All Korean Veterinary Vaccines to Have Consistent Efficacy: Strict Management from the Seed Stage

Animal and Plant Quarantine Agency to Implement 'Seed Lot System for Animal Vaccines' Next Year
Management Based on Designated 'Master Seed Strain'
Continuous Supervision Even After Product Approval

In order to enhance the competitiveness of Korean veterinary vaccines, management and supervision of vaccine seeds will be strengthened starting next year. Strict quality control will be implemented from the seed stage to ensure consistent efficacy and safe vaccine production. This is expected to further strengthen the global competitiveness of Korean veterinary vaccines.

The Animal and Plant Quarantine Agency announced on the 5th that it will fully implement the "Seed Lot System (SLS) for Veterinary Vaccines" starting January 1, 2026. The SLS is a system that manages vaccine seeds in the same way as seeds for crops, and has already been adopted in the United States, Europe, and Japan. The World Organisation for Animal Health (WOAH) has also established standards for the management of veterinary vaccine seeds and recommends them to its member countries.

Koo Hyunok, Head of the Animal Evaluation Division at the Animal and Plant Quarantine Agency, explained, "Just as good crops come from good seeds, good vaccines come from good vaccine seeds. Unlike other general pharmaceuticals, vaccines are produced from living organisms (seeds), so special management is required. To this end, we will verify the biological seeds, which are the raw materials for veterinary vaccine production, from the approval stage, and implement a vaccine quality control system that ensures manufacturers use only verified seeds in production."

On the 30th of last month, a researcher from the Animal and Plant Quarantine Agency was preparing for cell culture at a biosafety cabinet. Animal and Plant Quarantine Agency

The core of the SLS is to expand the verification process, which has so far focused on the final vaccine, to include the seed stage. Viruses or bacteria, which are the seeds needed to make vaccines, are living organisms and their genes can mutate during repeated cultivation. The virus in an attenuated vaccine, designed to only provide immunity, could become stronger, or it could mix with other microorganisms. Just as weeds can grow in a strawberry field, other bacteria or viruses could be introduced during vaccine production.

Koo emphasized, "If the seed's genes mutate or if bacteria or viruses are introduced incorrectly, the efficacy of the vaccine produced later may differ from that of the original vaccine. To prevent this, the SLS designates a 'master seed' and manages all processes based on this reference."

To implement this system, the Animal and Plant Quarantine Agency has conducted an in-depth analysis of international quality control standards for veterinary vaccines since 2021 and established domestic standards. In June last year, to minimize the impact on domestic industry, the agency set the basic direction for introducing the system by distinguishing between new and previously approved products. To this end, the agency held joint research and consultative meetings (six times) with domestic manufacturers and experts (33 companies), as well as in-depth discussions by industry sector (seven times). In April this year, the agency also developed quality control guidelines for seeds that must be submitted by companies when developing products and applying for approval.

The SLS stipulates verification and supervision by the Animal and Plant Quarantine Agency, as well as compliance requirements for manufacturers. The agency verifies whether the data submitted by companies on vaccine seeds at the product approval stage meet the standards, and after approval, it regularly supervises whether only the approved vaccine seeds are used. Manufacturers must conduct quality tests on seeds from the development stage according to the standards and submit quality control data for all biological materials used in the production of the final product.

The agency expects that this system will contribute to ▲improving quality ▲industrial development ▲animal welfare ▲securing international competitiveness. Koo stated, "Once this system is implemented, the quality will improve, and all vaccines will have the same effect, eliminating issues such as 'the previous vaccine worked well, but this one does not.' Managing vaccine seeds will also promote the development of new products, enhancing the overall competitiveness of the industry. Harmonization with seed management systems such as those of the WOAH will further strengthen the status and export competitiveness of Korean veterinary vaccines in the global market."

In particular, by verifying from the outset that no bacteria or viruses are mixed into the vaccine, the system will ensure the supply of high-quality and safe vaccines, thereby increasing the productivity of industrial animals and contributing to the health of companion animals. In addition, thorough inspections from the seed stage will guarantee the quality of the final product and reduce the need for repeated animal testing.

The agency plans to fully implement the SLS for new vaccines starting next year, and to phase in the system for previously approved vaccines, considering the time required for preparation. To ensure a smooth introduction, the agency will also develop and share, together with the industry, specific standard test procedures for detecting seed contamination and approximately 260 standard process documents for each product group. Koo added, "We will further strengthen technical training and public relations for the industry to ensure the successful establishment of the system. In addition, we will evaluate the results of the system's operation over the next three years, identify areas for improvement, and continue to enhance the system."