GlaxoSmithKline plc announced that the US FDA has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) 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. 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 (chickenpox). The approval for this new population expands the number of people who can be protected against shingles by Shingrix.
"We're proud to offer Shingrix in the US for the prevention of shingles in those who are immunocompromised, with FDA granting a broad indication for use in adults at increased risk of this disease," said Thomas Breuer, Chief Medical Officer, GSK Vaccines. "Older age and being immunocompromised are the most common risk factors for shingles disease. GSK is committed to this important patient population at increased risk for shingles disease and its complications by bringing them a vaccine option that can help prevent this painful condition."
"In addition to this new patient population, there are more than 100 million adults 50 years and older in the US already recommended to receive Shingrix," said Breuer. "We know many of these individuals missed recommended vaccines during the pandemic and we hope this can be a reminder to them to catch up on all their immunizations, including Shingrix."
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