44(1):53-60.


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