Vaccines and Preventable Diseases:
Updated Vaccine Label for Rotarix®
Questions and answers for health care professionals
On This Page:
- Summary of FDA announcement
- What new information has FDA approved for the Rotarix® vaccine prescribing information and patient labeling?
- Why is this information coming out now?
- Why should I use rotavirus vaccine to prevent my child from getting rotavirus disease if the vaccine may cause intussusception?
- Has rotavirus vaccine had a positive impact in the United States?
- Does this information mean that RotaTeq® is safer than Rotarix®?
- Are there U.S. studies to look at the safety of Rotarix?
- Why does the FDA label describe the Mexico study results based on the 31-day period after administration of the first dose of Rotarix?
- When should children get rotavirus vaccine?
- More information about intussusception
The U.S. Food and Drug Administration (FDA) announced on September 22, 2010, that it was adding information to the vaccine label for one of the two rotavirus vaccines available in the United States, Rotarix®, manufactured by GlaxoSmithKline. The information states that preliminary findings from a large study conducted in Mexico suggest that the vaccine may cause intussusception (a type of bowel blockage). If the risk for U.S. infants is similar to that found in the Mexico study, it would translate to 0 to 4 cases of intussusception from vaccine per 100,000 U.S. infants who receive the first dose of Rotarix.
Given that the information available suggests a small risk of intussusception caused by Rotarix, and given that the benefits of rotavirus vaccination are great, CDC continues to recommend Rotarix to prevent rotavirus disease, the most common cause of severe diarrhea among children. CDC also continues to recommend RotaTeq® to prevent rotavirus disease. Either vaccine may be used to protect infants and children from rotavirus disease.
The questions and answers below provide additional information for health care professionals and parents.
What new information has FDA approved for the Rotarix vaccine prescribing information and patient labeling?
Information has been added to the existing Intussusception Subsection of the Warnings and Precautions section of the Prescribing Information for Rotarix. The information gives preliminary results from a postmarketing study conducted in Mexico (the postmarketing phase is the time after a vaccine is approved and is in use). Results of the study suggest an increased risk of intussusception in the 31 days after the first dose of Rotarix, and most cases happened in the first 7 days after the first dose. If the risk for U.S. infants is similar to that found in the Mexico study, it would translate to 0 to 4 cases of intussusception from vaccine per 100,000 U.S. infants who receive the first dose of Rotarix.
No changes have been made to the Contraindications or Indications for Use of Rotarix. For more information, including the label change, see Rotarix Product Information and Supporting Documents.
This new information is the result of planned, ongoing safety monitoring.
BACKGROUND: Intussusception was found to be a side effect of the first rotavirus vaccine available in the United States, which was recommended for use in October 1998. As a result, that vaccine was voluntarily withdrawn from the market by the manufacturer in October 1999. That vaccine was estimated to cause intussusception in 1 infant out of every 10,000 infants who received it.
For the two new, next generation rotavirus vaccines available in the United States, the FDA evaluated safety data from large pre-approval studies that were specifically designed and conducted to see if either new vaccine increased the risk of intussusception. In each of these pre-approval studies, about 30,000–35,000 infants were given rotavirus vaccines. Both new vaccines were approved by FDA because these studies showed them to be safe and effective, and these studies did not show an increase in the risk of intussusception. However, even large safety studies may not always be able to detect events that happen rarely.
As with all vaccines, FDA and CDC committed to ongoing safety monitoring of the new rotavirus vaccines after they were approved for use. The manufacturers of both vaccines also committed to conduct postmarketing safety studies (the postmarketing phase is the time after a vaccine is approved and is in use). These ongoing studies gather more and more information as the vaccines are being used, and so it is possible to determine if the vaccines have a risk of intussusception that may have been too low to detect in the studies conducted before vaccine approval.
CURRENTLY: Rotarix vaccine has been available in the United States since 2008. About 2.7 million doses have been distributed. There are not enough safety data from ongoing studies in the United States to allow detection of a level of risk as low as the one found in the Mexico study. The manufacturer, as well as CDC and FDA, are monitoring the safety of this vaccine in the United States.
A safety monitoring study in Mexico conducted by the manufacturer beginning in 2008 shows that Rotarix vaccine may cause intussusception. If the risk for U.S. infants is similar to that found in the Mexico study, it would translate to 0 to 4 cases of intussusception from vaccine per 100,000 U.S. infants who receive the first dose of Rotarix. This risk estimate is much lower than the risk from the earlier rotavirus vaccine, which is no longer available.
There are good doctors and hospitals in my area, so why should I use rotavirus vaccine to prevent my child from getting rotavirus disease if the vaccine may cause intussusception?
The level of risk of intussusception found in the Mexico study reviewed by FDA is much lower than the risk of severe rotavirus disease in U.S. children who do not receive rotavirus vaccine. Given the low level of risk of intussusception following rotavirus vaccination, and given that rotavirus disease can be severe, CDC continues to recommend vaccination to prevent rotavirus disease.
Risk of intussusception following rotavirus vaccination: This new information suggests that the risk of intussusception from Rotarix vaccine is low:
- 0 to 4 U.S. infants out of 100,000 infants who receive the first dose of the vaccine.
Intussusception is a rare condition that happens among infants and children, and most of the time the cause is not known. When no rotavirus vaccine was used in the United States, each year about 1,900 infants developed intussusception before the age of 1 year. With rotavirus vaccination, if every U.S. infant received the first dose at the recommended age, and that caused intussusception in 0 to 4 infants out of 100,000 infants, this would mean 0 to 125 more cases of intussusception per year.
Risk of severe rotavirus disease in unvaccinated children: Rotavirus vaccines offer tremendous benefits by protecting infants and children from rotavirus disease. Rotavirus is the most common cause of severe diarrhea among infants and young children.
Before use of rotavirus vaccines, almost every U.S. child became infected with rotavirus before 5 years of age. U.S. children faced significant risks from rotavirus disease:
- 1 child out of every 70 children was hospitalized
- 1 child out of every 17 children went to a hospital emergency department
In the United States before rotavirus vaccination was available, an estimated 20 to 60 children died because of rotavirus disease each year.
Infants and children with rotavirus disease usually suffer watery diarrhea for 3 to 8 days, and vomiting and fever are common. Young children may lose interest in eating and drinking and become dehydrated because they do not take in enough fluids. In severe cases, children need to go to the hospital to receive fluids given directly into a vein using an intravenous line (IV).
The rotavirus vaccination program has had remarkable success in the United States. A U.S. study showed that RotaTeq vaccine was very effective (84%) in preventing severe rotavirus disease in vaccinated infants and young children. The vaccination program in the United States has reduced the number of infants and children needing hospitalization or emergency department care for rotavirus disease by about 85%.
BACKGROUND: Among infants born in early 2008, 60% received a full series of rotavirus vaccine. This is about how many would be expected within 2 years after a vaccine is introduced. About 90% of U.S. infants and children receive vaccines like polio and MMR that have been available for a long time. In fact, about 90% of U.S. infants and young children get all doses of most recommended vaccines.
The information currently available does not demonstrate an increased risk of intussusception with RotaTeq. However, the data available cannot rule out a risk of intussusception with RotaTeq as low as the risk currently reported with Rotarix in the Mexico study. Studies are ongoing.
BACKGROUND: In the United States, vaccine safety is constantly monitored using the Vaccine Adverse Event Reporting System (VAERS), co-sponsored by CDC and the FDA. VAERS collects and analyzes reports of adverse events (possible side effects) that happen after vaccination. VAERS is an early warning system to alert researchers to possible side effects, but the system is not set up to determine whether reported events are actually associated with receiving a particular vaccine. Other types of studies can answer this question. The Vaccine Safety Datalink (VSD), a network of 8 managed care organizations with data for more than 9 million people, is often used for such studies. The VSD is not only used to follow-up on possible side effects noted in VAERS, but it is also used independently in ongoing studies of vaccine safety after vaccines are approved and in use.
CURRENTLY: According to VAERS, an increased risk of intussusception may be possible in the first week after receiving the first dose of RotaTeq. A VSD study is being done to see if RotaTeq is associated with intussusception. It includes data on more than 800,000 total doses of the vaccine. This study has not found a risk of intussusception. However, the VSD study cannot rule out a risk of intussusception with RotaTeq as low as the risk currently reported with Rotarix in the Mexico study.
RotaTeq, made by Merck, has been available in the United States since February 2006. About 27 million doses have been distributed.
Rotarix vaccine has been available in the United States since 2008. About 2.7 million doses have been distributed. There are not enough safety data from ongoing studies in the United States to allow detection of a level of risk as low as the one found in the Mexico study. The manufacturer, as well as CDC and FDA, are monitoring the safety of this vaccine in the United States.
Why does the FDA label describe the Mexico study results based on the 31-day period after administration of the first dose of Rotarix?
The study in Mexico was designed to evaluate the 31-day period after vaccination, and the interim analysis follows that study design. However, as described in the FDA label, most of the cases of intussusception in the analysis occurred during the first week after the first dose. This period, the first week after the first dose of vaccine, is the best estimate of when intussusception cases caused by Rotarix might occur.
Rotavirus vaccines are approved for use only among infants, and not among children and adolescents.
- For one brand of vaccine (RotaTeq), infants should receive three doses of vaccine, one at ages 2, 4, and 6 months.
- For the other brand of rotavirus vaccine (Rotarix), infants should receive two doses of vaccine, one at ages 2 and 4 months.
For more information on recommended ages for rotavirus vaccination, see Recommended Immunization Schedules for Persons Age 0 through 18 Years [PDF-334 KB, 4 pages]
For more on intussusceptions, see Questions & Answers about Intussusception.
- Rotarix Rotavirus Vaccine: Rare Side Effect Possible
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- FDA: Rotarix
Changes to the label for Rotarix from U.S. Food and Drug Administration
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Content last reviewed on September 22, 2010
Content Source: National Center for Immunization and Respiratory Diseases