SK Bioscience has obtained product approval for its flu vaccine, Sky Cellflu, from Chile's health authorities, the first green light in a Latin American country, the South Korean vaccine developer said Thursday.
Starting with Chile, SK Bioscience is planning to expand the number of countries licensed for Sky Cellflu in Latin America. Chile's drug approval is widely considered a regional standard among Latin American countries, the company added.
Chile is the 10th country to have approved SK Bioscience's Sky Cellflu, following Malaysia, Thailand, the Philippines, Myanmar, Iran, Singapore, Pakistan, Mongolia and Brunei.
Compared to the existing fertilized egg-type flu vaccine, the production period for Sky Cellflu, which uses animal cells, is about half as short -- therefore giving the firm the advantage of being able to respond quickly to the emergence of pandemics or mutant viruses, it said.
People with egg allergies can also be safely inoculated, it added.
Sky Cellflu proved immunogenicity and safety in phase 3 clinical trials of 1,503 adults aged 19 or older at 10 domestic institutions, obtaining pre-qualification certification by the World Health Organization for the first time among cell-cultured flu vaccines.
Domestically, Sky Cellflu has led the flu vaccine market, accounting for 29 percent of local sales as of 2020, according to the firm's press release.
SK Bioscience CEO Ahn Jae-yong said, "Sky Cellflu’s production will resume this year, will expand its scope beyond the Korean market based on its proven product competitiveness."
"As our status as a global vaccine company has grown through the pandemic, various vaccines developed by SK Bioscience will become famous overseas," he added.