FDA Accepts Review of New GSK Prefilled Syringe Presentation

The FDA will be reviewing the regulatory application of a prefilled syringe presentation of GSK’s Shingrix, which is a recombinant zoster vaccine (RSV) for preventing shingles (herpes zoster).

Shingles results from the the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox.1 By the age of 50, VZV can be found in most adults,2 with the chance to reactivate as one gets older.3 Generally speaking, the immune system’s response to infection tends to decline as a person ages, which raises one’s chance of developing shingles.3

In total, about one million people in the United States develop shingles, with approximately 99% of US adults over the age of 50 having the virus that causes shingles inside their body, although not everyone will necessarily develop it.4 An estimated one million people develop shingles annually in the US.4

Concerning Shingrix, it eliminates the necessity of using different vials before administration, making it simpler for pharmacists, physicians and other HCPs who would be administering vaccines. Currently, the vaccine consists of a lyophilized (powder) antigen and a liquid adjuvant, which HCPs would combine before administering the vaccine. The new presentation has the same composition as the reconstituted vaccine—the submission is based on data showing similarities between the two.5

It’s important to note that GSK’s original shingles vaccine has been approved in the United States for shingles prevention in adults aged 50 years and older since the year 2017.6 In fact, data from the company’s ZOSTER-049 long-term follow-up phase III trial7—which followed participants for as many as 11 years following initial vaccination with Shingrix, showed that RZV maintains efficacy against shingles for more than a decade in adults over that age.

“These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of vaccination for some participants as they aged into their 70s, 80s and 90s,” said Phil Dormitzer, senior vice president and head of vaccines R&D. “With the vaccine now included in many national immunization programs around the world, these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunization strategies.”

For adults 18 and older who are or will be facing an increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy, it’s been approved since 2021.6

References

1. Harpaz R, et al. Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1–30.

2. Johnson, R.W., et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Therapeutic advances in vaccines. 2015;3(4):109–20.

3. Mueller, N.H., et al. Varicella zoster virus infection: clinical features, molecular pathogenesis of disease, and latency. Neurologic clinics. 2008;26(3):675–97.

4. CDC. About Shingles (Herpes Zoster). Available at https://www.cdc.gov/shingles/about/index.html. Last accessed: January 2025.

5. GSK data on file 2024.

6. Shingrix prescribing information. SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), suspension for intramuscular injection. Last accessed: January 2025.

7. New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade. GSK. April 17, 2024. Accessed January 10, 2025. https://www.gsk.com/en-gb/media/press-releases/new-long-term-data-show-shingrix-continues-to-provide-high-protection-against-shingles-in-adults-aged-50-and-over-for-more-than-a-decade/