mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach.
mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Suggested Approach.
复制标题
DOI：
10.1016/j.jaip.2020.12.047
复制
发表时间：
2021-04
期刊：
影响因子：
--
通讯作者：
Blumenthal KG
中科院分区：
文献类型：
--
作者：
Banerji A;Wickner PG;Saff R;Stone CA Jr;Robinson LB;Long AA;Wolfson AR;Williams P;Khan DA;Phillips E;Blumenthal KG
美国食品和药物管理局（FDA）最近为辉瑞BioNTech和Moderna的两种高效2019冠状病毒病（COVID-19）疫苗颁发了紧急使用授权（EUA）。这给处于全球大流行之中的数百万美国人带来了希望。FDA EUA对这两种疫苗的指导是，对于已知对COVID-19疫苗的任何成分有严重过敏反应（如速发型过敏反应）史的个体，不得接种疫苗。美国疾病控制和预防中心（CDC）还建议，对疫苗或注射剂有立即过敏反应史或有任何过敏反应史的个人，在接种COVID-19疫苗后观察30分钟。所有其他人在接种COVID-19疫苗后应观察15分钟。疫苗诊所的工作人员必须能够识别和管理过敏反应。FDA EUA后，尽管两项3期试验都发出了非常强烈的安全性信号，但可能的过敏反应报告引起了公众的关注。为了在全球广泛接种疫苗期间提供保证和支持，过敏症专科医生必须根据现有的最佳信息，并根据监管机构的更广泛建议，为个人提供明确的指导。本综述总结了疫苗过敏的流行病学，并提出了药物和疫苗过敏的专家意见知情的风险分层过敏专家使用的公共卫生和监管机构的指导。风险分层方案指导护理（1）具有不同过敏史的个体安全接受其第一剂mRNA COVID-19疫苗，以及（2）对第一剂mRNA COVID-19疫苗产生反应的个体。
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.
登录
查看更多内容
DOI：
10.3390/molecules23071700
发表时间：
2018-07-12
期刊：
Molecules (Basel, Switzerland)
影响因子：
--
作者：
Neun BW;Barenholz Y;Szebeni J;Dobrovolskaia MA
通讯作者：
Dobrovolskaia MA
DOI：
10.1016/s0140-6736(20)32661-1
发表时间：
2021-01-09
期刊：
Lancet (London, England)
影响因子：
--
作者：
Voysey M;Clemens SAC;Madhi SA;Weckx LY;Folegatti PM;Aley PK;Angus B;Baillie VL;Barnabas SL;Bhorat QE;Bibi S;Briner C;Cicconi P;Collins AM;Colin-Jones R;Cutland CL;Darton TC;Dheda K;Duncan CJA;Emary KRW;Ewer KJ;Fairlie L;Faust SN;Feng S;Ferreira DM;Finn A;Goodman AL;Green CM;Green CA;Heath PT;Hill C;Hill H;Hirsch I;Hodgson SHC;Izu A;Jackson S;Jenkin D;Joe CCD;Kerridge S;Koen A;Kwatra G;Lazarus R;Lawrie AM;Lelliott A;Libri V;Lillie PJ;Mallory R;Mendes AVA;Milan EP;Minassian AM;McGregor A;Morrison H;Mujadidi YF;Nana A;O'Reilly PJ;Padayachee SD;Pittella A;Plested E;Pollock KM;Ramasamy MN;Rhead S;Schwarzbold AV;Singh N;Smith A;Song R;Snape MD;Sprinz E;Sutherland RK;Tarrant R;Thomson EC;Török ME;Toshner M;Turner DPJ;Vekemans J;Villafana TL;Watson MEE;Williams CJ;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
3.2
作者：
Pidaparti, Mahati;Bostrom, Bruce
通讯作者：
Bostrom, Bruce
影响因子：
5.9
作者：
Coors, EA;Seybold, H;Mahler, V
通讯作者：
Mahler, V