Diagnostic Pacing Maneuvers for Supraventricular Tachycardia
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COVID-19 Vaccines: Update on Allergic Reactions
Anaphylaxis in the U S following COVID-19 vaccination Dec 19-20, 2020 ACIP meeting safety presentation: –CDC had identified 6 case reports of anaphylaxis following
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Centers for Disease Control and Prevention
Center for Preparedness and Response
COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions Clinician Outreach and Communication Activity (COCA) WebinarWednesday, December 30, 2020
Continuing Education
Continuing education will not be offered for this COCA Call.To Ask a Question
All participants joining us today are in listen-only mode.Using the Webinar System
Submit your question.
The video recording of this COCA Call will be posted at available to view on-demand a few hours after the call ends. If you are a patient, please refer your questions to your healthcare provider. For media questions, please contact CDC Media Relations at 404-639-3286, or send an email to media@cdc.gov.Centers for Disease Control and Prevention
Center for Preparedness and Response
Tom Shimabukuro, MD, MPH, MBA
CAPT, U.S. Public Health Service
Vaccine Safety Team Lead
COVID-19 Response
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Center for Preparedness and Response
Sarah Mbaeyi, MD, MPH
CDR, U.S. Public Health Service
Clinical Guidelines Team
COVID-19 Response
Centers for Disease Control and Prevention
National Center for Immunization & Respiratory DiseasesAnaphylaxis following mRNA COVID-19 vaccination
Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Vaccine Task Force
Vaccine Safety Team
Slides adapted from December 19-20, 2020 ACIP meeting presentation: Anaphylaxis Following m-RNA COVID-19 Vaccine Receipt, by
Thomas Clark, MD, MPH, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/05-COVID-CLARK.pdf
Anaphylaxis following COVID-19 vaccination in the UK Dec 8, 2020 ʹUK initiated vaccination with Pfizer-BioNTechCOVID-19 vaccine Dec 9, 2020 ʹUK authorities confirmed 2 cases of anaphylaxis after vaccinationACIP recommendations and CDC guidance for
COVID-19 vaccination
ACIP considered anaphylaxis risk during deliberations on Pfizer-BioNTechCOVID-19 vaccine during Dec 11-12,2020 meetings
Issued interim recommendation for use of Pfizer-BioNTechCOVID-19 vaccine
CDC issued:
Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites Anaphylaxis in the U.S. following COVID-19 vaccinationDec 19-20, 2020 ACIP meeting safety presentation:
CDC had identified 6 case reports of anaphylaxis following Pfizer-BioNTechvaccine meeting Brighton Collaboration criteria for anaphylaxis Cases occurred within recommended observation window and were promptly treated All suspect cases were notified through VAERS or CDC notification processes As of December 19, 2020, 9:45am EST ʹ272,001 doses of Pfizer-BioNTechCOVID-19 vaccine had been administeredCDC actions
Close coordination with FDA on safety monitoring
Continued enhanced monitoring for anaphylaxis cases through the Vaccine Adverse Event Reporting System (VAERS) Case reviews and consultation with allergy/immunology experts to provide guidance on evaluation of persons following anaphylaxis to COVID-19 vaccineYour role
Healthcare providers
Recognize, respond, and report anaphylaxis following COVID-19 vaccination to VAERS Report adverse events to VAERSin accordance with FDA EUA reporting requirements and CDC guidance vaccinated and encourage patients to participate in v-safeCommunicatewith patients on vaccine safety
co-managed byCDC and FDAVaccine Adverse Event
Reporting System
vaers.hhs.govHow to report an adverse event to VAERS
Go to vaers.hhs.gov
Submit a report online
For help:
call1-800-822-7967
email info@VAERS.org video instructions https://youtu.be/sbCWh cQADFE For COVID-19, FDA will issue VAERS reporting requirements under EUA; in addition, CDC encourages reporting of any clinically important adverse event following immunizationResources
cdc.gov/vsafeCDC asks that:
Healthcareproviders help us get
as many people to use v-safeas possible വgive a one-page info sheet to patients at the time of vaccination വcounsel patients on the importance of enrolling in v-safeCDC has created an electronic
version of the v-safeinfo sheet for distribution to public health and healthcare partnersHow to report an AE to VAERS
Go to vaers.hhs.govand submit a report online
For help: Call 1-800-822-7967 Email info@VAERS.org Videoinstructions www.youtube.com/watch?v=sbCWhcQADFEV-safe resources
cdc.gov/vsafeGeneral safety information
Contraindications and Precautions to
mRNA COVID-19 vaccination 17 18 Updated contraindications and precautions to vaccinationRecommendations apply to both Pfizer-BioNTech and
Moderna COVID-19 vaccines
Guidance may change as further information becomes available Definition of immediate allergic reaction to vaccine or medication: Any hypersensitivity-related signs or symptoms such as urticaria, angioedema, respiratory distress (e.g., wheezing, stridor), or anaphylaxis that occur within four hours following administration Contraindications to either of the mRNA COVID-19 vaccines: Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or to any of its components Immediate allergic reaction of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])* Immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)* Persons with an immediate allergic reaction to the first dose of an mRNA vaccine should not receive additional doses of either of the mRNA COVID-19 vaccinesContraindications to mRNA COVID-19 vaccination
* These persons should not receive mRNA COVID-19 vaccination at this time unless they have been evaluated by an allergist-
immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with
advanced medical care available).Pfizer-BioNTech and Moderna COVID-19 vaccines
19Ingredients*included in mRNA COVID-19 vaccines
*As reported in the prescribing information20DescriptionPfizer-BioNTechModerna
mRNAnucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2Lipids2[(polyethylene glycol)-2000]-N,N-
ditetradecylacetamide methoxypolyethylene glycol cholesterolcholesterol diyl)bis(2-hexyldecanoate)SM-102:heptadecan-9-yl 8-((2-hydroxyethyl)
(6-oxo-6-(undecyloxy) hexyl) amino) octanoateSalts,
sugars, buffers potassium chlorideTromethamine monobasic potassium phosphateTromethamine hydrochloride sodium chlorideAcetic acid dibasic sodium phosphate dihydrateSodium acetate sucrosesucroseIngredients*included in mRNA COVID-19 vaccines
*As reported in the prescribing information21DescriptionPfizer-BioNTechModerna
mRNAnucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2Lipids2[(polyethylene glycol)-2000]-N,N-
ditetradecylacetamide methoxypolyethylene glycol cholesterolcholesterol diyl)bis(2-hexyldecanoate)SM-102:heptadecan-9-yl 8-((2-hydroxyethyl)
(6-oxo-6-(undecyloxy) hexyl) amino) octanoateSalts,
sugars, buffers potassium chlorideTromethamine monobasic potassium phosphateTromethamine hydrochloride sodium chlorideAcetic acid dibasic sodium phosphate dihydrateSodium acetate sucrosesucrose Primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy proceduresInactive ingredient or excipient in medications
Used in a process called pegylation to improve therapeutic activity of some medications Cross-reactive hypersensitivity between PEG and polysorbates can occur Polysorbates are included as an excipient in some vaccines and other therapeutic agentsPolyethylene glycol (PEG)
Information on whether a medication contains PEG, a PEG derivative, or polysorbates can be found in the package insert. The NIH DailyMed databasemay also be used as a resource
Medications that contain PEG and/or polysorbate are described in the supplemental materials of Stone CA, et al. "Immediate hypersensitivity to polyethylene glycols and polysorbates:
more common than we have recognized." The Journal of Allergy and Clinical Immunology: In Practice7.5 (2019): 1533-1540.
Distinguishing allergic reactions from other types of reactions CharacteristicImmediate allergic reactions (including anaphylaxis)Vasovagal reactionVaccine side effects (local and systemic)