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ACIP COVID-19 Vaccines Work Group
Anaphylaxis Following m-RNA COVID-19
Vaccine Receipt
Thomas Clark, MD, MPH
December 19, 2020
For more information:
www.cdc.gov/COVID19
Anaphylaxis in UK Following COVID-19 Vaccination
December 8, 2020 – UK initiated vaccination with Pfizer-BioNTech
COVID-19 vaccine
December 9 – UK authorities confirmed 2 cases of anaphylaxis after
vaccination
Prescribing information for both Pfizer-BioNTech and Moderna COVID-19
vaccines contains information on anaphylaxis
–
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine is a
contraindication to vaccination
–
Appropriate medical treatment used to manage immediate allergic reactions must
be immediately available in the event an acute anaphylactic reaction occurs
following administration of the vaccine
2
CDC Guidance on Anaphylaxis Following COVID-19
Vaccination
ACIP considered anaphylaxis risk during deliberations on Pfizer-BioNTech
COVID-19 vaccine during December 11-12 meetings
December 12 – CDC published clinical considerations for use of Pfizer-
BioNTech COVID-19 vaccine
–
Included guidance on contraindications and precautions
(https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinical-
considerations.html#contraindications-precautions)
Anaphylaxis in US Following COVID-19 Vaccination
December 18
*
, 2020 – CDC has identified 6 case reports of anaphylaxis
following Pfizer-BioNTech vaccine meeting Brighton Collaboration criteria for
anaphylaxis
–
Cases were Brighton Collaboration levels 1 or 2
–
Additional case reports have been reviewed and determined not anaphylaxis
Cases occurred within recommended observation window and were
promptly treated
One case had a history of anaphylaxis following rabies vaccination
All suspect cases were notified through VAERS or CDC notification processes
These case reports are undergoing/will undergo clinical case review by CISA
December 19
**
– 272,001 doses of vaccine have been administered
*December 18, 2020 at 2300 hrs EST
**December 19, 2020 at 0945 hrs EST
CDC Actions Following Reports
Close coordination with FDA
Discussions with CISA investigators, NIH, Medicine and Healthcare
products Regulatory Agency (UK), Allergy/Immunology experts, and
other partners
Published Interim Considerations: Preparing for the Potential
Management of Anaphylaxis at COVID-19 Vaccination
Sites (https://www.cdc.gov/vaccines/covid-19/info-by-
product/pfizer/anaphylaxis-management.html)

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