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Rotavirus Vaccine

The rotavirus vaccine is used to protect against rotavirus, a virus that can cause severe diarrhea in young children. It comes in two forms; one (Rotarix) is given as two doses, and the other (RotaTeq) requires three doses. The vaccine is given by mouth and is often part of a child's routine childhood vaccination schedule.

What Is the Rotavirus Vaccine?

The rotavirus vaccine (Rotarix®, RotaTeq®) is a childhood vaccine approved to prevent rotavirus, a common but potentially serious childhood infection that causes severe diarrhea, sometimes resulting in hospitalization (and rarely, in death).
 
(Click What Is the Rotavirus Vaccine Used For? for more information on what the medication is used for, including possible off-label uses.)
 

Currently Marketed Rotavirus Vaccines

At this time, there are two different rotavirus vaccines available. Key differences between the two include:
 
  • Rotarix is given as two doses, while RotaTeq requires three doses.
     
  • The Rotarix two-dose series can be completed before the RotaTeq three-dose series.
     
  • Although both vaccines are given by mouth, RotaTeq comes in ready-to-use tubes, while Rotarix requires a little preparation by the healthcare provider (to mix it).
     
  • RotaTeq was approved before Rotarix, so most healthcare providers have more experience with RotaTeq.
     
  • Children with latex allergies should not take Rotarix; this is not a problem with RotaTeq.
     
  • Rotarix protects against the G1, G3, G4, and G9 types of rotavirus, while RotaTeq protects against the G1, G2, G3, and G4 types. As expected, the manufacturers of both vaccines argue that their particular vaccine provides better protection, due to these differences in protection against the various types of rotavirus.
     
Both of the currently available rotavirus vaccines are also different from RotaShield®, a previously available vaccine that was withdrawn from the market due to the risk of intussusception, a serious side effect. The currently available rotavirus vaccines do not appear to increase the risk of intussusception.
 

Thimerosal Content and Other Concerns

Parents who are concerned about exposing their children to thimerosal can be confident that the available rotavirus vaccines contain no thimerosal (a mercury-containing preservative), not even in trace amounts. Some parents are concerned about aluminum content of vaccines; these vaccines contain no aluminum.
 
These vaccines are not made from human fetal components, as some vaccines are. Rotarix is grown on a line of monkey kidney cells, and RotaTeq is made using bovine (cow) components.
  

Potential Side Effects

As with any vaccine, the rotavirus vaccine may cause side effects. However, not everyone who gets vaccinated will experience side effects. In fact, most children tolerate it well, with only minor side effects (if any).
 
If side effects do occur, in most cases, they are minor and either require no treatment or can easily be treated by you or your healthcare provider. Serious side effects are less common.
 
Some of the most common side effects include, but are not limited to:
 
(Click Side Effects of the Rotavirus Vaccine to learn more, including potentially serious side effects that you should report immediately to your healthcare provider.)
 

What Should You Tell Your Healthcare Provider?

You should talk with your child's healthcare provider before vaccination if your child has:
 
  • Diarrhea or vomiting
  • A blood disorder
  • A gastrointestinal (digestive) problem or condition
  • An immune-suppressing condition such as HIV or AIDS, diabetes, or cancer
  • Had any sort of a reaction to any vaccine in the past
  • A moderate to severe illness
  • Any relatives (or other close contacts) with a weakened immune system
  • Any allergies, including allergies to latex, foods, dyes, or preservatives.
     
Make sure to tell the healthcare provider about any medicines your child is taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 
(Click Precautions and Warnings With the Rotavirus Vaccine to learn more, including information on who should not take the drug.)
 

What About RotaShield?

In 1999, a different version of the rotavirus vaccine (called RotaShield) was removed from the market after it was found to be associated with a rare type of bowel obstruction called intussusception. Intussusception is a serious and life-threatening event that occurs when a part of the intestine gets blocked or twisted.
 
Both RotaTeq and Rotarix are different from the vaccine removed from the market. During clinical studies prior to the approval of RotaTeq and Rotarix, there was no apparent increased risk of intussusception. However, since approval, a number of cases of intussusception were reported in infants who received these vaccines.
 
Intussusception occurred at various times after vaccination. Some of these infants required hospitalization and surgery on their intestine or a special enema to treat this problem. It is important to remember that these cases occurred so rarely that they could be completely unrelated to the vaccine.
 
Nonetheless, be sure to call your child's healthcare provider right away if your child has any possible symptoms of intussusception, such as vomiting, diarrhea, severe stomach pain, blood in the stool, or a change in bowel movements.
 
It is important to contact your healthcare provider if you have questions or if your child has any of these symptoms, at any time after vaccination, even if it has been several weeks since the last dose (or even if your child has never received the vaccine).
 

How Does the Rotavirus Vaccine Work?

The rotavirus vaccine is a live attenuated vaccine. This means that it contains the living virus which has been altered in such a way as to prevent it from actually causing disease. However, the body's immune system still responds to it, providing future protection from the disease.
 
In general, live vaccines provide better protection from infections (compared to other types of vaccines) but can, in rare cases, actually cause the disease, particularly in people who have very weakened immune systems.
 

Getting the Rotavirus Vaccine

Some general considerations include the following:
 
  • This vaccine is given as two or three doses, depending on the particular vaccine. These simple dosing schedules are flexible enough to coincide nicely with standard well-baby visits.
     
  • This is one of the few vaccines that are given by mouth (not as an injection).
     
  • If your child spits out some or all of the vaccine, a replacement dose may be recommended for Rotarix, but not for RotaTeq.
     
  • There are no dietary restrictions; your child may eat or drink as usual (including breastfeeding) before and after the vaccine.
     
  • Children can be vaccinated if they have a minor illness, such as the common cold. However, the vaccine should be postponed if the child is moderately or severely ill.
     

Dosing Information

The particular dosing instructions vary, depending on whether your child is receiving RotaTeq or Rotarix.
 
(Click Rotavirus Vaccine Dosage for more information.)
 

Rotavirus Vaccine Drug Interactions

The rotavirus vaccine can potentially interact with a few medications (see Drug Interactions With the Rotavirus Vaccine).
 

Storage Methods

Rotarix should be stored in the refrigerator. The diluent (the liquid used to mix the vaccine) portion of Rotarix can be stored at room temperature. Once the vaccine is mixed, it can be stored at room temperature or under refrigeration but must be used within 24 hours.
 
RotaTeq should be stored in the refrigerator.
 
Neither vaccine should ever be frozen. Remember that the vaccines contain a live virus that could easily be destroyed by improper storage.
 

Is There a Generic Version of Rotavirus Vaccine?

This vaccine is not available in generic form (see Generic RotaTeq or Generic Rotarix).
 

Who Makes Rotavirus Vaccines?

Rotarix is made by GlaxoSmithKline Biologicals, while RotaTeq is made by Merck & Co., Inc.
 

Forms Available

RotaTeq is available in 2 mL ready-to-use, latex-free tubes. Rotarix comes in vials that contain the freeze-dried vaccine. The freeze-dried vaccine must be mixed with the diluent (the liquid portion in a prefilled oral applicator) before use. Mixing the two components properly results in a 1 mL dose.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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