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FDA approves pre-filled syringe formulation of shingles vaccine
Last reviewed: 27.07.2025
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The U.S. Food and Drug Administration (FDA) has approved a new prefilled syringe formulation of Shingrix (shingles vaccine, recombinant, adjuvanted) for the prevention of shingles (herpes zoster).
The current vaccine consists of two vials — a lyophilized (powdered) antigen and a liquid adjuvant — that health care workers mix together before administration. The new pre-filled syringe simplifies the vaccination process for health care workers. The indications for use for the pre-filled syringe are the same as the existing vaccine.
The syringe formulation is licensed in the United States for immunization of adults 50 years of age and older and individuals 18 years of age and older who have or will have an increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by a known disease or therapy.
The approval is based on data demonstrating technical comparability between the new and existing vaccine formulations.
“This new formulation of Shingrix has been developed to simplify the vaccination process and help healthcare workers provide protection against shingles, a disease that affects one in three adults in the US during their lifetime,” GSK chief scientific officer Tony Wood said in a statement.