Infant Vaccine Injury May Be Compensated

WASHINGTON (CN) - The Health Resources and Services Administration seeks comments on a proposed regulation that would add intussusception, or bowel blockage, as an compensable injury connected to the rotavirus vaccine given to infants.

The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program, according to the HRSA website. Aside from ensuring a supply of vaccines and stabilized costs, the program provides a forum for people injured by certain vaccines, according to the HRSA.

The program is a no-fault alternative to traditional lawsuits for resolving vaccine injury claims, the agency wrote. It provides compensation for victims, with the U.S. Court of Federal Claims deciding who gets paid. The Department of Justice also plays a role in the program.

Rotavirus is the most common cause of diarrhea in infants and children, which can lead to dehydration. Vaccines are available to defend against rotavirus. Post-market studies in the U.S., Mexico and Brazil, and published in The New England Journal of Medicine in 2011, however, identified an association between one vaccine, Rotarix, and intussusception, according to the HRSA in its action.

If the action is approved, intussusception will be the first injury linked to a rotavirus vaccine listed in the program's Vaccine Injury Table, according to the agency.

Intussusception is a disorder involving a section of intestine telescoping into another part of the intestine, which often blocks food or fluid from passing through, the HRSA noted.

Another rotavirus vaccine, RotaTeq, does not show "a statistically identifiable risk of intussusception, but the number of study patients exposed to the vaccine in the U.S. may not be large enough to rule out a very small attributable risk to the vaccine," according to the HRSA in its action.

The HRSA seeks comments on whether the disorder should be added to the general table under the rotavirus category as an assumed cause of the disorder for claims that meet the requirements published in the table for that injury.

Written comments are due by Jan. 21, 2014. A public hearing on this proposed rule will be held before the end of the public comment period.

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