What is Rotarix?
Rotarix is an oral vaccine (vaccine given by mouth) available in the following forms:
- powder and solvent to be mixed to form an oral suspension in an oral applicator,
- oral suspension in a pre-filled oral applicator or tube.
Rotarix contains a living attenuated (weakened) form of human rotavirus (strain RIX4414).
What is Rotarix used for?
Rotarix is used in infants from the sixth week of life as a vaccine to prevent gastroenteritis (diarrhea and vomiting) due to rotavirus infection. Rotarix is given based on official recommendations.
The vaccine can only be obtained with a prescription.
How is Rotarix used?
Rotarix is given in two doses at least four weeks apart. The first dose should be given after the sixth week of life of the newborn. It is preferable that both doses are administered within the 16th week of life, in any case never after the 24th week of life. The same vaccination protocol can be applied in premature infants born up to 13 weeks before the end (starting from 27 weeks of management age).
If the powder and solvent are used, they should be mixed together just before the vaccine is given and the resulting suspension should be introduced directly into the child's mouth using the oral applicator provided. If the ready-made oral suspension is used, the contents of the oral applicator or pre-filled tube must be introduced directly into the mouth of the newborn. Rotarix can be given at the same time as other vaccines.
How does Rotarix work?
Rotarix contains tiny amounts of rotavirus, a virus that causes gastroenteritis. The virus is alive, but has been weakened so as not to cause the disease and this makes it suitable for use in a vaccine. When the vaccine is given to a newborn, the immune system (the disease control system) recognizes the weakened virus as a foreign body and produces antibodies. An antibody is one
special protein that can neutralize or destroy an antigen, such as a virus. Following vaccination, the immune system will be able to produce antibodies more quickly in case of new exposure to the virus. This facilitates protection against gastroenteritis caused by rotavirus.
After vaccination with Rotarix, the percentage of newborns that produce antibodies against rotavirus ranges from 78 to 95%.
How has Rotarix been studied?
Clinical trials of Rotarix in humans have involved more than 72, 000 newborns and occurred in different locations around the world. The main study compared the efficacy and safety of the vaccine with a placebo (a dummy vaccine) and involved more than 63, 000 full-term babies (after a gestation of at least 36 weeks). The study was very broad as it was intended to verify whether the vaccine was capable of causing a very rare extremely serious complication, known as intussusception, a disease in which a part of the intestine slips inside another intestinal tract, causing a occlusion (a block). Efficacy was measured by observing how many newborns developed a severe form of rotavirus gastroenteritis in the months following vaccination and before reaching one year of age.
Another study compared the safety of Rotarix versus placebo and their ability to stimulate antibody production in 1 009 newborns, who were born no more than 13 weeks old. These results were compared with the findings from a study of full-term newborns vaccinated with Rotarix.
Four additional studies were then performed on over 3, 000 newborns, in order to demonstrate that the two forms of the vaccine had equivalent safety and efficacy in stimulating the production of antibodies against rotavirus.
What benefit has Rotarix shown during the studies?
Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus. In the main study, the number of severe rotavirus gastroenteritis cases decreased after Rotarix vaccination: 0.1% of Rotarix-vaccinated newborns, where their efficacy was evaluated, developed severe forms of rotavirus gastroenteritis (12 of more than 9 000) compared to 0.9% of newborns who received a placebo (77 out of almost 9 000).
The study of premature newborns showed that Rotarix was well tolerated and produced antibody levels comparable to those of full-term infants.
What is the risk associated with Rotarix?
In the main study, in which around 31 500 newborns received Rotarix and over 31 500 a placebo, nine infants developed intussusception after vaccination with Rotarix, compared with 16 who developed the disease after receiving a placebo vaccine . This shows that Rotarix does not carry a higher risk of developing intussusception. The most common side effects (seen in more than 1 patient in 10) are irritability and loss of appetite. For the full list of all side effects reported with Rotarix, see the Package Leaflet.
Rotarix should not be used in infants who may be hypersensitive (allergic) to any of the components of the vaccine. Rotarix should not be given to infants who have shown signs of allergy after receiving a previous dose of rotavirus vaccine, who have developed intussusception in the past or who have intestinal problems that could predispose them to develop such a complication. Vaccination with Rotarix should be postponed in infants who have a sudden high fever, diarrhea or vomiting. For the full list of usage restrictions, see the package leaflet.
Rotarix should never be given into a vein.
Like other vaccines, the use of Rotarix in very premature infants may pose a risk of respiratory apnea (short pauses in breathing cessation). The breathing of these newborns should be monitored for three days after vaccination, particularly after the first vaccination.
Why has Rotarix been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rotarix's benefits outweigh the risks for the vaccination of infants who have survived their sixth week for the prevention of gastroenteritis due to rotavirus infection. The Committee therefore recommended that Rotarix be given marketing authorization.
More information on Rotarix:
On 21 February 2006, the European Commission issued a marketing authorization valid for Rotarix, valid throughout the European Union, to GlaxoSmithKline Biologicals sa.
For the full EPAR for Rotarix, click here
Last update of this summary: 09-2009
