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An analysis of the risk for allergic reactions to ingredients of the COVID-19 mRNA Vaccine BNT162b2 (BioNTech/Pfizer)

Radoslaw Spiewak

Recommended citation format: Spiewak R: An analysis of the risk for allergic reactions to ingredients of the COVID-19 mRNA Vaccine BNT162b2 (BioNTech/Pfizer). Estetol Med Kosmetol 2020; 10: 005.en

DOI: http://dx.doi.org/10.14320/EMK.2020.005.en

The aim of this study was to assess the risk for allergic reactions to ingredients of Comirnaty™ (COVID-19 mRNA Vaccine BNT162b2 BioNTech/Pfizer) - the first COVID-19 vaccine authorized for the use in Poland.

Material and methods: A systematic review of scientific literature for allergic and anaphylactic reactions to ingredients that are present in the Comirnaty™ vaccine. For each ingredient, a literature query in PubMed was done using the following scheme: "X[title] AND (allergy[title] OR allergic[title] OR hypersensitivity[title] OR intolerance[title] OR anaphylactic[title] OR anaphylaxis[title])", where "X" symbolizes names of each ingredient, including possible synonyms. From the retrieved literature, data on the prevalence of allergic reactions as well as publised case reports were extracted. Based on these data, the allergological risk of administering the vaccine was assessed. Particular attention was paid to reports of anaphylactic reactions to individual ingredients.

Results: Of the ingredients, only allergic reactions to PEG (polyethylene glycols) were reported, which seem very rare considering the ubiquitous presence of PEGs in medicinal products and therapeutic drugs. No fatalities connected to PEGs were reported. There were no previous reports of allergic reactions to other ingredients of the vaccine.

Conclusions: Exciptients in the Comirnaty™ (COVID-19 mRNA Vaccine BNT162b2 BioNTech/Pfizer) vaccine are widely used in medicinal products and therapeutic drugs, The risk of allergic reactions to them seems very low. Among all excipients of the vaccine one - ALC-0159 is a derivative of polyethylene glycol, for which there are reports of allergic reactions, including anaphylaxis. Polyethylene glycols (PEGs) are widely used in drugs, cosmetics and other products, whereas allergic reactions are reported in a handful of patients annually, with no fatalities so far. Altogether, the risk of allergic reaction due to Comirnaty™ vaccination is very low.

Key words: COVID-19 vaccine, Comirnaty™, excipients, sensitizing potential, allergic reactions, allergy, anaphylaxis, risk assessment


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Full text in Polish: DOI: 10.14320/EMK.2020.005.pl

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Portal www.estetologia.pl służy udostępnianiu elektronicznej wersji czasopisma Estetologia Medyczna i Kosmetologia
Open Access, online ISSN 2084-2007; print ISSN 2084-199X, DOI: http://dx.doi.org/10.14320/EstetolMedKosmetol
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© Radosław Śpiewak Instytut Dermatologii (kontakt)
Document created: 22 October 2020, last updated: 31 December 2020