Rotavirus Prescribing Information, Labeling Changed

Change due to reports of immunodeficient infants with vaccine-acquired rotavirus infection
By Lindsey Marcellin
HealthDay Reporter

FRIDAY, June 11 (HealthDay News) -- New prescribing information and patient labeling for rotavirus vaccines has been approved by the U.S. Food and Drug Administration in response to reports of vaccine-acquired rotavirus infection in infants with severe combined immunodeficiency disorder (SCID), according to a report published in the June 11 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

Both types of rotavirus vaccine -- the pentavalent (RV5) vaccine manufactured by Merck, and the monovalent (RV1) vaccine manufactured by GlaxoSmithKline -- have received FDA approval for their new labeling. Since rotavirus vaccination began in 2006 in the United States, there have been five cases of vaccine-acquired rotavirus in infants with SCID reported in the medical literature, and an additional three cases reported to the Vaccine Adverse Event Reporting System. Seven of the eight cases were in infants vaccinated with RV5, and all were confirmed as being vaccine-acquired by reverse transcriptase polymerase chain reaction and nucleotide sequencing. All of the infants presented with diarrhea, and most had additional microbial pathogens at the time of diagnosis.

SCID occurs in approximately 40 to 100 infants in the United States each year, and the median age at diagnosis is 4 to 7 months. SCID includes life-threatening disorders caused by 15 or more single gene defects resulting in profound deficiencies in T- and B-lymphocyte function.

"Rotavirus vaccine (both RV5 and RV1) is contraindicated in infants diagnosed with SCID. Consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before rotavirus vaccine is administered," per the report.

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