■本研究旨在评估BNT162b2和CoronaVac疫苗接种后血栓栓塞事件与出血性卒中之间的关系。
■纳入2021年2月23日至9月30日期间Covid-19疫苗接种或SARS-CoV-2阳性检测28天内发生血栓栓塞事件或出血性中风的患者。估计了每100,000种covid-19疫苗剂量和SARS-CoV-2测试阳性病例的发生率。使用全港电子健康和疫苗接种记录的数据进行的改良自控病例系列(SCCS)分析。季节效应按月调整。
■总共施用了5,526,547剂BNT162b2和3,146,741剂CoronaVac。总共334和402个血栓栓塞事件,在BNT162b2和CoronaVac接种疫苗后28天内发生了57例和49例出血性中风病例,分别。两种covid-19疫苗每100,000剂量的血栓栓塞事件和出血性中风的粗发生率小于每100,000例SARS-CoV-2测试阳性病例。改良的SCCS在首次给药后14-27天检测到BNT162b2出血性中风的风险增加,调整后的IRR为2.53(95%CI1.48-4.34),第二次给药后0-13天,调整后的IRR为2.69(95%CI1.54-4.69)。两种疫苗的血栓栓塞事件均无统计学意义。
■我们检测到BNT162b2疫苗接种后出血性中风的可能安全信号。疫苗接种后血栓栓塞事件或出血性中风的发生率低于SARS-CoV-2检测阳性病例;因此,covid-19疫苗接种仍然是一项重要的公共卫生干预措施。
■这项研究由食品和卫生局的研究资助,香港特别行政区政府(参考COVID19F01)。
UNASSIGNED: This study aims to evaluate the association between thromboembolic events and hemorrhagic stroke following BNT162b2 and CoronaVac vaccination.
UNASSIGNED: Patients with incident thromboembolic events or hemorrhagic stroke within 28 days of covid-19 vaccination or SARS-CoV-2 positive test during 23 February to 30 September 2021 were included. The incidence per 100,000 covid-19 vaccine doses administered and SARS-CoV-2 test positive cases were estimated. A modified self-controlled
case series (SCCS) analysis using the data from the Hong Kong territory-wide electronic health and vaccination records. Seasonal effect was adjusted by month.
UNASSIGNED: A total of 5,526,547 doses of BNT162b2 and 3,146,741 doses of CoronaVac were administered. A total of 334 and 402 thromboembolic events, and 57 and 49 hemorrhagic stroke cases occurred within 28 days after BNT162b2 and CoronaVac vaccination, respectively. The crude incidence of thromboembolic events and hemorrhagic stroke per 100,000 doses administered for both covid-19 vaccines were smaller than that per 100,000 SARS-CoV-2 test positive cases. The modified SCCS detected an increased risk of hemorrhagic stroke in BNT162b2 14-27 days after first dose with adjusted IRR of 2.53 (95% CI 1.48-4.34), and 0-13 days after second dose with adjusted IRR 2.69 (95% CI 1.54-4.69). No statistically significant risk was observed for thromboembolic events for both vaccines.
UNASSIGNED: We detected a possible safety signal for hemorrhagic stroke following BNT162b2 vaccination. The incidence of thromboembolic event or hemorrhagic stroke following vaccination is lower than that among SARS-CoV-2 test positive cases; therefore, vaccination against covid-19 remains an important public health intervention.
UNASSIGNED: This study was funded by a research grant from the Food and Health Bureau, The Government of the Hong Kong Special Administrative Region (reference COVID19F01).