GSK Vaccines set to bring Shingrix, the latest shingles vaccination innovation, to market
LONDON — GlaxoSmithKline on Friday announced that the Food and Drug Administration has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
"Shingrix represents a significant scientific advancement in the field of vaccinology," stated Thomas Breuer, SVP and chief medical officer, GSK Vaccines. "The vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects one in tnree people in the United States. 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."
Following this approval from FDA, and pending a recommendation from ACIP, Shingrix will be available shortly.
On Oct. 13, Shingrix was approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older. Regulatory filings in the European Union, Australia and Japan are underway.