Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021.
Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021.
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DOI：
10.1136/ejhpharm-2021-002933
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发表时间：
2023-07
期刊：
影响因子：
--
通讯作者：
Marchesini F
中科院分区：
文献类型：
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作者：
Ossato A;Tessari R;Trabucchi C;Zuppini T;Realdon N;Marchesini F
2020年12月21日，欧盟委员会批准了抗新冠肺炎基因疫苗Bnt162b2(Comirnaty，辉瑞/BioNtech)在欧盟的有条件营销授权。这项流行病学、观察性、前瞻性和单中心研究的主要目的是确定以前感染新冠肺炎的受试者和接种Comirnaty后未感染的受试者在接种疫苗后发生的不良事件的数量、类型和严重程度，并比较两组受试者在第一次和第二次注射后一个月内发生的事件。数据是通过问卷调查收集的。结果包括IRCCS Sacro Cuore Don Calabria医院(意大利)所有医务人员(2030年)在2021年1月1日至2月28日期间接种疫苗的反应。在第一次和第二次接种后，报告了疫苗的不良反应。与之前没有感染过冠状病毒的参与者相比，在接种第一剂疫苗后出现一些副作用的参与者和之前感染过冠状病毒的参与者有统计学上的显著增加(p<；0.001，χ2=35.6)。46.76%(136)的既往感染者在接种第一针疫苗后出现了一些副作用，63.23%(184)的人在第二针后出现了一些副作用，而在没有感染者中，这一比例分别为29.15%(507)和70.79%(1231)。在第二次注射后出现副作用并且以前感染过的参与者的数量明显低于之前没有感染过的参与者(p=0.0094，χ2=6.743)。在这项试验中发现的大多数副作用也由制造商和美国食品和药物管理局报告。主动监测应始终持续不断地检查疫苗随着时间的推移的风险/效益比。
On 21 December 2020 the European Commission granted conditional marketing authorisation in the European Union for the anti-COVID-19 mRNA vaccine Bnt162b2 (Comirnaty, Pfizer/BioNTech). The main endpoint of this epidemiological, observational, prospective and monocentric study was to identify the number, types, and severity of adverse events following immunisation that occurred in subjects who had been previously infected with COVID-19, and in those who had not, after vaccination with Comirnaty, and to compare the two groups of subjects looking at events that occurred within a month after the first and the second dose. Data were gathered by a questionnaire. The results included the responses of all healthcare workers (2030) of the IRCCS Sacro Cuore Don Calabria Hospital (Italy) vaccinated between 1st January and 28th February 2021. Adverse effects of the vaccine were reported after the first and the second doses. There was a statistically significant increase (p<0.001, χ2=35.60) in participants who experienced some side-effects after receiving the first dose of the vaccine and who had previously been infected with the coronavirus, compared with participants who had not previously been infected. 46.76% (136) of the participants who had previously been infected experienced some side-effects after the first dose of vaccine, and 63.23% (184) experienced some side-effects after the second dose, compared with 29.15% (507) after the first dose and 70.79% (1231) after the second dose in those who had not been previously infected. The number of participants who experienced side-effects after the second dose and had previously been infected was significantly lower compared with participants who had not previously been infected (p=0.0094, χ2=6.743). Most of the side-effects identified in this trial were also reported by the manufacturer and the US Food and Drug Administration. Active surveillance should always continue to constantly check the vaccine’s risk/benefit ratio over time.
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DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
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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
DOI：
10.15585/mmwr.mm7008e3
发表时间：
2021-02-26
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
Gee J;Marquez P;Su J;Calvert GM;Liu R;Myers T;Nair N;Martin S;Clark T;Markowitz L;Lindsey N;Zhang B;Licata C;Jazwa A;Sotir M;Shimabukuro T
通讯作者：
Shimabukuro T
DOI：
10.1016/s0140-6736(21)00085-4
发表时间：
2021-01-30
期刊：
Lancet (London, England)
影响因子：
--
作者：
Cavaleri M;Enzmann H;Straus S;Cooke E
通讯作者：
Cooke E
影响因子：
5.1
作者：
Dreskin, Stephen C.;Halsey, Neal A.;Rosenwasser, Lanny J.
通讯作者：
Rosenwasser, Lanny J.
DOI：
10.2807/1560-7917.es.2021.26.6.2100096
发表时间：
2021-03
期刊：
Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin
影响因子：
--
作者：
Abu Jabal K;Ben-Amram H;Beiruti K;Batheesh Y;Sussan C;Zarka S;Edelstein M
通讯作者：
Edelstein M