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SINOVAC CoronaVac Shows Good Safety in Pregnant and Postpartum Women (Sinovac Vaccine)
SINOVAC Biotech Ltd. (NASDAQ: SVA)（以下简称“SINOVAC”或“公司”），作为中国领先的生物制药产品供应商，于12月17日发布了一篇题为“巴西孕妇及产后女性COVID-19疫苗安全性概况”的文章。该研究是与IQVIA巴西合作完成的，并发表在健康科学预印本服务器medRxiv上。
在这项研究中，从2021年4月至8月，共有252,430剂CoronaVac®疫苗被用于20至40岁的孕妇及产后女性。共报告了3,333例免疫后不良事件（AEFI）。结果表明，SINOVAC开发的COVID-19灭活疫苗CoronaVac在孕妇及产后女性中证明是安全的。研究数据还显示，与其他技术平台开发的COVID-19疫苗相比，CoronaVac的不良事件发生率较低。
在研究期间，74.06%的疫苗剂量用于21至35岁的人群。同时，76.66%的剂量在孕期接种。AEFI监测数据来自巴西不良事件监测信息系统（SI-EAPV）。
为什么有必要了解COVID-19疫苗在孕妇及产后女性中的安全性？
研究结果显示，尽管COVID-19的病死率（CFR）低于SARS和MERS，但该病毒具有高度传染性。大多数患者表现为轻症，但仍有约20%的感染者发展为重症甚至死亡。老年人、有基础疾病者、孕妇及产后女性更容易感染COVID-19。
与非孕妇相比，孕妇（感染COVID-19后）更易发展为重症，增加了住院、ICU、有创通气、体外膜肺氧合甚至死亡的风险。然而，目前阶段，关于疫苗在孕妇及产后女性中的安全性和有效性证据仍然缺乏，尤其是COVID-19疫苗在该人群中的安全性证据。鉴于此，建立针对这一高风险人群的疫苗安全性监测框架，并为其提供适当建议至关重要。
根据巴西国家COVID-19免疫计划（NIP），孕妇被视为COVID-19疫苗接种的优先人群。因此，早在2021年3月，巴西就开始为该人群接种疫苗，而CoronaVac®是首个获批用于孕妇及产后女性的疫苗。
孕妇及产后女性接种COVID-19疫苗的意义
The data show that the mortality rate of pregnant and postpartum women caused by COVID-19 is relatively high in Brazil, vaccination is a very important strategy to reduce the impacts of COVID-19 on pregnant and postpartum women as well as their fetuses. Brazil has prioritized this group in its national COVID-19 immunization program, thus more evidence is required to prove the protective efficacy and safety of vaccines. In this perspective, the study filled the gap of the safety data in this specific group of population and provide scientific evidence for pregnant and postpartum women vaccination in Brazil, as well as other countries around the world.
In addition, to evaluate the safety of the second and booster doses, as well as using different types of vaccines as the second or booster dose of COVID-19 vaccine for pregnant and postpartum women is still necessary so that further evidence could be provided to support a better vaccination program.
[About SINOVAC]
SINOVAC Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus71 (EV71), hepatitis A and B, seasonal influenza, 23-Valent pneumococcal polysaccharide (“PPV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella and mumps. SINOVAC’s COVID-19 vaccine, CoronaVac®, has been granted emergency use approval or conditional marketing authorization by over 40 countries or regions worldwide. Healive®, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by SINOVAC against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, SINOVAC was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing several new products including a Sabin-strain inactivated polio vaccine and combined vaccines. SINOVAC primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is seeking market authorization of its products in over 30 countries outside of China. For more information, please see the Company’s website at www.sinovac.com.
Correlated links:
The third dose of SINOVAC COVID-19 Vaccine – CoronaVac® in elderly persons can induce a rapid and favorable immune response with good safety