Rotavirus Vaccine: What you need to know.

Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis.

1. What is rotavirus?

Rotavirus is a virus that causes severe diarrhea, mostly in babies and young children.  It is often accompanied by vomiting and fever. 

Rotavirus is not the only cause of severe diarrhea, but it is one of the most serious.  Each year in the United States rotavirus is responsible for:

• more than 400,000 doctor visits
• more than 200,000 emergency room visits
• 55,000 to 70,000 hospitalizations
• 20-60 deaths

Almost all children in the U.S. are infected with rotavirus before their 5th birthday.  

Children are most likely to get rotavirus disease between November and May, depending on the part of the country.

Your baby can become infected by being around other children who have rotavirus diarrhea.

2. Rotavirus vaccine.

Better hygiene and sanitation have not reduced rotavirus diarrhea very much in the United States.  The best way to protect your baby is with rotavirus vaccine.
  
Rotavirus vaccine is an oral (swallowed) vaccine; not a shot.

Rotavirus vaccine will not prevent diarrhea or vomiting caused by other germs, but it is
very good at preventing diarrhea and vomiting caused by rotavirus.  Most babies who get the vaccine will not get rotavirus diarrhea at all, and almost all of them will be protected from severe rotavirus diarrhea. 

Babies who get the vaccine are also much less likely to be hospitalized or to see a doctor because of rotavirus infection.

3. Who should get rotavirus vaccine and when?

There are two brands of rotavirus vaccine. A baby should get either 2 or 3 doses, depending on which brand is used. The doses are recommended at these ages:
	First Dose:	2 months of age
	Second Dose:	4 months of age
	Third Dose:	6 months of age (if needed)

The first dose may be given as early as 6 weeks of age, and should be given by age 14 weeks 6 days.  The last dose should be given by 8 months of age.

Rotavirus vaccine may be given at the same time as other childhood vaccines.

Babies who get the vaccine may be fed normally afterward.

4. Some children should not get rotavirus vaccine or should wait.

A child who has had a severe (life-threatening) allergic reaction to a dose of rotavirus vaccine should not get another dose.  A child who has a severe (life threatening) allergy to any component of rotavirus vaccine should not get the vaccine.  Tell your doctor if your child has any severe allergies that you know of.

Children who are moderately or severely ill at the time the vaccination is scheduled should 	probably wait until they recover.  This includes children who have diarrhea or vomiting.  Ask your doctor or nurse.  Children with mild illnesses should usually get the vaccine.

Check with your doctor if your child has any	ongoing digestive problems.

Check with your doctor if your child’s immune system is weakened because of:
- H.I.V. AIDS, or any other disease that affects the immune system
- treatment with drugs such as long-term steroids
- cancer, or cancer treatment with x-rays or drugs

Check with your doctor if your child recently had a blood transfusion or received any other blood product (such as immune globulin).

In the late 1990s a different type of rotavirus vaccine was used.  This vaccine was found to be associated with an uncommon type of bowel obstruction called 
“intussusception,” and was taken off the market.

The new rotavirus vaccines have not been associated with intussusception.  

However, babies who have had intussusception, from any cause, they are at higher risk for getting it again. If your baby has ever had intussusception, discuss this with your doctor.

5. What are the risks from rotavirus vaccine?

A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of  rotavirus vaccine  causing  serious  harm, or death, is extremely small.

Most babies who get rotavirus vaccine do not have any problems with it.

Mild problems

Babies may be slightly more likely to be irritable, or tohave mild, temporary diarrhea or vomiting after getting a dose of rotavirus vaccine than babies who did not get the vaccine.

Rotavirus vaccine does not appear to cause any serious side effects.

If rare reactions occur with any new product, they may not be identified until thousands, or millions, of people have used it.  Like all vaccines, rotavirus vaccine will continue to be monitored for unusual or severe problems.

6. What if there is a moderate or severe reaction?

What should I look for?

Any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness.  These usually occur within the 	first few hours after vaccination.

What should I do?

Call a doctor, or get the person to a doctor right away.

Tell your doctor what happened, the date and time it happened, and when the
vaccination was given.
	
Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form.

Or you can file this report through the VAERS web site at w.w.w. dot v.a.e.r.s. dot o.r.g., or by calling 1-800-822-7967.

VAERS does not provide medical advice.

7. The National Vaccine Injury Compensation Program

In the rare event that you or your child has a serious reaction to a vaccine, a federal program has been created to help pay for the care of those who have been harmed.

For details about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at  w.w.w. dot h.r.s.a. dot g.o.v. slash vaccine compensation.

8. How can I learn more?

Your provider can give you the vaccine package insert or suggest other sources of information.

Call your local or state health department.

Contact the Centers for Disease Control and 	Prevention (C.D.C.):
- Call 1-800-232-4636 (1-800-C.D.C. I.N.F.O.)
- Visit CDC’s website at w.w.w. dot c.d.c. dot g.o.v. slash n.i.p.

Department of Health and Human Services
Centers for Disease Control and Prevention
National Immunization Program

Rotavirus Vaccine
8/28/08
Vaccine Information Statement (Interim)