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Pfizer-BioNTech Advisory for EUA COVID-19 Vaccine: What People With Allergies Should Know

DECEMBER 26, 2020 In the U.K., where the Pfizer-BioNTech vaccine has been available since early…

DECEMBER 26, 2020

In the U.K., where the Pfizer-BioNTech vaccine has been available since early December, two medical workers with a history of extreme allergic reactions had an adverse reaction after receiving the new vaccine. Recently a few health care workers in Alaska experienced an adverse reaction to the vaccine, leading U.K. and U.S. authorities to advise anyone with that condition to not take the vaccine.

With these cases and reported adverse events observed in the phase 3 clinical trial, the U.S. Emergency Use Authorization (EUA) approval for the Pfizer-BioNTech vaccine came with FDA guidance that people should not get the COVID-19 vaccine if you have ever 1) had a severe allergic reaction after a previous dose of this vaccine, 2) had a severe allergic reaction to any ingredient of this vaccine.

These are not likely high frequency events, but careful consideration is prudent as the vaccine is distributed to a larger population.   According to the FDA, the Pfizer BioNTech COVID-19 vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

While not noted in the FDA advisory, others have noted that individuals with an underlying allergic tendency should consult their health care provider and may have a higher tendency for adverse events with this vaccine.

When obtaining the vaccine it is important to share with your provider any medical conditions, including: any allergies, have a fever, have a bleeding disorder or are on a blood thinner, are immunocompromised or are on a medicine that affects the immune system, are pregnant or plan to become pregnant, are breastfeeding, or have received another COVID-19 vaccine.  It is recommended you consult with a health care provider before receiving a COVID-19 vaccination.

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