FDA approves new Shingrix indication
The Food and Drug Administration has cleared 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 — given intramuscularly in two doses — was initially approved by the FDA in 2017 for the prevention of shingles in adults 50 years of age or older.
"We're proud to offer Shingrix in the United States 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 of 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 United States 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."