Lou Portero

Urban Health Today

The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for herpes zoster prevention, offering a streamlined administration option that could improve vaccination rates among eligible adults.
The newly approved prefilled syringe eliminates the previous requirement for healthcare professionals to reconstitute two separate components before administration. The existing vaccine presentation consists of two vials—a lyophilized antigen and a liquid adjuvant—which must be combined prior to injection. The approval is based on data demonstrating technical comparability between the new and existing vaccine presentations.
“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” said Brigid Groves, Vice President of Professional Affairs at the American Pharmacists Association. Healthcare professionals have welcomed this development, as it simplifies the vaccination process while maintaining the same efficacy profile.
The prefilled syringe maintains the same patient eligibility criteria as the original formulation. It is licensed for immunization of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression. The Centers for Disease Control and Prevention recommends a two-dose series for both populations, with doses administered 2-6 months apart.
Herpes zoster affects approximately one million Americans annually. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not everyone will develop shingles. The condition presents as a painful, blistering rash that can persist for weeks and may lead to chronic complications such as postherpetic neuralgia.
“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,” stated Tony Wood, GSK’s Chief Scientific Officer.
The prefilled syringe is also under review by the European Medicines Agency, with submission accepted in January 2025. GSK plans additional regulatory filings in other markets as part of its broader immunization strategy. The original Shingrix vaccine demonstrated 97.2% efficacy in preventing herpes zoster in adults aged 50 and older compared to placebo.
 
<div class="post-references"><h3>References</h3>GSK Press Release: &#8220;US FDA approves GSK&#8217;s SHINGRIX in a prefilled syringe presentation&#8221; (July 17, 2025)
https://us.gsk.com/en-us/media/press-releases/us-fda-approves-gsk-s-shingrix-in-a-prefilled-syringe-presentation/
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The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for herpes zoster prevention, offering a streamlined administration option that could improve vaccination rates among eligible adults.The newly approved prefilled syringe eliminates the previous requirement for healthcare professionals to reconstitute two separate components before administration. The existing vaccine presentation consists of two vials—a lyophilized antigen and a liquid adjuvant—which must be combined prior to injection. The approval is based on data demonstrating technical comparability between the new and existing vaccine presentations.“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” said Brigid Groves, Vice President of Professional Affairs at the American Pharmacists Association. Healthcare professionals have welcomed this development, as it simplifies the vaccination process while maintaining the same efficacy profile.The prefilled syringe maintains the same patient eligibility criteria as the original formulation. It is licensed for immunization of adults aged 50 years and older, as well as those aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression. The Centers for Disease Control and Prevention recommends a two-dose series for both populations, with doses administered 2-6 months apart.Herpes zoster affects approximately one million Americans annually. Approximately 99% of US adults over 50 years old have the virus that causes shingles inside their body, although not everyone will develop shingles. The condition presents as a painful, blistering rash that can persist for weeks and may lead to chronic complications such as postherpetic neuralgia.“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,” stated Tony Wood, GSK’s Chief Scientific Officer.The prefilled syringe is also under review by the European Medicines Agency, with submission accepted in January 2025. GSK plans additional regulatory filings in other markets as part of its broader immunization strategy. The original Shingrix vaccine demonstrated 97.2% efficacy in preventing herpes zoster in adults aged 50 and older compared to placebo. <div class="post-references"><h3>References</h3>GSK Press Release: “US FDA approves GSK’s SHINGRIX in a prefilled syringe presentation” (July 17, 2025)
https://us.gsk.com/en-us/media/press-releases/us-fda-approves-gsk-s-shingrix-in-a-prefilled-syringe-presentation/
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Prefilled syringe eliminates the previous requirement for healthcare professionals to reconstitute two separate components.