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U.S. Department of Health and Human Services

Advisory Committees

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Rotarix: Labeling Change Information

Update for the Pediatric Advisory Committee to the U.S. FDA: Infants with Severe Combined Immunodeficiency Disease (SCID) diagnosed after receipt of live, oral rotavirus vaccine

ROTARIX® was licensed by FDA on April 3, 2008.  The Warnings and Precautions section of the label states: "Safety and effectiveness of ROTARIX in infants with known primary or secondary immunodeficiencies, including infants with human immunodeficiency virus (HIV), infants on immunosuppressive therapy, or infants with malignant neoplasms affecting the bone marrow or lymphatic system have not been evaluated."

In the past year, reports both in the literature 1,2  and to VAERS, have described infants who developed severe gastroenteritis (sometimes with prolonged vaccine viral shedding) following receipt of a live, oral rotavirus vaccine, and later were identified to have SCID. Three SCID cases were recently reported following administration of RotaTeq®. 1 Through 10/31/2009, VAERS received one report from outside the U.S. about a boy with SCID recognized only after he received ROTARIX.  This 3 month old male developed rotavirus gastroenteritis 33 days after his 2nd dose of ROTARIX, prior to his diagnosis of SCID.

After review of these reports, FDA revised the package insert and patient package insert for both rotavirus vaccines and listed SCID as a contraindication for use of a live oral rotavirus vaccine.  The ROTARIX label revision was completed on February 22, 2010.

SCID occurs in approximately 1 in 50,000-75,000 live births.3  The average age at the onset of symptoms is 2 months, which is also the age at which US infants routinely receive a first dose of live, oral rotavirus vaccine. The cases of SCID reported after receipt of live, oral rotavirus vaccine were infants not previously known to have an underlying immunodeficiency.

On 1/21/2010, the Secretary’s Advisory Committee for Heritable Disorders in Newborns and Children (ACHDNC) recommended addition of SCID to the newborn screening panel. Earlier diagnosis of SCID should provide an opportunity for earlier intervention and improved outcomes and would also help to identify infants who should not receive live, oral rotavirus vaccine.

  1. Patel NC et al.  Vaccine-acquired rotavirus in infants with severe combined immunodeficiency. N Engl J Med 2010; 362(4): 314-9.
  2. Werther RL et al.  Rotavirus vaccine induced diarrhea in a child with severe combined immune deficiency. Journal Allergy Clin Immunol 2009; 124 (3): 600.
  3. Secord EA, Oren E.  Severe Combined Immunodeficiency disease. Updated May 5, 2009.  Available from: http://emedicine.medscape.com/article/137265-overview   Accessed 15 February 2010.