Effectiveness of CoronaVac among healthcare workers in the setting of high SARS-CoV-2 Gamma variant transmission in Manaus, Brazil: A test-negative case-control study.
Effectiveness of CoronaVac among healthcare workers in the setting of high SARS-CoV-2 Gamma variant transmission in Manaus, Brazil: A test-negative case-control study.
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DOI：
10.1016/j.lana.2021.100025
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发表时间：
2021-09
期刊：
影响因子：
--
通讯作者：
Croda J
中科院分区：
文献类型：
--
作者：
Hitchings MDT;Ranzani OT;Torres MSS;de Oliveira SB;Almiron M;Said R;Borg R;Schulz WL;de Oliveira RD;da Silva PV;de Castro DB;Sampaio VS;de Albuquerque BC;Ramos TCA;Fraxe SHH;da Costa CF;Naveca FG;Siqueira AM;de Araújo WN;Andrews JR;Cummings DAT;Ko AI;Croda J
严重急性呼吸综合征冠状病毒2型变种伽玛病毒于2020年底在马瑙斯市出现，当时冠状病毒病(新冠肺炎)大规模死灰复燃，并已在巴西全国传播。疫苗在伽玛变种广泛传播的环境中的有效性尚未报道。我们进行了一项配对的试验阴性病例对照研究，以评估灭活疫苗CoronaVac在马瑙斯医护人员(HCW)中的有效性，在马瑙斯，在SARS-CoV-2流行的高峰期，伽玛变种占SARS-CoV-2基因分型样本的86%。我们对接种至少一剂疫苗后的有效性进行了早期分析，并对两剂计划的有效性进行了分析。主要结果是有症状的SARS-CoV-2感染。在早期的至少一剂和两剂分析中，研究人群分别是居住在马瑙斯的53,176名和53,153名18岁或以上的卫生工作者，他们拥有关于年龄、住所和疫苗接种状况的完整信息。在53,153名符合两剂分析条件的医务人员中，47,170人(89%)接受了至少一剂CoronaVac，2,656人(5%)在2021年1月19日至2021年4月13日接受了RT-PCR检测。在3195次RT-PCR检测中，有885次(28%)为阳性。选择了393和418对病例对照进行早期和两次剂量分析，分别按日历时间、年龄和邻里关系匹配。在RT-PCR样本采集日期之前接种两剂疫苗的人中，从第二次接种到样本采集日期的平均时间为14天(IQR 7-24)。在早期的分析中，至少接种一剂疫苗与在接受第一剂疫苗后14天或更长时间内出现症状的SARS-CoV-2感染的几率降低0.50倍(调整后的疫苗有效性(VE)，49.6%，95%可信区间11.3至71.4)。然而，我们估计，在接受第二次注射后14天或更长时间内，两剂方案对有症状的SARS-CoV-2感染的疗效较低(调整后的VE为36.8%，95%CI-54.9至74.2)。一项发现，在第一次接种后0-13天内，接种疫苗的人比未接种的人更有可能被感染(AOR 2.11，95%CI 1.36-3.27)，这表明未经测量的混淆导致了疫苗有效性估计的向下偏差。从这项关于CoronaVac有效性的试验阴性研究中得到的证据是复杂的，在这种情况下可能会受到偏见的影响。在流行伽玛变种传播的背景下，至少接种一剂疫苗对有症状的SARS-CoV-2感染显示出有效性。然而，两剂时间表的估计效力较低，这突出表明，在实施使用CoronaVac的疫苗接种运动时，需要保持非药物干预。奥斯瓦尔多·克鲁斯基金会(菲奥克鲁斯)；马瑙斯市卫生部长；维吉拉西亚基金会和亚马逊基金会
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant, Gamma, emerged in the city of Manaus in late 2020 during a large resurgence of coronavirus disease (COVID-19), and has spread throughout Brazil. The effectiveness of vaccines in settings with widespread Gamma variant transmission has not been reported. We performed a matched test-negative case-control study to estimate the effectiveness of an inactivated vaccine, CoronaVac, in healthcare workers (HCWs) in Manaus, where the Gamma variant accounted for 86% of genotyped SARS-CoV-2 samples at the peak of its epidemic. We performed an early analysis of effectiveness following administration of at least one vaccine dose and an analysis of effectiveness of the two-dose schedule. The primary outcome was symptomatic SARS-CoV-2 infection. For the early at-least-one-dose and two-dose analyses the study population was, respectively, 53,176 and 53,153 HCWs residing in Manaus and aged 18 years or older, with complete information on age, residence, and vaccination status. Among 53,153 HCWs eligible for the two-dose analysis, 47,170 (89%) received at least one dose of CoronaVac and 2,656 individuals (5%) underwent RT-PCR testing from 19 January, 2021 to 13 April, 2021. Of 3,195 RT-PCR tests, 885 (28%) were positive. 393 and 418 case-control pairs were selected for the early and two-dose analyses, respectively, matched on calendar time, age, and neighbourhood. Among those who had received both vaccine doses before the RT-PCR sample collection date, the average time from second dose to sample collection date was 14 days (IQR 7-24). In the early analysis, vaccination with at least one dose was associated with a 0.50-fold reduction (adjusted vaccine effectiveness (VE), 49.6%, 95% CI 11.3 to 71.4) in the odds of symptomatic SARS-CoV-2 infection during the period 14 days or more after receiving the first dose. However, we estimated low effectiveness (adjusted VE 36.8%, 95% CI -54.9 to 74.2) of the two-dose schedule against symptomatic SARS-CoV-2 infection during the period 14 days or more after receiving the second dose. A finding that vaccinated individuals were much more likely to be infected than unvaccinated individuals in the period 0-13 days after first dose (aOR 2.11, 95% CI 1.36-3.27) suggests that unmeasured confounding led to downward bias in the vaccine effectiveness estimate. Evidence from this test-negative study of the effectiveness of CoronaVac was mixed, and likely affected by bias in this setting. Administration of at least one vaccine dose showed effectiveness against symptomatic SARS-CoV-2 infection in the setting of epidemic Gamma variant transmission. However, the low estimated effectiveness of the two-dose schedule underscores the need to maintain non-pharmaceutical interventions while vaccination campaigns with CoronaVac are being implemented. Fundação Oswaldo Cruz (Fiocruz); Municipal Health Secretary of Manaus; Fundação de Vigilância em Saúde do Amazonas
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影响因子：
82.9
作者：
Ebinger JE;Fert-Bober J;Printsev I;Wu M;Sun N;Prostko JC;Frias EC;Stewart JL;Van Eyk JE;Braun JG;Cheng S;Sobhani K
通讯作者：
Sobhani K
影响因子：
64.5
作者：
Hoffmann M;Arora P;Groß R;Seidel A;Hörnich BF;Hahn AS;Krüger N;Graichen L;Hofmann-Winkler H;Kempf A;Winkler MS;Schulz S;Jäck HM;Jahrsdörfer B;Schrezenmeier H;Müller M;Kleger A;Münch J;Pöhlmann S
通讯作者：
Pöhlmann S
影响因子：
8.4
作者：
Amzat, Jimoh;Aminu, Kafayat;Danjibo, Maryann C.
通讯作者：
Danjibo, Maryann C.
影响因子：
82.9
作者：
Naveca, Felipe Gomes;Nascimento, Valdinete;Bello, Gonzalo
通讯作者：
Bello, Gonzalo
DOI：
10.1126/science.abh2644
发表时间：
2021-05-21
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Faria NR;Mellan TA;Whittaker C;Claro IM;Candido DDS;Mishra S;Crispim MAE;Sales FCS;Hawryluk I;McCrone JT;Hulswit RJG;Franco LAM;Ramundo MS;de Jesus JG;Andrade PS;Coletti TM;Ferreira GM;Silva CAM;Manuli ER;Pereira RHM;Peixoto PS;Kraemer MUG;Gaburo N Jr;Camilo CDC;Hoeltgebaum H;Souza WM;Rocha EC;de Souza LM;de Pinho MC;Araujo LJT;Malta FSV;de Lima AB;Silva JDP;Zauli DAG;Ferreira ACS;Schnekenberg RP;Laydon DJ;Walker PGT;Schlüter HM;Dos Santos ALP;Vidal MS;Del Caro VS;Filho RMF;Dos Santos HM;Aguiar RS;Proença-Modena JL;Nelson B;Hay JA;Monod M;Miscouridou X;Coupland H;Sonabend R;Vollmer M;Gandy A;Prete CA Jr;Nascimento VH;Suchard MA;Bowden TA;Pond SLK;Wu CH;Ratmann O;Ferguson NM;Dye C;Loman NJ;Lemey P;Rambaut A;Fraiji NA;Carvalho MDPSS;Pybus OG;Flaxman S;Bhatt S;Sabino EC
通讯作者：
Sabino EC