Rotavirus Vaccine

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Vaccines are the best way to protect against some very serious infections.

The Rotarix™ vaccine is an oral vaccine (given by mouth not injection) that protects against 5 serotypes of rotavirus; G1, G2, G3, G4 & G9.

What is rotavirus?

Rotavirus is the most common cause of diarrhea in infants and children. It may also cause stomach pain, vomiting and fever. Symptoms can range from mild stomach upset to severe dehydration that requires hospitalization. Once a person has rotavirus it takes 24 - 72 hours for symptoms to appear, and symptoms can last for 3 - 8 days.

Most children develop an infection caused by rotavirus at least once by the time they are 5 years of age. In Ontario, children under 2 years of age are most likely to have severe complications from rotavirus infections and require hospitalization.

Rotavirus is spread by the "fecal-oral" route, which means you become infected by putting something in your mouth that has been contaminated with the stool of a person with the virus. The virus can be found on toys and hard surfaces. The virus can be transmitted when these items are handled and then unwashed hands are put into the mouth or when the item itself is directly placed in the mouth.

The virus may also be present in the respiratory secretions (from coughing or sneezing) of an infected person. Transmission may also happen by eating or drinking contaminated food or water.

Who should get the vaccine?

Starting in August 2011, Rotarix™ vaccine will be publicly funded (free) in Ontario for all infants. This vaccine is given in two doses; at the 2 month and 4 month immunization visits. The series must be completed by 24 weeks of age.

There are no feeding restrictions before or after the vaccination is given. Infants can continue to be fed as usual before and after they receive their vaccination.

How well does the vaccine work?

The Rotarix™ vaccine has been shown to prevent 85-96% of all severe infections caused by rotavirus. During the first year following vaccination, it has been shown to prevent 70-87% of all rotavirus infections.

No vaccine is 100% effective however, if a child does develop rotavirus after receiving the vaccine, it is usually a milder case than those in people who are not vaccinated.

Who should not get this vaccine?

A health care provider may decide not to give this vaccine to:

• Infants with a high fever or serious infection worse that a cold. They should delay having the vaccine until they are better.
• Infants who have had a serious allergic reaction (anaphylaxis) to this vaccine in the past or who are allergic to any component of the vaccine:

Rotarix™ - human rotavirus RIX4414 strain (live, attenuated), Dulbecco’s Modified Eagle Medium (DMEM), sucrose, di-sodium adipate, and residual porcine circovirus type 1 (PCV-1). This product may contain latex.

***PCV-1 is not known to cause disease in animals and is not known to infect or cause disease in humans. There is no evidence that the presence of PCV-1 poses a safety risk.

• Infants with gastrointestinal or digestive illness or a history of intussusception (folding of the intestines causing a blockage).
• Infants who currently have diarrhea or vomiting. They should delay having the vaccine until they are better.
• Infants who are immunocompromised
• Infants who have recently received blood products.

What are the side effects of this vaccine?

Most babies who receive this vaccine do not have any side effects; less than 10% will have diarrhea and irritability, and less than 1% will have abdominal pain, rash and gas.

Rotarix™ is a live vaccine and the vaccine virus may be in your baby’s stool for up to 10 days following immunization. This can be of particular concern for immunocompromised people. Careful hand washing should be done after changing baby’s diaper to avoid possible transmission.

Serious side effects such as allergic reaction or intussusception (type of bowel obstruction) are very rare.

Rotarix™ has been studied for risk of developing intussusception, because of an association that was found with a previous vaccine Rotashield™ that was used in the United States in 1998. While there have  been large studies done that showed no association between Rotarix™ and intussusception, there has been a recent study from Brazil and Mexico (as they introduced Rotarix into their routine childhood immunization schedules in March 2006 and May 2007 respectively) that did show a short-term risk of intussusception (1-7 days following immunization).

While the risk of intussusception was found to be 1 in 51,000 in Mexico and 1 in 68,000 in Brazil, this same Rotavirus immunization program prevented ~80,000 hospitalizations and 1,300 deaths annually in these two countries. The risk of intussusception after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children.

This is not a complete list of side effects. You should always discuss the risks and benefits of any vaccine with a health care provider.

Is there an alternative to the vaccine?

There are no other treatments to prevent this disease.

Proper hand washing, especially after changing diapers, will help to prevent the spread of infection. To wash hands properly, rub all parts of the hands with soap and water for at least 15 seconds.

It is also helpful to avoid sharing objects such as toys and regularly cleaning them to help prevent the spread infection.

When should I seek medical attention?

If your baby develops any of the following particularly within seven days of receiving the vaccine, go to the nearest hospital: stomach pain with severe crying, several episodes of vomiting or blood in their stool.

You should also take your baby to the nearest hospital or call 911 if any of the following occur within three days of getting the vaccine:

• High fever (over 40°C or 104°F)
• Hives
• Swelling of the face or mouth
• Trouble breathing
• Convulsions or seizures
• Any other unexpected effects

If medical attention was required, please notify the health unit.

What else do I need to know?

After you or your child receive a vaccine, update the immunization record (Yellow Card). Keep it in a safe place.

The health unit is required to keep immunization records on file for all children enrolled in a day nursery or school. If your child receives immunizations from your health care provider, you can update your child’s record in any one of the following ways:

• Use the secure on-line form on our website (www.simcoemuskokahealth.org/immsonline)
• Fax a copy to 705-721-1495
• Mail a copy to: VPD Program, Simcoe Muskoka District Health Unit, 15 Sperling Drive, Barrie ON, L4M 6K9
• Drop off a copy at any one of our offices
• Call Your Health Connection at 705-721-7520 or 1-877-721-7520 (toll-free)

A confidential electronic database stores this information and it is available to you on request. It is important to note that health care providers do not routinely provide this information to the health unit.