Pre-filled Syringe Version of GSK’s Shingles Vaccine Approved by FDA
- by TVR Staff
- Published
- Vaccines
On July 17, 2025, officials at the U.S. Food and Drug Administration (FDA) granted a license to GSK plc (formerly GlaxoSmithKline) to distribute a pre-filled syringe version of Shingrix (Zoster Vaccine Recombinant Adjuvanted) vaccine to control outbreaks of shingles (herpes zoster) in adults. The pre-filled syringe version of Shingrix was approved for use by adults 50 years of age and older, as well as adults 18 years and older who are or will be at higher risk for the disease due to an immunodeficiency or immunosuppression disorder.1 2 3 4 5 6
The product has been under review by the FDA since January, and it remains unlicensed and under regulatory review by the European Medicines Agency (EMA).
“This new presentation of Shingrix was developed to streamline the vaccination process,” said Tony Wood, chief scientific officer for GSK.3 4
The current form of Shingrix, given in two doses, is made up of two vials—an antigen in the form of a powder and a liquid adjuvant—which are combined by health care professionals prior to administration. The pre-filled syringe version eliminates the need to reconstitute separate vials before giving the vaccine. It provides a “convenient method of administration,” said Brigid Groves, vice president of Professional Affairs for the American Pharmacists Association (APhA).3
Shingrix was first licensed by the FDA on Oct. 20, 2017 for healthy adults 50 years of age and over. It was subsequently approved in 2021 for immunocompromised adults 18 and older.7 8
Shingrix May Cause Guillain Barré Syndrome
The National Vaccine Information Center (NVIC) notes that, according to the U.S. Centers for Disease Control and Prevention (CDC), Shingrix is estimated to reduce the likelihood of developing shingles by more than 90 percent in those 50 and older, but that the length of protection from the vaccine beyond four years is unknown.9
NVIC also points out that FDA officials have expressed concerns about an increased risk of developing polio-like paralysis symptoms from Guillain Barré syndrome (GBS) after getting Shingrix vaccine, citing the regulatory agency’s requirement in 2021 that the Shingrix package insert contains the following language in the Warnings and Precautions section:
In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix.10
The postmarketing observational study to evaluate Shingrix adverse events was conducted by officials at the CDC, the FDA, and the Centers for Medicare & Medicaid Services (CMS) to determine whether there was a link between Shingrix and GBS in adults aged 65 and older. In a recent article published in The Vaccine Reaction, Rishma Parpia wrote:
Based on data from more than 3.7 million administered doses, the analysis found a small increased risk of GBS, particularly within 42 days after the first dose, estimated at approximately three to six additional cases per million doses.11
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Click here to view References:
No comments:
Post a Comment