Vaccine India

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Rotavirus is a double-stranded RNA virus of the family Reoviridae. Rotavirus is recognized as the most common cause of severe gastroenteritis in infants and young children. The virus enters the body through the mouth. Viral replication occurs in the villous epithelium of the small intestine. Infection may result in decreased intestinal absorption of sodium, glucose, and water, and decreased levels of intestinal lactase, alkaline phosphatase, and sucrase activity, and may lead to isotonic diarrhea.

The incubation period for rotavirus diarrhea is 1–3 days. The clinical manifestations of infection vary and depend on whether it is the first infection or reinfection. Infection may be asymptomatic, may cause self-limited watery diarrhea, or may result in severe dehydrating diarrhea with fever and vomiting.

The clinical features and stool characteristics of rotavirus diarrhea are nonspecific, and similar illness may be caused by other pathogens. As a result, confirmation of a diarrheal illness as rotavirus requires laboratory testing.

Rotavirus infection in infants and young children can lead to severe diarrhea, dehydration, electrolyte imbalance, and metabolic acidosis. Immunodeficient children may have more severe or persistent disease and may have evidence of abnormalities in multiple organ systems, particularly the kidney and liver.

Rotaviruses are shed in high concentration in the stool of infected persons. Transmission is by fecal-oral spread, both through close person-to-person contact and by fomites (such as toys and other environmental surfaces contaminated by stool). Rotaviruses are also probably transmitted by other modes such as fecally contaminated food and water and respiratory droplets.


RotaTeq is a live, oral vaccine that contains five reassortant rotaviruses developed from human and bovine parent rotavirus strains.

RotaTeq consists of the five human–bovine reassortants suspended in a solution of buffer (sodium citrate and phosphate) and stabilizer (sucrose). Each 2-mL vial of vaccine contains approximately 2 x 106 infectious units of each of the five reassortant strains. The vaccine formulation contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, and tissue culture media. Trace amounts of fetal bovine serum might be present. The vaccine contains no preservatives or thimerosal.

The duration of immunity from rotavirus vaccine is not known.


The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants without contraindications with three doses of rotavirus vaccine administered orally at ages 2, 4, and 6 months. The minimum age for the first dose is 6 weeks. The first dose should be administered between 6 and 12 weeks of age (that is, until age 13 weeks). Vaccination should not be initiated for infants older than 12 weeks because of insufficient data on safety of the first dose of rotavirus vaccine in older infants.

All three doses should routinely be separated by 2 months. However, the minimum interval between doses may be a short as 4 weeks if an accelerated schedule is required.

The maximum age for any dose of rotavirus vaccine is 32 weeks because of insufficient data on the safety and efficacy of rotavirus vaccine in infants after this age. Rotavirus vaccine should not be administered on or after age 32 weeks, even if fewer than three doses have been administered.

Rotavirus vaccine may be administered simultaneously with all other vaccines that are routinely given at the same ages (hepatitis B, DTaP, IPV, Hib, PCV). Breastfeeding does not appear to diminish immune response to three doses of vaccine. Children who are being breastfed should be vaccinated on schedule. Infants who have recovered from documented rotavirus infections may not be immune to all five serotypes present in the vaccine. These infants should complete the three-dose vaccination series by 32 weeks






More than 6 weeks

Rota viral vaccines

  (2/3 doses (depending on brand) at 4-8 weeks interval



Reports of intussusception among rotavirus vaccine have been received. Other Adverse Events are vomiting, diarrhea, nasopharyngitis, otitis media, bronchospasm.


Rotavirus vaccine is contraindicated for infants who are known to have had a severe allergic (anaphylactic) reaction to a vaccine component or following a prior dose of vaccine.

Clinicians should consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence. Children and adults who are immunocompromised because of congenital immunodeficiency, hematopoietic transplantation, or solid organ transplantation sometimes experience severe, prolonged, and even fatal rotavirus gastroenteritis.

ACIP recommends deferral of vaccination for infants who have received an antibody-containing product, including blood and immunoglobulin, for 6 weeks after receipt of the blood product.

Usually, rotavirus vaccine should not be administered to infants with acute, moderate to severe gastroenteritis or other acute illness until the condition improves. However, infants with mild acute gastroenteritis can be vaccinated, particularly if the delay in vaccination will delay the first dose of vaccine until 13 weeks of age or older.

Infants living in households with persons who have or are suspected of having an immunodeficiency disorder or impaired immune status can be vaccinated. The majority of experts believe the 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 and any subsequent theoretical risk for vaccine virus–associated disease. To minimize potential virus transmission, all members of the household should employ measures such as good handwashing after contact with the feces of the vaccinated infant (e.g., after changing a diaper). Infants living in households with a pregnant woman can be vaccinated.


The vaccine must be stored at refrigerator temperatures 2°C–8°C. The shelf life of properly stored vaccine is 24 months. The vaccine must not be frozen. RotaTeq should be administered as soon as possible after being removed from refrigeration.