Hitchings MDT et al.BMJ. 2022 Jun 13;377:e070102.

本文旨在评估在巴西Paulo State完成第一系列全病毒灭活疫苗CoronaVac(科兴生物技术)后，covid-19发病几率随时间的变化。RT-PCR证实有症状的covid-19以及相关的入院和死亡率之间的联系。条件logistic回归校正了性别、covid-19相关共病数量、种族和既往急性呼吸道疾病。

研究纳入02 741例患者，其中有症状的covid-19病例（n=52170）和有症状阴性对照（n=69115），形成43257组。疫苗接种结束后，有症状的covid-19调整后优势比随时间增加。此外，与序列完成后14-41天相比，covid-19相关住院或死亡的调整后比值比显著随时间增加:从70-97天的1.25(95%置信区间1.04 - 1.51)增加到182天之后的1.94(1.41 - 2.67)。

在65岁及以上人群中，首次接种CoronaVac疫苗3个月后，中度和重度covid-19结局的风险显著增加。这些发现为在这些接种灭活疫苗的人群中实施疫苗增强剂提供了支持性证据。关于渐弱的研究应该包括旨在揭示常见偏见的分析。

IAbstract

Objective: To estimate the change in odds of covid-19 over time following primary series completion of the inactivated whole virus vaccine CoronaVac (Sinovac Biotech) in São Paulo State, Brazil.

Design: Test negative case-control study.

Setting: Community testing for covid-19 in São Paulo State, Brazil.

Participants: Adults aged ≥18 years who were residents of São Paulo state, had received two doses of CoronaVac, did not have a laboratory confirmed SARS-CoV-2 infection before vaccination, and underwent reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 from 17 January to 14 December 2021. Cases were matched to test negative controls by age (in 5 year bands), municipality of residence, healthcare worker status, and epidemiological week of RT-PCR test.

Main outcome measures: RT-PCR confirmed symptomatic covid-19 and associated hospital admissions and deaths. Conditional logistic regression was adjusted for sex, number of covid-19 associated comorbidities, race, and previous acute respiratory illness.

Results: From 202 741 eligible people, 52 170 cases with symptomatic covid-19 and 69 115 test negative controls with covid-19 symptoms were formed into 43 257 matched sets. Adjusted odds ratios of symptomatic covid-19 increased with time since completion of the vaccination series. The increase in odds was greater in younger people and among healthcare workers, although sensitivity analyses suggested that this was in part due to bias. In addition, the adjusted odds ratios of covid-19 related hospital admission or death significantly increased with time compared with the odds 14-41 days after series completion: from 1.25 (95% confidence interval 1.04 to 1.51) at 70-97 days up to 1.94 (1.41 to 2.67) from 182 days onwards.

Conclusions: Significant increases in the risk of moderate and severe covid-19 outcomes occurred three months after primary vaccination with CoronaVac among people aged 65 and older. These findings provide supportive evidence for the implementation of vaccine boosters in these populations who received this inactivated vaccine. Studies of waning should include analyses designed to uncover common biases.

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