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Review 1: "Adverse reactions to BNT162b2 mRNA COVID-19 vaccine in medical staffs with a history of allergy"

This study claims that although the frequency of adverse reactions was higher in individuals with a subjective history of allergy, vaccination is considered safe. Reviewers agree with the importance of the idea this paper addresses but raise some key issues regarding its methods.

Published onOct 22, 2021
Review 1: "Adverse reactions to BNT162b2 mRNA COVID-19 vaccine in medical staffs with a history of allergy"
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key-enterThis Pub is a Review of
Adverse reactions to BNT162b2 mRNA COVID-19 vaccine in medical staffs with a history of allergy

AbstractSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID-19) vaccination is progressing globally. Several adverse reactions have been reported with vaccination against COVID-19. It is unknown whether adverse reactions to COVID-19 vaccination are severe in individuals with allergies. We administered the COVID-19 vaccine to the medical staff at Yamagata University Hospital from March to August 2021. Subsequently, we conducted an online questionnaire-based survey to investigate the presence of allergy and adverse reactions after vaccination and examined the association between allergy and adverse reactions after immunization.Responses were collected from 1586 subjects after the first vaccination and 1306 subjects after the second administration of the BNT162b2 mRNA COVID-19 vaccine. Adverse reactions included injection site pain, injection site swelling, fever, fatigue or malaise, headache, chills, nausea, muscle pain outside the injection site, and arthralgia. The frequency and severity of most adverse reactions were higher after the second vaccination compared to the first. The frequency of some adverse reactions and their severity were higher, and the duration of symptoms was longer in subjects with allergies than in subjects without allergies. Although several participants visited the emergency room for treatment after the first and second vaccinations, nobody was diagnosed with anaphylaxis.Given the serious consequence of COVID-19 and the reported high efficacy of this vaccine against this disease, we conclude that vaccination of allergic individuals is generally recommended.

RR:C19 Evidence Scale rating by reviewer:

  • Potentially informative. The main claims made are not strongly justified by the methods and data, but may yield some insight. The results and conclusions of the study may resemble those from the hypothetical ideal study, but there is substantial room for doubt. Decision-makers should consider this evidence only with a thorough understanding of its weaknesses, alongside other evidence and theory. Decision-makers should not consider this actionable, unless the weaknesses are clearly understood and there is other theory and evidence to further support it.



• The manuscript’s findings are subject to significant bias such as selection/responder bias (I am not sure percentage of the sample submitted surveys) and confounding (only univariate analyses are performed and the increased adverse reactions health care workers with an allergic history may be due to other factors, such as sex or condition).

Regarding the former bias, the size of the population is also useful to consider whether or not anaphylaxis should have been observed (on the order of 2.5 to 250 per million doses).

Regarding the latter bias, findings are potentially overstated as the statistical approach was not taken.

•The adverse effects studied are all nonallergic, not immune-mediated adverse effects (injection site reactions, headache, myalgia, arthralgia). Thus, it is not clear why the results considered the history of allergy as the exposure status in these individuals, with adverse effects as the observed outcome. I suppose this potential relation might be worth studying, but it does not seem like a manuscript's coherent focus.

•There are few studies on adverse reactions after mRNA vaccination that contain prior allergy history data. These data reports may be helpful for broader side effects/safety studies. I would not recommend this preprint in its current form; however, there is potential for the manuscript, with a significant revision in focus and approach. The research has somewhat unique data that is potentially complete. Although, they do not state how many received the survey (the research only includes the number of individuals who completed it).

•The writing could use additional effort to improve upon clarity. The literature review is inadequate.

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