The Food and Drug Administration (FDA) has approved an oral-dosing applicator-only presentation (liquid formulation) of Rotarix (rotavirus vaccine, live, oral) for the prevention of gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants. 

Previously, Rotarix was only available as a vial and oral dosing applicator presentation (lyophilized formulation), which required reconstitution prior to administration. The new liquid formulation of Rotarix does not require reconstitution or dilution before use. 

The approval of the liquid formulation was supported by international clinical trial data demonstrating noninferiority of immunogenicity when compared with the lyophilized formulation. Findings from a phase 3, randomized, multi-country study (ClinicalTrials.gov Identifier: NCT03954743) also showed similar reactogenicity and safety profiles for the liquid and lyophilized formulations.

“Achievements like this are at the heart of our quest to reduce barriers to vaccination and remain a vital public health tool against the threat of preventable infectious diseases like gastroenteritis caused by rotavirus,” said Temi Folaranmi, MD, Vice President US Medical and Clinical Affairs, Vaccines, GSK, “By creating a liquid formulation of Rotarix that can be administered without additional mixing on site, we aim to give health care providers a more convenient option.”

The Rotarix oral-dosing applicator-only presentation is supplied as a single 1.5mL dose in a prefilled oral-dosing applicator with a plunger stopper in a carton of 10. The Company expects to begin shipping the new liquid formulation in early 2023.

References

  1. US FDA approves new fully liquid presentation of GSK’s Rotarix vaccine to prevent gastroenteritis caused by rotavirus. News release. GlaxoSmithKline. November 7, 2022. Accessed November 9, 2022. https://us.gsk.com/en-us/media/press-releases/fda-approves-new-fully-liquid-presentation-of-rotarix/
  2. Rotarix. Package insert. GlaxoSmithKline; 2022. Accessed November 9, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Rotarix/pdf/ROTARIX-PI-PIL.PDF
  3. Lau YL, Leung TF, Cetin BS, et al. Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study. Published online March 25, 2022. Vaccine. doi.org/10.1016/j.vaccine.2022.02.065.