Shingles Vaccine Approved by FDA

The US Food and Drug Administration (FDA) approved Shingrix, GlaxoSmithKline’s (GSK) recombinant zoster vaccine (adjuvanted) against shingles (herpes zoster) for patients 50 and older, following unanimous approval during an advisory committee meeting in September.

The approval is based on positive results from phase 3 trials, wherein Shingrix demonstrated greater than 90% efficacy against shingles across all age groups, as well as sustained efficacy over a follow-up period of 4 years in more than 38,000 patients, according to a GSK statement.

“Shingrix represents a significant scientific advancement in the field of vaccinology,” said Thomas Breuer, MD, senior vice president and chief medical officer of GSK vaccines, in the statement. “The risk and severity of shingles increase 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, Shingrix also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic nerve pain and the most common health complication associated with shingles.

Advisory panelists who recommended the drug’s approval on September 13, 2017, weighed the vaccine’s risks, which include local or general short-duration reactogenicity. However, the rate of severe adverse effects, deaths, and immune-mediated diseases in the studies were proportional between treatment and placebo groups.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at its meeting on Wednesday, October 25, 2017.

Mary Bridgeman, PharmD, BCPS, BCGP, internal medicine clinical pharmacist, Robert Wood Johnson University Hospital, explains how the availability of two shingles vaccines provides patients with further opportunity to protect themselves.