Rotavirus vaccine maximum age for first dose

Both rotavirus vaccines (rotarix® and rotateq®) have been tested in large clinical trials involving thousands of children and have been shown to be safe and effective. nine out of every 10 children will survive severe rotavirus illness (fever, vomiting, diarrhea, and behavior changes), while about seven to eight out of 10 children will be completely protected from rotavirus disease.

Before a vaccine was available, many children who became ill with rotavirus were hospitalized. Currently, very few vaccinated children are hospitalized due to rotavirus disease (94% to 96% protected from hospitalization).

in april 2009, who's strategic advisory group of experts (sage) reviewed recent data on the efficacy and safety of 2 rotavirus vaccines, pentavalent rv5 (rotateq,® merck & co., whitehouse station, nj, usa) and monovalent rv1 (rotarix). ,® glaxosmithkline biologicals, rixensart, belgium). Based on a review of the evidence, sage recommends that all national immunization programs include vaccination against rotavirus for children. vaccine introduction is strongly recommended in countries where deaths from diarrheal diseases account for ≥10% of deaths among children under 5 years of age.

in the original trial with rotateq, infants were vaccinated with dose 1 between 6 weeks and 12 weeks of age; with rotarix, infants were vaccinated between 6 weeks and 14 weeks of age (in latin america) or between 6 weeks and 15 weeks of age (in europe). rotateq is delivered on a 3-dose schedule; rotarix only requires 2 doses. The maximum recommended age for the last dose of rotateq is 32 weeks; for rotarix it is 24 weeks and 6 days. In the United States, where rotateq is generally administered at ages consistent with those studied in the main trials, post-licensure safety data do not suggest increased intrinsic risk.

Based on these data, and to adjust the schedule between vaccines, sage recommends that the first dose of rotarix or rotateq be administered between 6 weeks and 15 weeks of age and the maximum age for administration of the last dose of either. The vaccine should be at 32 weeks. Saje noted that this expansion of the age limit for the use of this vaccine could increase the coverage of the first dose from about 57% to 70% and the coverage of the full course from about 36% to 54% in developing countries.

The committee supported sage's recommendation to increase age eligibility for rotavirus vaccination. Administration of the rotavirus vaccine at the recommended age in early childhood will provide high protection against rotavirus diarrhea in vaccinated children. However, in many developing countries, not all children receive vaccinations according to the recommended dosing schedule, and the challenges of timely immunization may be most acute in countries with high rates of early childhood mortality. data from rotarix and rotateq support the safety and efficacy of the new rotavirus vaccine. The level of intrinsic risk identified by the previous vaccine (rotashield,®) can be confidently ruled out, and no increased risk is likely as neither rotarix or rotateq signaled an increased risk. It has been hypothesized that a rotavirus vaccine given outside the recommended age may be associated with increased risk of pregnancy. no adequate data directly support this hypothesis, and the committee concluded that even with a theoretical increase in risk, the benefits of vaccination would outweigh the potential risk of pregnancy. Therefore, the committee recommended raising the age eligibility for vaccination beyond the maximum age recommended by sage, to maximize vaccine coverage, especially in countries with high rates of childhood mortality due to diarrheal diseases.

Although data support the safety and efficacy of both rotarix and rotateq, ongoing evaluation is needed to provide additional data for the expanded age range. National immunization programs that choose to extend the age eligibility for giving the first dose of rotavirus vaccine to children older than 15 weeks or the last dose to more than 32 weeks should be encouraged to initiate monitoring for efficacy and safety. the rate of intussusception in unvaccinated infants is higher in older infants, and even with the increased risk associated with vaccination, the incidence of intussusception in temporal association with vaccination is higher in infants vaccinated >15 weeks of age than in younger infants. in this case and interpreting the significance of the reported rates will require a systematic approach to internal monitoring. effective risk-communication strategies will also be essential.