RotaTeq

What is RotaTeq?

RotaTeq is a vaccine available as an oral solution in single-dose vials. It contains five live rotavirus strains, each of which carries a different antigen (G1, G2, G3, G4 and P1 [8]).

What is RotaTeq used for?

RotaTeq is a vaccine given to children starting at six weeks of age to prevent gastroenteritis (diarrhea and vomiting) caused by rotavirus. RotaTeq is given according to official recommendations.

The medicine can only be obtained with a prescription.

How is RotaTeq used?

RotaTeq is given as a three-dose cycle at intervals of at least four weeks for each dose. The vaccine is given by pouring the vial directly into the mouth of the newborn. The first dose should be administered between the sixth and twelfth week of life. It is preferable that the last dose is administered before 20-22 weeks of life; in any case, all three doses must be administered within 26 weeks of life (six months). RotaTeq can be administered concomitantly with other vaccines, with the exception of the oral polio vaccine (in this case a two-week interval between the administration of the two vaccines must be spent).

RotaTeq can be given to premature babies as long as the pregnancy has lasted at least 25 weeks. The first dose should be given six weeks after birth.

How does RotaTeq work?

There are different types of rotaviruses responsible for gastroenteritis, depending on the antigens they carry. An antigen is a specific structure that the body can recognize as "foreign" and for which it is able to produce an antibody, a protein substance that can neutralize or destroy the antigen. RotaTeq is composed of viruses containing the antigens of some of the most common types of rotaviruses. When the child receives the vaccine, the immune system (ie the system that fights against diseases) develops antibodies against these antigens, helping to prevent rotavirus infections in the environment that carry the same or very similar antigens.

How has RotaTeq been studied?

The effects of RotaTeq were first tested in experimental models before being studied in humans. Overall, the RotaTeq studies involved more than 72, 000 children, of whom about 2, 000 were premature births. About half of the children were vaccinated and the remaining half received a placebo (a dummy treatment). The effectiveness of the vaccine has been studied in around 6, 000 children among all those involved. The main study was conducted on a broad spectrum (over 70, 000 children involved), in order to verify whether the vaccine was able to cause a very rare, serious complication, the intussusception, a condition in which a part of the intestine slips to inside of another intestinal tract, causing an occlusion (a block). The effectiveness of the vaccine was assessed on the basis of the number of children who contracted rotavirus gastroenteritis during the next "rotavirus season" (ie the time of year when rotaviruses circulate causing infections; these are usually the months most cold, ie from winter to early spring).

What benefit has RotaTeq shown during the studies?

In the nearly 6, 000 children studied for the effectiveness of the vaccine, the number of cases of rotavirus gastroenteritis, caused by viruses with the same antigens present in the vaccine, decreased after vaccination with RotaTeq: among children vaccinated with RotaTeq, in fact, there were 82 cases (including one serious) of rotavirus gastroenteritis, compared to 315 cases found among subjects who were given placebo (of which 51 were severe). The study also showed that, in the case of children vaccinated with RotaTeq, fewer hospital admissions or urgent emergency department visits for rotavirus gastroenteritis.

What is the risk associated with RotaTeq?

During the main study, in which around 35 000 children received RotaTeq and 35 000 placebo, in six cases intussusception occurred in the 42 days following the administration of a dose of RotaTeq, compared to the five recorded among treated children with placebo. The most common side effects (seen in more than 1 patient in 10) are pyrexia (fever), diarrhea and vomiting. For the full list of all side effects reported with RotaTeq, see the Package Leaflet.

RotaTeq should not be used in children who may be hypersensitive (allergic) to the active substance or any of the other substances, or who have shown signs of allergy following the administration of a dose of RotaTeq or another rotavirus vaccine. RotaTeq should not be given to children with a history of intussusception or intestinal problems that could predispose them to this complication, or even to children with a weakened immune system. For the full list of usage restrictions, see the package leaflet.

Like other vaccines, the use of RotaTeq in very premature infants can pose a risk of respiratory apnea (short pauses in breathing cessation). The breathing of these newborns should be monitored for three days after vaccination.

Why has RotaTeq been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the studies performed, it appears that RotaTeq protects against rotavirus gastroenteritis caused by specific types of the virus. The risk of reporting intussusception following vaccination, even if contained, cannot be excluded; therefore, this eventuality will be carefully monitored after the vaccine has been placed on the market.

The Committee decided that RotaTeq's benefits are greater than its risks in vaccinating children from the age of six weeks to prevent rotavirus gastroenteritis and therefore recommended that it be given marketing authorization.

What measures are being taken to ensure the safe use of RotaTeq?

The company that makes RotaTeq will verify some of the undesirable effects of the vaccine after it is placed on the market, in particular the undesirable effects on the digestive system.