November 8, 2022
(press release)
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“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
Rotarix was first approved by the FDA in 2008, and until now, it has only been available in the US as a vial and oral dosing applicator presentation (lyophilized formulation), which must be reconstituted before administration. The new oral-dosing applicator-only presentation is fully liquid and does not require reconstitution prior to use. Both the lyophilized and liquid formulations of Rotarix are given by mouth as a two-dose series and contain the same live, human attenuated rotavirus strain and are manufactured using similar processes. Today’s approval of the liquid formulation of Rotarix is supported by international clinical trial data demonstrating non-inferiority of immunogenicity and showing similar safety and tolerability when compared to the lyophilized formulation. Doses of Rotarix in the liquid formulation are expected to begin shipping in early 2023. About rotavirus Rotavirus can cause severe, watery diarrhea as well as vomiting, fever and abdominal pain in infants and young children. Children may need to be hospitalized and can even die due to dehydration.1 Before vaccines were available, nearly all children in the US became infected with rotavirus before their fifth birthday. Now, rotavirus vaccines are estimated to prevent about 40,000-50,000 hospitalizations among infants and young children in the US each year.2 About Rotarix Rotarix is a vaccine 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. The US Prescribing Information is available at: Important Safety Information for Rotarix The following is based on the US Prescribing Information for Rotarix. Please consult the full Prescribing Information for all the labelled safety information. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK’s Q3 Results for 2022 and any impacts of the COVID-19 pandemic. 1
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