From Meryl Nass, MD
This article basically says there is at least a 20 fold greater chance of
developing intussusception 3-14 days after rotavirus vaccine than if you
had no vaccine during that period. Yet it took years to definitively
identify this adverse reaction
The New England Journal of Medicine -- February 22, 2001 -- Vol. 344,
Intussusception among Infants Given an Oral Rotavirus Vaccine
Trudy V. Murphy, Paul M. Gargiullo, Mehran S. Massoudi, David B. Nelson,
Aisha O. Jumaan, Catherine A. Okoro, Lynn R. Zanardi, Sabeena Setia,
Fair, Charles W. LeBaron, Benjamin Schwartz, Melinda Wharton, John R.
Livingood, for the Rotavirus Intussusception Investigation Team
Background. Intussusception is a form of intestinal
obstruction in which a segment of the bowel prolapses into a more distal
segment. Our investigation
began on May 27, 1999, after nine cases of infants who had
intussusception after receiving the tetravalent rhesus-human reassortant
(RRV-TV) were reported to the Vaccine Adverse Event Reporting
Methods. In 19 states, we assessed the potential association
between RRV-TV and intussusception among infants at least 1 but less
than 12 months
old. Infants hospitalized between November 1, 1998, and June
30, 1999, were identified by systematic reviews of medical and
Each infant with intussusception was matched according to age
with four healthy control infants who had been born at the same hospital
as the infant
with intussusception. Information on vaccinations was verified
by the provider.
Results. Data were analyzed for 429 infants with
intussusception and 1763 matched controls in a case-control analysis as
well as for 432 infants with
intussusception in a case-series analysis. Seventy-four of the
429 infants with intussusception (17.2 percent) and 226 of the 1763
percent) had received RRV-TV (P=0.02). An increased risk of
intussusception 3 to 14 days after the first dose of RRV-TV was found in
case-control analysis (adjusted odds ratio, 21.7; 95 percent
confidence interval, 9.6 to 48.9). In the case-series analysis, the
incidence-rate ratio was
29.4 (95 percent confidence interval, 16.1 to 53.6) for days 3
through 14 after a first dose. There was also an increase in the risk of
after the second dose of the vaccine, but it was smaller than
the increase in risk after the first dose. Assuming full implementation
of a national program
of vaccination with RRV-TV, we estimated that 1 case of
intussusception attributable to the vaccine would occur for every 4670
to 9474 infants
Conclusions. The strong association between vaccination with
RRV-TV and intussusception among otherwise healthy infants supports the
existence of a
causal relation. Rotavirus vaccines with an improved safety
profile are urgently needed. (N Engl J Med 2001;344:564-72.)
From the Epidemiology and Surveillance Division (T.V.M.,
P.M.G., D.B.N., A.O.J., L.R.Z., E.F., C.W.L., M.W., J.R.L.), the
Division (M.S.M., S.S.), and the Data Management Division
(C.A.O., P.M.G.), National Immunization Program, Centers for Disease
Prevention, Atlanta. Address reprint requests to Dr. Murphy at
the Epidemiology and Surveillance Division, National Immunization
Clifton Rd. NE, Mail Stop E-61, Atlanta, GA 30333, or at
The members of the Rotavirus Intussusception Investigation
Team are listed in the Appendix.
The members of the Rotavirus Intussusception Investigation
Team were as follows: State and City Health Departments: California
State Department of
Health Services -- K.C. Cummings, A.C. Kimura, C. O'Malley
(primary investigator), G. Rothrock, N. Smith, and D.J. Vugia; Chicago
Public Health -- I. Ramos and U. Samala; Georgia Department of
Human Resources, Division of Public Health -- K. Arnold (primary
Robmann (primary investigator), L. Scott, T. Seegmueller, G.
Siebert, and T. Turski; Illinois Department of Public Health -- M.
Andreasen, D. Bartling,
J. Daniels, M.H. Fahrenwald, S. Frederick, J. Girdley, C.
Jennings (primary investigator), J.E. Lang, M. Nappi (primary
investigator), D. Rowe, and
S.W. Smith; Indiana State Department of Health -- D. Bixler
(primary investigator), J. Butwin, S. Fang, B. Sheets, W. Staggs, and R.
investigator); Maryland Department of Health and Mental
Hygiene -- D.M. Dwyer (primary investigator), M.A. Harder, W. Lane, B.
Roche, S. Schoenfeld, and N. Thayer; Michigan Department of
Community Health -- J. Blostein, M. Matuck (primary investigator), A.
Stoltman (primary investigator), and P. Vranesich; Minnesota
Department of Health -- S. Alcorn, L. Anderson, S. Brenner, K.
Danila (primary investigator), K. Ehresmann (primary
investigator), L. Ehrlich, F. Fong, D. Hiatt, T. Jenkins, R. Kynfield,
K. LeDell, C. Lexau, J. Liu, J.
Loos, P. Lynch, H. Margellos, C. Miller, C. Olson, J. Rainbow,
M. Raymond, K. Russel, B. Sayler, E. Swanson, L. Triden, and K. White;
Department of Health -- D. Donnell (primary investigator), F.
Kahn, F. Lyndon, H. Marx, M.F. Skala, V. Tomlinson (primary
investigator), and M.
Warwick (primary investigator); Nebraska Health and Human
Services System -- C. Allensworth, G. Borden (primary investigator), and
(primary investigator); New Jersey Department of Health and
Senior Services -- K. Aquino, E. Bresnitz (primary investigator), K.
Byrd, L. Charland,
A. Farrell, L. Franklin, M.P. Gerwel (primary investigator),
F. Jennes, D. Lipira, R. Marler, C. O'Donnell (primary investigator), J.
Stanbury, and V.P. Yarmlak; New York State Department of
Health -- B. Arthur, M. Amyot, B. Anderson, R. Bentowski, B.
Burke, K. Cardina, R. Colvin, A. Dunham, E. Foster, R. Gioia,
A. Grzelecki, S. Hayes, D. Hilfsein, G. McPhee, P. Moran, B. Naizby, M.
C. O'Conner-Walker, P. O'Hanlon (primary investigator), J.
Ranches, M. Serunkuuma, R. Stiles-Tice, N. Spina, H. Tetley, and C.
Waters; New York
City Department of Health -- N. Bradford, A. Delgado, S.
Friedman, R. Gross, C. Hernandez, M. Holland (primary investigator), M.
investigator), D. Meyers, B. Mojica, E. Morgan, S. Rubin, A.
Seaborough, M. Simmons, and M. Straker; North Carolina Department of
Human Services -- N. Macormack, A. Pope (primary
investigator), B. Rowe-West, K. Ryan, and K. Southwick (primary
Department of Health -- M. DiOrio (primary investigator), E.
Koch (primary investigator), and F. Smith; Pennsylvania Department of
Public Health --
C.M. Baysinger, C. Berringer, P.H. Britz, S. Carlson, P.J.
Crawford, J.M. Dormann, A. Gray, R. Groner, D. Hawk, C. Johnson, C.
Kuti, A. Ligi, K.
Lindahl, P. Lurie (primary investigator), J. Lutz, M. Maron,
J. McMahon, S. Miller (primary investigator), P. Montalbano, S.
Silvestri, D. Sowa, L.M.
Stetson, C. Teacher, S. Thomas, L. Van Parijs, A. Yang, and
S.H. Yeager; South Carolina Department of Health and Environmental
Control -- J.
Gibson, J. Iskander (primary investigator), and D. Roberts;
Tennessee Department of Health -- C. Alexander, D. Arnold, B. Barnes, L.
Bilbro, E. Booth, C. Brady, V. Brinsko, L. Cathey, M.E.
Chesser, A.S. Craig (primary investigator), E. Dickey, T. Finke, J.
Fowler, L. Gaspard, S.
Hall, R.M. Heller, I. Himelright, T. Jones, D. Levine, J.
Narramore (primary investigator), J. Painter, K. Shields, S. Slavinski,
M. Snowden, T.
Spillman, G. Swinger, R. Taylor, and G. Young; Texas
Department of Health -- D. Evans, A. Friedman, O. Gonzalez, L. Henefy,
J. Jackson, R. Jones,
C. Kilborn, M.J. Lowrey, D.M. Perrotta (primary investigator),
D. Romnes, J. Shultz-Banks, M. Smoot, N. Walae, and B. Walsh; Virginia
Department -- H. Callaway, C. Chandross, A. Colon, A. Cornell,
M. Escasenas, A. Greeley, A. Guyet, M. Hemenway, A. Jindal, S. Jones, T.
Morgan, R. Nixon, A. Redmond, S. Redmond, B. Rouse, J. Spence,
R.B. Stroube, S. Stuckey, L. Vasquez, and D. Woolard (primary
and Wisconsin Department of Health and Family Services -- J.P.
Davis (primary investigator) and M. Schuknecht. Epidemic Intelligence
Officers and Preventive Medicine Residents of the CDC (all of
whom served as primary or secondary investigators assigned to the state
indicated): J. Ackelsberg (New York), A. Anderson (Ohio), E.
Bancroft (California), L. Barnes (Tennessee), K. Becker (North
Carolina), C. Benally
(Texas), D.S.B. Blythe (Maryland), R. Burr (Pennsylvania), M.
Cortese (Chicago), H. Dao (Indiana), I. Gonzalez (Missouri), L.
Hasbrouck (Texas), J.
Heffelfinger (New York City), A. Karpati (New Jersey), K.
Kohler (Indiana), V. Lamar (Ohio), S. Lister (Pennsylvania), C. Lockett
Lyss (New York City), K. McDuffie (Texas), S. McLaughlin
(South Carolina), F. Mostashari (New York City), T. Naimi (Minnesota),
(Missouri), J. Perz (Tennessee), E. Quiroz (Ohio), A. Ramsey
(Wisconsin), D. Raymond (Michigan), M. Reynolds (Pennsylvania), J.
(Virginia), J. Samuelson (Georgia), S. Santibanez (Nebraska),
T. Tiwari (Texas), T.H.F. Tsang (California), A. Uzicanin (New York
Verstraeten (Illinois), M. Wilkins (Michigan), K. Williams
(Georgia), and J. Zevallos (Texas). Commissioned Corps, Public Health
Epidemiologists, and Other Staff at the CDC: J. Alexander, J.
Alongi, E. Alvarado, L. Boseman, R. Chen, K. Cox, C. Curwick, H. Dang,
L. Fehrs, E. Finch, L. Galloway, A. Golaz, E. Graves, D.
Hamilton, R. Harpaz, C. Hill, C.K. Jalonen, D. Jarvis, M. Kownaski, W.
Lasota, R. Nelson,
U. Parashar, A. Pelletier, B.A. Prescott, R. Prevots, K. Reed,
L. Rodewald, S. Roush, J. Seward, K. Sharp, K. Stout, J. Tuyen, C.
Weisbord, E. West, B. Wilson, E. Yacovone, and L. Zimmerman.
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