The evaluation of data for Skycovion is one of several European Medicines Agency’s data reviews underway in relation to COVID-19 vaccines. As the pandemic continues to evolve, the agency said it critical that the EU has a wide array of vaccines and treatments to ensure countries can combat the pandemic effectively.
The EMA’s human medicines committee (CHMP) is reviewing data on how well the vaccine triggers the production of antibodies against the original strain of SARS-CoV-2. SK Chemicals also submitted data on the safety and quality of the vaccine.
After reviewing the data, the CHMP will issue an opinion on whether to grant a conditional marketing authorization. The EU Commission will then make a legally binding decision.
Skycovion is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine, in combination of GSK’s pandemic adjuvant.
The development of the jab has also been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 Program. The shot is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, and HPV vaccines.
The results of the global Phase III clinical trial showed that Skycovion induces neutralizing antibody responses and had an acceptable safety and the reactogenicity profile compared to the control vaccine, AstraZeneca’s Vaxzevria, used in the study, according to SK biosciences.
The results of extended phase I/II clinical trials also showed that there was a high immune response to the Omicron variant BA.1 after a booster of Skycovion, continued the company.
SK bioscience said it intends to make its vaccine available through the COVAX Facility for procurement and equitable allocation worldwide should an Emergency Use Listing (EUL) be obtained from the World Health Organization (WHO).
Meanwhile, it also outlined how it is planning to develop a combination vaccine candidate targeting both flu and COVID-19 simultaneously using the Skycovion platform.
Skycovion won market approval from South Korea’s Ministry of Food and Drug Safety back in June.