The U.S. Food and Drug Administration has approved a supplemental update for GSK’s AREXVY RSV vaccine, introducing a vial–prefilled syringe format and expanded manufacturing capabilities
Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has approved a supplemental biologics license application for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), authorizing a new vial–prefilled syringe (vial-PFS) presentation along with updated manufacturing provisions.
The new format consists of a vial containing the lyophilized RSVPreF3 antigen and a prefilled syringe containing the AS01E adjuvant suspension. This dual-component system is designed to simplify reconstitution, reduce preparation steps, and improve handling efficiency in clinical settings.
Under this approval, the manufacturer is authorized to produce both the antigen and adjuvant components at multiple facilities using designated filling lines. The update also permits final packaging and labeling of the vial-PFS presentation, supporting broader production scalability and supply continuity.
The FDA has confirmed a shelf life of 36 months for each component when stored at 2°C to 8°C. The final expiration date of the packaged product will be determined by the earliest expiry among the antigen and adjuvant components.
As part of the regulatory update, revised labeling including the package insert, carton, and container labels has been approved. The company is required to submit final structured labeling within 14 days in accordance with FDA requirements.
In addition, the sponsor has committed to a postmarketing study evaluating plunger-stopper movement for the prefilled syringe system, with the final report expected by December 15, 2026.
AREXVY remains indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, and in individuals aged 18 through 59 years who are at increased risk for RSV-LRTD. This supplemental approval does not modify the vaccine’s clinical efficacy or safety profile; instead, it focuses on improving product presentation, usability, and manufacturing flexibility.
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