The pentavalent rotavirus and monovalent rotavirus vaccines are contraindicated in infants with severe combined immunodeficiency, according to recommendations from the Centers for Disease Control and Prevention.
The agency advised the contraindication in response to reports of vaccine-acquired rotavirus infection developing in infants with severe combined immunodeficiency (SCID) who had received the rotavirus vaccines, according to a report.
Vaccine manufacturers Merck & Co. and GlaxoSmithKline Biologicals had already revised the package inserts for their respective rotavirus vaccine products—RV5 and RV1—with approval from the Food and Drug Administration. Merck revised the labeling for RV5 in December 2009, and GlaxoSmithKline revised its labeling for RV1 in February 2010.
The CDC decided to recommend the contraindication after consulting with the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP), and reviewing the available data.
According to the CDC, SCID “includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T- and B-lymphocyte function,” and the estimated incidence among infants in the United States is approximately 40–100 cases each year. Usually SCID is diagnosed after an infant has acquired a severe or potentially life-threatening infection caused by one or more pathogens, the CDC said (MMWR 2010;59:687–8).
The median age at diagnosis of SCID is 4–7 months, which overlaps with the ages for rotavirus vaccination recommended by ACIP (ages 2, 4, and 6 months for RV5; ages 2 and 4 months for RV1).
Rotavirus vaccination was introduced in the United States in 2006. Since then, the CDC said that five cases of vaccine-acquired rotavirus infection occurred among infants with SCID (four in the United States, one in Australia) who were vaccinated with the RV5.
“Two additional U.S. cases of vaccine-acquired infection in RV5-vaccinated infants with SCID and one case of vaccine-acquired infection in an RV1-vaccinated infant with SCID from outside the United States were reported to the Vaccine Adverse Event Reporting System (VAERS),” according to the report.
All eight infants (four male, four female) were diagnosed with SCID at age 3–9 months and had received one to three doses of rotavirus vaccine before the diagnosis. All the infants had diarrhea, and most had additional infections (such as Pneumocystis jiroveci, rhinovirus, Salmonella, Escherichia coli, and Giardia) at the time of SCID diagnosis, the CDC said.
For infants with “known or suspected altered immunocompetence,” the CDC recommends consultation with an immunologist or infectious disease specialist “before rotavirus vaccine is administered.”