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GlaxoSmithKline’s Shingrix recommended for EU approval in shingles prevention
GlaxoSmithKline has announced that its vaccine Shingrix has been recommended for European regulatory approval for the prevention of shingles.
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for Shingrix for the prevention of shingles and post-herpetic neuralgia.
This non-live, recombinant subunit adjuvanted vaccine is given intramuscularly in two doses, and is the first shingles vaccine to combine a non-live antigen with a specifically designed adjuvant to generate a strong and sustained immune response.
Shingles is caused by reactivation of the varicella zoster virus, which also causes chickenpox. A person's risk for shingles increases sharply after 50 years of age, with nearly all adults in this age group having the virus dormant in their nervous system.
Dr Thomas Breuer, senior vice-president and chief medical officer of GlaxoSmithKline Vaccines, said: "Shingrix is specifically designed to overcome the age-related weakening of the immune system and is an important step forward in the prevention of shingles."
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