Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities
Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an “industrialized process” approach and (vi) political safe harbor.
References
[1]
Chen, R.T.; Glasser, J.W.; Rhodes, P.H.; Davis, R.L.; Barlow, W.E.; Thompson, R.S.; Mullooly, J.P.; Black, S.B.; Shinefield, H.R.; Vadheim, C.M.; et al. Vaccine Safety Datalink project: A new tool for improving vaccine safety monitoring in the United States. Pediatrics 1997, 99, 765–773, doi:10.1542/peds.99.6.765.
[2]
Baggs, J.; Gee, J.; Lewis, E.; Fowler, G.; Benson, P.; Lieu, T.; Naleway, A.; Klein, N.P.; Baxter, R.; Belongia, E.; et al. The Vaccine Safety Datalink: A model for monitoring immunization safety. Pediatrics 2011, 127, S45–S53, doi:10.1542/peds.2010-1722H.
[3]
Zhou, W.; Pool, V.; Iskander, J.K.; English-Bullard, R.; Ball, R.; Wise, R.P.; Haber, P.; Pless, R.P.; Mootrey, G.; Ellenberg, S.S.; et al. Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS)—United States 1991–2001. Morb. Mortal. Weekly Report 2003, 52, 1–24.
[4]
Taylor, B.; Miller, E.; Farrington, C.P.; Petropoulos, M.C.; Favot-Mayaud, I.; Li, J.; Waight, P.A. Autism and measles, mumps, and rubella vaccine: No epidemiological evidence for a causal association. Lancet 1999, 353, 2026–2029.
[5]
Skowronski, D.M.; Strauss, B.; De Serres, G.; MacDonald, D.; Marion, S.A.; Naus, M.; Patrick, D.M.; Kendall, P. Oculo-respiratory syndrome: A new influenza vaccine-associated adverse event? Clin. Infect. Dis. 2003, 36, 705–713, doi:10.1086/367667.
[6]
Sun, Y.; Christensen, J.; Hviid, A.; Li, J.; Vedsted, P.; Olsen, J.; Vestergaard, M. Risk of Febrile Seizurs and Epilepsy After Vaccination with Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, and Haemophilus Influenzae Type b. J. Am. Med. Assoc. 2012, 307, 823–831, doi:10.1001/jama.2012.165.
[7]
Liang, X.F.; Liu, D.W.; Li, K.L.; Wu, W.D.; Zhu, B.P.; Wang, H.Q.; Luo, H.M.; Cao, L.S.; Zheng, J.S.; Yin, D.P.; et al. Safety of Influenza A (H1N1) Vaccine in Postmarketing Surveillance in China. N. Engl. J. Med. 2011, 364, 638–647, doi:10.1056/NEJMoa1008553.
[8]
Ali, M.; Do, C.G.; Clemens, J.D.; Park, J.K.; von Seidlein, L.; Truong, M.T.; Vu, T.D.; Le, T.H.; Dang, T.D. The use of a computerized database to monitor vaccine safety in Viet Nam. Bull. World Health Organ. 2005, 83, 604–610.
[9]
Barlow, W.E.; Davis, R.L.; Glasser, J.W.; Rhodes, P.H.; Thompson, R.S.; Mullooly, J.P.; Black, S.B.; Shinefield, H.R.; Ward, J.I.; Marcy, S.M.; et al. Centers for Disease Control and Prevention Vaccine Safety Datalink Working Group. The risk of seizures after receipt of whole-cell pertussis or measles, mumps and rubella vaccine. N. Engl. J. Med. 2001, 345, 656–661, doi:10.1056/NEJMoa003077.
[10]
Thompson, W.W.; Price, C.; Goodson, B.; Shay, D.K.; Benson, P.; Hinrichsen, V.L.; Lewis, E.; Eriksen, E.; Ray, P.; Marcy, S.M.; et al. Vaccine Safety Datalink Team. Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years. N. Engl. J. Med. 2007, 357, 1281–1292, doi:10.1056/NEJMoa071434.
[11]
Price, C.S.; Thompson, W.W.; Goodson, B.; Weintraub, E.S.; Croen, L.A.; Hinrichsen, V.L.; Marcy, M.; Robertson, A.; Eriksen, E.; Lewis, E.; et al. Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism. Pediatrics 2010, 126, 656–664, doi:10.1542/peds.2010-0309.
[12]
France, E.K.; Glanz, J.; Xu, S.; Hambidge, S.; Yamasaki, K.; Black, S.B.; Marcy, M.; Mullooly, J.P.; Jackson, L.A.; Nordin, J.; et al. Vaccine Safety Datalink Team. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics 2008, 121, e687–e692, doi:10.1542/peds.2007-1578.
[13]
Horton, R. Vioxx, the implosion of Merck, and aftershocks at the FDA. Lancet 2004, 364, 1995–1996, doi:10.1016/S0140-6736(04)17523-5.
[14]
Topol, E.J. Failing the Public Health-Rofecoxib, Merck, and the FDA. N. Engl. J. Med. 2004, 351, 1707–1708, doi:10.1056/NEJMp048286.
[15]
Centers for Disease Control and Prevention. Rotavirusvaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb. Mortal. Weekly Report 1999, 48, 1–20.
[16]
Committee on Infectious Disases. Prevention of rotavirus disease: Guidelines for use of rotavirus vaccine. Pediatrics 1998, 102, 1483–1491, doi:10.1542/peds.102.6.1483.
[17]
Murphy, T.V.; Gargiullo, P.M.; Massoudi, M.S.; Nelson, D.B.; Jumaan, A.O.; Okoro, C.A.; Zanardi, L.R.; Setia, S.; Fair, E.; LeBaron, C.W.; et al. Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine. N. Engl. J. Med. 2001, 344, 564–572, doi:10.1056/NEJM200102223440804.
[18]
Kramarz, P.; France, E.K.; DeStefano, F.; Black, S.B.; Shinefield, H.; Ward, J.I.; Chang, E.J.; Chen, R.T.; Shatin, D.; Jerrold, H.; et al. Population-based study of rotavirus vaccination and intussusception. Pediatr. Infect. Dis. J. 2001, 20, 410–416, doi:10.1097/00006454-200104000-00008.
[19]
Ellenberg, S.S.; Foulkes, M.A.; Midthun, K.; Goldenthal, K.L. Evaluating the Safety of New Vaccines: Summary of a Workshop. Am. J. Public Health 2005, 95, 800–807, doi:10.2105/AJPH.2004.039438.
[20]
Davis, R.L.; Kolczak, M.; Lewis, E.; Goodman, M.; Shay, D.K.; Platt, R.; Black, S.; Shinefield, H.; Chen, R.T. Active surveillance of vaccine safety: A system to detect early signs of adverse events. Epidemiology 2005, 16, 336–341, doi:10.1097/01.ede.0000155506.05636.a4.
[21]
Vaccine Safety at Centers for Disease Control and Prevention Home Page, Available online: http://www.cdc.gov/vaccinesafety/Activities/vsd/rca.html (accessed on 8 March 2013).
[22]
Centers for Disease Control and Prevention. Prevention and control of meningococcal disease; recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb. Mortal. Weekly Report 2005, 54, RR07:1–RR07:21.
[23]
Centers for Disease Control and Prevention. Guillain-Barre syndrome among recipients of Menactra—Meningococcal conjugate vaccine—United States, June–July 2005. Morb. Mortal. Weekly Report 2005, 54, 1023–1025.
[24]
Centers for Disease Control and Prevention. Update: Guillain-Barre syndrome among recipients of Menactra—meningococcal conjugate vaccine—United States, June 2005–September 2006. Morb. Mortal. Weekly Report 2006, 55, 1120–1124.
[25]
Advisory Committee on Immunization Practices. Use of Combination Measles, Mumps, Rubella and Varicella Vaccine. Recommendations from the Advisory Committee on Immunization Practices (ACIP). Morb. Mortal. Weekly Report 2007, 59, RR03:1–RR03:12.
[26]
Kulldorff, M.; Davis, R.L.; Kolczak, M.; Lewis, E.; Lieu, T.; Platt, R. A maximized sequential probability ratio test for Drug and Vaccine Safety Surveillance. Sequential Analysis 2011, 30, 58–78, doi:10.1080/07474946.2011.539924.
[27]
Lieu, T.A.; Kulldorff, M.; Davis, R.L.; Lewis, E.M.; Weintraub, E.; Yih, K.W.; Yin, R.; Brown, J.S.; Platt, R. Real-Time Vaccine Safety Surveillance for the Early Detection of Adverse Events. Med. Care 2007, 45, S89–S95.
[28]
Yih, W.K.; Nordin, J.D.; Kulldorff, M.; Lewis, E.; Lieu, T.; Shi, P.; Weintraub, E. An Assessment of the Safety of Adolescent and Adult Tetanus-Diphtheria-Acellular Pertussis (Tdap) Vaccine, Using Active Surveillance for Adverse Events in the Vaccine Safety Datalink. Vaccine 2009, 27, 4257–4262.
[29]
Belongia, E.A.; Irving, S.A.; Shui, I.M.; Kulldorff, M.; Lewis, E.; Yin, R.; Lieu, T.A.; Weintraub, E.; Yih, W.K.; Li, R.; et al. Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events after Pentavalent, Bovine-Derived Rotavirus Vaccine. Pediatr. Infect. Dis. J. 2010, 29, 1–5, doi:10.1097/INF.0b013e3181af8605.
[30]
Klein, N.P.; Fireman, B.; Yih, W.K.; Lewis, E.; Kulldorff, M.; Ray, P.; Baxter, R.; Hambidge, S.; Nordin, J.; Naleway, A.; et al. For the Vaccine Safety Datalink. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures. Pediatrics 2010, 126, e1–e8, doi:10.1542/peds.2010-0665.
[31]
Yih, W.K.; Kulldorff, M.; Fireman, B.H.; Shui, I.M.; Lewis, E.M.; Klein, N.P.; Baggs, J.; Weintraub, E.S.; Belongia, E.A.; et al. Active surveillance for adverse events: The experience of the vaccine safety datalink project. Pediatrics 2011, 127, S54–S64, doi:10.1542/peds.2010-1722I.
