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Rotavirus
ROTAVIRUS AND ROTAVIRUS VACCINE

The following information is provided as a public service by the National Vaccine Information Center to help you understand the disease rotavirus and the rotavirus vaccine so you can make an informed decision regarding the use of this vaccine. This information is not intended to serve as medical advice but as background information that you can use to educate yourself and ask your doctor questions.

NVIC encourages you to become fully informed about rotavirus, rotavirus vaccine and speak with one or more trusted health care professionals before making a decision about vaccination. 

Whenever making a major health care decision for yourself or your child, especially one that involves use of a pharmaceutical product such as a vaccine, obtaining information from many different sources and consulting health care professionals you trust is important.

Becoming an informed health care consumer will empower you to ask your doctor questions and help you to take control of your health choices. If your doctor does not support your informed health choices, consider consulting another doctor who will work as a partner with you in making important health care decisions for yourself or your child.

What is Rotavirus?

Rotavirus is the most common cause of severe diarrhea among children worldwide.

There are many different strains of rotavirus that can infect humans or animals, including monkeys, cows and sheep. There are five main strains that cause more than 90 percent of human rotavirus infections in developed countries, such as the U.S., but rotavirus strains are more diverse in developing countries.

Infants younger than three months old may not develop diarrhea symptoms when they are infected with rotavirus because they have maternal antibodies transferred from their mother to protect them in the first few months of life, including through breastfeeding.  By the age of five, most children have had several rotavirus infections and have developed natural antibodies that protect them from symptoms of diarrhea when they are re-infected as they get older.

In non-tropical climates like the U.S., rotavirus infections are more likely to occur in the colder winter months than in the summer.

The incubation period for rotavirus disease is approximately 2 days. Primary symptoms include vomiting and watery diarrhea for 3 to 8 days. Fever and abdominal pain occur frequently. Immunity after first infection is incomplete, but repeat infections tend to be less severe than the original infection. By age five, most healthy children do not exhibit symptoms of severe diarrhea when re-infected with rotavirus because each previous re-exposure to the disease has built a stronger immunity.

According to 1Harrison’s Principles of Internal Medicine, symptoms of rotavirus include:

  • Frequent vomiting
  • Abdominal pain
  • Lethargy (child won’t focus on you, is less responsive to touch or words)
  • Less frequent urination
  • No tears when crying
  • Dry, cool skin
  • Fever
  • Frequent, watery diarrhea (often foul-smelling, green or brown)
  • Dry or sticky mouth
  • Extreme thirst

How Do You Get Rotavirus?

Rotavirus is very contagious; it spreads when infants or young children come into contact with an infected person’s body fluids or feces, or items that have come in contact with the feces of an infected person.  Most cases of rotavirus occur in children ages 3 months to 35 months old.

The primary mode of transmission of rotavirus is the passage of the virus in stool to the mouth of another child, known as a fecal-oral route of transmission. The virus can live for hours on hands and even longer on hard surfaces.

Is Rotavirus a Communicable Disease – Can It Be Spread Person-to-Person?

Yes (see above). The CDC estimates that, by age 3, almost every US child has had a case of rotavirus. Once a child has been infected with a strain of rotavirus, he or she develops antibodies and is either immune for life or has a milder case if infected with that same strain in the future. Most healthy children, who are infected with several strains of rotavirus in the first few years of life, develop lifelong natural immunity to rotavirus infection.

According to the CDC, rotavirus spreads easily. Large amounts of rotavirus are shed in the stool of infected persons and rotavirus is easily spread on contaminated hands and objects.

Children can spread rotavirus both before and after they become sick with diarrhea. They can sometimes pass the virus to other members of the family and close contacts. In the US, rotavirus infections can cause diarrhea in adults caring for children, in the elderly, and in adults who are traveling, but this occurs less often than in children.

Frequent hand washing is an important way to cut down on transmission of rotavirus and other viral or bacterial infections. 

How Do You Treat Rotavirus?

Normally rotavirus does not require special treatment. Rest and fluids to prevent dehydration work well.  In more serious cases, it is possible that hospitalization and intravenous re-hydration also may be necessary. In underdeveloped countries that lack sanitation and access to good medical care, including re-hydration therapy for severely dehydrated children suffering with diarrhea, rotavirus infection can be fatal.

Once You Have Had Rotavirus Can You Get It Again?

Yes – but it is usually milder. There are several different strains of rotavirus, and it is estimated that all children get repeat infections with different strains in their first few years of life. However, subsequent rotavirus infections usually are milder. After several infections with different strains of the virus, most children develop natural, long lasting immunity to rotavirus.

Can Rotavirus Cause Injury and/or Death?  

There is a gap in medical knowledge in terms of predicting who will have a mild case of rotavirus and who will have a life-threatening or even fatal case of this disease.

Most children need only rest and fluids to recover from rotavirus. However, untreated dehydration from loss of fluids and electrolytes can cause death.

That is why it is important to make sure that your child has plenty of fluids when he/she is sick with any kind of severe diarrhea and is taken to a hospital if there is change in consciousness (excessive sleep or unresponsiveness), high or persistent fever, vomiting, failure to eat, drink or urinate, and other signs that your child may be dehydrated and in need of re-hydration therapy.

How Many Children Are Hospitalized or Die from Rotavirus in the U.S.?

According to the CDC in 1999, rotavirus was causing 20 to 40 infant deaths annually in the US when the first rotavirus vaccine, RotaShield, was introduced. It was estimated that about 50,000 hospitalizations occurred in the US because of severe diarrhea and dehydration.

Today, even though almost all US infants receive vaccines for rotavirus, and despite efforts to improve the management of childhood rotavirus-associated diarrhea, hospitalizations of children in the U.S. with the disease have not significantly declined in the past two decades: the CDC says rotavirus infection is still responsible for an estimated 400,000 doctor visits; more than 200,000 emergency room visits; and 55,000 to 70,000 hospitalizations in the US.

The CDC also says that 20 to 60 infant deaths now die every year in the US due to rotavirus infection. The CDC says that children ages 6 months to 24 months old are most at risk for serious complications or death from rotavirus, when supportive treatment, or re-hydration, is not given during the illness.

In another report by the CDC, health officials note that since the introduction of the RotaTeq vaccine in 2006, “the 2007--08 and 2008--09 rotavirus seasons were shorter, later, and characterized by substantially fewer positive rotavirus test results, compared with median data for 2000--2006 from a national network of sentinel laboratories.”

This same report also said, “Further study is needed to characterize the contribution of routine rotavirus childhood vaccination, herd immunity, provider testing patterns, or other factors.”

What Is the Incidence of Rotavirus in the Rest of the World?
According to the CDC, in developing countries, rotavirus is a major cause of childhood deaths, causing more than a 527,000 deaths each year in children younger than 5 years old, mostly in developing countries.

What is the Rotavirus Vaccine?

Two rotavirus vaccines have been approved for use in the US. These vaccines differ in how they are made and in the number of doses prescribed when they are given. Both are given orally and contain genetically engineered live attenuated human rotavirus strains or hybrid human-bovine reassortment rotavirus strains.

About RotaTeq® Vaccine in Brief

NEWS ALERT:  On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2.  To date the vaccine manufactuer, Merck, has not given any information regarding if, or when, PCV1 and PCV2 will be removed from this vaccine.  Although PCV1 has not been associated with clinical disease in pigs, PCV2 is a lethal pig virus that causes immune suppression and a serious wasting disease in baby pigs that damages lungs, kidneys, the reproductive system, brain and ultimately causes death.  The FDA recommended temorpary suspension of the use of Rotarix vaccine on March 22nd after DNA from PCV1 was identified in Rotarix, but did not call for suspension of the use of RotaTeq vaccine after PCV2 was found in RotaTeq.  On June 1st, NVIC called on Merck to volunartarily withdraw RotaTeq from the market until PCV2, especially, is removed from the vaccine.
RotaTeq vaccine is manufactured by Merck and was licensed by the FDA in 2006. Description: RotaTeq is a genetically engineered vaccine made of live, attenuated human-bovine hybridized reassortant rotaviruses. Other ingredients include sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. It does not contain preservatives.

Schedule:RotaTeq is administered at 2, 4, and 6 months of age. The CDC advocates giving the rotavirus vaccine at the same time as other childhood vaccines.


NVIC NOTE: There are some doctors who either administer vaccines singly or limit the numbers of vaccines given simultaneously on the same day. If you want your baby to receive fewer vaccines on the same day and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

  • Estimated Effectiveness: RotaTeq will not prevent diarrhea or vomiting caused by viruses other than rotavirus. Studies indicate RotaTeq will prevent about 74 percent of rotavirus cases, about 98 percent of severe cases, and about 96 percent of hospitalizations due to rotavirus.

  • According to the vaccine package insert, RotaTeq may not protect all vaccine recipients against rotavirus.
  • Commonly Reported Reactions: Diarrhea, vomiting, irritability, otitis media (inflammation of the middle ear), nasopharyngitis (inflammation of the nasal passages and cold-like symptoms), and bronchospasm (asthma and bronchitis-like symptoms).
  • More Serious Reported Reactions: Intussusception (bowel blockage) and Kawasaki Disease (inflammation of the blood vessels)

About Rotarix® Vaccine in Brief

NEWS ALERT: On March 22, 2010 the FDA announced that components of an extraneous virus have been found in Rotarix vaccine. The FDA stated that “FDA is recommending that healthcare practitioners temporarily suspend use” of Rotarix vaccine in the U.S. “while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk. The agency recently became aware that an independent US academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals.”  On May 7th, a special meeting of the Vaccines  Related Biological Products and Advisory Committee (VRBPAC) was held to discuss rotavirus vaccine contamination.  Rotarix vaccine manufacturer, GlaxoSmithKline, pledged at the May 7th meeting to reformulate Rotarix and remove PCV1 DNA from the vaccine.  On May 14th, the FDA withdrew the recommendation for suspension of the use of Rotarix vaccine.  No date was given for when Rotarix will be free from contamination from PCV1 DNA.

Rotarix vaccine is manufactured by GlaxoSmithKline and was licensed by the FDA in 2008.

  • Description:Rotarix is a genetically engineered vaccine made of live attenuated human rotaviruses. Other ingredients include: amino acids, dextran, sorbitol, sucrose, and Dulbecco’s Modified Eagle Medium (DMEM). DMEM contains sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red.
  • The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. There is no preservative in Rotarix.
  • Schedule:Rotarix is administered at 2 and 4 months of age. The CDC advocates giving the rotavirus vaccine at the same time as other childhood vaccines.

NVIC NOTE: There are some doctors who either administer vaccines singly or limit the numbers of vaccines given simultaneously on the same day. If you want your baby to receive fewer vaccines on the same day and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.
Estimated Effectiveness: According to a study reported in the New England Journal of Medicine, the efficacy of Rotarix against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis.
Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001).

  • Commonly Reported Reactions: temporary diarrhea, fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
  • More Serious Reported Reactions: ear infection, pneumonia

Also, according to the Rotarix package insert: Since FDA approval, reports of infants with intussusception have been received by Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred.

Other reported side effects include: Kawasaki disease (a serious condition involving inflammation of the blood vessels that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands, and feet and, if not treated, death can occur).

Who Does the Advisory Committee on Immunization Practices (ACIP) Recommend Take This Vaccine?
ACIP provides recommendations for use of a rotavirus vaccine  to be administered to all infants in a 2-dose series at ages 2 and 4 months. For more information on ACIP recommendations, visit the CDC website here.

Is the Rotavirus Vaccine Mandated in State Vaccine Laws?
A state-by-state inquiry by NVIC found that, although the rotavirus vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP), it is not mandated in any state – yet.
However, some states have been adding this vaccine as a prerequisite to enrolling in infant childcare facilities. According to the CDC and the vaccine manufacturer package inserts, if a child has not had rotavirus vaccine by 32 months of age, then he/she should not get it at all.

Also, according to the CDC and the Advisory Committee on Immunization Practices (ACIP), vaccination should not be initiated on infants older than 12 weeks because of insufficient data on safety of the first dose of rotavirus vaccine in older infants.

For more information about which vaccines your state requires, go here on the NVIC website.

Should Rotavirus Vaccine Be Mandated?

While the National Vaccine Information Center (NVIC) supports the availability of rotavirus vaccine for all who wish to exercise fully informed and voluntary consent to administer the vaccine to their children, NVIC opposes laws requiring parents without their voluntary consent to give their babies rotavirus vaccine to attend daycare or pre-school for the following reasons:

  • All vaccines only provide temporary immunity and can fail to provide even temporary immunity for some children.
  • Most babies experience infection with several strains of rotavirus in the first years of life and develop antibodies that lead to natural, lifelong immunity to the infection.
  • In the U.S., rotavirus infection very rarely leads to serious complications or death if appropriate medical care, including re-hydration and nutrition support, is given.
  • Rotavirus vaccine is a pharmaceutical product and, like all pharmaceutical products, rotavirus vaccine has been associated with serious side effects. There are few ways to predict which babies are at higher risk than others for suffering a life threatening or fatal reaction to rotavirus vaccination.
  • Informed consent to medical risk taking is a human right  Laws requiring  vaccination, especially in states that do not allow citizens to exercise exemptions to vaccination free from societal sanctions, is a violation of  the right to exercise informed consent to medical risk taking.

Who Should NOT Get the Rotavirus Vaccine?

According to the Rotarix vaccine manufacturer package inserts, your baby should NOT get Rotarix if he or she:

  • has had an allergic reaction after getting a dose of Rotarix
  • is allergic to any of the ingredients in this vaccine
  • A doctor has told you that your baby’s digestive system is not normal.

According to the RotaTeq vaccine package insert, your baby should NOT get RotaTeq if he or she:

  • has shown hypersensitivity (allergic reaction) after receiving a dose of RotaTeq
  • is allergic to any component in the vaccine
  • has a severe combined immunodeficiency disease (SCID)

Also, according to the RotaTeq manufacturer package insert, there is insufficient data to support giving RotaTeq to babies with indeterminate HIV status who are born to mothers with HIV/AIDS.

Additionally, the RotaTeq package insert says that there is no safety or efficacy clinical data on the administration of RotaTeq to babies who are potentially immunocompromised, including:

  • Infants with blood dyscrasias, leukemia, lymphomas of any type, or malignant neoplasms affecting the bone marrow or lymphatic system
  • Infants on immunosuppressive therapy
  • Infants with primary and acquired immunodeficiency states, including HIV/AIDS, cellular immune deficiencies, and hypogammaglobulinemic and dysgammaglobulinemic states.
  • Infants who have received a blood transfusion or blood products within 42 days

This is what the CDC has to say about who should NOT get a rotavirus vaccine:

Infants with a severe allergy to latex should NOT get Rotarix, which has latex rubber in its oral applicator. Also, according to the CDC, some babies should NOT get rotavirus vaccine or should wait, including

  1. A baby who has had a previous severe (life-threatening) allergic reaction to a dose of rotavirus vaccine should not get another dose. A baby who has a severe (life threatening) allergy to any component of rotavirus vaccine should not get the vaccine. Tell your doctor if your baby has any severe allergies that you know of, including a severe allergy to latex.
  2. Babies who are moderately or severely ill at the time the vaccination is scheduled should probably wait until they recover. This includes babies who have moderate or severe diarrhea or vomiting. Ask your doctor or nurse.

NVIC NOTE: Some doctors only vaccinate babies who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting with or more other trusted health care professionals before vaccinating.  

  1. Babies who have had intussusception (bowel obstruction and collapse) from any cause are at higher risk for getting it again. If your baby has ever had a bowel obstruction, be sure to tell your doctor.

Check with your doctor if your baby’s immune system is weakened because of:

  • HIV/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

The CDC also has issued these PRECAUTIONS about rotavirus vaccine:

  • Altered Immunocompetence – Practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence; consultation with an immunologist or infectious diseases specialist is advised.

Children and adults who are immunocompromised because of congenital immunodeficiency, hematopoetic transplantation, or solid organ transplantation sometimes experience severe, prolonged and even fatal rotavirus gastroenteritis.

The CDC also states that NO safety or efficacy data are available for the administration of rotavirus vaccine to infants who are potentially immunocompromised, including

  • Infants with primary and acquired immunodeficiency states, including cellular immunodeficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.
  • Infants with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system
  • Infants on immunosuppressive therapy (including high dose systemic corticosteroids);
  • Infants who are HIV-exposed or infected. (Even though there is no safety or efficacy data available for the administration of rotavirus vaccine to infants who are HIV exposed infected,  the CDC says that the following considerations support vaccination of HIV-exposed or infected infants because:
  •  (1) the HIV diagnosis may not be established in infants born to HIV-infected mothers before the age of the first rotavirus vaccine dose; only 1.5 to 3 percent of HIV-exposed infants in the US will be determined to be HIV-infected; and
  • (2) vaccine strains of rotavirus are considerably attenuated).

NVIC Note: Some doctors only vaccinate children who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

  • Acute Gastroenteritis – According to the CDC, rotavirus vaccine should not be administered to babies with acute, moderate to severe gastroenteritis until the condition improves. However, the CDC says that infants with mild acute gastroenteritis can be vaccinated, particularly if the delay in vaccination might be substantial and might make the child ineligible to receive vaccine (e.g., aged ≥15 weeks 0 days before the vaccine series is started).

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

The CDC also states that rotavirus vaccine has not been studied among infants with concurrent acute gastroenteritis. In these infants, the immunogenicity and efficacy of rotavirus vaccine can theoretically be compromised. For example, infants who receive oral poliovirus vaccine (OPV) during an episode of acute gastroenteritis in some circumstances have diminished poliovirus antibody responses.

  • Moderate to Severe Illness – As with all other vaccines, the CDC states that presence of a moderate or severe acute illness with or without fever is a precaution to administration of rotavirus vaccine.

The CDC also advises that infants with a moderate to severe acute illness should be vaccinated as soon as they have recovered from the acute phase of the illness.

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick at the time of vaccination with a coinciding viral or bacterial infection. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

  • Preexisting Chronic Gastrointestinal Disease – The CDC states that infants with preexisting gastrointestinal conditions (e.g., congenital malabsorption syndromes, Hirschsprung’s disease, short-gut syndrome) who are not undergoing immunosuppressive therapy could benefit from rotavirus vaccine vaccination, and ACIP considers the benefits to outweigh the theoretical risks.

However, the CDC also states there are no data are available on the safety and efficacy of rotavirus vaccine for infants with preexisting chronic gastrointestinal disease.

  • Previous History of Intussusception – The CDC states that practitioners should consider the potential risks and benefits of administering rotavirus vaccine to infants with a previous history of intussusception.

According to CDC, infants with a history of intussusception are at higher risk for a repeat episode of intussusception compared to those who have never had intussusception

How Effective Is the Rotavirus Vaccine?

According to the RotaTeq package insert RotaTeq may not protect all vaccine recipients against rotavirus.

According to the Rotarix package insert, the efficacy of this vaccine in clinical trials ranged from 71.9 percent to 10 percent, depending on the trial location and the severity/type of rotavirus. The average efficacy was 95 percent.

The package insert also says that safety and effectiveness of Rotarix in infants with chronic gastrointestinal disorders have not been evaluated.

According to the CDC, most babies who get vaccinated with RotaTeq® or Rotarix® will not get diarrhea from rotavirus, and almost all of them will be protected from severe diarrhea caused by rotavirus. The CDC says this means that babies who get vaccinated are much less likely to be hospitalized or to see a doctor because of diarrhea from rotavirus.

The CDC advocates giving the rotavirus vaccines at the same time as other childhood vaccines, usually at 2, 4 or 6 months. 

NVIC NOTE: There are some doctors who either administer vaccines singly or limit the numbers of vaccines given simultaneously on the same day. If you want your baby to receive fewer vaccines on the same day but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating. 

In March 2008, the CDC said in this press release that rotavirus activity for 2007-2008 appeared to be less severe than in previous seasons, and that the vaccine possibly could have helped bring rotavirus numbers down.

The FDA reports that in clinical studies, RotaTeq prevented 74 percent of all rotavirus gastroenteritis cases and nearly all of the severe cases. The vaccine also prevented about 96 percent of hospitalizations.

Can the Rotavirus Vaccine Cause Injury and/or Death?

Vaccines are pharmaceutical products and, like all pharmaceutical products, carry a biological risk of injury or death that can be greater for some than others. The risk for injury or death from vaccination depends upon the vaccine or vaccines given and the individual’s health at time of vaccination, vaccine reaction history, and personal or family medical history.

There is a gap in medical knowledge in terms of predicting who will have an adverse reaction to vaccination, including reactions to the rotavirus vaccine, and who will not.

However, reading the vaccine manufacturers’ package inserts (see below) under “contraindications, warnings and precautions, and adverse reactions,” will help you weigh the vaccine’s benefits and risks before making a decision for your child.

 According to the CDC, the new rotavirus vaccines do not appear to cause serious side effects in most babies, even though the FDA issued a Public Health Notification* on one of the vaccines, RotaTeq, in 2007 (see reference below).

It is important to remember that the CDC also says that “reactions can occur with any new product, and that they may not be identified until thousands or millions of people have used it,” and that, “like all vaccines, rotavirus vaccine will continue to be monitored for unusual or severe problems.”

Special Reported Vaccine Risk Issues with RotaTeq and Rotarix:

RotaShield Vaccine Withdrawal

In 1999, the first rotavirus vaccine called RotaShield (a live genetically engineered human-rhesus monkey reassortment vaccine) was voluntarily withdrawn from the market by the manufacturer.

The withdrawal came after a CDC analysis of adverse event reports to the Vaccine Adverse Event Reporting System (VAERS) raised a red flag. The CDC found that there was an increase in reports of intussusception (a type of bowel obstruction that occurs when the bowel folds in on itself) and other gastrointestinal disorders among infants who had received RotaShield.

RotaTeq Vaccine FDA Advisory

In February 2007, the FDA issued a Public Health Notification on RotaTeq after a review of VAERS data revealed 28 confirmed reports of intussusception after RotaTeq vaccination:
The reported 28 cases occurred after dose 1, dose 2 and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days.

Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported.
Then, in March 2007, the CDC apparently reversed the FDA’s observation by issuing a new statement. A portion of the new statement says:

“Postmarketing surveillance data available to date do not suggest that RotaTeq is associated with intussusceptions. The reported number of VAERS intussusception cases among infants vaccinated with RotaTeq does not exceed the number of expected background cases.”

In June 2007, the FDA approved a label change for Rota Teq by Merck to include Kawaski syndrome (inflammation of the blood vessels) occurring in five case before the vaccine’s licensure, and three after the licensure. An additional unconfirmed case was found in the Vaccine Safety Datalink project.

Despite the additional information, the CDC and FDA continued to stress the safety of Rota Teq.

However, a 2008 Medical News Today press release announcing that Rota Teq had received pre-qualification status by the World Health Organization, manufacturer information said:

In post-marketing experience, intussusception (including death) and Kawasaki Disease have been reported in temporal association with ROTATEQ.

Although the new statement issued by the CDC in 2007 said that it was not possible to know how many cases of intussusceptions were caused naturally and how many might have been caused by the vaccine, it is important to remember that CDC officials used estimates based on the number of RotaTeq doses distributed to assume the number of RotaTeq doses actually administered.

Recognizing the possibility that “estimates” could skew the data and objectivity of the CDC’s conclusions, the CDC added this caveat to the March 2007 statement:
“The findings in this report are subject to at least two additional limitations. First, the proportion of distributed doses of RotaTeq that had been administered could not be determined. If the number of doses administered was overestimated, the expected background number of cases would decrease and the potential for an association between vaccine and risk for intussusception would increase.

“Second, although the most robust data available were used to estimate background rates for intussusception hospitalizations, the accuracy and completeness of these data have not been verified.

“A preliminary study suggests that hospital discharge diagnoses might not include some intussusception cases, such as those managed in non-inpatient settings (e.g., emergency departments, short-stay units, or 23-hour observation units) (9); thus, the background incidence of intussusception might have been underestimated.
“In addition, electronically coded data on intussusception might not represent true cases (10). The likelihood of finding an association between vaccine and intussusception might increase or decrease depending on the effect of these factors.”

Because of a possible link between RotaTeq and intussusception, the DHHS Advisory Commission on Childhood Vaccines (ACCV), in its March 2008 meeting, recommended that RotaTeq be included on the CDC’s Rapid Cycle Analysis (RCA) surveillance system.

The goal of an RCA is to monitor adverse events following vaccination (possible side effects) in near real time, so the public can be informed quickly of possible risks. For more information on RCA’s, go to the CDC’s RCA website here.

Also, in October 2009, the CDC approved a label change for RotaTeq to include information on reports of Kawasaki Syndrome (inflammation of the blood vessels) in infants who get RotaTeq. The label change did not affect the CDC’s vaccination policy or schedule regarding RotaTeq.

What Does the RotaTeq Manufacturer Say?

   According to the Merck manufacturer product information package insert, there is:

No safety or efficacy data available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised 

No safety or efficacy data available for the administration of RotaTeq to infants with a history of gastrointestinal disorders (e.g., active acute gastrointestinal illness, chronic diarrhea, failure
to thrive, history of congenital abdominal disorders, abdominal surgery and intussusception).

Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

Also according to the package insert, safety and efficacy of RotaTeq have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

Rotarix Vaccine Pre-Licensure Clinical Trials Questions & 2010 Suspension

Rotarix Vaccine was licensed in 2008 and, by February 2010, no increase in numbers of cases of intussusception had been reported after use of Rotarix vaccine.

According to the CDC, babies may be slightly more likely to be irritable, or to have mild, temporary diarrhea or vomiting and ear infection after getting a dose of rotavirus vaccine than babies who did not get the vaccine.

Serious adverse events reported after Rotarix vaccination have included bronchitis, pneumonia, convulsions and death.

In clinical settings, Rotarix’s manufacturer, GlaxoSmithKline, reported other adverse events such as fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.

During the the FDA approval process for Rotarix in 2008, the consumer member of the FDA Vaccines and Related Biological Products Advisory Committee, NVIC Director of Research & Patient Safety, Vicky Debold, PhD, RN maintained that the safety of Rotarix vaccine had not been adequately proven in pre-licensure clinical trials. 

Debold noted that there were more deaths among the healthy infants who received Rotarix compared to those who received a placebo.

She also pointed out that the clinical trials did not include premature, sick and otherwise biologically compromised infants, and asked the committee, "What is going to happen when this vaccine is given to children in the real world?"

An FDA staff report analyzing GSK pre-licensure clinicial trial data also revealed a statistically significant increase in deaths related to pneumonia among infants who got Rotarix versus the placebo.

NEWS ALERT: On March 22, 2010 the FDA announced that components of an extraneous virus have been found in Rotarix vaccine. The FDA stated that “FDA is recommending that healthcare practitioners temporarily suspend use” of Rotarix vaccine in the U.S. “while the agency learns more about components of an extraneous virus detected in the vaccine. There is no evidence at this time that this finding poses a safety risk. The agency recently became aware that an independent US academic research team, using a novel technique, has found DNA from porcine circovirus 1 (PCV1) in Rotarix. PCV1 is not known to cause illness in humans or other animals.”

What Does the Rotarix® Vaccine Manufacturer Say?

According to the Rotarix package insert:

  • Safety and effectiveness in infants with known primary or secondary immunodeficiencies have not been evaluated.
  • Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated.
  • Safety and effectiveness in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.

Can Live Rotavirus Vaccine Transmit Vaccine Strain Virus?

Yes, the rotavirus vaccine manufacturers acknowledge it is possible to transmit the vaccine strain rotavirus to others who come in close contact with a recently vaccinated child.

The GlaxoSmithKline manufacturer product information insert for Rotarix states:

 “There is a possibility that the live vaccine virus can be transmitted to non-vaccinated contacts. The potential for transmission of vaccine virus following vaccination should be weighed against the possibility of acquiring and transmitting natural rotavirus.”

Merck’s RotaTeq product information insert contains nearly the same language:

“RotaTeq is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.”

For more information on how the CDC monitors vaccine safety issues, visit the CDC safety website here.

Traditional Preventive Health Approaches

The best defense against transmission of infectious disease, including natural and live vaccine strain rotavirus infection, is sanitation and cleanliness. Washing your hands after changing your baby’s diaper; keeping the changing table clean by washing it with soap and hot water; and disposing of baby diapers promptly in a secure container are all sanitation measures that can help prevent transmission of natural or vaccine strain live virus through contact with body waste products.

Whether you choose to vaccinate for rotavirus, or not, if your child is in daycare, make sure that your daycare provider maintains the highest standards of cleanliness. As your child grows up, you can emphasize the importance of hand washing and not sharing eating utensils and drinking cups.

Vaccine Cost Effectiveness:  

Universal use of rotavirus vaccine by all infants living in the U.S. costs as much or more than notusing the vaccine on a mass basis according to a study reported to the FDA in 2007 – and that conclusion is assuming 100 percent effectiveness and no vaccine adverse events. 

Read the Manufacturer Product Information Package Inserts:

What is a Vaccine Information Statement (VIS)?

Vaccine Information Statements (VIS) are created by federal health officials at the  Centers for Disease Control in accordance with vaccine safety provisions in the National Childhood Vaccine Injury Act of 1986.

They are printed information sheets that briefly describe diseases and vaccines, and are mandated by federal law to be given to a person receiving a government recommended or mandated vaccine, or to the parent or legal guardian of that person beforeadministration of the vaccine(s).

Why Do I Need to Read Both the Vaccine Manufacturer Product Information Package Insert and the Vaccine Information Statement Before I Make a Vaccine Decision?

Vaccine Information Statements are just one or two pages long and do not contain the detail that manufacturer product information package inserts do.

Reading the package insert will help you learn exactly what components, including preservatives, adjuvants and other additives, are contained in the vaccine and how the vaccine is made.

The package insert will also give you more complete information about (1) reported adverse health outcomes, including injuries and deaths reported in pre-licensure clinical trials and post-marketing surveillance; and (2) reasons why your child should not use a particular vaccine (contraindication) according to the vaccine’s manufacturer.

You can ask your physician (or vaccine administrator) for the manufacturer product information package insert and the CDC’s Vaccine Information Statement (VIS) in advance of the date your child is scheduled to be vaccinated. You can also read the manufacturer product information inserts for rotavirus vaccine here on NVIC.org.

To Read the Rotavirus Vaccine VIS Statements Prepared by the CDC, click here.

Read the Vaccine Information Statement for Combined Vaccines here (since the rotavirus vaccine is sometimes given in combination with other vaccines).

Report a Rotavirus Vaccine Reaction to the Government Vaccine Adverse Events Reporting System (VAERS)

Search VAERS Vaccine Adverse Event Reports on MedAlerts Database

Report a Rotavirus Vaccine Reaction to NVIC

Report Harassment by Doctors, Health or School Officials 

Has your doctor or a vaccine provider refused to report a serious health problem after rotavirus vaccination to the federal Vaccine Adverse Event Reporting System (VAERS), or discouraged you from reporting a vaccine reaction you or your child experienced?

Have you been threatened or harassed for making vaccine decisions which do not conform with government recommendations or state mandates?

NVIC supports your right to make informed, voluntary health care decisions. Report harassment for making informed vaccination choices here.

NVIC Press Releases, Reports & Commentaries:

 

REFERENCE SOURCES FOR THIS PAGE: 

CENTERS FOR DISEASE CONTROL

FOOD AND DRUG ADMINISTRATION

MEDICAL LITERATURE

MEDICAL ORGANIZATIONS AND UNIVERSITIES

HEALTH INFORMATION WEBSITES

MEDIA REPORTS




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