Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey.
Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey.
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DOI：
10.3390/life11030249
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发表时间：
2021-03-17
期刊：
影响因子：
--
通讯作者：
Bakerly ND
中科院分区：
文献类型：
--
作者：
Mathioudakis AG;Ghrew M;Ustianowski A;Ahmad S;Borrow R;Papavasileiou LP;Petrakis D;Bakerly ND
开展了一项在线调查，以比较不同接受群体中现有新冠肺炎疫苗的安全性、耐受性和反应性。本次调查于2021年2月启动，历时11天。在调查完成前7天接种第一剂新冠肺炎疫苗≥的接受者符合条件。评估接种副反应的发生率和严重程度。这项调查由2002名受访者完成，其中26.6%的人以前感染过新冠肺炎。既往新冠肺炎感染与任何副作用(风险比1.08，95%可信区间(1.05-1.11))、发热(2.24(1.86-2.70))、呼吸困难(2.05(1.28-3.29))、流感样疾病(1.78(1.51-2.10))、疲劳(1.34(1.20-1.49))和局部反应(1.10(1.06-1.15))的风险增加相关。它还与导致住院治疗的严重副作用的风险增加相关(1.56(1.14-2.12))。虽然与基于病毒载体的疫苗相比，基因疫苗的副作用发生率较高(1.06(1.01-1.11))，但这些副作用通常较温和(p<；0.001)，主要是局部反应。重要的是，接受信使核糖核酸疫苗接种的患者报告的全身反应发生率(RR<；0.6)相当低，包括过敏反应、肿胀、流感样疾病、呼吸困难和疲劳，以及需要住院治疗的副作用(0.42(0.31-0.58))。我们的研究证实了最近的随机对照试验(RCT)的结果，该结果表明新冠肺炎疫苗通常是安全的，严重副作用有限。我们的研究首次将既往的新冠肺炎疾病与疫苗接种副作用的增加联系起来，并证明了信使核糖核酸疫苗引起的全身副作用更温和，频率更低，但局部反应更多。
An online survey was conducted to compare the safety, tolerability and reactogenicity of available COVID-19 vaccines in different recipient groups. This survey was launched in February 2021 and ran for 11 days. Recipients of a first COVID-19 vaccine dose ≥7 days prior to survey completion were eligible. The incidence and severity of vaccination side effects were assessed. The survey was completed by 2002 respondents of whom 26.6% had a prior COVID-19 infection. A prior COVID-19 infection was associated with an increased risk of any side effect (risk ratio 1.08, 95% confidence intervals (1.05–1.11)), fever (2.24 (1.86–2.70)), breathlessness (2.05 (1.28–3.29)), flu-like illness (1.78 (1.51–2.10)), fatigue (1.34 (1.20–1.49)) and local reactions (1.10 (1.06–1.15)). It was also associated with an increased risk of severe side effects leading to hospital care (1.56 (1.14–2.12)). While mRNA vaccines were associated with a higher incidence of any side effect (1.06 (1.01–1.11)) compared with viral vector-based vaccines, these were generally milder (p < 0.001), mostly local reactions. Importantly, mRNA vaccine recipients reported a considerably lower incidence of systemic reactions (RR < 0.6) including anaphylaxis, swelling, flu-like illness, breathlessness and fatigue and of side effects requiring hospital care (0.42 (0.31–0.58)). Our study confirms the findings of recent randomised controlled trials (RCTs) demonstrating that COVID-19 vaccines are generally safe with limited severe side effects. For the first time, our study links prior COVID-19 illness with an increased incidence of vaccination side effects and demonstrates that mRNA vaccines cause milder, less frequent systemic side effects but more local reactions.
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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：
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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：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
DOI：
10.1016/s0140-6736(20)32466-1
发表时间：
2021-12-19
期刊：
Lancet (London, England)
影响因子：
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作者：
Ramasamy MN;Minassian AM;Ewer KJ;Flaxman AL;Folegatti PM;Owens DR;Voysey M;Aley PK;Angus B;Babbage G;Belij-Rammerstorfer S;Berry L;Bibi S;Bittaye M;Cathie K;Chappell H;Charlton S;Cicconi P;Clutterbuck EA;Colin-Jones R;Dold C;Emary KRW;Fedosyuk S;Fuskova M;Gbesemete D;Green C;Hallis B;Hou MM;Jenkin D;Joe CCD;Kelly EJ;Kerridge S;Lawrie AM;Lelliott A;Lwin MN;Makinson R;Marchevsky NG;Mujadidi Y;Munro APS;Pacurar M;Plested E;Rand J;Rawlinson T;Rhead S;Robinson H;Ritchie AJ;Ross-Russell AL;Saich S;Singh N;Smith CC;Snape MD;Song R;Tarrant R;Themistocleous Y;Thomas KM;Villafana TL;Warren SC;Watson MEE;Douglas AD;Hill AVS;Lambe T;Gilbert SC;Faust SN;Pollard AJ;Oxford COVID Vaccine Trial Group
通讯作者：
Oxford COVID Vaccine Trial Group
DOI：
10.1001/jama.2020.24865
发表时间：
2021-01-12
期刊：
JAMA
影响因子：
--
作者：
Woolf SH;Chapman DA;Lee JH
通讯作者：
Lee JH
影响因子：
10
作者：
Arnold DT;Hamilton FW;Milne A;Morley AJ;Viner J;Attwood M;Noel A;Gunning S;Hatrick J;Hamilton S;Elvers KT;Hyams C;Bibby A;Moran E;Adamali HI;Dodd JW;Maskell NA;Barratt SL
通讯作者：
Barratt SL