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This clinical update reports that 1,893,360 doses were administered during the first several days of distribution of the Pfizer-BioNTech COVID-19 vaccine and that 21 cases of anaphylaxis were reported from these vaccinations. None of these reactions resulted in death, and the estimated case rate was 11.1 per million doses. The majority of affected patients had a history of allergies, and 33% had a history of prior anaphylaxis. Additionally, 83 cases of non-anaphylaxis allergic responses were recorded.
These preliminary data suggest that the Pfizer-BioNTech COVID-19 vaccine is associated with a low rate of anaphylaxis, although precautions to monitor for this potential side effect should be routinely taken for patient safety. Vaccination is still strongly encouraged for infection control and public health purposes.
– Amy S. Korwin, MD
This abstract is available on the publisher's site.
December 11, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, administered as 2 doses separated by 21 days. Shortly after, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use. Following implementation of vaccination, reports of anaphylaxis after the first dose of the Pfizer-BioNTech COVID-19 vaccine emerged. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours.