UK confirmed 2 cases of anaphylaxis after 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
Anaphylaxis in UK Following COVID-19 Vaccination
2
 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 PfizerBioNTech COVID-19 vaccine
- Included guidance on contraindications and precautions
(https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/clinicalconsiderations.html#contraindications-precautions)
CDC Guidance on Anaphylaxis 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 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/05-COVID-CLARK.pdf