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The Center for Vaccine Awareness and Research

Vaccines by disease: Learning more about the rotavirus vaccine

This vaccine is important because it protects against rotavirus, a virus that can lead to severe diarrhea. Almost all children living in the United States are infected by this virus by their 5th birthday, but most severe infections occur in children 6 months to 3 years of age.

While most rotavirus infections are mild with vomiting and watery diarrhea lasting three to seven days, approximately one in 50 infections leads to severe dehydration. It was estimated in 2006, before there was a vaccine, that rotavirus causes more than 250,000 emergency room visits, up to 50,000 hospitalizations, and between 20 to 60 deaths in the U.S.  

Prevention is the key to avoiding rotavirus infection, and the most effective prevention method is giving the rotavirus vaccine.


Who should receive the rotavirus vaccine?
All healthy infants should receive the series of rotavirus vaccine.  There are two different vaccines, one that is given by mouth in three doses (Rotateq®) and one that is given by mouth in two doses (Rotarix®).  In order for a rotavirus vaccine to be fully effective, the proper number of doses should be given to children when they are the following ages:

  • 2 months (as early as 6 weeks)
  • 4 months
  • 6 months (for only Rotateq®)

Infants should have received all doses by the time they are 8 months of age.

Who should not receive the rotavirus vaccine?

  • Infants younger than 6 weeks of age
  • Children older than 8 months
  • Children who have had a severe allergic reaction to any component of the rotavirus vaccine or a previous dose of the vaccine
  • Children with a weakened immune system

Parents should speak to their child’s primary health care provider before getting the rotavirus vaccine.

Review the vaccination schedule for those who start late on a vaccine or are more than one month behind.
 

When did the rotavirus vaccine become available?
The Food and Drug Administration (FDA) licensed the first rotavirus vaccine (RotaShield®) in 1998. Its use was suspended in 1999 because a number of children who were vaccinated developed intussusception, a serious disease where the bowel is blocked.


In 2006, the FDA licensed a new rotavirus vaccine called RotaTeq®. In a study of more than 70,000 children, the chance of developing intussusception was similar in children who received RotaTeq® and those who received a placebo.  In 2008, the FDA licensed another rotavirus vaccine called Rotarix®. Again there was the same chance of developing intusseption in children receving placebo as in those receiving Rotarix®.  Both vaccines are given by mouth, prevent the same amount of infection and severe disease, and are safe.

When was Rotarix® immunization temporarily stopped?
In March 2010, The Food and Drug Administration (FDA) reported that one of the two rotavirus vaccines, Rotarix®, made by GlaxoSmithKline, was found to have pieces of non-harmful porcine (pig) circovirus in it. Neither pigs nor humans get sick from this virus.  However, the FDA asked that healthcare providers temporarily stop using Rotarix® in infants so they could investigate the finding. There are no identified safety concerns for already vaccinated infants.


How does someone become infected with rotavirus?
This highly contagious virus is spread from person-to-person contact.

How effective is the rotavirus vaccine?
Approximately 98 percent of children who receive this vaccine do not get severe rotavirus diarrhea, and 74 to 79 percent of children do not get rotavirus diarrhea at all.

Are there any serious side effects of the rotavirus vaccine?
Serious risks from the rotavirus vaccine are rare. Mild side effects may include temporary mild diarrhea or vomiting.

How do I learn more about this vaccine?
The best person to ask about this or any vaccine is your child’s pediatrician or your primary health care provider. Your provider can answer your questions and give you more information on the rotavirus vaccine.

Immunization is the best thing you can do for your child to protect against rotavirus.