The FDA has approved a new prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). According to the company, the updated format eliminates the need for reconstitution of two separate vials, streamlining administration and reducing complexity for healthcare providers. The approval is based on data showing technical comparability to the current two-vial version.¹

How Will the New Shingrix Presentation Benefit Providers and Patients?

“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” said Brigid Groves, VP, professional affairs, American Pharmacists Association, in a press release. “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.”

Same Shingrix Indications, Streamlined Format

GSK stated that the new presentation maintains the same indications: for adults aged 50 years and older, and for adults aged 18 years and older who are immunocompromised or immunosuppressed. Additionally, the Centers for Disease Control and Prevention (CDC) continues to recommend a two-dose regimen for these populations.¹

Regulatory and Clinical History of Shingrix

Shingrix was first approved in October 2017 for the prevention of shingles in adults over 50 years of age, based on results from a Phase III clinical trial program evaluating its efficacy, safety, and immunogenicity in more than 38,000 people.² In 2021, approval was expanded to adults aged 18 years or older who are, or who will be, at an increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy.³

Efficacy and Safety Data

According to prescribing information, the vaccine has shown 71.8% efficacy in patients aged 18 to 49 years. Additionally, it has shown 67.3% efficacy in people aged 50 years or older, with an overall efficacy of 67.3%.

Common adverse events reported with Shingrix across age groups include pain, redness, swelling, myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms. These symptoms were observed in adults aged 50 years and older, as well as in immunocompromised patients aged 18 to 49 years who received autologous hematopoietic stem cell transplants.⁴

Shingles Impact and Risk in the US Population

According to the CDC, around one in three people in the United States will develop shingles during their lifetime. While most people will only have it once, it is possible to get it multiple times.

Anywhere from 1% to 4% of people who develop shingles will be hospitalized. Older adults with a weakened immune system have a higher probability of needing hospital care.

This accounts for approximately 30% of shingles hospitalizations. Fewer than 100 people in the United States die from shingles annually, with most deaths occurring in older adults with weakened immune systems. Approximately 10% to 18% of patients with shingles will eventually develop postherpetic neuralgia, which also increases with age.⁵

Supporting Broader Access Through Innovation

“At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community,” said Tony Wood, chief scientific officer, GSK, in the press release. “This new presentation of Shingrix 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.”

References

1. US FDA approves GSK’s Shingrix in a prefilled syringe presentation. GSK. July 17, 2025. Accessed July 17, 2025. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-shingrix-in-a-prefilled-syringe-presentation/
2. FDA Approves Shingrix. Drugs.com. October 20, 2017. Accessed July 17, 2025. https://www.drugs.com/newdrugs/shingrix-zoster-vaccine-recombinant-adjuvanted-approved-u-s-prevention-shingles-4616.html
3. Shingrix Approved in the US for Prevention of Shingles in Immunocompromised Adults. Drugs.com. July 26, 2021. Accessed July 17, 2025. https://www.drugs.com/newdrugs/shingrix-approved-us-prevention-shingles-immunocompromised-adults-5612.html
4. HIGHLIGHTS OF PRESCRIBING INFORMATION. GSK. Accessed July 17, 2025. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF
5. Shingles Facts and Stats. CDC. Accessed July 17, 2025. https://www.cdc.gov/shingles/data-research/index.html