Rotavirus vaccine is the most recent addition to the panel of immunizations in early life and has been recently reviewed by the World Health Organization (WHO) Weekly Epidemiological Record [58] as well as by Dennehy [19]. Protection against rotavirus infection is of major clinical interest, as it is the leading cause of severe diarrhea in children less than 5 years globally, with over 25 million outpatient visits and over 2 million hospitalizations yearly. Licensed in 2006, two live attenuated oral rotavirus vaccines, monovalent human rotavirus vaccine Rotarix® and the pentavalent bovine-human vaccine RotaTeq, replaced their counterpart RotaShield®, which was withdrawn from the market in 1999 because of a possible association with intussusception. The two new vaccines have a similar safety and efficacy profile but a different immunization schedule: Rotarix is administered in a 2-dose schedule between 6 and 12 weeks (at least 4 weeks apart) and RotaTeq as 3 doses at 2, 4 and 6 months (first dose between 6–12 weeks and subsequent doses at 4–10 weeks intervals, with the first dose given no later than 12 weeks and the third dose given before the age of 32 weeks). The first dose of these vaccines should not be given to infants older than 12 weeks, as the safety has not been established, and this confers a potentially higher risk of intussusception. According to the Global Advisory Committee on Vaccine Safety and their data on post-licensure surveillance until June 2007, the use of these vaccines was not associated with an increased risk of intussusception or other serious adverse events [58]. Rare complications included mild and transient symptoms from the respiratory or gastrointestinal tract. The vaccines are contraindicated in infants with a history of intussusception or anatomical malformations possibly predisposing for intussusception. Of note, neither of these vaccines contains thiomersal.
Both vaccines provide 74–85% protection against rotavirus diarrhea of any severity and ~90–100% protection against severe rotavirus disease that extends to the second year of follow-up. Both vaccine dose and host factors (e.g. MatAb, interfering bacterial and viral agents, and malnutrition) are believed to determine extent of the immune response. Although optimal surrogate markers for vaccine efficacy have yet to be clearly defined, intestinal virus-specific IgA has correlated with protection and serum IgA responses to the VP4 and VP7 surface structural proteins have been used as end points, though cell-mediated immunity is believed to contribute to anti-rotaviral defense as well [59]. As clinical efficacy has thus far been demonstrated mainly in the U.S., Europe and Latin America, the WHO has not yet recommended global inclusion of rotavirus vaccines into national immunization programs until its potential is confirmed in all regions of the world.
Rotavirus vaccine is the most recent addition to the panel of immunizations in early life and has been recently reviewed by the World Health Organization (WHO) Weekly Epidemiological Record [58] as well as by Dennehy [19]. Protection against rotavirus infection is of major clinical interest, as it is the leading cause of severe diarrhea in children less than 5 years globally, with over 25 million outpatient visits and over 2 million hospitalizations yearly. Licensed in 2006, two live attenuated oral rotavirus vaccines, monovalent human rotavirus vaccine Rotarix® and the pentavalent bovine-human vaccine RotaTeq, replaced their counterpart RotaShield®, which was withdrawn from the market in 1999 because of a possible association with intussusception. The two new vaccines have a similar safety and efficacy profile but a different immunization schedule: Rotarix is administered in a 2-dose schedule between 6 and 12 weeks (at least 4 weeks apart) and RotaTeq as 3 doses at 2, 4 and 6 months (first dose between 6–12 weeks and subsequent doses at 4–10 weeks intervals, with the first dose given no later than 12 weeks and the third dose given before the age of 32 weeks). The first dose of these vaccines should not be given to infants older than 12 weeks, as the safety has not been established, and this confers a potentially higher risk of intussusception. According to the Global Advisory Committee on Vaccine Safety and their data on post-licensure surveillance until June 2007, the use of these vaccines was not associated with an increased risk of intussusception or other serious adverse events [58]. Rare complications included mild and transient symptoms from the respiratory or gastrointestinal tract. The vaccines are contraindicated in infants with a history of intussusception or anatomical malformations possibly predisposing for intussusception. Of note, neither of these vaccines contains thiomersal.Both vaccines provide 74–85% protection against rotavirus diarrhea of any severity and ~90–100% protection against severe rotavirus disease that extends to the second year of follow-up. Both vaccine dose and host factors (e.g. MatAb, interfering bacterial and viral agents, and malnutrition) are believed to determine extent of the immune response. Although optimal surrogate markers for vaccine efficacy have yet to be clearly defined, intestinal virus-specific IgA has correlated with protection and serum IgA responses to the VP4 and VP7 surface structural proteins have been used as end points, though cell-mediated immunity is believed to contribute to anti-rotaviral defense as well [59]. As clinical efficacy has thus far been demonstrated mainly in the U.S., Europe and Latin America, the WHO has not yet recommended global inclusion of rotavirus vaccines into national immunization programs until its potential is confirmed in all regions of the world.
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