shingrix :: Article CreatorFDA Approves Prefilled Vaccine Presentation For Shingrix
This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for healthcare professionals.
The FDA has approved a new, prefilled syringe option of GSK's Shingrix (Zoster Vaccine Recombinant) for the prevention of shingles (herpes zoster), according to a news release published today. This version simplifies the current shingles vaccine process for healthcare professionals by offering both vaccine components, a lyophilized (powder) antigen and a liquid adjuvant, in one syringe, thus eliminating the need for reconstitution.
"The prefilled syringe presentation of GSK's shingles vaccine is good news, providing a convenient method of administration," Brigid Groves, vice president of professional affairs, American Pharmacists Association, said in the news 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."
Shingles is a viral infection that causes a painful, blistering rash, usually appearing on one side of the body. People develop shingles when the varicella-zoster virus (VZV), the same virus that causes chickenpox, reactivates in their body. Although anyone can get shingles, it is more common in adults over the age of 50, as 99% of adults in this age range already have the virus in their body. Approximately 1 million people develop shingles every year in the United States, and although most only get shingles once, it can be recurrent. Shingles can also lead to serious complications, the most common being long-term nerve pain called postherpetic neuralgia, or PHN, according to the Centers for Disease Control and Prevention.
Shingrix was initially approved by the FDA in 2017 for adults ages 50 and older as well as adults 18 and older at an increased risk of shingles due to immunodeficiency or immunosuppression. Compared to placebo, in patients 50 and older, Shingrix reduced the risk of developing herpes zoster by 97.2%, according to efficacy studies. In patients at least 18 years of age, Shingrix had an overall efficacy rate of 68%, according to the prescribing information.
The CDC currently recommends individuals receive two doses of the shingles vaccine, with the second dose administered at least 2 months after the first dose, according to the Shingrix prescribing information.
The safety of Shingrix for individuals ages 50 and older was evaluated in two placebo-controlled studies consisting of 29,305 subjects. The most common adverse reactions were pain at the injection site (78%), myalgia (45%) and fatigue (45%).
In a separate safety study, individuals ages 18 and older with increased risk of shingles also reported pain at the injection site (88%), fatigue (64%) and myalgia (58%). An increased risk of Guillain-Barré syndrome was seen in the 42 days following Shingrix administration.
Patients with Medicare Part D have an out-of-pocket cost of $0 for Shingrix. In addition, 96% of private insurance plans fully cover Shingrix.
Shingrix is not recommended for anyone with a previous severe allergic reaction to the vaccine components. Current data is insufficient to determine whether Shingrix is safe for pregnant or breastfeeding women. Shingrix is also not intended to prevent primary varicella infection (chickenpox), the release says.
This presentation of Shingrix is also currently undergoing regulatory review by the European Medicines Agency (EMA). Filing acceptance was received in January 2025, according to the news release.
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FDA Approves GSK's Shingrix In A Prefilled Syringe Presentation
The prefilled syringe presentation offers a convenient administration option to healthcare professionals.
GSK has received the Food and Drug Administration's approval for a prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals.
The existing vaccine presentation consists of two vials, a lyophilised (powder) antigen and a liquid adjuvant, which healthcare professionals combine prior to administering. The approval of the new presentation is based on data demonstrating technical comparability between the new and existing vaccine presentation.2
Brigid Groves, vice president of professional affairs, American Pharmacists Association, said, "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."
Consistent with the existing indications for Shingrix, the prefilled syringe presentation is licensed in the United States 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 caused by known disease or therapy.
[Read more: Kroger's Dr. Marc Watkins weighs in on the importance of vaccinations amid measles outbreak]
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GSK said the Centers for Disease Control and Prevention recommends two doses of GSK's shingles vaccine to prevent shingles and related complications in adults aged 50 years or over, and two doses for adults aged 19 years or over who are or will be immunodeficient or immunosuppressed.
Tony Wood, chief scientific officer, GSK, said, "At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community. 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."
GSK Lifts Outlook As Specialty Medicines, Vaccines Fuel Growth
British pharmaceutical giant GSK Plc GSK shares rose on Wednesday after reporting second-quarter results that surpassed analyst expectations and led the company to raise its full-year 2025 guidance.
Driven by exceptional growth in Specialty Medicines and Vaccines, GSK's second-quarter sales reached $10.66 billion (7.98 billion British pounds), a 6% increase at constant currency, exceeding analyst estimates of $10.33 billion.
Core earnings jumped 15% at constant currency to $1.24 per share (46.5 pence) outperforming the consensus forecast of $1.12.
Also Read: After Merck, Chinese Biotech Hengrui Pharma Collaborates With GSK In Worth $12 Billion Pact
The company attributed this core earnings growth to the strong performance of its Specialty Medicines and Vaccines divisions, coupled with higher royalty income and a disciplined escalation of investment in key research and development (R&D) areas, particularly within Oncology and Vaccines.
Vaccine sales jumped 5% (+9% at constant currency or cc) to 2.09 billion pounds, reflecting growth in Meningitis vaccines related to uptake following expanded recommendation and public funding of Bexsero in Europe, as well as growth in Shingrix driven by launch uptake in France and strong demand across several other European markets and Japan.
Arexvy sales reached 66 million pounds, up 6% (+13% cc). Meningitis vaccine sales increased 17% (+22% cc) to 379 million, while established vaccine sales of 787 million increased 2% (+6% cc). Shingrix sales reached 853 million pounds, up 3% (+6% cc).
In July, the FDA agreed to review the application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk.
Also in July, the FDA extended the review period for the Biologics License Application (BLA) for GSK's Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy.
Specialty Medicines sales grew by double-digit percentages (+10% and 15% cc) in the quarter to 3.33 billion pounds, reflecting continued growth across disease areas, with strong performances in HIV, Respiratory, Immunology & Inflammation, and Oncology. General Medicines sales fell by 10% (-6% cc) to 2.57 billion pounds.
GSK is progressing on 14 major pipeline opportunities, each with a potential value of over 2 billion pounds, set to launch between 2025 and 2031.
Phase 3 study for tebipenem, a new antibiotic for complicated urinary tract infections, was stopped early because it worked so well. The company plans to file for approval by the end of the year. Phase 3 development for depemokimab, aimed at treating COPD, has begun with the launch of the ENDURA study program.
Key trials expected to begin in the second half of 2025 include GSK'227, a B7H3-targeting antibody-drug conjugate for small cell lung cancer, GSK'981 (IDRx-42) for second-line treatment of gastrointestinal stromal tumors, Efimosfermin for MASH, and an ultra-long-acting injectable HIV treatment combining cabotegravir and rilpivirine, to be given every four months.
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Addressing a broader macroeconomic concern, GSK acknowledged the U.S. Administration's initiation of an investigation under Section 232 of the Trade Expansion Act, which seeks to ascertain the potential effects of pharmaceutical product imports on national security.
The company said it is well-positioned to respond to the potential financial impact of tariffs, with mitigation options identified. According to Reuters, GSK's CFO indicated an anticipation of some tariffs coming in the second half of the year, which are expected to lower the gross margin slightly.
GSK raised its full-year 2025 guidance and says it includes tariffs enacted thus far and the European tariffs indicated this week. It now expects sales to increase toward the top of the 3%–5% range.
Core operating profit and earnings are also expected to grow towards the top end of the 6% to 8% range. Specialty Medicine sales are expected to increase in the low teens versus prior guidance of a low double-digit percentage.
Vaccine revenue is expected to decline by a low single-digit percent to broadly stable compared to the prior outlook of a decrease of low single-digit percent, and general medicine sales are expected to be broadly stable.
Price Action: At last check on Wednesday, GSK stock was up 3.57% to $40.37 during the premarket session.
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