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SCID added as contraindication for rotavirus vaccines
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GlaxoSmithKline and Merck have updated the patient labeling and prescribing information for their respective rotavirus vaccines to include severe combined immunodeficiency (SCID) as a contraindication, according to a recently published report.
The CDC added the contraindication after reviewing available research and consulting with members of the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices.
“Consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before rotavirus vaccine is administered,” the researchers wrote.
Reports of vaccine-acquired rotavirus infection in infants with SCID who had received the penatavalent (RV5, RotaTeq, Merck) or monovalent rotavirus vaccine (RV1, Rotarix, GlaxoSmithKline) prompted the CDC’s discussion and data review. Seven cases — six in the United States and one in Australia — were linked to RV5, and one occurring outside the United States was related to RV1. Five of these cases surfaced in literature on the subject, according to the CDC, while the other three were found via the Vaccine Adverse Event Reporting System.
All infants had received one to three doses of vaccine before SCID diagnosis — which, for all, occurred between ages 3 and 9 months. They also all experienced diarrhea at the time of diagnosis, and most had additional infections, such as Pneumocystis jirovecii, rhinovirus or Salmonella. Prolonged shedding of vaccine virus, lasting up to 11 months, was noted in at least six infants.
Enzyme immunoassay was used to diagnose rotavirus infection in seven of the eight infants, and this diagnosis was confirmed by reverse transcription-polymerase chain reaction and nucleotide sequencing for all patients.