FDA approves SHINGRIX labeling update, adding injection site induration, new Guillain-Barré syndrome observational study data, and revised vial presentation details.
Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration (FDA) has approved a supplemental application for Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX), introducing several clinically relevant updates to the vaccine’s prescribing information. The decision reflects refinements based on postmarketing safety data and presentation details.
One of the key changes involves the Postmarketing Experience section, where “injection site induration” has now been formally added under general disorders and administration site conditions. While injection site reactions are already well recognized with vaccines, this update provides clearer documentation of induration as an observed postmarketing event.
More notably, the revised labeling incorporates findings from Study EPI-ZOSTER-032 concerning the risk of Guillain-Barré syndrome (GBS) following SHINGRIX vaccination. The update specifically includes information related to the observed risk window extending through 42 days post-vaccination. Guillain-Barré syndrome, a rare neurological disorder involving immune-mediated nerve damage, has been under continued surveillance across multiple vaccines. The inclusion of these observational study findings aligns with the FDA’s emphasis on transparency in communicating safety signals derived from real-world data.
In addition to safety-related updates, the FDA has approved a modification to the vaccine’s presentation description. The labeling now removes references to a vial configuration supplied in a one-dose carton, indicating adjustments in how the product presentation is characterized rather than changes to the vaccine formulation itself.
As part of the approval process, the FDA instructed GlaxoSmithKline Biologicals to submit the final content of labeling in Structured Product Labeling (SPL) format within 14 days. The agency also reiterated standard regulatory expectations regarding promotional materials, emphasizing that all claims must remain consistent with approved labeling and supported by substantial evidence.
Reference
Supplement Approval, Shingrix (GSK Biologicals), STN: BL 125614/1206, https://www.fda.gov/media/191162/download?attachment
