By Todd Neale, Staff Writer, MedPage Today
Published: June 10, 2010
ATLANTA — Rotavirus vaccine should not be given to infants with severe combined immunodeficiency (SCID), according to new CDC guidance.
The makers of the two live rotavirus vaccines — GlaxoSmithKline Biologicals (Rotarix) and Merck (RotaTeq) — had revised their labels in line with the change in December and February, respectively, with FDA approval.
The CDC announced the addition of severe combined immunodeficiency to the list of contraindications for the vaccines in the June 11 issue of Morbidity and Mortality Weekly Report, following consultations with members of the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP) and a review of the data.
Furthermore, “consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before rotavirus vaccine is administered,” the agency said.
Merck and GlaxoSmithKline Biologicals made the labeling changes in response to eight reports of vaccine-acquired rotavirus infection in infants with severe combined immunodeficiency since the 2006 approval of RotaTeq. Seven were related to the pentavalent RotaTeq and the last was related to the monovalent Rotarix, which was approved in 2008.
Five of the cases — four in the U.S. and one in Australia — were reported in the literature and another three — two in the U.S. and one from outside the U.S. — were reported to the Vaccine Adverse Event Reporting System.
All of the infants, who were diagnosed with severe combined immunodeficiency at between 3 and 9 months of age and had received at least one dose of the vaccine before diagnosis, had diarrhea from the rotavirus infection.
In all eight cases, vaccine-acquired rotavirus infection was confirmed by reverse-transcription-polymerase chain reaction and nucleotide sequencing.
Prolonged shedding of the virus was documented in at least six cases with a duration of up to 11 months.
For infants in whom it is not contraindicated, rotavirus vaccination is recommended by ACIP in three doses at ages 2, 4, and 6 months for RotaTeq and in two doses at ages 2 and 4 months for Rotarix.