Safety of an inactivated COVID-19 vaccine in patients with - wheat-dependent exercise-induced anaphylaxis

Main Article Content

Zhirong Du
Jia Yin

Keywords

wheat-dependent exercise-induced anaphylaxis, COVID-19, vaccine, safety, allergic reactions

Abstract

Background: Inactivated vaccines against coronavirus disease-2019 (COVID-19) offer an effective public health intervention to mitigate this devastating pandemic. However, little is known about their safety in patients with wheat-dependent exercise-induced anaphylaxis (WDEIA).


Methods: We recruited 72 WDEIA patients and 730 healthy matched controls who received an inactivated COVID-19 vaccine. Participants were monitored for 4 weeks after each immunization for adverse reactions and completed questionnaires regarding local and systemic reactions at 7 and 28 days after each vaccination. For those who had received the COVID-19 vaccine prior to enrollment, adverse event data were obtained retrospectively.


Results: Local and systemic adverse events occurred at similar rates in the WDEIA group and the control group. In both groups, injection-site pain and fatigue were the most common local and systemic reactions, respectively. Compared with healthy controls, more allergic events were reported in the WDEIA group (after dose 1, 0.5% vs. 4.2%, p=0.019; after dose 2, 0% vs. 1.4%, p=0.089). Allergic reactions mainly manifested as rash, urticaria, and edema, which were mild and controllable. No serious allergic events were reported.


Conclusions: The adverse event profile of inactivated COVID-19 vaccine did not differ between WDEIA patients and healthy controls. The risk of allergic reactions in patients with WDEIA seems higher, but no anaphylaxis was reported, and the allergic reactions were controllable. Inactivated COVID-19 vaccines appear to be well-tolerated in WDEIA patients, but patients with potential allergy risks should be cautious.

Abstract 317 | PDF Downloads 166 HTML Downloads 99 XML Downloads 31

References

1. Walker PGT, Whittaker C, Watson OJ, Baguelin M, Winskill P, Hamlet A, et al. The impact of COVID-19 and strategies for mitigation and suppression in low-and middle-income countries. Science. 2020;369(6502):413–422. 10.1126/science.abc0035

2. COVID-19 weekly epidemiological update [Internet]. [cited 2021 Aug 17]. Available from: http://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19---17-august-2021

3. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603–2615. 10.1056/NEJMoa2034577

4. Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: A randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020;396(10249):479–488. 10.1016/s0140-6736(20)31605-6

5. Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US-December 14, 2020–January 18, 2021. JAMA. 2021;325(11):1101–1102. 10.1001/jama.2021.1967

6. Shimabukuro T, Nair N. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine. JAMA. 2021;325(8):780–781. 10.1001/jama.2021.0600

7. Liotti L, Bianchi A, Bottau P, Caimmi S, Crisafulli G, Franceschini F, et al. COVID-19 vaccines in children with cow’s milk and food allergies. Nutrients. 2021;13(8):2637. 10.3390/nu13082637

8. Scherf KA, Brockow K, Biedermann T, Koehler P, Wieser H. Wheat-dependent exercise-induced anaphylaxis. Clin Exp Allergy. 2016;46(1):10–20. 10.1111/cea.12640

9. Jiang N, Yin J, Wen L, Li H. Characteristics of anaphylaxis in 907 Chinese patients referred to a Tertiary Allergy Center: A retrospective study of 1,952 episodes. Allergy Asthma Immunol Res. 2016;8(4):353–361. 10.4168/aair.2016.8.4.353

10. Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, 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):181–192. 10.1016/s1473-3099(20)30843-4

11. Zhao J, Zhao S, Ou J, Zhang J, Lan W, Guan W, et al. COVID-19: Coronavirus vaccine development updates. Front Immunol. 2020;11:602256. 10.3389/fimmu.2020.602256

12. Kounis NG, Koniari I, de Gregorio C, Velissaris D, Petalas K, Brinia A, et al. Allergic reactions to current available COVID-19 vaccinations: Pathophysiology, causality, and therapeutic considerations. Vaccines (Basel). 2021;9(3):221. 10.3390/vaccines9030221

13. Du Z, Gao X, Yin J. Gut microbiome alterations in patients with wheat-dependent exercise-induced anaphylaxis. Int Immunopharmacol. 2020;84:106557. 10.1016/j.intimp.2020.106557

14. Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization systemic allergic reaction grading system: Is a modification needed? J Allergy Clin Immunol Pract. 2017;5(1):58–62. 10.1016/j.jaip.2016.11.009

15. Rojas-Pérez-Ezquerra P, Crespo Quirós J, Tornero Molina P, Baeza Ochoa de Ocáriz ML, Zubeldia Ortuño JM. Safety of new mRNA vaccines against COVID-19 in severely allergic patients. J Investig Allergol Clin Immunol. 2021;31(2):180–181. 10.18176/jiaci.0683

16. Nilsson L, Brockow K, Alm J, Cardona V, Caubet JC, Gomes E, et al. Vaccination and allergy: EAACI position paper, practical aspects. Pediatr Allergy Immunol. 2017;28(7):628–640. 10.1111/pai.12762

17. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: A randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021;21(1):39–51. 10.1016/s1473-3099(20)30831-8

18. Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, 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):803–812. 10.1016/s1473-3099(20)30987-7

19. Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: Interim analysis of 2 randomized clinical trials. JAMA. 2020;324(10):951–960. 10.1001/jama.2020.15543

20. Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, et al. Randomized, double-blinded and placebo-controlled phase II trial of an inactivated SARS-CoV-2 vaccine in healthy adults. Clin Infect Dis. 2021;73(1):e3949–e3955. 10.1093/cid/ciaa1703

21. Kim MA, Lee YW, Kim SR, Kim JH, Min TK, Park HS, et al. COVID-19 Vaccine-associated anaphylaxis and allergic reactions: Consensus statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group. Allergy Asthma Immunol Res. 2021;13(4):526–544. 10.4168/aair.2021.13.4.526

22. McNeil MM, DeStefano F. Vaccine-associated hypersensitivity. J Allergy Clin Immunol. 2018;141(2):463–472. 10.1016/j.jaci.2017.12.971

23. Zubeldia JM, Ferrer M, Dávila I, Justicia JL. Adjuvants in allergen-specific immunotherapy: Modulating and enhancing the immune response. J Investig Allergol Clin Immunol. 2019;29(2):103–111. 10.18176/jiaci.0349

24. Caubet JC, Ponvert C. Vaccine allergy. Immunol Allergy Clin North Am. 2014;34(3):597–613.