794. Adverse events following rotavirus vaccination in immunocompromised infants: Reports to the Vaccine Adverse Event Reporting System (VAERS) 2006- 2015
Session: Poster Abstract Session: Vaccines: Safety and Adverse Events
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • IDWeek _Rotavirus Abstract-Number 794.pdf (231.8 kB)
  • Background:

    Prolonged vaccine-acquired rotavirus infection is known to occur in infants with severe combined immunodeficiency disease (SCID) after US-licensed live-attenuated rotavirus vaccine (RV). Some data support RV use in Human Immunodeficiency Virus (HIV) infection, but data for other immunocompromising conditions (IC), including in-utero exposure to monoclonal antibodies (MAB), are limited.

    We characterize adverse events (AE) after RV in infants with IC reported to the Vaccine Adverse Event Reporting System (VAERS).

    Methods:

    We searched VAERS, a US passive surveillance system, for RV reports received from 02/2006 – 12/2015 in infants with IC. Potential IC were identified using standard coding terms and a text string search for MAB. Reports were reviewed to verify the diagnosis and describe the primary AE, without assessing AE causality.

    Results:

    Of 17,473 RV reports, 91 met search criteria for potential IC; 33% (30/91) had confirmed IC. No report described in-utero MAB exposure. The median vaccination age was 2 months. Only 2 reported RV administration after IC diagnosis (HIV). Diarrhea was the most common primary AE reported (Table).

       

     

    IC (n)

    Primary AEs (n)

    Hospitalized

     (n)

    Number of Deaths

    Reported Cause

    SCID (17)

    Diarrhea (13)c

    Pneumonia (1)

    Failure to thrive (1)

    Rotavirus viremia (1)

    None (1) d

    14

    2

    Pneumonia; Unknown

    Antibody deficiency a (5)

    Diarrhea (4) c

    Eczema (1)

    4

    0

    Perforin deficiency (3)

    Hemophagocytic syndrome (3)

    3

    0

    HIV infection (2)

    Diarrhea (1) c

    Pneumonia (1)

    1

    1

    Respiratory failure

    DiGeorge syndrome (1)

    Bronchiolitis (1)

    1

    0

    Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) Syndrome (1)

    Diarrhea (1) c

     

    1

    1

    Human bocavirus infection

    Secondary immunodeficiency b (1)

    Diarrhea (1) c

     

    1

    0

    a Hypogammaglobinemia=3, IgA deficiency=1, Unspecified antibody deficiency=1

    bHypogammaglobulinemia and low T-cells due to protein-losing enteropathy

    c  Stool tested for rotavirus 19 (13 SCID, 6 non-SCID); 11 positive. Vaccine strain virus identified in 9 (8 SCID, 1 IPEX)

    d Vaccination error

    Conclusion:

    AE after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to MAB.

    A. Patricia Wodi, MD1, Oidda Museru, MSN, MPH1, Laura Polakowski, MD, MSPH2, Pedro Moro, MD, MPH1, Paige Lewis, MSPH1, Margaret Cortese, MD3 and Karen Broder, MD1, (1)Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, GA, (2)US Food and Drug Administration, Silver Spring, MD, (3)National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA

    Disclosures:

    A. P. Wodi, None

    O. Museru, The Centers for Diseases Control and Prevention (CDC): Employee , Salary

    L. Polakowski, None

    P. Moro, None

    P. Lewis, None

    M. Cortese, None

    K. Broder, None

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.