GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe presentation of Shingrix, the company’s vaccine for the prevention of shingles (herpes zoster). The updated format eliminates the need for healthcare professionals to manually mix two separate components prior to administration, streamlining the vaccination process.
Shingrix, previously available as two separate vials—one containing a lyophilized antigen and the other a liquid adjuvant—must be mixed before use. The new prefilled syringe format offers a more convenient option, which could increase efficiency and help improve adult immunization rates.
“This is good news for both healthcare providers and patients,” said Brigid Groves, Vice President of Professional Affairs at the American Pharmacists Association. “A prefilled syringe simplifies the process, making it easier to administer protection against a painful and preventable disease.”
The FDA’s approval follows data demonstrating technical comparability between the new and existing vaccine presentations. The prefilled syringe remains approved for adults aged 50 and older, as well as those 18 and older who are immunocompromised or at increased risk of shingles due to disease or medical treatment.
Tony Wood, Chief Scientific Officer at GSK, stated, “This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals in protecting patients from shingles—a disease that affects one in three U.S. adults in their lifetime.”
The new format is also under regulatory review in Europe, with the European Medicines Agency accepting GSK’s filing earlier this year. The company plans to pursue regulatory submissions in additional markets as part of its strategy to expand access to adult vaccines globally.