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A Look at Each Vaccine: Rotavirus Vaccine

The Centers for Disease Control and Prevention approved a rotavirus vaccine for use in the United States in 2006. The vaccine, called RotaTeq®, is given as a series of three doses by mouth at 2 months, 4 months and 6 months of age and can be given with other vaccines typically administered at those times. A second vaccine, called Rotarix®, was approved for use in June 2008 and is given as a series of two doses by mouth at 2 months and 4 months of age.

What is rotavirus?

Rotavirus is a virus that infects the lining of the intestines. Although not typically known by its name, most parents recognize rotavirus by its symptoms — high fever, persistent and severe vomiting and diarrhea. By 5 years of age nearly all children have been infected with rotavirus.

Before the vaccine, each year in the U.S., rotavirus caused:

How is the rotavirus vaccine made?

The first rotavirus vaccine, RotaTeq, is made from a strain of rotavirus that was originally isolated from a calf. Human rotavirus proteins responsible for evoking protective antibodies, but incapable of causing disease, were also added. This combination of a calf rotavirus, which can't cause disease in children, with human rotavirus proteins, which protect against disease, allows babies to develop immunity without getting sick.

The second rotavirus vaccine, Rotarix, is made from one type of rotavirus originally isolated from a person and weakened in the lab.

Does the rotavirus vaccine have side effects?

Studies of more than 130,000 infants showed that the vaccine did not cause vomiting, diarrhea, fever, irritability or poor feeding.

In 1999, a different rotavirus vaccine, called Rotashield®, was removed from the market because it was found to cause a rare form of intestinal blockage. The Rotashield vaccine was made using a strain of rotavirus originally isolated from a monkey and is no longer available in the U.S. The current rotavirus vaccines do not cause the same problem. Studies showed that the incidence of intestinal blockage was the same in children who did or didn't receive the vaccine.

Do the benefits of the rotavirus vaccine outweigh the risks?

Without a rotavirus vaccine, approximately 55,000 to 70,000 children born in the U.S. would be hospitalized with rotavirus each year. Since the vaccine has been in use, this number has decreased by about 80 percent. There are no severe side effects from rotavirus vaccine. Therefore, the benefits of the rotavirus vaccine clearly outweigh the risks.

All infants
Disease Risks Vaccine Risks
  • Fever
  • Vomiting and diarrhea
  • Dehydration caused by severe vomiting and diarrhea can be fatal
  • Low-grade fever
  • Mild vomiting and diarrhea


Plotkin SA, Orenstein W, and Offit PA. Rotavirus vaccines in Vaccines, 6th Edition, 2012, 669-687.

Reviewed by: Paul A. Offit, MD
Date: May 2013

Materials in this section are updated as new information becomes available. The Vaccine Education Center staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.


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Rotavirus Vaccine Q&A

"Rotavirus: What you should know" Q&A sheet: