Sanofi Pasteur Korea, the vaccines division of the French multinational pharmaceutical Sanofi, announced Tuesday it will launch its quadrivalent vaccine, VaxigripTetra, early next month.
The Ministry of Food and Drug Safety approved the vaccine on June 20 as the seventh of its kind.
“We are proud to introduce VaxigripTetra and hope it will help families in Korea who want more protection from the disease. [The drug]’s immunogenicity and safety have been proven in 24 countries around the world including Korea,” said Sanofi Pasteur Korea CEO Baptiste de Clarens at a press conference held in downtown Seoul Tuesday.
Four large-scale global clinical trials conducted in Europe, Asia, North America, and Oceana in around 4,000 patients proved the safety and efficacy of VaxigripTetra, the company said.
The results showed non-inferiority to Vaxigrip regarding immunogenicity and showed superiority for the newly added B strain virus, the company said. The drug’s safety also proved equal to Vaxigrip.
Pharmaceutical companies have been jumping into the quadrivalent influenza vaccine market, previously dominated by trivalent vaccines that protected against three strains of influenza -- two A strains and one B strain. Sanofi has been no exception.
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In recent years, two distinct influenza B strains (B/Victoria and B/Yamagata) have started to co-circulate in varying and unpredictable proportions worldwide, creating demand for four-strand vaccines that protect against both two A strains and two B strains.
“It becomes increasingly difficult to determine which strain will circulate each year. But we have seen the arrival of several quadrivalent vaccines launched this year along with our VaxigripTetra causing the market to be realigned to these types of vaccines,” said Baptiste de Clarens.
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VaxigripTetra vaccine can be administered to those aged 3 and older against both influenza B strains. It is the newest addition to the company’s Vaxigrip family of influenza vaccines.
“Although there have been no head-to-head studies proving the therapy’s superiority to other similar products, we believe VaxigripTetra stands out regarding good manufacturing practices that originate in France and distributed worldwide,” a company official said. “We also proved the superiority of this product through a well-designed clinical trial that encompassed a large number of participants around the world.”
The product will be priced “similarly to competing products,” the official added.