FDA Approves GSK's SHINGRIX in Prefilled Syringe Form

GSK plc has achieved a significant milestone in the enhancement of shingles prevention with the US Food and Drug Administration (FDA) endorsing a new prefilled syringe version of SHINGRIX, the recombinant adjuvanted zoster vaccine. This innovative syringe format aims to streamline the vaccination process, eliminating the previous requirement for healthcare providers to mix separate vials before administering the vaccine.

Traditionally, SHINGRIX was provided in two-part vials: a lyophilized antigen and a liquid adjuvant, which needed to be combined by healthcare professionals before use. The FDA's approval of the prefilled syringe presentation is underpinned by data affirming its technical equivalency to the current format, reinforcing its efficacy and safety.

Brigid Groves, the Vice President of Professional Affairs at the American Pharmacists Association, has welcomed this development, highlighting the convenience and efficiency it brings to vaccine administration. She noted that this approval marks a pivotal step in promoting the prevention of shingles, a disease known for its painful symptoms.

In alignment with existing guidelines for SHINGRIX, the prefilled syringe is approved for adults 50 years and older, as well as those aged 18 and above who are at an increased risk of shingles due to immunodeficiency or immunosuppression. The Centers for Disease Control and Prevention (CDC) recommends two doses of SHINGRIX for these populations to prevent shingles and its complications.

Tony Wood, GSK’s Chief Scientific Officer, articulated the company's ongoing commitment to scientific advancement and practical solutions for healthcare needs. He emphasized that the new presentation of SHINGRIX was designed to make the vaccination process more efficient for healthcare professionals, aiding in the protection against shingles. This disease affects approximately one-third of the US adult population during their lifetime.

The prefilled syringe is not only gaining ground in the US but is also under regulatory review by the European Medicines Agency (EMA), indicating GSK's dedication to expanding the vaccine's accessibility globally. Pending the review's outcome, this development could significantly impact adult immunization rates internationally.

Shingles, a condition caused by the reactivation of the varicella-zoster virus (VZV), leads to a painful rash and affects an estimated one million individuals in the US annually. The virus is dormant in about 99% of US adults aged over 50 and can reactivate as immune system strength diminishes with age.

SHINGRIX is a recombinant zoster vaccine formulated to prevent shingles in adults over 50. It combines a glycoprotein E antigen with an AS01B adjuvant system to enhance immune responses. This combination seeks to counteract the natural age-related decline in immune function, which heightens the challenge of safeguarding older adults from shingles. SHINGRIX is also approved in various countries for adults at increased risk of shingles due to weakened immune systems.

In summary, the FDA’s approval of the prefilled syringe presentation of SHINGRIX represents a significant advancement in the fight against shingles. By simplifying the vaccination process, this development not only benefits healthcare providers but also enhances the potential for broader immunization coverage, offering renewed hope in the prevention of this debilitating disease.