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GlaxoSmithKline : FDA Approves Shingrix To Prevent Shingles In Immunocompromised Adults

The US Food and Drug Administration has approved Shingrix--Zoster Vaccine Recombinant, Adjuvanted-- for the prevention of shingles in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy, GlaxoSmithKline Plc. (GSK.L,GSK) said in a statement.

Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals.

Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older. Shingrix is not indicated for prevention of primary varicella infection or chickenpox.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has begun discussions to consider recommendations for use of Shingrix in immunocompromised adults, GlaxoSmithKline said.

Shingrix was previously approved by the European Commission for prevention of shingles and post-herpetic neuralgia (PHN) in adults 18 years of age or older at increased risk of shingles and granted marketing authorization on August 25, 2020.

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