Active surveillance of vaccine safety - A system to detect early signs of adverse events

被引:98
作者
Davis, RL
Kolczak, M
Lewis, E
Nordin, J
Goodman, M
Shay, DK
Platt, R
Black, S
Shinefield, H
Chen, RT
机构
[1] CDC, Off Genom & Dis Prevent, Coordinating Ctr Hlth Promot, Atlanta, GA 30341 USA
[2] Univ Washington, Dept Epidemiol, Seattle, WA 98195 USA
[3] Univ Washington, Dept Pediat, Seattle, WA 98195 USA
[4] Kaiser Permanente No Calif, Vaccine Study Ctr, Oakland, CA USA
[5] Hlth Partners Res Fdn, Minneapolis, MN USA
[6] Harvard Pilgrim, Boston, MA USA
[7] Harvard Vanguard, Boston, MA USA
关键词
D O I
10.1097/01.ede.0000155506.05636.a4
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Background: There currently are no population-based systems in the United States to rapidly detect adverse events after newly introduced vaccines. To evaluate the feasibility of developing such systems, we used 5 years of data from 4 health maintenance organizations within the Centers for Disease Control and Prevention (CDC) Vaccine Safety Datalink. Methods: Within every year, each week's vaccinated children were followed for 4 weeks, and rates of adverse events were compared with rates among children of similar ages before the introduction of the new vaccine. We assessed risks for intussusception after rotavirus vaccination and risks for fever, seizures, and other neurologic adverse events after the change from whole cell diphtheria-tetanuspertussis (DTPw) to acellular DTP vaccine (DTPa). We used sequential probability ratio testing, adjusted for age, sex, calendar time, season, and HMO, and with a stopping value based on the probability of an adverse event under the null hypothesis and under a preset alternative hypothesis. Results: We detected an increase in intussusception after 2589 vaccine doses of rotavirus vaccine, about the same time initial reports of intussusception were made to the Vaccine Adverse Events Reporting System. Decreases in risk for fever, seizures, and other abnormal neurologic events became detectable within 12 weeks, 42 weeks, and 18 months, respectively, after the change from DTPw to DTPa. Conclusions: We conclude that it is feasible to develop systems for rapid and routine population-based assessments of new vaccine safety.
引用
收藏
页码:336 / 341
页数:6
相关论文
共 15 条
  • [1] [Anonymous], MMWR
  • [2] *CDCP, 2003, MMWR-MORBID MORTAL W, V52, P639
  • [3] CHEN R, 2003, VACCINES
  • [4] THE VACCINE-ADVERSE-EVENT-REPORTING-SYSTEM (VAERS)
    CHEN, RT
    RASTOGI, SC
    MULLEN, JR
    HAYES, SW
    COCHI, SL
    DONLON, JA
    WASSILAK, SG
    [J]. VACCINE, 1994, 12 (06) : 542 - 550
  • [5] Vaccine Safety Datalink project: A new tool for improving vaccine safety monitoring in the United States
    Chen, RT
    Glasser, JW
    Rhodes, PH
    Davis, RL
    Barlow, WE
    Thompson, RS
    Mullooly, JP
    Black, SB
    Shinefield, HR
    Vadheim, CM
    Marcy, SM
    Ward, JI
    Wise, RP
    Wassilak, SG
    Hadler, SC
    Swint, E
    Hardy, JR
    Payne, T
    Immanuel, V
    Benson, P
    Draket, J
    Drew, L
    Mendius, B
    Ray, P
    Lewis, N
    Fireman, BH
    Jing, J
    Wulfsohn, M
    Lugg, MM
    Osborne, P
    Rastogi, S
    Patriarca, P
    Caserta, V
    [J]. PEDIATRICS, 1997, 99 (06) : 765 - 773
  • [6] Acellular pertussis vaccines
    Decker, MD
    Edwards, KM
    [J]. PEDIATRIC CLINICS OF NORTH AMERICA, 2000, 47 (02) : 309 - +
  • [7] Safety considerations for new vaccine development
    Ellenberg, SS
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2001, 10 (05) : 411 - 415
  • [8] Use of risk-adjusted CUSUM and RSPRT charts for monitoring in medical contexts
    Grigg, OA
    Farewell, VT
    Spiegelhalter, DJ
    [J]. STATISTICAL METHODS IN MEDICAL RESEARCH, 2003, 12 (02) : 147 - 170
  • [9] Population-based study of rotavirus vaccination and intussusception
    Kramarz, P
    France, EK
    Destefano, F
    Black, SB
    Shinefield, H
    Ward, JI
    Chang, EJ
    Chen, RT
    Shatin, D
    Hill, J
    Lieu, T
    Ogren, JM
    [J]. PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2001, 20 (04) : 410 - 416
  • [10] Intussusception among infants given an oral rotavirus vaccine.
    Murphy, TV
    Gargiullo, PM
    Massoudi, MS
    Nelson, DB
    Jumaan, AO
    Okoro, CA
    Zanardi, LR
    Setia, S
    Fair, E
    LeBaron, CW
    Schwartz, B
    Wharton, M
    Livingood, JR
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (08) : 564 - 572