School of Public Health, Southeast University; Nanjing, China.
NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Expert Rev Vaccines. 2021 Jan;20(1):1-11. doi: 10.1080/14760584.2021.1875823. Epub 2021 Feb 1.
Quadrivalent Influenza Vaccine (Sinovac Biotech) is a quadrivalent split-virion-inactivated influenza vaccine approved in China in June 2020 for individuals ≥3 years of age. It contains 15 µg hemagglutinin per strain including A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, which could potentially improve protection against influenza B viruses.
In this review, we summarize the development of quadrivalent influenza vaccines in China and foreign countries, and assess the immunogenicity and safety from the phase I and III clinical trials of Quadrivalent Influenza Vaccine in individuals ≥3 years of age. We also discuss the potential application of Quadrivalent Influenza Vaccine in young children 6-35 months of age according to the results of the phase III trial.
The immunogenicity and safety profiles of Quadrivalent Influenza Vaccine containing two A and two B strains were comparable to the trivalent vaccines for the shared strains. The addition of a second B strain to the trivalent vaccine could induce superior immune responses for the alternate B strain. Since the two B strains co-circulated worldwide, the introduction of quadrivalent influenza vaccines has been expected to be a cost-effective strategy.
四价流感疫苗（科兴）是一种四价裂病毒灭活流感疫苗，于 2020 年 6 月在中国获得批准，用于 3 岁及以上人群。它包含每株 15μg 的血凝素，包括 A/H1N1、A/H3N2、B/Victoria 和 B/Yamagata，这可能有助于提高对乙型流感病毒的保护。
在这篇综述中，我们总结了国内外四价流感疫苗的发展情况，并评估了 3 岁及以上人群中四价流感疫苗的 I 期和 III 期临床试验的免疫原性和安全性。我们还根据 III 期试验的结果，讨论了四价流感疫苗在 6-35 月龄婴幼儿中的潜在应用。
含两种 A 型和两种 B 型的四价流感疫苗的免疫原性和安全性与共有的三价疫苗相当。在三价疫苗中加入第二种 B 型株，可以诱导对替代 B 型株的更好免疫反应。由于两种 B 型株在全球范围内共同流行，因此人们期望引入四价流感疫苗是一种具有成本效益的策略。
