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The research project on pregnant women receiving the quadrivalent influenza virus subunit vaccine has achieved interim progress
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- Time of issue:2025-11-05
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(Summary description)Recently, a mid-term progress summary meeting for the research project on the safety and immunogenicity of the quadrivalent influenza virus subunit vaccine (HRK-X®) in pregnant women was grandly held at the First Affiliated Hospital of Chongqing Medical University.
The research project on pregnant women receiving the quadrivalent influenza virus subunit vaccine has achieved interim progress
(Summary description)Recently, a mid-term progress summary meeting for the research project on the safety and immunogenicity of the quadrivalent influenza virus subunit vaccine (HRK-X®) in pregnant women was grandly held at the First Affiliated Hospital of Chongqing Medical University.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2025-11-05 08:55
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Recently, a mid-term progress summary meeting for the research project on the safety and immunogenicity of the quadrivalent influenza virus subunit vaccine (HRK-X®) in pregnant women was grandly held at the First Affiliated Hospital of Chongqing Medical University.
This study was initiated on March 1, 2025, by the company in collaboration with the First Affiliated Hospital of Chongqing Medical University and the Yuzhong District Center for Disease Control and Prevention in Chongqing. The commencement of this research marks a significant milestone in the prevention and control of influenza among pregnant women in China, providing crucial data support to enhance the vaccination rate of influenza vaccines among pregnant women, reduce maternal and infant health risks associated with influenza, and establish a protective barrier for maternal health during pregnancy. It also fills the gap in scientific evidence from the Chinese population, reinforcing the international consensus that "receiving the influenza vaccine during pregnancy is safe.".
Pregnant women are one of the high-risk groups for influenza and related complications. During pregnancy, various physiological and immune system changes increase their susceptibility to the flu virus, leading to relatively severe clinical symptoms upon infection. Research has found that pregnant women not only face a higher risk of severe illness and death compared to non-pregnant individuals but also an increased likelihood of adverse pregnancy outcomes (such as miscarriage, premature birth, and congenital fetal defects).
By receiving the quadrivalent influenza virus subunit vaccine, pregnant women can significantly reduce their risk of contracting the flu, greatly lowering the likelihood of severe illness, premature birth, stillbirth, and congenital fetal defects. Additionally, maternal antibodies provide protection for the developing fetus and newborns aged 0 to 6 months.
The quadrivalent influenza virus subunit vaccine (HRK-X®) employs a unique process to extract key effective antigens (HA and NA) from the influenza virus. It ensures high purity (≥85%) and excellent safety while demonstrating superior immunogenicity. The product's multiple quality standards exceed those of the Chinese Pharmacopoeia and European Pharmacopoeia, reaching internationally advanced levels. The newly released 《Chinese Influenza Vaccine Prevention and Vaccination Technical Guidelines (2025–2026)》also includes Phase III clinical data for the quadrivalent influenza virus subunit vaccine across all populations, noting that compared to split vaccines, subunit vaccines remove internal viral proteins, resulting in higher purity of antigenic active components and better safety.
In September this year, this product was approved for use in individuals aged 6 months and above, becoming the first and only quadrivalent influenza virus subunit vaccine approved for the entire population at full dosage in China. This high-quality vaccine, featuring high purity, low adverse reactions, excellent safety, and superior immunogenicity, aligns with global vaccine development trends by standardizing vaccine formulations for all individuals aged 6 months and above. It significantly enhances the convenience of vaccination and management, providing broader population coverage and more effective immune protection for influenza prevention and control in China.
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