FDA gives OK to shingles vaccine for those at risk
The recent FDA decision to expand its approval of Shingrix to include immunocompromised adults 18 years and older is the first step toward providing protection against shingles to more at-risk individuals. The vaccine, manufactured by GlaxoSmithKline, was originally approved by the FDA in 2017 for immunocompetent adults aged 50 and older.1
The FDA’s move is based on clinical studies examining the safety and efficacy of Shingrix in patients aged 18 and older who had undergone an autologous hematopoietic stem cell transplant or treatment for hematological malignancies. Additional data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed because of known disease or therapy. This group included patients with HIV, solid tumors, and renal transplants.
“Older age and being immunocompromised are the most common risk factors for shingles disease,” explained Thomas Breuer, chief medical officer of GSK Vaccines, in a prepared statement. “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.”
A cross-sectional analysis of data from the 2013 National Health Interview Survey administered by the US Census Bureau revealed that more than 4% of adults surveyed had been told by a physician that they were immunocompromised. Almost 3% of those surveyed reported current immunosuppression. The rate was highest in women, White individuals, and people aged 50 to 59 years.2
Immunocompromised individuals are at greater risk for developing opportunistic infections and experiencing the reactivation of chronic infections, as well as other health problems. In addition, patients are often unable to receive vaccines because of their condition.
Immunocompromised individuals are at greater risk of developing shingles and associated complications, including postherpetic neuralgia, than immunocompetent individuals. Age, gender, race, and overall health are risk factors for developing shingles in the general population.
In his statement, Breuer noted that in addition to the immunocompromised patient population, more than 100 million adults aged 50 and older in the United States also are eligible to receive Shingrix.1
Virtually all individuals over the age of 40 carry the varicella zoster virus associated with shingles. The virus initially causes chickenpox and then is dormant in the nervous system for decades before reactivating to cause shingles.
Shingrix is administered in 2 doses given 2 to 6 months apart. For immunocompromised adults who would benefit from a shorter vaccination schedule, GSK states that the dosing schedule can be changed to 1 to 2 months.
Shingrix is included on the 2021 vaccination schedule for adults issued by the CDC’s Advisory Committee on Immunization Practices (ACIP). The committee is reportedly considering recommendations for the vaccine’s use in immunocompromised adults.
Shingrix is not contraindicated in immunocompromised persons but is not recommended by ACIP at this time, according to the CDC.3 The committee will review evidence for modifying its vaccine policy as it becomes available.1 The guidance states that Shingrix can be administered to individuals who are taking low-dose immunosuppressive medication or are anticipating immunosuppression, and to those who have recovered from an immunocompromising illness.