PMC:7787218 / 1212-3211 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/7787218","sourcedb":"PMC","sourceid":"7787218","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7787218","text":"The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom was the first to authorize emergency use of the Pfizer–BioNTech mRNA vaccine. On December 8, 2020, within 24 hours after the start of the U.K. mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine. On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer–BioNTech mRNA vaccine, and general vaccination of health care workers was started on Monday, December 14. On December 15, a 32-year-old female health care worker in Alaska who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine. The participants who had these initial three reported cases of anaphylaxis would not have been excluded on the basis of their histories from the mRNA vaccine clinical trials.1,2 Since the index case in Alaska, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported in the United States after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000, the known and stable incidence of anaphylaxis associated with other vaccines. The EUA for the Moderna mRNA vaccine was issued on December 18, and it is currently too soon to know whether a similar signal for anaphylaxis will be associated with that vaccine; however, at this time a small number of potential cases of anaphylaxis have been reported, including one case on December 24 in Boston in a health care worker with shellfish allergy who was carrying auto-injectable 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