FDA Approves Zoster Vaccine Recombinant Prefilled Syringe Presentation for Shingles Prevention

The FDA has approved a prefilled syringe presentation of the zoster vaccine recombinant, adjuvanted (RZV, Shingrix; GSK), for the prevention of herpes zoster, commonly known as shingles. The approval of the prefilled syringe simplifies the vaccination process by removing the need to reconstitute separate vials prior to administration.¹

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“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration. The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation,” Brigid Groves, vice president of professional affairs, American Pharmacists Association, said in a news release.¹

RZV Indications

RZV is a nonlive vaccine designed to prevent shingles in adults aged 50 years and older. It combines the glycoprotein E antigen with the AS01B adjuvant system, which could help improve the immune response in older adults. Additionally, RZV is approved to treat individuals aged 18 years and older who are or will be at increased risk of shingles due to immunodeficiency or immunosuppression.¹

The vaccine was first approved by the FDA in October 2017 for adults aged 50 years and older, based on phase 3 clinical trials that evaluated RZV’s efficacy, safety, and immunogenicity. Results from the pooled analysis revealed that RZV demonstrated efficacy against shingles greater than 90% across all age groups, as well as sustained efficacy over a follow-up period of 4 years.²

Aligning with RZV’s indications, the CDC currently recommends 2 doses of RZV to prevent shingles and related complications in adults aged 50 years or older, and 2 doses for adults aged 19 years or over who are immunodeficient or immunosuppressed.¹

The previous vaccine presentation includes a lyophilized antigen and a liquid adjuvant that health care professionals must combine before administering the vaccine to a patient, which could slow the immunization process. The new form of RZV, which does not require mixing, was approved based on data that demonstrated technical comparability between the new and existing vaccines, deeming that both were effective.¹

“This new presentation of [RZV] was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that 1 in 3 US adults will develop in their lifetime,” Tony Wood, chief scientific officer from GSK, said in the news release.¹

Shingles Signs and Symptoms

Nearly 99% of individuals residing in the US aged 50 years and older have the virus that causes shingles in their body; however, not everyone will experience the virus. It typically presents as a painful rash and is estimated to impact 1 million individuals each year in the US. In most cases, individuals only develop shingles once in their lifetime, although the illness can reoccur.^1,3

Symptoms of shingles usually only affect a small section on one side of the body, including pain, burning, or tingling; sensitivity to touch; a red rash that begins a few days after the pain; fluid-filled blisters that break open and crust over; and itching. Additionally, some individuals could also experience fever, headache, sensitivity to light, and fatigue. Pain caused by shingles can be severe, and depending on its location, it may be mistaken for heart-, lung-, or kidney-related complications. In some cases, individuals may experience this pain even without developing the characteristic rash. The rash most often appears as a band of blisters wrapping around one side of the torso, but it can also emerge around 1 eye or on 1 side of the neck or face.³

REFERENCES

1. US FDA approves GSK’s SHINGRIX in a prefilled syringe presentation. GSK. News release. July 17, 2025. Accessed July 17, 2025. https://us.gsk.com/en-us/media/press-releases/us-fda-approves-gsk-s-shingrix-in-a-prefilled-syringe-presentation/

2. Pharmacy Times staff. FDA Approves New Herpes Zoster Vaccine. Pharmacy Times. October 22, 2017. Accessed July 17, 2025. https://www.pharmacytimes.com/view/fda-approves-new-herpes-zoster-vaccine

3. Shingles. Mayo Clinic. News release. August 20, 2022. Accessed July 17, 2025. https://www.mayoclinic.org/diseases-conditions/shingles/symptoms-causes/syc-20353054