Competition in the quadrivalent influenza vaccine market will likely become fiercer, as Korea will add these vaccines to the national immunization program (NIP) next year.

Sanofi Pasteur_사노피 announced Tuesday that its quadrivalent flu vaccine, VaxigripTetra, had gained the Ministry of Food and Drug Safety’s approval as the seventh vaccine of its kind, following GlaxoSmithKline’s_{글락소스미스클라인} Fluarix Tetra, the Green Cross’s_녹십자 GCFlu Quadrivalent, and SK Chemical’s_SK케미칼 SKY Cell Flu Quadrivalent.

Quadrivalent flu vaccines protect against four different strains of flu viruses: two influenza A strains (H1N1, H3N2) and two influenza B strains (B/Yamagata, B/Victoria). Up till now, trivalent flu vaccines had protected against only three different flu viruses, meaning the vaccine did not protect against the B virus strain not included in the vaccine.

“Because the two strains of influenza B viruses circulate in many forms according to season and region, the quadrivalent flu vaccine has become necessary to protect against both strains,” a Sanofi official remarked. “The World Health Organization (WHO) is recommending flu vaccinations for everyone over the age of six.”

Both WHO and the Korean Society of Infectious Diseases are recommending people to get vaccinated.

GSK’s Fluarix Tetra was the first quadrivalent flu vaccine approved in Korea in December 2014 for children and adults three years and over, and the Green Cross became the second domestic producer to release its GCFlu Quadrivalent in May last year for those over three years old and younger than 65.

SK Chemical released SKY Flu Quadrivalent in December 2015 for adults, and later gained the ministry’s approval for the drug to be used for children and adolescents (between 3 and 18 years of age). It has become the first domestic product to have vaccines for people available for those three years and older.

The ministry has since approved Boryung Biopharma’ Boryung ⅤTetra Vaccine Inj. for those older than three years of age and younger than 65, Korea Vaccine’s injection for adults aged 19 to 65, and Il-Yang Pharm.’s vaccine for adults over 19.

Sanofi Pasteur’s VaxigripTetra has now become the successive quadrivalent injection to receive the ministry’s approval for use on all children and adults over three years old, following GSK and SK Chemical.

Domestic companies are now keen to carry out additional clinical studies that target children less than three years old since the current vaccines are for children and adults over three years old.

SK Chemicals has entered into Phase III clinical trials for its SKY Cell Flu Quadrivalent last October. Green Cross has recently has gained approval to carry out phase 3 clinical trials for its vaccine on infants under three years old.

Meanwhile, GSK’s Fluarix Tetra, the current market leader, has applied for the U.S. Food and Drug Administration’s approval for indications for infants under three years of age and is preparing to apply for a domestic license.

hwz@docdocdoc.co.kr

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