mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach
| Autor: | Paul D. Williams, Aleena Banerji, Anna R. Wolfson, Cosby A. Stone, Lacey B. Robinson, Elizabeth J. Phillips, Aidan A. Long, Kimberly G. Blumenthal, Rebecca R. Saff, David A. Khan, Paige G. Wickner |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Emergency Use Authorization Allergy Polyethylene glycol Octoxynol mRNA Drug allergy Guidelines Polyethylene Glycols 03 medical and health sciences Special Article 0302 clinical medicine Pandemic medicine Humans Immunology and Allergy 030212 general & internal medicine Intensive care medicine Anaphylaxis Risk stratification CDC Centers for Disease Control and Prevention COVID-19 Coronavirus disease 2019 SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 business.industry Public health COVID-19 Allergens medicine.disease FDA Food and Drug Administration Polysorbate Vaccination 030228 respiratory system PEG Polyethylene glycol VAERS Vaccine adverse event reporting System Allergic reactions Allergists business Vaccine EUA Emergency Use Authorization |
| Zdroj: | The Journal of Allergy and Clinical Immunology: In Practice The Journal of Allergy and Clinical Immunology. in Practice |
| ISSN: | 2213-2198 |
| DOI: | 10.1016/j.jaip.2020.12.047 |
| Popis: | The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post–FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|