SK Bioscience Benefits From Global Vaccine Sales

SK bioscience is working to rapidly respond to the spread of infectious diseases through its mRNA vaccine platform. It also plans to develop new pipelines by strengthening its research and development capacity, including advanced BSL-3 research facilities.

The company is currently manufacturing British-Swedish pharmaceutical giant AstraZeneca’s and Novavax’s COVID-19 vaccine under a contract development and manufacture (CDMO) deal.

Vaccine Development

Vaccine development is a complex and time-consuming process. Innovative technologies and approaches, such as reverse vaccinology and next-generation platforms, can help researchers develop vaccines faster and more effectively. These technologies can also improve the manufacturability and storage stability of vaccines.

IVI helped SK Bioscience develop its COVID-19 vaccine candidate, SKYCovione, and supported the vaccine’s successful clinical development and WHO emergency use listing (EUL). We continue to work with SK Bioscience and CEPI to ensure equitable access to this vaccine for all nations.

SK Bioscience’s new vaccine production facility in Songdo will be the largest in South Korea and is expected to produce more than two billion doses per year. This will allow SK Bioscience to meet global demand for its existing vaccines, including cell-culture-based influenza, hepatitis B and HPV, as well as its new COVID-19 vaccine and other emerging vaccines targeting neglected diseases. It will also accelerate securing of the country’s vaccine sovereignty by reducing dependence on foreign vaccine imports.

Vaccine Manufacturing

Manufacturing vaccines is a complex process. The development and testing of the production technology, construction and maintenance of facilities and compliance with local and international regulations are all expensive for manufacturers. However, a vaccine’s long product life-cycle ensures that manufacturers recover the initial investment in development.

Vaccine manufacturers must submit detailed documentation of Current Good Manufacturing Practices (cGMP) to their National Regulatory Authorities (NRAs) as well as to those of countries where they want to market their products. In addition, they must regularly undergo unannounced regulatory inspections to verify adherence to cGMP and to monitor the quality of their vaccines.

To ensure availability of the vaccine during the endemic phase of the COVID-19 pandemic, CEPI has reserved manufacturing capacity with companies such as SK bioscience and GC Pharma in South Korea for SKYCovione. This will enable the vaccine to be manufactured quickly and made available for procurement by organizations such as UNICEF and WHO after obtaining an emergency use authorization (EUL) at the global level.

Vaccine Sales

Vaccine sales are divided into vaccines against viral diseases (hepatitis, influenza, human papillomavirus) and bacterial disease (meningococcal, diphtheria, tetanus, pertussis). Pediatric injection products account for the majority of the global vaccine revenue, driven by worldwide growing birth cohort and increasing pediatric vaccination doses.

SK Bioscience posted robust earnings this year, thanks to contracts with AstraZeneca and Novavax Inc to produce their COVID-19 vaccines. The South Korean company produces the undiluted solutions and drug substances in these contracts and handles the entire manufacturing process, including putting the vaccine into vials or syringes and sealing them for shipping.

The company also developed SKYCellFluTM, the world’s first cell-culture based influenza vaccine that was prequalified by WHO in 2019, and SKYZosterTM, the second WHO prequalified varicella vaccine for shingles. By locating its new global R&D center in Songdo, the smart city 18 miles from Seoul, SK Bioscience hopes to establish itself as an international vaccine manufacturer, and pursue purchases of next-generation platform technologies, such as cell and gene therapies.

Vaccine Distribution

When the vaccine production process is complete, it must be delivered to a network of delivery sites. The actual set of distribution sites will vary by location, but may include hospitals and medical practices, pharmacies, state and local public health departments, and government-run mass vaccination centers. The availability of these sites will have a direct impact on equitable access to the vaccine.

SK bioscience has received authorisation for its recombinant protein COVID-19 vaccine SKYCovion from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The vaccine was developed using a recombinant protein technology, which is designed to induce high neutralising antibodies. It can also be stored at ambient temperature, which reduces costs by avoiding the need for costly ultra-cold chain facilities.

Studies have found that at the macro level, factors influencing the unequal distribution of the vaccine include economic characteristics (Stability and country’s economy, GDP per capita, financial support, Human development index), Infrastructure and health system (Vaccine information system, Functional cold chains in vaccine transport, Medical and non-medical infrastructure and facilities per capita, Healthcare provision and access), Legal and politics (Vaccination allocation rules, health policies, Political ideology and racial bias) and Epidemiologic and demographic factors (Covid-19 incidence rate, Vulnerability to covid-19, Life expectancy). The existence of fair laws and policies can lead to greater equity in vaccine distribution.