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GSK gets nod for shingles vaccine in Europe, Japan
  • By Marian Chu
  • Published 2018.03.29 18:31
  • Updated 2018.03.29 18:31
  • comments 0

GlaxoSmithKline said Thursday that it snagged approvals from both European and Japanese regulatory bodies for its shingles vaccine Shingrix to be used as a preventive measure for those over 50 years of age.

Shingrix protects against shingles, a viral infection characterized by painful and blistering rashes, and postherpetic neuralgia (PHN), which is a complication that occurs after a shingles infection. The recombinant zoster vaccine is administered intramuscularly in two doses, GSK said.

Both shingles and PHN are caused by the varicella-zoster virus, which also causes chickenpox in children. The virus remains latent in the nervous system following childhood but may be reactivated as shingles in later life as the immune system weakens with age.

“The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection,” said Dr. Thomas Breuer, senior vice-president and chief medical officer of GSK Vaccines. “Shingrix was developed specifically to overcome this decline and to help protect people over 50 as we get older.”

The varicella-zoster virus vaccine showed more than 90 percent efficacy in clinical trials, Breuer noted. The U.S. Centers for Disease Control and Prevention recommends Shingrix as a preventive measure against shingles for adults over 50.

The European Commission and the Japanese Ministry of Health, Labor and Welfare’s approvals mark the third and fourth go-ahead for the vaccine. Canadian and U.S. health regulators approved the vaccine in October 2017.

The company will also apply for approval in Korea, according to a GSK Korea official.

yjc@docdocdoc.co.kr

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