A realistic goal for a rotavirus vaccine is to duplicate the degree of protection against disease that follows natural infection
Rotavirus infection stimulates the immune system—including those of neonates [26]—to protect against future rotavirus infections. [27]
As the chart below indicates, natural infection offers children protection against future moderate-to-severe diarrhea:*
- 1 rotavirus infection, 87% protective
- 2 rotavirus infections, 100% protective [27]
*In a surveillance study in Mexico City from Oct 1987 to Oct 1988 of newborns recruited at birth and monitored for 2 years (N=200).
Natural rotavirus infection is highly protective in infants [27]
In this study, 1 or 2 natural rotavirus infections was also protective—but
to a lesser extent—against subsequent mild diarrhea and asymptomatic infections.
[27]
A rotavirus infection can be of any magnitude—even asymptomatic—and provide
protection against subsequent rotavirus illness.
[27]
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Indications and Usage
ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.
Important Safety Information
- In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
- History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication.
- Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration.
- Administration in infants suffering from acute diarrhea or vomiting should be delayed.
- Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.
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