Vaccine Info

Rotarix Rotavirus Vaccine

Authored by
Last reviewed
August 1, 2021
Fact checked by
Robert Carlson, MD

Rotarix Vaccine Description

GSK's Rotarix is a live, attenuated rotavirus vaccine derived from the human 89-12 strain, which belongs 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.

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 that has already developed 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. The U.S. FDA's package insert is available at this link. DrugBank: Rotavirus vaccine (DB10276).

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

Rotarix Vaccine 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 6 weeks to 24 weeks of age.

Rotavirus spreads easily 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 is also able to reduce hospitalizations for all gastroenteritis, regardless of cause.

Rotarix Vaccine Dosage

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose, and the 2-dose series should be completed by 24 weeks of age.

What if my baby spits out the vaccine or vomits immediately after having it? The oral vaccine will be given again. Do not worry about overdosing. Even if some of the vaccine was swallowed the first time, there's no harm in having 2 doses at the same time, says the UK's NHS.

Rotarix Vaccine News

July 28, 2021 - GSK announced its financial results. Rotarix sales were up 3% AER, 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 5 years by 68.4%.

March 4, 2021 - GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises. Thomas Breuer, Chief Medical Officer, GSK Vaccines, said in a press release, “We are delighted to become the first company to offer a rotavirus vaccine through the Humanitarian Mechanism for use with some of the 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 rotavirus vaccine available to more children living in humanitarian crises thanks to a landmark pricing agreement with the manufacturer, GSK. Rotavirus vaccine is the second vaccine to be accessed through the scheme, which 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 available was the pneumococcal vaccine.

June 5, 2009 - The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals’ vaccine against rotavirus, Rotarix™. Additionally,  the WHO's Strategic Advisory Group of Experts (SAGE) also recommended that rotavirus vaccination be included in all national immunization programs. Together, 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 expands on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas. The WHO prequalification is necessary for UN agencies and the GAVI Alliance to purchase rotavirus vaccines on behalf of developing countries.

Clinical Trials

No clinical trials found