SK Bioscience Gets Approval for Quadrivalent Flu Vaccine in Indonesia

SK bioscience, a prominent vaccine and biotech company focused on promoting global health, has received approval from Indonesia's Food and Drug Agency (BPOM) for its SKYCellflu Quadrivalent prefilled syringe. This marks the first time a domestically produced influenza vaccine has been approved in Indonesia. SKYCellflu is the world's first quadrivalent cell-cultured influenza vaccine.

Indonesia, with a population exceeding 280 million, is the fourth most populous country globally and possesses a rapidly expanding pharmaceutical market. Market research by Innsight10 projects Indonesia's flu vaccine market to grow from USD 38.5 million in 2022 to USD 69.1 million by 2030. The country's unique geography, extending over both Northern and Southern Hemispheres, means it is subject to the World Health Organization's flu vaccination guidelines for both regions.

With the approval of SKYCellflu for Northern Hemisphere influenza strains, SK bioscience is hopeful for quick approval of its flu vaccine for Southern Hemisphere strains by Indonesia's Food and Drug Agency. SKYCellflu has achieved WHO Prequalification (PQ) certification, establishing its acceptable immunogenicity and safety standards through rigorous clinical trials. It remains the only cell-cultured influenza vaccine available in South Korea.

Cell-cultured vaccines offer several advantages over traditional egg-based vaccines, including shorter production times that make them more suitable for rapid responses to pandemics and new variants. Additionally, cell-cultured vaccines do not require antibiotics or preservatives. They are also less prone to mutations during production, ensuring a closer match to the circulating influenza strains.

In SK bioscience's research, repeated subculturing—where cells are transferred from one culture medium to another—demonstrated that no mutations occurred in the cells used for SKYCellflu production, compared to the mutations found in three proteins within the virus when using fertilized eggs. These findings were shared at the 2019 Korea Interscience Working Group on Influenza (KIWI) Symposium.

SKYCellflu has already been approved in several Asian nations, including Malaysia, Thailand, Myanmar, Iran, Singapore, Pakistan, Mongolia, and Brunei. It received approval in Chile last year, marking its first entry into the South American market. SK bioscience is poised for significant global expansion, aiming to establish itself as a major player in the international vaccine market.

Jaeyong Ahn, CEO of SK bioscience, expressed optimism about the global acceptance of their vaccines. He highlighted that SK bioscience's growth into a global vaccine brand is bolstered by successive WHO PQ certifications and global approvals of their vaccines, including those for shingles, chickenpox, and typhoid.

SK bioscience continues to leverage cutting-edge technology to develop and manufacture vaccines, striving for equitable access worldwide. Collaborating with various governments, regulatory bodies, healthcare providers, and medical experts, SK bioscience is dedicated to providing high-quality vaccines and enhancing public healthcare solutions globally.