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Review 2: "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 2: "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 authors provide a retrospective study on the general safety of COVID-19 vaccines, focusing mainly on potential adverse effects on the so-called "allergic" (in truth, the "self-reported allergic"). Noteworthy, none of the authors seem to be involved in the care of allergic patients/work in allergology. This fact is quite patent, namely on the rationale of this work. Furthermore, there is a mix-up of concepts. Pathologies with completely diverse mechanisms - asthma, allergic rhinitis, drug allergy, food allergy, anaphylaxis, and adverse drug reactions - are placed in the same box. The authors also show that those with the so-called "history of allergy" have worse outcomes regarding short-term and long-term adverse reactions. However, they fail to provide a rationale for this event in the discussion. They fail to mention why, for instance, drug allergy would be more likely a cause for allergy/anaphylaxis to these vaccines. I urge the authors not to give up on this publication which certainly has its merits, but strongly advise that an allergologist be involved in this work so that the methods may be revised. The manuscript/rationale may be improved upon.

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