GSK's Shingrix vaccine approved in US for shingles prevention in adults 50+

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline plc's (GSK) Shingrix vaccine for the prevention of shingles (herpes zoster) in adults aged 50 years and older. This approval marks a significant step in addressing a condition that affects approximately one in three Americans over their lifetime.

Approval of Shingrix is based on a comprehensive clinical trial program involving over 38,000 participants. Pooled analysis of these studies demonstrated efficacy of greater than 90% across all age groups for preventing shingles. The vaccine also showed sustained efficacy over a four-year follow-up period and reduced the incidence of postherpetic neuralgia (PHN), the most common complication of shingles.

Shingrix is a non-live, recombinant subunit vaccine administered intramuscularly in two doses. It was developed to overcome the age-related decline in immunity that increases the risk of shingles reactivation. An estimated one million cases of shingles occur annually in the United States, with the risk increasing significantly with age.

Following the FDA approval, the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for its use. Shingrix was previously approved in Canada and regulatory filings are underway in the European Union, Australia, and Japan.