# Presentation: 108577

## Rotavirus and Rotavirus Vaccine

**Epidemiology and Prevention of Vaccine-Preventable Diseases**
**National Immunization Program**
**Centers for Disease Control and Prevention**

**Revised January 2007**

## Rotavirus

**First identified as cause of diarrhea in 1973**
**Most common cause of severe diarrhea in infants and children**
**Nearly universal infection by 5 years of age**
**Responsible for up to 500,000 diarrheal deaths each year worldwide**

## Electron micrograph of rotavirus

**Electron micrograph of rotavirus**

## Reovirus (RNA)
VP7 and VP4 antigens define virus serotype and induce neutralizing antibody
5 predominant strains in U.S.  (G1-G4, G9) and account for 90% of isolates
Strain G1 accounts for 73% of infections
Very stable and may remain viable for weeks or months if not disinfected

**VP7 and VP4 antigens define virus serotype and induce neutralizing antibody**
**5 predominant strains in U.S.  (G1-G4, G9) and account for 90% of isolates**
**Strain G1 accounts for 73% of infections**
**Very stable and may remain viable for weeks or months if not disinfected**

**Rotavirus**

## Rotavirus Pathogenesis

**Entry through mouth**
**Replication in epithelium of small intestine**
**Replication outside intestine and viremia uncommon**
**Infection leads to isotonic diarrhea**

## Rotavirus Immunity

**Antibody against VP7 and VP4 probably important for protection**
**First infection usually does not lead to permanent immunity**
**Reinfection can occur at any age**
**Subsequent infections generally less severe**

## Rotavirus Clinical Features

**Incubation period 1-3 days**
**Clinical manifestations depend on whether it is the first infection or reinfection**
**First infection after age 3 months generally most severe**
**May be asymptomatic or result in severe dehydrating diarrhea with fever and vomiting**
**Gastrointestinal symptoms generally resolve in 3 to 7 days**

## Rotavirus Complications

**Severe diarrhea**
**Dehydration**
**Electrolyte imbalance**
**Metabolic acidosis**
**Immunodeficient children may have more severe or persistent disease**** **

## Rotavirus Disease Burden in the United States

**Estimated 2.7 million cases per year**
**95% of children infected by 5 years of age**
**The most severe disease occurs among children 3-24 months of age**
**Highest incidence among children 3 to 35 months of age**
**Responsible for 5%-10% of all gastroenteritis episodes among children younger than 5 years of age  **

## Rotavirus Disease in the United States

**Annually responsible for:**
**More than 400,000 physician visits**
**More than 200,000 emergency dept visits**
**55,000-70,000 hospitalizations**
**20-60 deaths**
**Annual direct and indirect costs are estimated at approximately $1 billion **

## Rotavirus Epidemiology

**Reservoir****	****	****	****Human-GI tract**** **
**Transmission****	****	****Fecal-oral, fomites**
**	****	****	****	****	****	**
**Temporal****	****	****	****Fall and winter ****pattern****	****	****	****	****(temperate areas)**** **
**Communicability****	****	****2 days before to 10****	****	****	****	****	****days after onset**

## Risk Groups for Rotavirus Diarrhea

**Groups with increased exposure to virus**
**Children in child care centers**
**Children in hospital wards   (nosocomial rotavirus)**
**Caretakers, parents of these children**
**Children, adults with immuno- deficiency related diseases (e.g. SCID, HIV, bone marrow transplant)**

## Rotavirus Vaccine

**Created by genetic reassortment**
**Causes nonhuman rotavirus strains to express human rotavirus antigens on their surface**
**Nonhuman rotaviruses have low     pathogenicity for humans**
**Replicate but do not cause disease**

## Rotavirus Vaccine (Rota)

**Rotavirus Vaccine (Rota)**

**Human**

**Animal**

**Tissue**
**Culture**

**Reassortant**

## Rotavirus Vaccine (RotaTeq®)

**Approved by FDA in February 2006**
**Contains five reassortant rotaviruses developed from human and bovine parent rotavirus strains**
**Vaccine viruses suspended in a solution of buffer (sodium citrate and phosphate) and stabilizer**
**Contains no preservatives or thimerosal   **

## Rotavirus Vaccine Efficacy

**Phase III trials included more than 70,000 infants in 11 countries **
**Efficacy**
**All rotavirus disease - 74%**
**Severe rotavirus disease - 98%**
**Physician visits for diarrhea-86% reduction**
**Rotavirus-related hospitalization-96% reduction**
**Efficacy of fewer than 3 doses is not known **

***N Eng J Med***** 2006;354:23-33**

## Rotavirus VaccineRecommendations

**Routine immunization of all infants without contraindications**
**Administered at 2, 4, and 6 months of age**
**Minimum age of first doses is 6 weeks**
**First dose should be administered between 6 and 12 weeks of age (until age 13 weeks)**
**Do not initiate series after 12 weeks of age**

***MMWR***** 2006;55:(RR-12):1-13.**

## Minimum interval between doses is 4 weeks
Maximum age for ANY dose is 32 weeks
Do not administer on or after age 32 weeks, even if fewer than three doses have been administered 

**Maximum age for ANY dose is 32 weeks**
**Do not administer on or after age 32 weeks, even if fewer than three doses have been administered **

**Rotavirus Vaccine****Recommendations**

***MMWR***** 2006;55:(RR-12):1-13.**

## Administer simultaneously with all other indicated vaccines
Breastfeeding infants should be vaccinated on usual schedule
Vaccinate infants who have recovered from documented rotavirus infection
Do not repeat dose if infant spits out or regurgitates vaccine- administer remaining doses on schedule

**Breastfeeding infants should be vaccinated on usual schedule**
**Vaccinate infants who have recovered from documented rotavirus infection**
**Do not repeat dose if infant spits out or regurgitates vaccine- administer remaining doses on schedule**

**Rotavirus Vaccine****Recommendations**

***MMWR***** 2006;55:(RR-12):1-13.**

## Rotavirus Vaccine and Intussusception

**Within 42 days**
**of vaccination**
**Within 1 year**
**of vaccination**

**Vaccine**
**Recipients**
**6 cases**
**13 cases**

**Placebo**
**Recipients**
**5 cases**
**15 cases**

***New Eng J Med***** 2006;354:23-33**

## Rotavirus VaccineAdverse Reactions*

**Vomiting****	****	****	****15% **
**Diarrhea****	****	****	****24% **
**Nasopharyngitis****	****  7%**
**Fever ****	****	****	****	****43%**
**No serious adverse reactions reported**

***MMWR***** 2006;55:(RR-12):1-13.**

## Rotavirus VaccineContraindications

**Severe allergic reaction to a vaccine component or following a prior dose of vaccine **

## Rotavirus VaccinePrecautions*

**Altered immunocompetence**
**Recent receipt of blood product**
**Acute, moderate to severe gastroenteritis or other acute illness **
**Pre-existing chronic GI disease**
**Infants with history of intussusception**

***the decision to vaccinate if a precaution is present should be made on a case-by-case risk and benefit basis**

## Rotavirus Vaccine and Preterm Infants

**Few data available**
**ACIP supports the vaccination of a preterm infant if:**
**the infant is at least 6 weeks of  age; and**
**is being or has been discharged   from the hospital; and**
**is clinically stable**

***MMWR***** 2006;55:(RR-12):1-13.**

## Immunosuppressed Household Contacts of Rotavirus Vaccine Recipients

**Protection of the immunocompromised household member afforded by vaccination of young children in the household outweighs the small risk for transmitting vaccine virus to the immunocompromised household member **
**Household should employ measures such as good handwashing after contact with the feces of the vaccinated infant **

## Rotavirus Vaccine Storage and Handling

**Provided as a single 2-mL oral dose in a buffered stabilizer solution**
**Store at 36-46°F (2-8°C)**
**Shelf life of properly stored vaccine is 24 months**
**Do not freeze**
**Administer as soon as possible after being removed from refrigeration   **

## National Immunization ProgramContact Information

**Telephone****	****800.CDC.INFO**** **
**Email****	****	****	****nipinfo@cdc.gov**** **
**Website****	****	****www.cdc.gov/nip**