The drug's approval follows a unanimous positive opinion from the Vaccines and Related Biological Products advisory committee on Sept 13.
Following unanimous advisory committee approval last month, the US Food and Drug Administration (FDA) has greenlighted GlaxoSmithKline’s Shingrix, a preventative vaccine for shingles (herpes zoster) in patients aged 50 and up.
The drug’s approval is based on positive results from phase 3 trials, wherein Shingrix demonstrated efficacy against shingles greater than 90% 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 Dr Thomas Breuer, 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.”
By preventing shingles, Shingrix also reduced 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 weighed the vaccine’s risks, which included 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 US 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.
According to Simon Murray, MD, clinical assistant professor of Medicine at Rutgers Medical School, “the current shingles vaccine we have now is not adequate. [Shingrix is] a killed vaccine, not a live vaccine, mixed with some immune stimulants that makes it more immunogenic.”