July 26, 2021
GlaxoSmithKline’s Shingrix® (zoster vaccine recombinant, adjuvanted) has received U.S. FDA approval for an expanded indication to prevent shingles (herpes zoster). Previously approved only for adults who are at least 50 years old, Shingrix can now be used to vaccinate adults at least 18 years of age who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by disease or therapy. Shingrix first received FDA approval in 2017.
Shingles occurs when a dormant viral infection – the same infection that causes chickenpox – becomes active again. The reactivated virus causes a blistered rash that can be extremely painful. It may also cause stomach issues, fever, chills, and headache. Anyone who has had chickenpox can develop shingles, but it’s most likely to occur in people over 50 years of age as well as individuals who are immunocompromised due to factors such as disease and immunosuppressive medications.
Approval of the new Shingrix indication is based on a clinical study in which the vaccine was found to reduce the incidence of shingles in patients who were undergoing stem cell transplants or treatment for cancers of the blood, bone marrow, and lymph nodes. Recommended dosing under the expanded indication is two 0.5mL intramuscular injections given two six months apart. For individuals who would benefit from a shorter vaccination schedule, the vaccine can be given one to two months apart.