FDA, CDC investigating anaphylactic reactions to Pfizer vaccine
At the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee Thursday on meeting about a potential recommendation of an emergency use authorization of Moderna’s vaccine, officials discussed concerns over anaphylactic reactions to Pfizer's vaccine.
Dr. Doran Fink, deputy director-clinical of the Division of Vaccines and Related Products Applications at the FDA, highlighted the two cases of allergic reactions -- one of which was anaphylaxis -- in health workers in Alaska on Wednesday.

Last week, in the U.K., there were also two cases of anaphylaxis after the Pfizer vaccine was administered. As a result, prior to emergency authorization, the FDA clarified its guidance, saying it is safe for people with any history of allergies, but not for those who might have a known history of severe allergic reaction to any “ingredient” of the vaccine.
Fink said the FDA anticipates there may be more reports of allergic reactions to the vaccines, and they will be investigated as they occur.
The FDA is coordinating with the Centers for Disease Control and Prevention to further investigate cases in the U.S. The FDA is also working with Pfizer to further revise the fact sheets and prescribing information for the vaccine to highlight CDC guidelines for post-vaccination monitoring and management of allergic reactions.
Fink noted that this “revision will be in addition to the information already included in the contraindications and warnings, including the facilities where vaccines are being administered should ensure that medical treatment for managing serious allergic reactions is immediately available.”
Fink said the same recommendations will be done for the Moderna vaccine, if it is authorized for use under an EUA.
ABC News’ Anne Flaherty, Stephanie Ebbs, Sophie Tatum and Arielle Mitropoulos contributed to this report.








