FDA and CDC give thumbs up to Shingrix.
Pharmacists now have two choices when it comes to protecting their patients from potentially debilitating shingles.
The FDA has unanimously approved Shingrix, a new shingles vaccine from GlaxoSmithKline (GSK), and the CDC’s Advisory Committee on Immunization Practices (ACIP) took the unusual step of recommending Shingrix over its competition, Merck’s Zostavax. ACIP also advised adults who have received Zostavax to get revaccinated with Shingrix.
Shingles is a painful and sometimes debilitating reactivation of the varicella zoster virus (VZV), which also causes chickenpox. More than 99% of the U.S. population over the age of 50 carry VZV, and an estimated 1 million cases of shingles occur annually, affecting one in three people. It typically presents as a painful, itchy rash with burning, shooting, or stabbing pain that can last for up to four weeks.
Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses. Zostavax contains a weakened VZV and is administered in one dose. Both vaccines are intended for use in adults aged 50 years and older.
While Zostavax reduces the risk of shingles by 51% percent, clinical trials show that Shingrix is much more effective. “The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles,” said Thomas Breuer, MD, Senior Vice President and Chief Medical Officer for GSK, in a prepared statement. “The risk and severity of shingles increases with age as the immune system loses the ability to mount a strong and effective response to infection. Shingrix was developed specifically to overcome the age-related decline in immunity.”
By preventing shingles, both vaccines also eliminate the risk of postherpetic neuralgia (PHN), a chronic and debilitating nerve pain that is the most common complication associated with the disease. PHN occurs in close to 20% of all shingles cases and can last months or even years.
Shingrix works by combining the antigen glycoprotein E and ASO1B, an adjuvant system, to create an immune response in the recipient. Its most common side effects are pain, redness and swelling at the injection site, muscle pain, fatigue, headache, shivering, fever, and nausea.
While noting that Shingrix offers greater protection against shingles than Zostavax, a medical officer in the CDC’s Division of Viral Disease told The New York Times that the incidence of side effects related to Shingrix was higher than with Zostavax.
“Patients and health care providers should be aware that this vaccine is very effective, but it also causes more reactions than they may be used to with other adult vaccines,” said Dr. Kathleen Dooling. “All indications are these are not dangerous to one’s health, but they may interfere with your daily activities for a few days.”
GSK says Shingrix will be available in November and cost about $280.