FDA Approves Prefilled Syringe Presentation for Shingles Vaccine

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The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster).

The existing vaccine consists of two vials — a lyophilized (powder) antigen and a liquid adjuvant — that health care professionals combine prior to administration. The new prefilled syringe simplifies the vaccine administration process for health care professionals. The indications for the prefilled syringe are consistent with existing indications for the vaccine. The prefilled syringe presentation is licensed in the United States for immunization of adults 50 years and older, as well as those aged 18 years and older who are or will be at increased risk for shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.

The approval was based on data showing technical comparability between the new and existing vaccine presentation.

“This new presentation of Shingrix was developed to streamline the vaccination process, supporting health care professionals to provide protection against shingles, a disease that one in three U.S. adults will develop in their lifetime,” Tony Wood, chief scientific officer at GSK, said in a statement.

Approval of the prefilled syringe presentation of Shingrix was granted to GSK.

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Source: HealthDay

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