Informed Consent: Rotavirus

There are several vaccinations recommended in the US schedule for 2 months of age.  This is one of them.

What is this disease?

Rotavirus is a viral infection of the GI tract.  It is the most common cause of severe gastroenteritis worldwide.  The disease involves vomiting and diarrhea, the biggest risk is dehydration.  The virus is stable in the environment (can last weeks to months if not disinfected) and is transmitted by the oral-fecal route.  All children, even those that are vaccinated will likely contract this virus multiple times.  This disease is typically active seasonally in temperate climates, December-June.  All children in the US are likely to contract this by age 5.  Adult symptoms are less severe than those of children.

Rotavirus Stats

With natural infection from the first encounter with rotavirus:  38% of children will be immune, 77% are subsequently protected from diarrhea in future infections, and 87% are protected from severe diarrhea in future infections.  Each subsequent infection provides more protection in the future.

Of note, dehydration is a serious problem when it comes to young children and should never be taken lightly.  78% of children who die due to diarrhea-related dehydration are infants.  Diarrheal deaths of children declined 75% between 1968-1985 and then stabilized at approximately 300 deaths per year.  Early recognition of dehydration and rehydrating a child early is key.  Premature babies are more at risk for complications due to dehydration for up to two years of age.

Prior to vaccination in the US, 4/5 children under 5 years old had rotavirus gastroenteritis.  Out of those children:  1/7 required medical care (highest incidence 3-35 months old), 1/70 were hospitalized, and 1/200,000 died from the disease.  In children under 5, 20-60 annual deaths were attributed to rotavirus.  Winter infant deaths from rotavirus used to peak due to diarrhea and dehydration, but thankfully this pattern has virtually disappeared since 1985.  

Vaccination began in 2006 in the U.S.  Post-vaccination rates of rotavirus have decreased 74-90%.  Seasonal patterns still exist.  

In 2004, WHO estimated that 527,000 children under age 5 died from rotavirus worldwide.  In 2013, this had declined to 215,000. Approximately 2/3 of those deaths in 2013 were in the Indian subcontinent or Africa.   


How do you treat this disease?

There is no cure.  Treatment is by hydrating the person orally, or in severe cases intravenously.

Extra caution about handwashing and diaper disposal should be used for duration of the illness and for up to 10 days after symptoms first appear.  Be mindful that good sanitation procedures do not always eliminate this virus.

How long is a typical course of this disease?  

Two-three days after infection with the virus, the person will display symptoms which will last approximately 3-7 days.  You are infectious immediately upon infection, for up to 10 days after first symptoms are displayed.

Immunocompromised children tend to have more severe and more complicated cases.  They can also shed the virus for up to 30 days after infection.

Children under 3 months rarely are infected.  This is hypothesized to be due to breastfeeding.  Breastfeeding protects children because the mothers are passing on antibodies to the infant in the milk.  

How effective is this vaccine?

Both current versions tested 74% effective for any rotavirus gastroenteritis, 98% effective for severe rotavirus gastroenteritis for one year.  Various studies worldwide have found vaccination 85-96% effective.  In the US RV5 has been shown to be highly effective for up to 3 years.

Side-effects of vaccine

Your child should not get this vaccine if: they have had a history of intussusception, they have an allergic reaction to the vaccine or any component of it, they have SCID, they currently have gastroenteritis of any type, or are currently are in the NICU.

Use caution and consult with a specialist if your child is immunocompromised.

Possible risks proven in large studies:  intussusception (1-2 cases per 100,000 vaccinated), diarrhea, vomiting, ear, nose, and throat irritations, bronchospasm, cough, runny nose, irritability, and gas.

Vaccine Injury Data 10/3/16

  • Claims filed:  76 injury, 1 death; 45 were compensated

Adverse Reaction and reporting interval for VAERS:

  • Events described in manufacturer’s package insert as contraindications to additional doses of vaccine.  Insert is available on FDA website.

In the recent past there has been an incident of pig viruses in one of the vaccines.

Different versions of this vaccine

An old version of the vaccine, Rotashield, was used for only 1998.  It was pulled from the market because of the risk of intussusception.  This version is no longer used.

RV5 aka Rotateq (Merck):  5 strains, oral vaccine.  Child may shed virus in their stools for up to 5 days post vaccination.  Three doses at 2, 4, and 6 months.  Minimum age:  6 weeks.  Maximum age for first dose:  12 weeks.  Maximum age for any dose:  32 weeks.

RV1 aka Rotarix (GlaxoSmithKline):  1 strain, oral vaccine.  Child may shed virus in their stools for up to 30 days.  Two doses at 2 and 4 months.  Minimum age 6 weeks.  Maximum age for first dose:  14 weeks and 6 days.  Maximum age for any dose:  24 weeks.  Contraindicated for latex allergies.

There has been, to date, no study comparing the effectiveness of the two versions.  

A minimum of 4 weeks should be between doses.  If an infant spits up the vaccine, it is recommended that they not be given any extra, and that you maintain the schedule as if the infant did not regurgitate.  It is a good idea to use the same version for all doses.

Please pay special attention to length of stool shedding listed above.  Use extra care with diaper changes and be sure to wash hands thoroughly.  Although, rotavirus can be pretty stubborn to get rid of even with good sanitation.


Recommended standard schedules in the US and all Canadian provinces is at 2 months and again at 4 months.

Some alternative schedules recommend not vaccinating against rotavirus unless you live in an area that you do not have access to healthcare services, others stick to the recommended schedule for rotavirus or follow the vaccination recommendations, e.g. give the recommended 3 doses of Rotateq (RV5).


  • CDC
  • FDA
  • Kilgore PE, Holman RC, Clarke MJ, Glass RI. Trends of diarrheal disease-associated mortality in U.S. children, 1968 through 1991. JAMA 1995;274:1143-8.
  • National Vaccine Injury Compensation Program Data Report-10/3/2016
  • VAERS table of reportable events following vaccination
  • WHO

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