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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Background on Rotavirus Vaccines

After evaluating data from extensive clinical and non-clinical tests, FDA licensed GlaxoSmithKline’s Rotarix vaccine in April 2008.  The vaccine currently accounts for an estimated 25 percent of the U.S. market in rotavirus vaccines.  The rest of the market is held by RotaTeq, a vaccine produced by Merck and Co., Inc.  FDA licensed RotaTeq in February 2006.  Pre- and postmarket studies have shown both vaccines to be highly effective at preventing serious gastrointestinal disease caused by rotavirus.  No serious or unexpected safety concerns have been identified in postmarket surveillance of either Rotarix or RotaTeq.

What is Rotarix?

Rotarix is one of two live-attenuated (weakened) viral vaccines licensed to prevent rotavirus disease, which can cause severe diarrhea and dehydration in young infants.

The active ingredient in Rotarix is a live-attenuated human rotavirus. It causes a slight infection that typically produces no symptoms, but creates immunity against rotavirus.

Rotarix is sold in the United States as a powder that is to be dissolved in a liquid that comes with the vaccine in a pre-filled oral applicator.  The vaccination series consists of two 1-mL doses administered by mouth.  The first dose can be given beginning at six weeks of age and the second at least four weeks after the first dose, but before the child reaches 24 weeks of age.

How was Rotarix developed and studied before it was licensed by FDA?

Rotarix was developed from a live, weakened form of a rotavirus that was originally isolated from a child at Cincinnati Children’s Hospital.  GlaxoSmithKline took over development of the vaccine and conducted clinical trials in the United States and overseas.

The data submitted to FDA to demonstrate the efficacy of Rotarix in preventing rotavirus gastroenteritis came from two placebo-controlled, randomized clinical trials conducted in 17 countries in Europe and Latin America that included a total of 24,163 enrolled children.  These studies have shown the vaccine to be more than 80 percent effective in preventing severe gastrointestinal disease caused by rotavirus.

The data submitted to FDA to support the safety of Rotarix included results from 8 clinical studies that evaluated a total of 71,209 infants who received Rotarix (N = 36,755) or placebo (N = 34,454).  The most common adverse reactions reported during clinical trials for Rotarix were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

In 7 of the clinical studies, solicited and unsolicited reports of adverse events, serious adverse events, and cases of intussusception, a serious bowel condition, were collected.  In the other study, cases of intussusception and serious adverse events were collected.  In this study, there was no increase in the risk of intussusception in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants).  FDA concluded that the available data supported the safety of the vaccine.  The manufacturer is conducting postmarket safety studies involving more than 40,000 infants to provide additional safety information.

What countries currently use Rotarix?

In addition to FDA, the European Medicines Agency and numerous other foreign regulatory authorities have licensed Rotarix.  The vaccine is now licensed in 114 countries.

How many doses of Rotarix have been sold?

About 68 million doses of Rotarix have been sold worldwide, including approximately 2.5 million doses in the United States.  With two doses recommended for each child, this means that at most approximately 1 million children have been vaccinated with Rotarix in the United States and approximately 30 million worldwide, with the majority in Latin America.  No unexpected pattern of serious adverse reactions to the vaccine has been reported in any country.

What other rotavirus vaccines are currently available?

The other licensed rotavirus vaccine is Merck’s RotaTeq, also a live-attenuated viral vaccine taken by mouth.  RotaTeq was created by combining rotaviruses obtained from humans and cattle.  It was tested in more than 70,000 children, primarily in the United States and Finland, and licensed in the United States in February 2006.  The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered by mouth starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals.  The third dose should not be given after 32 weeks of age.

RotaTeq and Rotarix have had a significant impact on gastrointestinal disease caused by rotaviruses in the countries where they have been introduced.  Studies in the United States have shown that vaccination has resulted in an estimated 60% reduction in rotavirus disease compared to the pre-vaccine era.

Is FDA’s announcement about the presence of DNA from PCV1 in Rotarix related to the new Rotarix information presented to the FDA's Pediatric Advisory Committee on March 22, 2010?

These two issues are not related.  An update on the postmarket safety experience for Rotarix had already been planned as part of the FDA’s March 22, 2010 Pediatric Advisory Committee meeting.  The update included information regarding the February 22, 2010 FDA revision of the package insert and patient package insert to include Severe Combined Immunodeficiency Disease (SCID) as a contraindication for use.

Is FDA’s announcement about the presence DNA from PCV1 in Rotarix related to what happened with Rotashield, a different rotavirus vaccine no longer on the market?

These two issues are not related.  Rotashield was voluntarily withdrawn from the market after studies suggested an elevated risk of intussusception, a rare but serious bowel condition, in infants who had received the vaccine.  Rotashield was made using different materials from Rotarix.  Rotarix has been extensively studied, before and after approval, and found to have an excellent safety record.  There is no evidence at this time that the presence of DNA from PCV1 in Rotarix poses a safety risk to patients.