FDA Approves GSK’s Shingles Vaccine

On Oct. 23, 2017, GlaxoSmithKline (GSK) announced that FDA approved its shingles vaccine, Shingrix (zoster vaccine recombinant, adjuvanted), for patients aged 50 years and older. The US Centers for Disease Control and Prevention’s advisory committee on immunization practices (ACIP) was scheduled to vote on a recommendation for the use of Shingrix at its meeting on Oct. 25, 2017.

Following FDA’s approval and pending a recommendation from ACIP, Shingrix will be available shortly, according to the company. The vaccine was approved earlier in October 2017 for use in Canada in the same indication. The company also has regulatory filings underway in the European Union, Australia, and Japan.

Dr. Thomas Breuer, senior vice president and chief medical officer of GSK Vaccines said in a company press release: “Shingrix represents a significant scientific advancement in the field of vaccinology. 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 [three] 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.”