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Sanofi Pasteur Korea gets expanded indication for VaxigripTetra
  • By Marian Chu
  • Published 2018.06.25 12:10
  • Updated 2018.06.25 12:10
  • comments 0

Sanofi Pasteur Korea said Monday that it got an expanded indication from the Ministry of Food and Drug Safety for its four-strain influenza vaccine VaxigripTetra to be used on infants six months to three years old.

VaxigripTetra

The approval allows the vaccine to be used to inoculate infants, children, adolescents, adults, and elderly during the upcoming flu influenza season in September, the company said. Influenza is a potentially fatal disease that results in around 250,000 to 500,000 deaths per flu season.

The vaccine was approved by large-scale global clinical trial results conducted on 5,400 infants aged six to 35 months for a year, and nine months in 43 centers on four continents such as Europe, Asia, South America, and Oceania.

Findings showed that administering VaxigripTetra two times on infants from six to 35 months had a 68.4 percent preventive effect against influenza caused by a virus strain similar to the vaccine.

Comparing the immunogenicity to Vaxigrip showed non-inferiority to the three virus strains included in the existing trivalent vaccine and showed superior immunogenicity to the added B type virus. The safety profile was equal to Vaxigrip, according to the company.

VaxigripTetra contains two A strains (A/H1N1 and A/H3N2), and two B strains (B/Victoria and B/Yamagata) to protect against the two distinct influenza B strains that co-circulate worldwide unpredictably.

One shot of VaxigripTetra protects against influenza caused by the four types of virus strains for infants over six months of age. However, children under nine years of age who have no experience with getting an influenza vaccine need to get two shots with more than four weeks in between.

“We are very pleased that VaxigripTetra injection’s inoculation age has been expanded to infants older than six months to become a four-strain influenza vaccine used to inoculate the whole family,” Sanofi Pasteur Korea CEO Baptiste de Clarens said.

yjc@docdocdoc.co.kr

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