What is RotaTeq?
RotaTeq is a vaccine manufactured by Merck and Co. Inc., (Merck) licensed by FDA in 2006 for the prevention of rotavirus gastroenteritis in infants 6 weeks to 32 weeks of age.

What is rotavirus and how commonly does it occur?
Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. In the United States, the disease occurs more often during the winter, with the most activity occurring from November to May. Most children, whether in the US or elsewhere, are infected with rotavirus before they are two years old.

Sometimes diarrhea and vomiting due to rotavirus infection can lead to the loss of body fluids (dehydration) which in some instances may be severe enough to require hospitalization. Before the introduction of rotavirus vaccine in the United States, rotavirus resulted in an estimated 55,000 – 70,000 hospitalizations and 20 - 40 infant deaths each year. However, in developing countries, rotavirus gastroenteritis is a major cause of childhood death and is estimated to cause several hundred thousand deaths annually.
Once an infant has been exposed to rotavirus, it takes approximately 2 days for symptoms to appear. Infants and children develop vomiting and watery diarrhea that may last 3-8 days, and fever and abdominal pain occur frequently. A child may have rotavirus gastroenteritis more than once, because there are many different rotavirus types, but repeat infections tend to be less severe than the original infection.

How is rotavirus gastroenteritis treated?
Treatment for rotavirus infection mainly involves drinking fluids containing water with salts and certain minerals (oral rehydration). Such treatment is usually effective; however, severe cases may require a visit to the emergency room or hospitalization so that lost body fluids can be replaced with fluids given through a thin tube placed into the veins (IV or intravenous line).

How is rotavirus spread?
Rotavirus is contagious and the infection is usually spread from person to person, through the fecal-oral route. Fecal-oral transmission occurs when bacteria or viruses found in the stool of one child are swallowed by another child. This can occur when small amounts of fecal matter may be found on surfaces such as toys, books, clothing, etc. and on the hands of parents or child-care providers; but are usually invisible. Rotavirus may also be transmitted through intake of fecally-contaminated water or food or by respiratory droplets that people sneeze, cough, drip, or exhale. Rates of the illness among children in developed and less developed countries are similar.

How is RotaTeq given?
The vaccine is a liquid given by mouth with the first dose given between 6-12 weeks of age and two additional doses administered at 4- to 10-week intervals. All three doses should be completed before a child reaches 32-weeks of age. RotaTeq may be given to pre-term infants according to their age in weeks since birth.

Can toddlers or older children be vaccinated with RotaTeq?
No, the vaccine should be given to infants with the first dose at 6-12 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.

How well does RotaTeq work to prevent rotavirus gastroenteritis?
Overall, approximately 72,000 healthy infants were studied worldwide in randomized placebo-controlled studies to look at both the safety of RotaTeq and how well it works. The data showing how well RotaTeq prevents rotavirus gastroenteritis comes from almost 7,000 of these infants from the United States and Finland. In these studies, RotaTeq prevented 74% of all rotavirus gastroenteritis cases and 98% of the severe cases.

In addition, RotaTeq reduced the need for hospitalization for gastroenteritis due to rotavirus by 96%.

Are there are any possible side effects associated with the use of RotaTeq?
During the clinical trial studies, rates of serious adverse events were similar in infants receiving RotaTeq compared to those infants who did not receive the vaccine.
The following were reported more often in infants who received RotaTeq, when compared to those who received placebo; diarrhea (24.1% in RotaTeq recipients vs 21.3% in those receiving placebo), vomiting (15.2% in RotaTeq recipients vs 13.6% in those receiving placebo), ear infection (14.5% in RotaTeq recipients vs 13.0% in those receiving placebo), runny nose and sore throat (6.9% in RotaTeq recipients vs 5.8% in those receiving placebo), wheezing and coughing (1.1% in RotaTeq recipients vs 0.7% in those receiving placebo).

Another vaccine to prevent rotavirus infection was voluntarily withdrawn from the market by the manufacturer in 1999 because of cases of intussusception associated with the administration of that particular vaccine. Has the risk for intussusception been evaluated for RotaTeq?

Intussusception is a rare blockage of the intestine and occurs when one portion of the intestine telescopes into a nearby portion.

A large study of over 70,000 infants designed specifically to assess a risk of intussusception similar to what was found for the previous rotavirus vaccine was conducted before licensure of RotaTeq. The results of this study did not show an increased risk of intussusception for RotaTeq when compared to those infants who received placebo. To further observe RotaTeq for the potential that it could be associated with increased rates of intussusception or other serious adverse events, Merck, conducted another study of over 85,000 infants after licensure. The Centers for Disease Control and Prevention (CDC) also conducted a large study in its Vaccine Safety Datalink Program (VSD), which evaluated the safety of over 786,000 RotaTeq doses (309,000 first doses). Vaccination with RotaTeq was not associated with an increased risk of intussusception in the prelicensure study, the postlicensure study conducted by Merck or the VSD postlicensure study.  However, several studies conducted in other countries after approval suggested a potential increased risk of intussusception following both RotaTeq and another rotavirus vaccine, Rotarix. Rotarix, manufactured by GlaxoSmithKline Biologicals, was licensed by FDA in 2008.

Therefore, in 2010, FDA launched a study in its Mini-Sentinel Postlicensure Rapid Immunization Safety Monitoring (PRISM) program to assess the potential risk of intussusception among U.S. infants after receiving rotavirus vaccines. In the PRISM study, an increased risk of intussusception was observed within 21 days following the first dose of RotaTeq, with the majority of cases occurring in the first 7 days.  Based on these results, approximately 1 to 1.5 additional cases of intussusception occur per 100,000 vaccinated US infants within 21 days following the first dose of RotaTeq.

What happens with intussusception?

Intussusception occurs most often where the small intestine joins the large intestine. Because the two walls of the intestines press against each other, this causes inflammation, swelling, and eventually decreased blood flow. If it is not detected early, internal bleeding, a hole in the intestines and infection in the abdomen may occur because the intestinal tissue has died from the decreased blood flow. With prompt detection and treatment, almost all patients fully recover. Intussusception can occur spontaneously in the absence of vaccination and can occur in people of any age, but generally occurs between the ages of 5 and 9 months. In the U.S. it occurs in approximately 34 in 100,000 infants per year.

What does FDA want healthcare providers, parents and caregivers to keep in mind when RotaTeq is administered?

FDA believes that the benefits of vaccination with RotaTeq continue to outweigh the risks associated with vaccination, including the risk of intussusception.  FDA recommends that parents closely watch their infants for signs of intussusception, especially within the first 7 days after vaccination with RotaTeq or Rotarix. These symptoms include stomach pain, vomiting, diarrhea, blood in the stool or change in bowel movements.  It is important to contact the child's healthcare provider if the child has any of these signs at any time after vaccination, even if it has been several weeks since the last dose of vaccine.

Who should not be immunized with RotaTeq?

Infants with any of the following should not be immunized with RotaTeq:

• allergy to any of the ingredients of RotaTeq
• allergic reaction after getting a previous dose of RotaTeq
• Severe Combined Immunodeficiency Disease
• history of intussusception

Are there certain diseases or conditions that should be discussed with the healthcare provider before RotaTeq is administered?

Parents should inform their baby’s healthcare provider about any of the following that might be a reason for their baby not to receive RotaTeq:

• known or suspected weakened immune systems caused by treatments that they are taking such as radiation or a class of drugs called corticosteroids, or due to conditions such as HIV, cancer, blood disorders (e.g., leukemia), and kidney or other organ transplant (see the approved labeling for additional information)
• infants born to mothers with HIV unless it has been established that the infant is not infected with HIV
• temperature greater than or equal to 100.5oF (38.1oC)
• previous history of rotavirus infection
• active, short-term, gastrointestinal illness
• repeated gastrointestinal problems, such as frequent diarrhea and failure to thrive
• history of stomach or abdominal disorders that have been present since birth
• history of abdominal surgery
• receipt of a blood transfusion or blood products, including immunoglobulins within 42 days
• living in a household with persons whose immune systems are weakened and therefore cannot fight off infections as well

Each time before an infant receives a dose of RotaTeq, parents should discuss with their healthcare provider any health problems that their infant may have and any medications that their infant is currently taking or has been prescribed.

Can RotaTeq be administered with other vaccines?

In prelicensure studies, RotaTeq was administered with diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), inactivated poliovirus vaccine (IPV), haemophilus influenzae type b conjugate vaccine (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine. There was no evidence for reduced antibody responses to the vaccines that were administered at the same time as RotaTeq.

How can I report a serious side effect with RotaTeq, or other vaccines, to FDA?

Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and CDC. For a copy of the vaccine reporting form, call 1-800-822-7967 or report on line to http://www.vaers.hhs.gov