Vaccine Info

Rotarix Rotavirus Vaccine

Authored by
Last reviewed
July 28, 2023
Fact checked by
Robert Carlson, MD

Rotarix Vaccine 2023

GSK's Rotarix (Rotavirus Vaccine, Live, Oral) is a live, attenuated rotavirus vaccine derived from the human 89-12 strain belonging to the G1P type. This rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The Rotarix vaccine is used to help prevent disease in children. Rotarix works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. However, this vaccine will not treat an active infection already set in the body. The global clinical development program spanned five continents and demonstrates that Rotarix protects against the most common circulating strains (G1 and non-G1 rotavirus strains), including the emerging G9 strain.

On November 7, 2022, the U.S. Food and Drug Administration (FDA) approved an oral-dosing applicator-only presentation (liquid formulation) of ROTARIX, which prevents rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare ROTARIX by removing the need to reconstitute the vaccine dose at the point of use.

ROTARIX was first approved by the FDA in 2008. The U.S. FDA's package insert is available at this link. DrugBank: Rotavirus vaccine (DB10276).

UK-based GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and healthcare companies.

Rotarix Indication

Rotarix is a vaccine indicated for preventing 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 six weeks to 24 weeks. Rotavirus spreads quickly among infants and young children. The virus can cause severe watery diarrhea, vomiting, fever, and abdominal pain. Children who get rotavirus disease can become dehydrated and may need to be hospitalized. The U.S. CDC recommends that infants get the rotavirus vaccine to protect against rotavirus disease. Rotarix can also reduce hospitalizations for all gastroenteritis, regardless of cause. On September 5, 2022, BMJ Global Health wrote rotavirus was the leading cause of diarrhea requiring hospitalization among young children in 28 low- and middle-income countries despite the introduction of the rotavirus vaccine.

Rotarix Dosage

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants at six weeks. There should be at least four weeks between the first and second dose, and the 2-dose series should be completed by 24 weeks of age.

Rotarix Vaccine News

July 26, 2023 - GSK plc announced that established vaccine growth in Q223 was driven by Rotarix, benefitting from the favorable impacts of a US CDC stockpile borrow in 2022 and replenishment in the current quarter.

October 18, 2022 - The JAMA Network published: Rotavirus Leads Global Diarrhea Hospitalizations Among Young Children.

August 22, 2022 - Nigeria has the second-highest number of deaths from rotavirus, accounting for 14 percent of all childhood rotavirus deaths worldwide. The agency said approximately 50,000 children under five die before their fifth birthday due to rotavirus infection.

June 9, 2022 - A peer-reviewed study - Association Between Rotavirus Vaccination and Antibiotic Prescribing among Commercially Insured U.S. Children, 2007-2018 - These results demonstrate that rotavirus vaccines reduce antibiotic prescribing for acute gastroenteritis, which could help reduce the growth of antibiotic resistance.

February 9, 2022 - GSK reported Rotarix sales were down 3% AER but up 1% CER to £541 million, reflecting global demand recovery.

July 28, 2021 - GSK announced its financial results. Rotarix sales were up 3% AER and 9% CER to £132 million, reflecting increased channel stocking on wholesaler purchasing patterns in the USA.

May 10, 2021 - A new study's findings from a meta-analysis revealed that Rotarix vaccinations reduced rotavirus gastroenteritis in children younger than five years by 68.4%.

March 4, 2021 - GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises. In a press release, Thomas Breuer, Chief Medical Officer of GSK Vaccines, said, "We are delighted to become the first company to offer a rotavirus vaccine through the Humanitarian Mechanism for use with some children most vulnerable to severe diarrhoeal disease."

March 4, 2021 - Médecins Sans Frontières, Save the Children, UNICEF, and the World Health Organization welcome the opportunity to make the rotavirus vaccine available to more children living in humanitarian crises thanks to a landmark pricing agreement with the manufacturer, GSK. The rotavirus vaccine is the second vaccine to be accessed through the scheme. It depends on manufacturers making their vaccines available at their lowest price for use in emergencies - across countries of all income levels. The first to be made public was the pneumococcal vaccine.

June 5, 2009 - The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals' vaccine against rotavirus, Rotarix™. The WHO's Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunization programs. These WHO decisions open the door to making rotavirus vaccines available to children worldwide. The WHO prequalification will accelerate access to the vaccine in Asia and Africa and expand on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas. In addition, the WHO prequalification is necessary for U.N. agencies and the GAVI Alliance to purchase rotavirus vaccines for developing countries.

Rotarix Vaccine Clinical Trials

GSK's Rotarix has completed over 40 clinical trials.



Clinical Trials

No clinical trials found