Disease & Vaccine Information

Rotavirus Overview



rotavirus

Rotavirus

The rotavirus is a very contagious RNA virus that belongs to the Reoviridae family, and is thought to be the most common cause of severe diarrhea among children worldwide.  Laboratory testing is required to confirm a diagnosis of rotavirus  and most cases occur in children ages three to 35 months; however older children and adults can still develop the infection. 

Virtually all children become infected with rotavirus in the first five years of life. Infants younger than three months of age 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.  The virus spreads when individuals come into contact with an infected person’s body fluids or feces, or items that have been in contact with the feces of an infected person.  Click to learn more about Rotavirus…

Rotavirus Vaccine

There are two FDA approved oral rotavirus vaccines available for use in the United States and are approved for use in infants between the ages of six and 24 weeks. Both vaccines contain genetically engineered live attenuated human rotavirus strains, but differ in how they are made and in the number of doses prescribed when they are given. Both vaccines are live virus vaccines and transmission of vaccine virus has been reported from vaccine recipients to non-vaccinated contacts. These vaccines have not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.    Click to learn more about Rotavirus vaccines…

Quick Facts
Rotavirus
  • 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. 
  • By 1980, the CDC had declared rotavirus to be the most frequent cause of serious gastrointestinal illness in infants and toddlers and estimated that the virus caused between 20 and 60 deaths annually in the United States. The infection, however, has never been a nationally notifiable disease, therefore it is not known how many cases actually occur each year. 

Rotavirus Vaccine

  • Common side effects from the rotavirus vaccines include 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). Reported serious adverse reactions following rotavirus vaccination include intussusception (bowel blockage), Kawasaki Disease (inflammation of the blood vessels), ear infection and pneumonia.   
  • Contraindications to vaccination include severe allergic reaction (anaphylaxis) to vaccine or vaccine component, history of intussusception, and Severe combined immunodeficiency (SCID). 

Click to read more Quick Facts…

Learn More About Rotavirus and Rotavirus Vaccine

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

What is Rotovirus?

rotavirus

The rotavirus is a nonenveloped RNA virus that belongs to the Reoviridae family. According to the World Health Organization (WHO), rotaviruses are the most common cause of severe diarrhea among children worldwide. 

Most cases of rotavirus occur in children ages three to 35 months; however older children and adults can still develop the infection.  Virtually all children become infected with rotavirus in the first five years of life. Infants younger than three months of age 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. 

Rotavirus is very contagious. The virus spreads when individuals come into contact with an infected person’s body fluids or feces, or items that have been in contact with the feces of an infected person.   The incubation period for rotavirus disease is approximately two days. Primary symptoms include vomiting and watery diarrhea for three to eight days. Fever, abdominal pain, and loss of appetite occur frequently. 

The virus can live for hours on hands and for days on hard surfaces. It is also very resistant to most disinfectants. In non-tropical climates like the U.S., rotavirus infections are more likely to occur in the colder winter months than in the summer. 

Laboratory testing is required to confirm a diagnosis of rotavirus because clinical symptoms of the illness are similar to those caused by other pathogens. 

It is possible to have rotavirus infection more than once since neither the vaccine or natural infection confers full immunity to all strains of the virus.  Symptoms on re-exposure to the disease are usually less severe because each additional exposure strengthens immunity. 

Ensuring adequate hydration of a child with rotavirus infection is important to prevent dehydration – the most frequent complication of the illness. Symptoms of dehydration include crying without tears, dry mouth, decreased urine output, excessive sleepiness or irritability, and dizziness.  If dehydration occurs, it may be necessary for the child to be hospitalized for treatment with intravenous (IV) fluids. Severe dehydration can lead to shock, convulsions, and even death. 

In 2013, rotavirus illness was estimated to cause 215,000 deaths globally, and most deaths occurred in developing countries.  This death rate has significantly decreased from the estimated 528,000 rotavirus-associated deaths that occurred in 2000. 

Strains of rotavirus can infect both humans or animals, such as cows, sheep and monkeys, but animal rotaviruses differ from human ones, and rarely cause infection in humans.  Worldwide, over 60 different strains of rotavirus have been identified.  Additionally, certain strains found in the RotaTeq vaccine have reassorted to become vaccine-derived strains capable of causing gastrointestinal illness. This reassortment has been found to occur in one to three percent of rotavirus cases that have been sequenced. 

The virus is made up of three shells that contain 11 gene segments. There are two proteins on the outermost shell that confirm the serotype of the virus – VP4, or the P-protein, and VP7, or the G-protein. 

There are six G- and P-protein combination viruses that are most commonly found in the U.S. -  P[4] G2, P[6] G9, P[8] G3, P[8]G1, P[8] G4, and P[8] G9; however, in recent years, P[8]G12[26] has emerged as a cause of serious rotavirus infection in the U.S. and abroad. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Is Rotavirus contagious?

rotavirus

Rotavirus is very contagious. The virus is primarily spread through the fecal-oral route and can be transmitted through person to person contact or through contact with items that are contaminated with infected feces. Transmission of the virus through contaminated food or water is not frequently seen.  Anyone can become infected with rotavirus, but most cases occur in children ages three to 35 months old. Nearly all children will be infected by the age of five. 

The virus can be found in the stool up to 2 days prior to the onset of diarrhea and can still be present for up to ten days after the initial symptoms. Immunocompromised individuals may have the virus present in their stool for more than a month. 

According to the CDC, after one rotavirus infection, 38 percent of children will not have a second rotavirus infection, 77 percent will be protected against rotavirus diarrhea, and 87 percent will be protected against severe diarrhea. Any subsequent rotavirus infections will be less severe that the initial one. 

The virus can live for hours on hands and for days on hard surfaces. It is also very resistant to most disinfectants. In non-tropical climates such as the U.S., rotavirus infections occur more frequently during the fall and winter. Infections in tropical climates have a less seasonal pattern. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What is the History of Rotavirus in America and Other Countries?

rotavirus

While diarrheal infections have always been present, identification of the rotavirus as one cause of the illness was only recently discovered. In 1973, a team of Australian researchers examining the intestinal tissues and feces of children with diarrhea through electron micrography discovered the presence of a novel wheel-shaped virus fragment. This virus was given the name “rotavirus” after the Latin word for wheel - rota.   

By 1980, the CDC had declared rotavirus to be the most frequent cause of serious gastrointestinal illness in infants and toddlers and estimated that the virus caused between 20 and 60 deaths annually in the United States. It was also estimated to cause 400,000 physician visits, 200,000 emergency room visits, and between 55,000 and 70,000 hospitalizations.  The infection, however, was not, and still is not, a nationally notifiable disease, therefore the exact numbers of infections and deaths from rotavirus are not known. 

It was also noted in 1980 that most infants developed the illness during the winter months in non-tropical regions. Many cases of rotavirus were also preceded by respiratory symptoms which included nasal congestion, cough, and ear infections. Vomiting was found to occur prior to the onset of diarrhea, and when infants and children were given only clear fluids, vomiting ceased within 24 hours. Researchers also reported that while gastrointestinal illnesses were common, deaths were rare. In 1980, it was still not known exactly how the virus was spread but it was assumed that this occurred through the fecal-oral route. Transmission through respiratory droplets was also suspected; however, scientists had been unable to isolate the virus in the respiratory tract. 

By 1983, researchers were still uncertain about the prevalence of the virus in the environment, and the incidence of infections in communities. They were also not sure how long the virus could persist in the environment, and whether it was readily transmitted through food, water, air, or additional sources. Research priorities included the development of a test that could rapidly identify the specific virus, the establishment of a universal classification for each group and type of rotavirus, and the development of a vaccine against the virus. 

The most common serotypes of rotavirus were noted to be G1, G2, G3, and G4 and they accounted for more than 80 percent of all human rotavirus strains. 

In January of 1989, the CDC established the National Rotavirus Surveillance System (NRSS) to collect data on rotavirus incidence and epidemiology. The surveillance system consisted of 99 laboratories who began providing data on confirmation of rotavirus. For a 23-month period, from January 1989 to November 1990, only 20 percent of the over 48,000 samples collected were positive for rotavirus. During the data collection period, rotavirus occurred most frequently in February and least often in October. Researchers also noted that approximately 500 children died each year from diarrheal disease and estimated that 20 percent of these deaths were attributable to rotavirus. Health officials also reported that hospitalizations and deaths from rotavirus were preventable by aggressive oral hydration – but stated that this strategy was under-utilized. 

By 1992, public health officials reported that rotavirus infections began in western states in November and reached its peak in December and January; however, in eastern states, rotavirus activity began in January and peaked in February and March.  They had no explanation for this occurrence as it was not tied to rotavirus strain variation. 

Between 1986 and 1999, published studies reported that approximately 22 percent of childhood diarrhea hospitalizations were due to rotavirus. Globally, 440,000 yearly rotavirus deaths in children under the age of 5 were estimated. However, this was noted to be a significant decrease from 1985, when approximately 873,000 infants were estimated to die from the illness. 

Rotavirus serotype G9 was first detected in the United States in 1987 and by 1995, it was believed to be the fifth most common serotype and was found in multiple countries including India, Brazil, Italy, and more. 

Rotavirus Vaccine Introduced

On August 31st, 1998, the first vaccine targeting rotavirus, RotaShield, received FDA approval for use in children. At this time, health officials estimated that 2.7 million children under the age of five developed the illness each year, which resulted in 50,000 hospitalizations and 500,000 physician appointments. The rates were reported to be much higher in developing countries, with public health officials estimating that the virus caused about 800,000 deaths each year.

The approved reassortant (mix of genetic material from different species) vaccine, a tetravalent rhesus-human reassortant rotavirus vaccine (RRV-TV) contained a rhesus monkey rotavirus with serotype G3 specificity and reassortant rhesus-human rotaviruses with G1, G2, and G4  specificity to target the four common serotypes of rotavirus. The vaccine was reported to be between 49 and 68 percent effective against any rotavirus diarrhea and between 61 and 100 percent effective against severe rotavirus diarrhea. 

At the time of the vaccine’s recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP), it was noted that few cases of rotavirus occurred in infants younger than 3 months of age, while infants and children between four and 36 months were most affected. Rotavirus was rarely symptomatic in adults; however, it was still found at times to cause illness in parents of children with the infection, those with immunocompromising conditions, travelers to underdeveloped countries, and the elderly. 

RotaShield Vaccine Suspended

By the spring of 1999, however, several reports of intussusception following RotaShield vaccine administration had been made to the Vaccine Adverse Events Reporting System (VAERS) and on July 16, 1999, the CDC announced that it was suspending its recommendation of RotaShield due to the increasing number of reported intussusception cases.    Later that year, at the CDC’s October ACIP meeting, the committee voted to withdraw its recommendation in light of evidence which found that intussusception occurred in one out of every 5,000 infants who received the vaccine.   

RotaTeq Vaccine Introduced

In 2006, when RotaTeq, the second oral live rotavirus vaccine received approval for use in the United States, the most common rotavirus serotypes were P1A[8]G1, P1B[4] G2, P1A[8] G3, P1A[8] G4, P1A[8] G9,and P2A[6] G9. It was reported that in infants between three and 35 months of age, the first rotavirus infection would likely be the most severe and 40 percent of children would not have any further rotavirus infections. Seventy-five percent of children would be protected against subsequent rotavirus gastroenteritis, and 88 percent would be protected against subsequent severe rotavirus gastroenteritis. The initial first natural infection was reported to protect an infant against severe rotavirus gastroenteritis in the future but that asymptomatic or mild infections might still occur. 

These same six distinct rotavirus serotypes were also noted to be the predominant circulating strains in the United States when ROTARIX, the third oral live rotavirus vaccine was recommended for use by ACIP in 2008. 

Surveillance of rotavirus serotypes in the United States following the introduction of RotaTeq found that G3 replaced G1 as the strain most frequently detected and that additional uncommon serotypes had also been detected. Additionally, by the 2007-2008  season, the mean age of rotavirus cases in children less than 3 years had increased significantly. The authors concluded that “These findings underscore the need for careful monitoring of strains to assess possible vaccine pressure-induced changes and vaccine effectiveness against various rotavirus genotypes.” 

G12 rotaviruses were first detected in the Philippines in 1987 among children under the age of two, but then not detected again until 1998. However, since 1998, G12 rotavirus strains have been detected globally.  One of the first outbreaks of G12 rotavirus in the U.S. occurred in Rochester, New York in 2006-2007 and this strain contributed to a 72 percent increase in the number of rotavirus cases. Since this first large outbreak, G12 strains have continued to be detected in the U.S. and abroad.       

Rotavirus Vaccine Shedding

Since the introduction of vaccines targeting rotavirus, vaccine-derived rotavirus strains have also been detected and studies have found that shedding of these viruses do occur and can persist for weeks to months.        Additionally, vaccine strain and vaccine-derived rotaviruses have been found to cause gastrointestinal illness in both immunocompromised and immunocompetent infants.       

While rotavirus gastroenteritis has decreased following the introduction of RotaTeq and ROTARIX vaccines, norovirus gastroenteritis has emerged and is currently the most common cause of gastroenteritis in children.    Norovirus, or Norwalk virus, was first identified in 1929 and initially referred to in the medical literature as “winter vomiting disease”. Symptoms of the illness included nausea, vomiting, diarrhea, stomach cramps and fever. 

Reports of norovirus outbreaks began increasing in 2002  and the CDC currently estimates that norovirus is responsible for 19 to 21 million cases of acute gastroenteritis, 109,000 hospitalizations and 900 deaths annually, with most deaths occurring among the elderly. 

The exact number of rotavirus cases in the U.S. is unknown as the virus is not considered nationally notifiable.  The World Health Organization (WHO) estimates that 215,000 children under age five will die from the illness, with most deaths occurring in developing countries. 
 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can Rotavirus Cause Injury and Death?

rotavirus

Many children infected with rotavirus recover at home and require only oral fluids to replace those lost through vomiting and diarrhea. If severe vomiting occurs, treatment with intravenous (IV) fluids may be necessary to ensure adequate hydration.

Untreated dehydration from loss of fluids and electrolytes can lead to shock, convulsions, and even death.  Symptoms of dehydration include crying without tears, dry mouth, decreased urine output, excessive sleepiness or irritability, and dizziness. 

According to the World Health Organization (WHO), rotaviruses are the most common cause of severe diarrhea among children worldwide. In 2013, rotavirus illness was estimated to cause 215,000 deaths globally, and most deaths from the infection occurred in developing countries. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Getting Rotavirus?

rotavirus

Anyone can become infected with rotavirus; however, infants and young children between three and 35 months of age are at highest risk. By the age of five, most children will have become infected with the virus.  Most infections occur during the winter and spring and infected individuals can spread the virus both before and after developing symptoms. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Suffering from Rotavirus Complications?

rotavirus

Severe dehydration and diarrhea from rotavirus can cause metabolic acidosis and electrolyte imbalances in infants and young children. There is no reliable way to predict who will suffer these serious complications.

Immunocompromised children such as those who have received solid organ or bone marrow transplants, or who suffer from congenital immunodeficiency may be at higher risk for complications. These complications may include severe gastrointestinal illness that persists, and these children may have abnormal findings in several organ systems, including the liver and kidney. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can Rotavirus be Prevented and What are the Treatment Options?

rotavirus

It is very difficult to prevent rotavirus infection because the virus is common in the environment and resistant to most disinfectants and anti-bacterial cleaners. The virus can persist on the hands for several hours and on dry and hard surfaces for days.

Proper handwashing, especially before eating and after using the bathroom or changing diapers, is the best way to reduce the risk of virus transmission.  As the virus can remain on hard and dry surfaces for days, it is also important not to use items that may be contaminated.  

Once infection does occur, treatment includes oral fluid replacement to prevent dehydration. In serious cases, hospitalization and intravenous (IV) fluids may be required.  Rotavirus infections can be fatal if severe dehydration occurs. Deaths from rotavirus usually occur in underdeveloped countries that lack sanitation and access to medical care. 

It is possible to have rotavirus infection more than once since neither the vaccine or natural infection confers full immunity to all strains of the virus.4 According to the CDC, after one rotavirus infection, 38 percent of children will not have a second rotavirus infection, 77 percent will be protected against rotavirus diarrhea, and 87 percent will be protected against severe diarrhea. Any subsequent rotavirus infections will be less severe that the initial one. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What is Rotavirus Vaccine?

rotavirus

There are two FDA approved rotavirus vaccines available for use in the United States. 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 (cow) reassortment rotavirus strains.

About RotaTeq® Vaccine in Brief

  • Ages:  RotaTeq live oral vaccine is approved for use in infants between the ages of six and 32 weeks (see Merck product insert for recommended schedule and other indications.)
  • Description: RotaTeq is a genetically engineered vaccine made of live, attenuated human-bovine hybridized reassortant (mix of genetic material from different species) 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.
  • Estimated Efficacy: 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.
  • Use with other vaccines: In pre-licensing clinical trials, RotaTeq was given simultaneously with DTaP, IPV (polio), hepatitis B, Haemophilus Influenzae Type B (HIB), and pneumococcal conjugate vaccines; however, no information is available on administering RotaTeq with influenza vaccine.
  • Commonly Reported Adverse Events: Vomiting, diarrhea, irritability, fever, otitis media, nasopharyngitis, and bronchospasm.
  • Serious Reported Adverse Events: Intussusception, bronchiolitis, pneumonia, fever, gastroenteritis, urinary tract infection, hematochezia (fresh blood in the stool), seizures, Kawasaki disease, anaphylactic reaction, urticaria, angioedema, and death
  • Contraindications to RotaTeq vaccination:
    • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
    • Severe Combined Immunodeficiency Disease (SCID)
    • A history of intussusception
  • Precautions to RotaTeq vaccination:
    • Infants born to HIV infected mothers unless it has been determined that the infant does not have HIV infection
    • Infants with weakened immune systems
    • Fever greater than 100.5F (38.1C)
    • Current gastrointestinal illness
    • History of rotavirus infection
    • History of gastrointestinal illness and frequent diarrhea
    • Failure to thrive
    • History of stomach problems since birth
    • History of abdominal surgery
    • Receipt of blood or blood products within 42 days
    • Living in a home with individuals who are immunocompromised

RotaTeq is a live virus vaccine and transmission of vaccine virus has been reported from vaccine recipients to non-vaccinated contacts. This vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2.  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 temporary suspension of the use of ROTARIX vaccine on March 22, 2010 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.   To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines. 

About ROTARIX® Vaccine in Brief

  • Ages:  ROTARIX live oral vaccine is approved for use in infants between the ages of six and 24 weeks (see GlaxoSmithKline product insert for recommended schedule and other indications.)
  • 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 prevents its inactivation due to the acidic environment of the stomach.
  • Estimated Efficacy: According to a study published 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).  
  • Use with other vaccines: In pre-licensing clinical trials, ROTARIX was given simultaneously with PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine, Haemophilus Influenzae Type B (HIB), and pneumococcal conjugate vaccines; however, no information is available on administering ROTARIX with influenza vaccine.
  • Commonly Reported Adverse Events: Diarrhea, fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
  • Serious Reported Adverse Events: Intussusception, Kawasaki Disease, hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID), idiopathic thrombocytopenic purpura, convulsions, pneumonia and death.
  • Contraindications to ROTARIX vaccination:
    • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
    • Severe Combined Immunodeficiency Disease (SCID)
    • A history of intussusception
    • A history of uncorrected congenital malformation of the gastrointestinal tract that would make an infant susceptible to intussusception
  • Precautions to ROTARIX vaccination:
    • Current gastrointestinal illness
    • History of rotavirus infection
    • History of gastrointestinal illness and frequent diarrhea
    • Latex sensitivity – the tip caps of the prefilled oral applicators of the diluent contain natural rubber latex
    • Infants with weakened immune systems
    • Living in a home with individuals who are immunocompromised

ROTARIX is a live virus vaccine and transmission of vaccine virus has been reported from vaccine recipients to non-vaccinated contacts. This vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

On March 22, 2010, the FDA announced that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners temporarily suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1; however, they reported that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals.  On May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue.  PCV1 remains a contaminant  of the ROTARIX vaccine. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What is the History of Rotavirus Vaccines in America and Other Countries?

history

Rotavirus vaccine development began soon after the virus was discovered in 1973, and in August 1998, the FDA approved RotaShield, an oral live virus vaccine containing four components (tetravalent) derived from a strain of rhesus monkey rotavirus.  Manufactured by Wyeth-Lederle, the vaccine was approved to be administered in a 3-dose series at about 2, 4, and 6 months.  

RotaShield Clinical Trial Data

Prior to the vaccine’s approval, Dr. Margaret Reynolds of the U.S. Rotavirus Efficacy Group presented information on the U.S. pre-licensing clinical trials at the February 12-13, 1997 CDC Advisory Committee on Immunization Practices (ACIP) meeting. 

In her presentation, Reynolds reported that in the U.S., clinical trials involved 1,278 infants between five and 25 weeks of age and the infants were randomized to receive a placebo, a monovalent vaccine, or the tetravalent rotavirus vaccine (RotaShield). Infants participating in the study were also permitted to receive other routine vaccines and safety was only studied for five days following administration of each vaccine dose. Fever, diarrhea, and vomiting were noted adverse events following vaccine administration, and four vaccine recipients were hospitalized for these symptoms, with one testing positive for rotavirus. All reactions occurred following administration of dose one or dose two, and primarily on day three or four post vaccination. Many infants who participated in the study also experience a runny nose. 

This study reported that the tetravalent rotavirus vaccine had an overall vaccine efficacy against all rotavirus serotypes of 49 percent; however, efficacy rates were reported to be better against severe disease. 

Intussusception, a serious condition where a segment of the intestines slides inside another, was noted in the pre-licensing clinical trials and briefly discussed in the FDA review process; however, members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) chose to ignore the findings and the vaccine was approved for use on August 31, 1998. Additional discussions on intussusception and its association to RotaShield vaccine occurred at the June 1997 and February 1998 ACIP meetings but the panel dismissed any connection. 

Serious Vaccine Reactions Follow RotaShield Vaccine Approval

On March 19, 1999, the CDC published its recommendation on the use of RotaShield vaccine and reported that five cases of intussusception, a serious bowel blockage requiring medical attention, had occurred in infants who had received a rotavirus vaccine in comparison to the one case among placebo recipients. The panel, however, reported this finding to be statistically insignificant. 

By the spring of 1999, several reports of intussusception following RotaShield vaccine administration had been made to the Vaccine Adverse Events Reporting System (VAERS). No mention of safety concerns regarding RotaShield were made at the June 1999 ACIP meeting; however, on July 16, 1999, the CDC announced that it was suspending its recommendation of RotaShield due to the increasing number of intussusception reports.    Later that year, at the CDC’s October ACIP meeting, the committee voted to withdraw its recommendation in light of evidence which found that intussusception occurred in one out of every 5,000 infants who received the vaccine.   

Investigation Reveals Conflicts of Interest in Vaccine Approval Process

In August of 1999, the Committee on Government Reform launched an investigation into Federal vaccine policy as it pertained to possible conflicts of interest among Federal policy-makers.  The Committee focused its investigations on the CDC’s Advisory Committee on Immunization Practices (ACIP) and members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Their investigation found numerous conflicts of interest among members of both committees and raised significant concerns regarding the approval process for vaccines, including the RotaShield vaccine. 

Conflicts identified with VRBPAC included: 

  • Many VRBPAC committee members were found to have significant ties to industry, owned stock, or else received funding from pharmaceutical companies.
  • VRBPAC members reported concerns regarding RotaShield but still chose to vote for the vaccine.
  • For the RotaShield vaccine approval vote, five temporary members were permitted to vote even though the committee’s charter only allowed for four.
  • Committee members who were ineligible to vote due to conflicts were still allowed to participate in discussions.
  • Despite term limits, several committee members were permitted to remain on committees for many years. Additionally, some members were found to serve on both the FDA and the CDC even though this was against policy.

Conflicts identified with ACIP included: 

  • ACIP members did not fully declare their conflicts of interest.
  • Committee members were given a blanket waiver that allowed them to participate in discussions on any topic, even if there was a conflict of interest.
  • ACIP members were permitted to vote on vaccine recommendations, even when they had financial ties to drug companies developing similar or related vaccines.
  • ACIP liaison members were not required to disclose their organization’s financial conflicts of interest.
  • For the ACIP rotavirus work group, seven out of the ten members had identifiable conflict of interests with vaccine interest groups and pharmaceutical products. Additionally, the meetings were held in private and no meeting notes were taken. One work group member who had significant conflicts of interest and was ineligible to vote on RotaShield use was permitted to work extensively on the recommendations.
  • ACIP failed to include any consumer representatives even though they were required to.

The review of the ACIP and VRBPAC practices resulted in the following recommendations to the Department of Health and Human Services (DHHS) by the Committee on Government Reform: 

“1. Individuals who serve on advisory committees involving vaccines should have no financial ties to vaccine manufacturers.

2. Public participation on ACIP and VRBAC needs to be increased substantially.

3. Conflict of Interest waivers should be used more stringently.

4. A balance of policy perspectives should be incorporated into consideration of appointments of committee members.

5. Any level of stock ownership in vaccine manufacturers should not be allowed by committee members.

6. Department personnel need to insure that all documentation is fully and adequately completed.

7. Full explanation of participation as expert witnesses in legal cases needs to be a part of financial disclosures.

8. Individuals who have patents for vaccines for the same disease under discussion should not be allowed to participate in the discussion or vote of ACIP or VRBAC.

9. Individuals who are developing vaccines for the same disease under discussion should be not be allowed to participate in the discussion or vote of ACIP and VRBAC.

10. Working groups should be replaced by fully constituted Subcommittees on both the VRBAC and ACIP.

11. Individuals should not be allowed to participate on two DHHS advisory committees at the same time.

12. Individuals should not serve excessively long terms on a committee.

13. The FDA should reconsider its policy on using temporary voting members.

14. ACIP should not consider making a recommendation on a vaccine until it has been licensed by the FDA.

15. CDC should follow the same policy in identifying affected companies for vaccine discussions as the FDA does and exclude participation of any individual who has a conflict.

16. Organizations who send liaison members to participate in council meetings, should offer full disclosure of ties to the pharmaceutical industry.

17. The Department should review its policies and practices regarding conflicts of interest, participation on advisory committees, and terms of service, public participation, and balance of views and expertise.”

RotaTeq Vaccine Clinical Trial Data

Wyeth-Lederle was not the only pharmaceutical company working on a rotavirus in the 1990s. Both Merck and GlaxoSmithKline were actively in development of a vaccine and on February 3, 2006, the FDA approved Merck’s RotaTeq live oral rotavirus vaccine for use in infants six to 32 weeks for the prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4.    Data submitted to the FDA by Merck indicated that the vaccine also induced antibodies against a selection of rotavirus serotypes that contained P1.

Two pre-licensing clinical trials examined the vaccine’s efficacy against rotavirus gastroenteritis. One study reported an overall vaccine efficacy of 74 percent through the first year after vaccination. The second study examined the vaccine’s efficacy against naturally occurring rotavirus gastroenteritis caused by the serotypes contained in the vaccine. In this study, Merck reported the vaccine to have an efficacy of 72.5 percent while the FDA reported an efficacy of 71 percent. 

While RotaTeq was tested against a placebo in pre-licensing clinical trials, both groups received all routinely recommended vaccines at the same time. These vaccines included COMVAX (Hepatitis B and HIB), INFANRIX (DTaP), IPOL (inactivated polio) and PREVNAR (pneumococcal). According to the clinical data provided by Merck to the FDA, the incidence of diarrhea, vomiting, otitis media (ear infection), nasopharyngitis, and bronchospasm were statistically higher among infants in the RotaTeq group versus those in the placebo control group. 

Merck also reported that no increased risk of intussusception was seen between day 42 and day 60 in the RotaTeq group compared to the placebo group and no clustering of cases occurred within a 7- day or 14- day period post vaccination. Six cases of intussusception occurred in the RotaTeq group compared to five cases in the placebo control group.  Other serious adverse event reported in pre-licensing clinical trials included seizures, urinary tract infections, gastroenteritis, bronchiolitis, pneumonia, and pyrexia. 

Fifty-two deaths (25 in the RotaTeq group versus 27 in the control group) occurred among the approximately 70,000 infants who participated in the phase 3 clinical trials. Sudden Infant Death Syndrome (SIDS) was the most common cause of death. Other causes included  meningitis, bronchopneumonia, pyelonephritis, motor vehicle accidents, injuries and one death from intussusception. The intussusception death occurred 99 days post RotaTeq vaccination. 

Vaccine virus shedding and transmission was also studied prior to the vaccine’s licensure and it was reported to occur in nine percent of cases. Nearly all cases occurred after the first vaccine dose and the longest time point at which shedding occurred following vaccination was at 15 days. Horizontal transmission, however, was not evaluated by Merck during pre-licensing clinical trials.   

RotaTeq Approved for Infants

The CDC’s ACIP, which had begun discussions on RotaTeq in 2005, voted in February 2006 for all infants to receive 3 vaccine doses at 2, 4, and 6 months of age. The vaccine, however, was not recommended if the first dose were to be administered after 12 weeks of age and should not be given to any infant older than 32 weeks. 

Contraindications to RotaTeq administration included a severe hypersensitivity to any ingredient found in the vaccine or a previous serious allergic reaction. ACIP also noted that the vaccine had not been tested in infants with altered immune systems and issued a precaution to practitioners who might be considering the use of the vaccine in this population. Additionally, the vaccine was not recommended for use when an infant was experiencing acute, moderate to severe gastroenteritis until symptoms had improved; however, the vaccine was still recommended for infants with mild gastroenteritis symptoms even though no testing had been done on the use of the vaccine in infants experiencing acute gastroenteritis. 

ROTARIX Vaccine Approved for Infants

On April 3, 2008, the FDA approved ROTARIX, a second live oral rotavirus vaccine for use in infants six through 24 weeks of age. Manufactured by GlaxoSmithKline, this vaccine was approved to be administered at as a 2-dose series for the prevention of rotavirus gastroenteritis cause by serotypes G1, G3, G4, and G9.   

Pre-licensing clinical trials of ROTARIX involved approximately 63,000 infants. In these trials, ROTARIX was tested against a placebo; however, both the ROTARIX group as well as the placebo group also received all additionally recommended age appropriate vaccines (pertussis, diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b (Hib), pneumococcal conjugate, and poliovirus) in nearly all studies. 

No increased risk of intussusception was noted in the pre-licensing clinical trials; however, other serious adverse events including deaths were reported. Among all studies, 118 deaths were reported, with a statistically significant increase in the number of pneumonia-related deaths reported among infants who received ROTARIX in comparison to those who received the placebo. Additionally, higher rates of convulsions and pneumonia as well as irritability, flatulence, and bronchitis were seen among ROTARIX vaccine recipients. 

In June 2008, ACIP voted to recommend the use of ROTARIX as a second option for the prevention of rotavirus gastroenteritis but no preference was given to either rotavirus vaccine. ACIP also stated that the first dose of rotavirus vaccine needed to be administered between six weeks and 14 weeks and 6 days of age and that the vaccine series must be completed prior to 8 months of age. 

ROTARIX Contraindications

Contraindications to receiving rotavirus vaccines included a history of severe allergic reaction to a previous vaccine dose or to any component of the vaccine. ROTARIX was not recommended for infants with a severe latex allergy due to the presence of latex in the vaccine’s oral applicator. Infants with a latex allergy could receive RotaTeq as the applicator for this vaccine did not contain latex. 

Precautions to vaccination included infants who were immunocompromised or potentially immunocompromised, infants who were acutely ill with moderate to severe gastroenteritis or those moderate to severely ill, infants with pre-existing chronic gastrointestinal disorders and those with a history of intussusception. 

Infants with bladder exstrophy or spina bifida, a population known to be at a higher risk for latex allergies, were recommended to receive RotaTeq in lieu of ROTARIX; however, if RotaTeq was not available, ACIP stated that vaccination with ROTARIX was still preferential over no vaccine. 

Limited data on the safety or effectiveness of rotavirus vaccines on premature infants was available when ACIP published its updated guidelines but committee members considered the benefits to rotavirus vaccination to outweigh the risks and recommended routine vaccination for this population. Infants in the NICU, however, were not recommended to receive the vaccine due to the risk of vaccine-strain shedding that could potentially harm an acutely ill infant in the same unit. 

ACIP recommended that all rotavirus vaccine doses administered be of the same product but stated that vaccination should not be deferred because the previously administered vaccine type was not known. 

ROTARIX Vaccine Contaminated with Porcine Circovirus

On March 22, 2010, the FDA announced that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1. They did, however, report that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals. 

On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2.  Although PCV1 had not been associated with clinical disease in pigs, PCV2 was known to be a lethal pig virus that caused 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 temporary suspension of the use of ROTARIX vaccine on March 22, 2010 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.  

However, one week later, on May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue.  PCV1 remains a contaminant  of the ROTARIX vaccine and PCV1 and PCV2 continue to contaminate RotaTeq vaccines. 

On June 11, 2010, the CDC issued revised recommendations and added severe combined immunodeficiency (SCID) as a contraindication to receiving rotavirus vaccines. SCID is a group of rare disorders caused by mutations in various genes involved in the function and development of T- and B- lymphocytes. The addition of this contraindication occurred following reports of vaccine-acquired rotavirus infections and prolonged vaccine-strain shedding within this specific population. 

The CDC updated its rotavirus vaccine recommendations once more in October 2011 and added a prior history of intussusception as a contraindication of rotavirus vaccines. In this updated recommendation, the CDC reported that infants with a history of intussusception are at a higher risk for a repeated case; however, no data was available to determine the risk of a subsequent case of intussusception after rotavirus vaccination in infants with a prior history of intussusception.  Intussusception between day one and day 21 following the first and second dose of rotavirus vaccine was recognized as a vaccine injury and added to the National Vaccine Injury Compensation Program’s Vaccine Injury Table on July 23, 2015. 

In 2018, the CDC reported that only 73.2 (71.6–74.7) percent of children between 19 and 35 months of age had received the rotavirus vaccine series in 2017.  Currently only Idaho, Louisiana, North Dakota, Ohio, Pennsylvania, Rhode Island, West Virginia, and Wyoming require rotavirus vaccination for childcare enrollment;  however, exemptions may be available. More information on vaccine exemptions for school and childcare can be found on our NVIC State Law & Vaccine Requirements Page.

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

How Effective are Rotavirus Vaccines?

rotavirus

RotaTeq Vaccine Effectiveness 

According to the package insert, RotaTeq vaccine will prevent about 74 percent of rotavirus cases, about 98 percent of severe cases, and about 96 percent of hospitalizations due to rotavirus.

No efficacy or safety information is available on the use of RotaTeq in immunocompromised infants as this was not evaluated in clinical trials. Safety and efficacy information is also unavailable for use of the vaccine in infants with a history of gastrointestinal disease, including those with chronic diarrhea, acute gastrointestinal illness, history of congenital abdominal disorders, abdominal surgery, or failure to thrive.

RotaTeq may not prevent diarrhea or vomiting caused by viruses other than the rotavirus strains covered within the vaccine.

ROTARIX Vaccine Effectiveness 

According to the package insert, from infancy through one year, ROTARIX efficacy against severe rotavirus gastroenteritis was 84.7 percent in infants who received two vaccine doses, and 81 percent among those receiving one dose. ROTARIX efficacy against hospitalizations for rotavirus gastroenteritis through one year was 85 percent in infants receiving two vaccine doses and 80.8 percent among those receiving one dose.

Two studies evaluated the efficacy of ROTARIX against all rotavirus gastroenteritis infections and against severe rotavirus gastroenteritis through two seasons. In the first study, ROTARIX efficacy was reported at 78.9 percent against all rotavirus gastroenteritis through two rotavirus seasons, but only 71.9 percent for cases occurring during the second season after vaccination. Against severe rotavirus gastroenteritis, ROTARIX efficacy through two rotavirus seasons was 90.4 percent, but only 85.6 percent for cases occurring during the second season after vaccination. ROTARIX efficacy in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 96 percent.

In the second study, ROTARIX efficacy was reported at 80.5 percent against severe rotavirus gastroenteritis through two rotavirus seasons, and 79 percent for cases occurring during the second season after vaccination. ROTARIX efficacy in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 83 percent.

The effectiveness or safety of administering ROTARIX to infants with chronic gastrointestinal disorders or in infants with known primary or secondary immunodeficiencies was not evaluated in clinical trials prior to licensing.

Overall Effectiveness of Rotavirus Vaccine

In the U.S., researchers have reported that rotavirus vaccines have decreased the number of rotavirus infections requiring medical attention. However, researchers also note that since vaccine’s introduction, the G12P[8] rotavirus strain has emerged. While not directly covered by ROTARIX or RotaTeq, these vaccines appear to offer protection against the G12P[8] strain in infants and young children.  Additionally, since vaccine introduction, researchers have noted that epidemics of rotavirus are now occurring every two years. 

In 2019, the Cochrane Collaboration published a system data review of the available rotavirus vaccines. This data review reported the following: 

  • In high mortality countries in the first-year post vaccination, ROTARIX vaccine was found to decrease the rate of severe rotavirus infection by 63 percent and severe all-cause diarrhea infection by 27 percent. In the second year, ROTARIX was found to decrease the rate of severe rotavirus infection by 35 percent and severe all-cause diarrhea infection by 17 percent. ROTARIX had no impact on reducing all-cause mortality rates in high mortality countries. 
  • In low mortality countries, ROTARIX vaccine was reported to decrease the number of severe rotavirus infection by 84 percent and severe all-cause diarrhea infection by 41 percent. In the second-year post-vaccination, ROTARIX was found to decrease the rate of severe rotavirus infection by 82 percent and severe all-cause diarrhea infection by 37 percent. After three years, ROTARIX did not reduce the rates of severe rotavirus infection but one study found a 27 percent decrease in all-cause diarrhea infection. ROTARIX had no impact on reducing all-cause mortality rates in low mortality countries. 
  • For RotaTeq vaccine, in high mortality countries in the first-year post vaccination, the vaccine was found to decrease the rate of severe rotavirus infection by 57 percent but had no impact on reducing the rates of all-cause diarrhea. In the second year, RotaTeq was found to decrease the rate of severe rotavirus infection by 41 percent and severe all-cause diarrhea infection by 15 percent. RotaTeq had no impact on reducing all-cause mortality rates in high mortality countries. 
  • In low mortality countries in the first-year post vaccination, RotaTeq was found to decrease the rate of severe rotavirus infection by 92 percent but no data was collected to determine the vaccine’s impact on all-cause diarrhea rates. In the second year, RotaTeq was found to decrease the rate of severe rotavirus infection by 82 percent but again, no studies looked at the vaccine’s impact on all-cause diarrhea rates. RotaTeq had no impact on reducing all-cause mortality rates in low mortality countries. 

Following the introduction of the vaccine for use in infants, most studies reported that the use of rotavirus vaccines had resulted in declines of rotavirus gastroenteritis among populations for which the vaccine is not approved (i.e. adults and the elderly); however, a more recent study from Finland noted an increased rate of hospitalizations among older persons when compared to the pre-vaccine era. 

In 2007, after the introduction and widespread use of ROTARIX in 2006, health officials from Brazil noted that:

“this vaccine appears less effective in preventing severe rotavirus gastroenteritis caused by P[4]G2 strains, and immunologic  pressure  exerted  by  the  vaccine  may  cause  emergence of rotavirus genotypes that are not controlled by the vaccine. This possibility could change the pattern and distribution  of  the  most  prevalent  rotavirus  strains  in  the  vaccinated population.” 

Though their findings were criticized by the CDC and others,    the study authors presented additional data to support their concerns and called for the need to further monitor rotavirus serotype circulation post-vaccination.  A 2009 published study on rotavirus strain distribution in Brazil noted that the vaccinated children were less at risk for severe diarrhea caused by this strain but that the vaccination program needed to be continuously monitored due to the possible emergence of rotavirus strains not covered by the vaccine. 

Surveillance of rotavirus serotypes in the United States following the introduction of RotaTeq found that G3 replaced G1 as the strain most frequently detected and that additional uncommon serotypes had also been detected. Additionally, by the 2007-2008  season, the mean age of rotavirus cases in children less than three years had increased significantly. The authors concluded that: 

“These findings underscore the need for careful monitoring of strains to assess possible vaccine pressure-induced changes and vaccine effectiveness against various rotavirus genotypes.” 

In 2018, the CDC published a report detailing three separate rotavirus outbreaks which had occurred in California in 2017. In their report, they conclude that while rotavirus vaccines were effective at preventing severe illness, they did not always prevent infection or protect against milder symptoms. They also noted that rotavirus infection does occur among adult populations and can spread quickly among persons living in a communal setting. 

A 2018 Japanese study evaluating the effectiveness of rotavirus vaccines against an emerging strain of rotavirus (G8P[8] strain) found that while the vaccines were effective against moderate and severe illness, they were not effective against mild illness during an outbreak of this unusual strain. 

In 2020, researchers from Finland published a paper reporting that while high rates of rotavirus vaccination decreased the risk of disease, rotaviruses were still actively circulating. They reported that new strains of rotavirus had emerged, including a G12P[8], and stated that this “might be a potential alarm sign.”  They also noted that high vaccination rates will likely lower rotavirus disease rates, but that virus elimination will not be achievable. 

Vaccine Shedding and Infection

Both RotaTeq and ROTARIX are live virus vaccines and it is possible for a vaccine recipient to shed the vaccine-strain virus to others. Persons most at risk for developing rotavirus through vaccine virus shedding are those who are immunocompromised and are exposed to a recently vaccinated infant.   

In addition to vaccine virus shedding and transmission, infections from vaccine-derived strains can also occur. Vaccine-derived viruses are caused by a reassortment of the vaccine strain virus during its replication and elimination from the body. This type of rotavirus infection occurs when the genetic material in the rotavirus vaccine strains combine differently (reassortment) and create a new (novel) strain of the virus. This novel vaccine-derived virus is then eliminated from the vaccine recipient’s body (i.e bowel movement) and is transmissible to others and capable of also causing gastrointestinal illness.       

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can Rotavirus Vaccines Cause Injury and Death?

vaccine injury

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(s) 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. 

Vaccine Reactions and Injuries

According to the CDC, mild vomiting and diarrhea, as well as irritability can occur after rotavirus vaccine administration. The use of rotavirus vaccines is also associated with an increased risk of intussusception, a serious blockage of the bowel requiring medical attention and that may require surgical intervention. The CDC estimates that this increased risk of intussusception occurs within the first week post-vaccination of the first or second vaccine dose at a rate between one in 20,000 and one in 100,000 infants who receive the vaccine. 

The CDC also acknowledges the presence of porcine circovirus DNA in the rotavirus vaccines, but reports that there are no known safety concerns involving the contaminants and that the viruses do not infect people. 

Adverse events reported by Merck in the vaccine package insert for RotaTeq live rotavirus vaccine include: 

  • Commonly Reported Adverse Events: Vomiting, diarrhea, and irritability, fever, otitis media, nasopharyngitis, and bronchospasm.
  • Serious Reported Adverse Events: Intussusception, bronchiolitis, pneumonia, fever, gastroenteritis, urinary tract infection, hematochezia (fresh blood in the stool), seizures, Kawasaki disease, anaphylactic reaction, urticaria, angioedema, and death.

Adverse events reported by GlaxoSmithKline in the vaccine package insert for ROTARIX live rotavirus vaccine include: 

  • Commonly Reported Adverse Events: Diarrhea, fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
  • Serious Reported Adverse Events: Intussusception, Kawasaki Disease, hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID), idiopathic thrombocytopenic purpura, convulsions, pneumonia and death.

The most commonly reported serious adverse reaction associated with rotavirus vaccines is intussusception. Intussusception occurs when one part of the intestine pulls inward into itself and can block food from passing through the intestine. If blood supply to the affected part of the intestine occurs, death of that segment of the intestine may occur. Additionally, if a hole occurs in the intestine, this can lead to infection, dehydration, shock and can be life-threatening.   

In 1998, the first rotavirus vaccine, RotaShield, received FDA approval for use and was recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) for use in infants; however, by July 1999, multiple reports of intussusception following vaccine administration had been reported to the Vaccine Adverse Events Reporting System (VAERS). Because of this safety signal, the CDC recommended that RotaShield not be used until November 1999 and that parents of recently vaccinated infants call their health care provider immediately should symptoms of intussusception present in their infants.  On October 22, 1999, ACIP voted to stop the use of RotaShield and the vaccine was withdrawn from the market by the manufacturer. 

Both RotaTeq and ROTARIX, the two rotavirus vaccines available for use in the U.S. can cause intussusception. The federal government acknowledges intussusception occurring between one- and 21-days after the first or second dose of rotavirus vaccine as a vaccine injury and has included this on the Vaccine Injury Table. 

In addition to intussusception, rotavirus vaccines have also been associated with Kawasaki Disease, a childhood disease which causes inflammation of the walls of the body’s blood vessels. Specifically, in the phase 3 licensing clinical trials of RotaTeq, rates of Kawasaki Disease within 42 days of vaccine administration were higher among infants who received the vaccine in comparison to those who did not. Published case studies and reports of Kawasaki Disease post RotaTeq vaccination have also been reported to the Vaccine Adverse Events Reporting System (VAERS) post-licensure. Some studies, however, have not found an increased risk of Kawasaki Disease post rotavirus vaccine administration.   

On March 22, 2010, the FDA announced that it has become aware that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners temporarily suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1; however, they reported that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals.  On May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue.  PCV1 remains a contaminant  of the ROTARIX vaccine. 

On May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2. Although PCV1 had not been associated with clinical disease in pigs, PCV2 was known to be a lethal pig virus that caused 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 temporary suspension of the use of ROTARIX vaccine on March 22, 2010 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.  To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines. 

Reported Vaccine Reactions and Injury Compensation

Using the MedAlerts search engine, as of August 31, 2022, there have been 36,452 adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with rotavirus vaccines. Of these reported adverse events, 11,642 were listed as serious and 911 were deaths.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.       

As of September 1, 2022, there have been 120 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following rotavirus vaccination, including six deaths and 114 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 73 children who have filed claims for rotavirus vaccine injury.

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Suffering Rotavirus Vaccine Complications?

rotavirus

According to the CDC, infants most at risk for complications from rotavirus vaccines include: 

  • Infants with primary and acquired immunodeficiency states, hypogammaglobulinemic and dysgammaglobulinemic states, and cellular immunodeficiencies
  • Infants with lymphomas, leukemia, blood dyscrasias, or other malignant neoplasms which affect the lymphatic system or bone marrow
  • Infants receiving immunosuppressive therapies
  • Infants who are HIV positive or who have been exposed to HIV
  • Infants who are ill with a moderate or severe gastrointestinal illness
  • Infants who are ill with a moderate or severe illness, with or without fever

The use of rotavirus vaccines increases an infant’s risk of intussusception. Infants with a previous history of intussusception are at a higher risk of a repeat episode of intussusception. 

Infants with the following medical conditions may be at a greater risk of harm from RotaTeq vaccination: 

  • Infants born to HIV infected mothers unless it has been determined that the infant does not have HIV infection
  • Infants with weakened immune systems
  • Fever greater than 100.5F (38.1C)
  • Current gastrointestinal illness
  • History of rotavirus infection
  • History of gastrointestinal illness and frequent diarrhea
  • Failure to thrive
  • History of stomach problems since birth
  • History of abdominal surgery
  • Receipt of blood or blood products within 42 days

Infants with the following medical conditions may be at a greater risk of harm from ROTARIX vaccination: 

  • Current gastrointestinal illness
  • History of rotavirus infection
  • History of gastrointestinal illness and frequent diarrhea
  • Latex sensitivity – the tip caps of the prefilled oral applicators of the diluent contain natural rubber latex. Infants with a latex sensitivity or allergy may be at risk of harm if exposed to the oral applicators
  • Infants with weakened immune systems

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who Should Not Get Rotavirus Vaccine?

contraindication

Contraindications to receiving the RotaTeq vaccine documented in Merck’s package insert include: 

  • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
  • A diagnosis of Severe Combined Immunodeficiency Disease (SCID)
  • A history of intussusception

Infants with the following medical conditions may be at a greater risk of harm from RotaTeq vaccination: 

  • Infants born to HIV infected mothers unless it has been determined that the infant does not have HIV infection
  • Infants with weakened immune systems
  • Fever greater than 100.5F (38.1C)
  • Current gastrointestinal illness
  • History of rotavirus infection
  • History of gastrointestinal illness and frequent diarrhea
  • Failure to thrive
  • History of stomach problems since birth
  • History of abdominal surgery
  • Receipt of blood or blood products within 42 days

Infants living with immunocompromised individuals might put others at risk of rotavirus infection through vaccine strain shedding and transmission from RotaTeq vaccines.

RotaTeq is FDA approved for use in infants between six and 32 weeks of age. Infants under six weeks or older than 32 weeks should not receive RotaTeq. 

Contraindications to receiving the ROTARIX vaccine documented in GlaxoSmithKline’s package insert include: 

  • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
  • A diagnosis of Severe Combined Immunodeficiency Disease (SCID)
  • A history of intussusception
  • A history of uncorrected congenital malformation of the gastrointestinal tract that would make an infant susceptible to intussusception

Infants with the following medical conditions may be at a greater risk of harm from ROTARIX vaccination: 

  • Current gastrointestinal illness
  • History of rotavirus infection
  • History of gastrointestinal illness and frequent diarrhea
  • Latex sensitivity – the tip caps of the prefilled oral applicators of the diluent contain natural rubber latex. Infants with a latex sensitivity or allergy may be at risk of harm if exposed to the oral applicators
  • Infants with weakened immune systems

Infants living with immunocompromised individuals might put others at risk of rotavirus infection through vaccine strain shedding and transmission from ROTARIX vaccines.

ROTARIX is FDA approved for use in infants between six and 24 weeks of age. Infants under six weeks or older than 24 weeks should not receive ROTARIX. 

The first dose of rotavirus vaccine should not be administered to an infant after 14 weeks and 6 days of age and no vaccine doses should be administered after eight months of age. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What Questions Should I Ask My Doctor About Rotavirus Vaccines?

questions

NVIC’s If You Vaccinate, Ask 8! downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions. Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for rotavirus on NVIC's “Quick Facts” at the top of this page.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. ROTARIX and RotaTeq vaccine product inserts are located on the Food and Drug Administration’s website.

Other questions that may be useful to discuss with your doctor before getting the rotavirus  vaccine are: 

  • If other vaccines in addition to rotavirus vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
  • What should I do if my child has a high fever or appears very ill after vaccination?
  • What other kinds of reaction symptoms should I call to report after rotavirus vaccination?
  • If the rotavirus vaccine doesn’t protect my child, do I have any other options for preventing rotavirus infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.  

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS).

You may also submit a report directly to VAERS, if your doctor fails or refuses to make a report, as well as search the VAERS database to learn more about reactions that have been reported for vaccines in use in the U.S. To learn more about your reporting options, visit NVIC’s Report  Vaccine Reactions—It’s the Law webpage.

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Selected NVIC Press Releases, Reports & Commentaries Related to Rotavirus

resources

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Selected Medical Literature & Resources Related to Rotavirus

rotavirus

IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

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