IMPORTANT: FDA Licenses new Rotarix liquid formulation

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Dear Immunization Partners,

Please share the following information with providers in your jurisdiction.

On November 4, 2022, FDA licensed a new formulation of Rotavirus Vaccine, Live, Oral (Rotarix, GSK). The new formulation is free of porcine circovirus (PCV) and comes as a liquid in a squeezable tube that does not require mixing or dilution. The single dose oral applicator increases provider convenience. Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. Rotarix is approved for use in infants 6 weeks and up to 24 weeks of age.  Each dose of 1.5 mL is administered orally. See package insert for preparation and administration directions.

Both the lyophilized (requires reconstitution) and liquid rotavirus vaccine presentations will remain in use until the lyophilized formulation is used up or expires.

See the FDA Rotarix main page for more information.

CDC and MDHHS do not endorse one rotavirus product over the other.

Your Immunization Nurse Education Team,
Andrea, Dianne, Heidi, Lisa, Sarah, and Terri