China is the first to develop a successful global vaccine

On September 3, the A-type H1N1 flu vaccine developed by Beijing Kexing Biological Products Co., Ltd. received its drug approval number from the State Food and Drug Administration (SFDA). This marked a historic milestone as it became the first A-type H1N1 flu vaccine globally to receive a production batch number. The entire development process, from the moment the company obtained the virus strain directly from the World Health Organization (WHO) on June 8, took just 87 days. The journey of vaccine development—from initial research, trial production, clinical trials, on-site inspections, registration checks, to final review and approval—was an extraordinary effort. Vaccine manufacturers, regulatory agencies, health departments, and disease control centers across China worked in unison to accelerate the timeline, aiming to ensure that people could be vaccinated as soon as possible. "Every day we save in the development of the vaccine means one more day of protection for the public," emphasized the urgency behind this mission. In April 2009, when the H1N1 flu virus spread rapidly from North America to the rest of the world, the need for a fast-acting vaccine became critical. As one of the most effective tools in controlling the outbreak, the timely development of the influenza A H1N1 vaccine was essential. Obtaining WHO-provided virus strains was the first step for vaccine manufacturers. On June 3 at 8 PM, with support from customs and quality inspection authorities, the H1N1 influenza vaccine produced by the WHO-approved laboratory was delivered to Hualan Biological Engineering Co., Ltd. in Henan. As the first Chinese company to receive the strain, Hualan Bio began its vaccine development immediately. "From researchers to managers and frontline workers, every minute counted during this period," said Fan Lan, Executive Vice President of Hualan Bioengineering. He reflected on the past three months, noting that nearly all employees treated the project as their top priority, working around the clock with little time for rest or meals. On September 1, Hualan Biological's split H1N1 vaccine passed expert review by the National Drug Evaluation Center and was expected to receive its SFDA approval number before September 4. This achievement came just three months after the company received the standard strain, aligning closely with Beijing Kexing’s timeline. Yin Weidong, director of Beijing Kexing Biological Products, highlighted the importance of early vaccine availability: "With China’s large population, even a day’s delay can have significant consequences. Being able to vaccinate key groups earlier can help reduce the impact of the pandemic." Meanwhile, government agencies were also actively involved. From June to August, the SFDA issued several important guidelines, including the Notice on Preparing for the Production of Influenza A H1N1 and the Emergency Work Plan for Special Approval of Pandemic Influenza Vaccines. These policies laid a solid foundation for accelerating the approval process. Under the principle of “no reduction in procedures and no compromise on standards,” the SFDA implemented a “three-synchronization” approach in the vaccine review and approval process. This included synchronizing technical reviews with enterprise submissions, production site inspections with manufacturing processes, and sample testing with internal quality checks. “This is the power of scientific management that optimized workflows and boosted efficiency in vaccine development,” said Zhang Wei, Director of the Drug Registration Department at the SFDA. “No matter how much pressure we faced, we always believed in one thing: science,” he added. Influenza A (H1N1) was a completely new virus, and in the early stages of the outbreak, global knowledge about it was limited. Despite the challenges, the collaboration between industry and government ensured that China could respond swiftly and effectively to the pandemic.

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