FDA Approves and CDC Recommends Shingrix Vaccine to Prevent Shingles

GlaxoSmithKline (GSK) has received U.S. Food and Drug Administration approval for its Shingrix vaccine to prevent shingles (herpes zoster) in patients 50 years and older. Approval is based on positive results from Phase III trials that demonstrated efficacy against shingles greater than 90 percent across all age groups, as well as sustained efficacy over a follow-up period of four years in more than 38,000 patients. Shingrix also reduced overall incidence of postherpetic neuralgia, a form of chronic nerve pain and the most common health complication associated with shingles. The vaccine’s risks include local or general short-duration reactogenicity, and the rates of severe adverse effects, deaths and immune-mediated diseases in the studies were proportional between treatment and placebo groups.

“Shingrix represents a significant advancement in the field of vaccinology,” said Thomas Breuer, MD, senior vice president and chief medical officer of GSK vaccines. “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.” The day after FDA approval, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the use of Shingrix to prevent shingles over Merck’s Zostavax vaccine that is less effective, but was the only shingles vaccine on the market for over a decade. ACIP also recommended that adults who have received the older vaccine get the new one. The recommendation is awaiting formal endorsement by CDC, which normally takes a couple of months.