Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to American Journal of Preventive MedicineReferences
- A call to action for the new decade of vaccines.Lancet. 2011; 378: 298-302
- Measles outbreak – California, December 2014–February 2015.MMWR Morb Mort Wkl Report. 2015; 64: 153-154
- Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.Lancet. 1998; 351: 637-641
- Retraction – Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.Lancet. 2010; 375: 445
- Vaccines are not associated with autism: an evidence-based meta-analysis of case–control and cohort studies.Vaccine. 2014; 32: 3623-3629
- Safety of vaccines used for routine immunization of U.S. children: a systematic review.Pediatrics. 2014; 134: 325-337
- Geographic clusters in under immunization and vaccine refusal.Pediatrics. 2015; 135: 280-289
- Impact of anti-vaccine movements on pertussis control: the untold story.Lancet. 1998; 351: 356-361
- Hepatitis B vaccination and French Society ten years after the suspension of the vaccination campaign: how should we raise infant immunization coverage rates?.J Clin Virol. 2009; 46: 202-205
- What led to the Nigerian boycott of the polio vaccination campaign?.PLoS Med. 2007; 4: e73
- Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action.Lancet Infect Dis. 2014; 14: 227-238
- Vaccine Special Issue on Vaccine Hesitancy.Vaccine. 2015; 33: 4155-4156
- Editors’ introduction: vaccine safety throughout the product life cycle.Pediatrics. 2011; 127: S1-S4
- The Vaccine Adverse Event Reporting System (VAERS).Vaccine. 1994; 12: 542-550
- Routine childhood vaccination against smallpox reconsidered.N Engl J Med. 1969; 281: 1220-1224
- Smallpox and its eradication. World Health Organization, Geneva1988
- Poliomyelitis prevention in the United States. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR Recomm Rep. 2000; 49 (quiz CE1–7): 1-22
- Polio endgame: the global introduction of inactivated polio vaccine.Expert Rev Vaccines. 2015; 14: 749-762
- National childhood vaccine injury compensation act.Pediatrics. 1988; 82: 264-269
- Comparative effectiveness of acellular versus whole-cell pertussis vaccines in teenagers.Pediatrics. 2013; 131: e1716-e1722
- Recommendations of the International Task Force for Disease Eradication.MMWR Recomm Rep. 1993; 42: 1-38
- Pertussis vaccine encephalopathy: ’Oh! Let us never, never doubt’….Dev Med Child Neurol. 2010; 52: 883-884
- The first pharmacoepidemiologic investigations: national drug safety policy in the United States, 1901–1902.Perspect Biol Med. 2008; 51: 188-198
- Regulation and testing of vaccines.in: Plotkin S.A. Orenstein W.A. Offit P.A. Vaccines. 6th ed. Saunders, Edinburgh2012: 1427-1446
- Vaccine analysis: strategies, principles, and control.1st ed. Springer, New York, NY2014
- Current Good Manufacturing Practice Requirements for Combination Products.Federal Register. 2013; : 4307-4323
- Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines. EMA/CHMP/VWP/141697/2009 ed.European Medicines Agency, London2010 ([Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/08/WC500095721.pdf)
- WHO Expert Committee on Biological Standardization.World Health Organ Tech Rep Ser. 2015; : 63-87
- A global regulatory science agenda for vaccines.Vaccine. 2013; 31: B163-B175
- CBER Strategic Plan for Regulatory Science and Research.2012
- Developing Countries Vaccine Manufacturers Network: doing good by making high-quality vaccines affordable for all.Vaccine. 2013; 31: B176-B183
- Regulation of vaccines in developing countries.in: Plotkin S. Orenstein W.A. Offit P.A. Vaccines. 6th ed. Saunders, Edinburgh2012: 1454-1463
- Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. 2007
- Template protocol for clinical trials investigating vaccines – focus on safety elements.Vaccine. 2013; 31: 5602-5620
- The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).Vaccine. 2015; 33: 73-75
- Live virus vaccines based on a yellow fever vaccine backbone: standardized template with key considerations for a risk/benefit assessment.Vaccine. 2015; 33: 62-72
- Pharmacoepidemiology studies of vaccine safety.in: Strom B.L. Kimmel S.E. Hennessy S. Pharmacoepidemiology. 5th ed. Wiley-Blackwell, Chichester, West Sussex, UK2012: 423-468
- Perspectives on the design and analysis of prelicensure trials: bridging the gap to postlicensure studies.Clin Infect Dis. 2001; 33: S323-S326
- The Vaccine Safety Datalink: successes and challenges monitoring vaccine safety.Vaccine. 2014; 32: 5390-5398
- The Food and Drug Administration’s Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise.Pharmacoepidemiol Drug Saf. 2012; 21: 291-297
- Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network.Pediatrics. 2011; 127: S65-S73
U.S. Food and Drug Administration. Guidance for Industry: Postmarketing Studies and Clinical Trials - Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act 2011 [updated April 2011; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf.
- The structure, role, and procedures of the U.S. Advisory Committee on Immunization Practices (ACIP).Vaccine. 2010; 28: A68-A75
U.S. Food and Drug Administration (FDA). Charter of the Vaccines and Related Biological Products Advisory Committee 2014 [updated January 9, 2014; cited 2015 August 11]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm129571.htm.
U.S. Food and Drug Administration (FDA). Charter of the Pediatric Advisory Committee to the Food and Drug Administration 2014 [updated September 18, 2014; cited 2015 August 11]. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm116525.htm.
- The role of public health informatics in enhancing public health surveillance.MMWR Surveill Summ. 2012; 61: 20-24
- The Vaccine Adverse Event Reporting System (VAERS) form Version 2.0 (proposed).in: National Vaccine Advisory Committee meeting September 9, 2014: National Vaccine Program Office/HHS. 2014 ([cited 2015 August 11]. Available from: http://www.hhs.gov/nvpo/nvac/meetings/upcomingmeetings/NVAC%20Meeting%20Materials/tab_7.3_shimabukuro_vaers_2_0_enote.pdf)
- Request for Comment on Draft Vaccine Adverse Event Reporting System (VAERS) 2.0 Form.Federal Register. November 24, 2014; 79: 69853-69854
- Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.Federal Register. 2014; 79: 33072-33092
- Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports.Federal Register. 2014; 79: 33200-33201
- Using electronic medical records to enhance detection and reporting of vaccine adverse events.J Am Med Inform Assoc. 2007; 14: 731-735
- Automated Detection and Reporting of Vaccine Adverse Events: ESP-VAERS.in: Adult and Pediatric Vaccines at IDWeek 2013; October 3, 2013, San Francisco, CA2013
- Small Business Innovation Research/Small Business Technology Transfer.2013 ([cited 2015 August 11]. Available from: http://www.sbir.gov/sbirsearch/detail/679697)
- Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine.JAMA Pediatr. 2014; 168: 211-219
- Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system.Am Stat. 1999; 53: 177-190
- Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA’s spontaneous reports database.Drug Saf. 2002; 25: 381-392
- Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010–2011 seasonal influenza virus vaccine.Drug Saf. 2013; 36: 547-556
- Active computerized pharmacovigilance using natural language processing, statistics, and electronic health records: a feasibility study.J Am Med Inform Assoc. 2009; 16: 328-337
- Vaccine adverse event text mining system for extracting features from vaccine safety reports.J Am Med Inform Assoc. 2012; 19: 1011-1018
- The Vaccine Safety Datalink: a model for monitoring immunization safety.Pediatrics. 2011; 127: S45-S53
- Real-time vaccine safety surveillance for the early detection of adverse events.Med Care. 2007; 45: S89-S95
- An efficient statistical algorithm for a temporal scan statistic applied to vaccine safety analyses.Vaccine. 2011; 30: 3986-3991
- Near real-time surveillance for influenza vaccine safety: proof-of-concept in the Vaccine Safety Datalink Project.Am J Epidemiol. 2010; 171: 177-188
- Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010–2011.Vaccine. 2012; 30: 2024-2031
- Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink.Vaccine. 2011; 29: 8279-8284
- H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project.Am J Prev Med. 2011; 41: 121-128
- Mini-Sentinel Cber/Prism Methods Protocol: Pilot Of Self-Controlled Tree-Temporal Scan Analysis For Gardasil Vaccine, Version 2.0.2015
- Clinical Classifications Software: Healthcare Cost and Utilization Project (HCUP).Agency for Healthcare Research and Quality, Rockville, MD2015 March
- TreeScan: Software for the Tree-Based Scan Statistic.2014 (Available from:)
- Drug safety data mining with a tree-based scan statistic.Pharmacoepidemiol Drug Saf. 2013; 22: 517-523
- Maternal immunization to benefit the mother, fetus, and infant.Obstet Gynecol Clin North Am. 2014; 41: 521-534
- Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season.MMWR Morbidity and mortality weekly report. 2015; 64: 818-825
- Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012.MMWR Morbidity and mortality weekly report. 2013; 62: 131-135
- Safety of immunization during pregnancy: a review of the evidence of selected inactivated and live attenuated vaccines.Vaccine. 2014; 32: 7057-7064
- Maternal influenza immunization and birth outcomes of stillbirth and spontaneous abortion: a systematic review and meta-analysis.Clin Infect Dis. 2014;
- Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes.J Am Med Assoc. 2014; 312: 1897-1904
- Vaccines and pregnancy: past, present, and future.Semin Fetal Neonatal Med. 2014; 19: 161-169
- Maternal vaccination: moving the science forward.Hum Reprod Update. 2015; 21: 119-135
- Pregnancy and Lactation Labeling Final Rule. 2014 ([updated 12/04/14; cited 2015 August 11]. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm)
- Draft Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products. 2014 ([updated Dec 2014; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf)
- The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. National Academies Press, Washington (DC)2013
- National, state, and selected local area vaccination coverage among children aged 19–35 months – United States, 2013.MMWR Morb Mort Wkl Report. 2014; 63: 741-748
- A population-based cohort study of under vaccination in 8 managed care organizations across the United States.JAMA Pediatr. 2013; 167: 274-281
- Designing tomorrow’s vaccines.N Engl J Med. 2013; 368: 551-560
- Trends in vaccine adjuvants.Expert Rev Vaccines. 2011; 10: 539-550
- Recent trends in vaccine delivery systems: a review.Int J Pharm Investig. 2011; 1: 64-74
- Microneedle-based vaccines.Curr Top Microbiol Immunol. 2009; 333: 369-393
- Sublingual vaccination.Hum Vaccin. 2011; 7: 110-114
- Systems biology as defined by NIH: an intellectual resource for integrative biology.NIH Catal. 2011; 19: 1-12
U.S. National Institutes of Health (NIH). Talking Glossary of Genetic Terms: Personalized Medicine. National Human Genome Research Institute. Available from: http://www.genome.gov/glossary/index.cfm?id=150.
- The top five “game changers’’ in vaccinology: toward rational and directed vaccine development.OMICS. 2011; 15: 533-537
- Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development. 2013 ([updated October 2013; cited 2015 August 11]. Available from: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/PersonalizedMedicine/UCM372421.pdf)
- Lessons learned in the analysis of high-dimensional data in vaccinomics.Vaccine. 2015; 33: 5262-5270
Remarks by the President in State of the Union Address, January, 20, 2015. 2015. [cited 2015 August 11]. Available from: http://www.whitehouse.gov/the-press-office/2015/01/20/remarks-president-state-union-address-january-20-2015.
- Facilitators Report, Lessons learned exercise, ECDC Vaccine Adverse Event Surveillance and Communication: (VAESCO II) project.European Centers for Disease Control and Prevention, Stockholm2009 ([cited 2015 August 11]. Available from: http://vaesco.net/vaesco/news/extras/01/text_files/file/VAESCO%20facilitator%20report%20lessons%20learned%20fxd%20CVupdated_August312012%20.pdf)
- Combining multiple healthcare databases for postmarketing drug and vaccine safety surveillance: why and how?.J Intern Med. 2014; 275: 551-561
- Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe.Br Med J. 2011; 343: d3908
- Narcolepsy in association with pandemic influenza vaccination – a multi-country European epidemiological investigation.ECDC, Stockholm2012 ([updated September 2012; cited 2015 August 11]. Available from: http://vaesco.net/vaesco/results/main/04/text_files/file/ECDC%202012%20VAESCO%20Narco%20report%20FULL.pdf)
- The incidence of narcolepsy in Europe: before, during, and after the influenza A(H1N1)pdm09 pandemic and vaccination campaigns.Vaccine. 2013; 31: 1246-1254
- Guillain-Barre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccines: a multinational self-controlled case series in Europe.PLOS ONE. 2014; 9: e82222
- Immunization in developing countries.Vaccines. 6th ed. Elsevier Saunders, Philadelphia2013: 1369-1394
- The introduction of new vaccines into developing countries.Vaccine. 1999; 17: 646-652
- Impact of BRICS’ investment in vaccine development on the global vaccine market.Bull World Health Organ. 2014; 92: 436-446
- Global trends and challenges in vaccine safety.Pediatric Health. 2009; 3: 329-335
- Global Vaccine Safety Blueprint Geneva.Department of Immunization, Vaccines and Biologicals, 2012
World Health Organization (WHO). The Global Vaccine Safety Initiative (GVSI) WHO. Available from: http://www.who.int/vaccine_safety/initiative/en/ [updated November 2014].
- The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level.Bull World Health Organ. 2014; 92: 695-696
- Global Vaccine Safety Initiative portfolio of activities Switzerland.WHO, 2013 (Available from:)
- Global Vaccine Safety Blueprint: The Landscape Analysis Geneva.Department of Immunization, Vaccines and Biologicals, 2012
- Strengthening national regulatory authorities.2012 (Available from:)
- Lessons learnt from enhancing vaccine pharmacovigilance activities during MenAfriVac™ introduction in African countries, 2010 to 2013.CID. 2015; (in press)
- Global Advisory Committee on Vaccine Safety: Preparing for malaria vaccine introduction.Wkly Epid Rec. 2015; 90: 18-20
- Global Advisory Committee on Vaccine Safety: Preparing for dengue vaccine introduction.Wkly Epid Rec. 2015; 90: 17-28
- An Ebola vaccine: first results and promising opportunities.Lancet. 2015; ([Epub ahead of print](pii: S0140-6736(15)61177-1. doi: 10.1016/S0140-6736(15)61177-1.))
Council for International Organizations of Medical Sciences (CIOMS), 2013. Available from: http://www.cioms.ch/.
- Decade of vaccines. Editorial.Vaccine. 2013; 31: B3-B4
- Roadmap for the international collaborative epidemiologic monitoring of safety and effectiveness of new high priority vaccines.Vaccine. 2013; 31: 3623-3627
Indepth Network, Better Health Information for Better Health Policy, Available from: http://www.indepth-network.org/.
- International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.Vaccine. 2013; 31: 4448-4458
- Developing sustainable funding for vaccine safety infrastructure.Vaccine. 2010; 28: 1133-1134
- The Jordan report: accelerated development of vaccines 2012.NIH, NIAID, 2012 (NIH publication no. 11-7778)
- Vaccines, new opportunities for a new society.Proc Natl Acad Sci U S A. 2014; 111: 12288-12293
- Vaccination greatly reduces disease, disability, death and inequity worldwide.Bull World Health Organ. 2008; 86: 140-146
- Evaluating the safety of new vaccines: summary of a workshop.Am J Public Health. 2005; 95: 800-807
- The rise (and fall?) of parental vaccine hesitancy.Hum Vaccines Immunother. 2013; 9: 1755-1762
- Individual versus public priorities in the determination of optimal vaccination policies.Am J Epidemiol. 1986; 124: 1012-1020
- Vaccine safety controversies and the future of vaccination programs.Pediatr Infect Dis J. 2005; 24: 953-961
- Vaccine hesitancy: an overview.Hum Vaccines Immunother. 2013; 9: 1763-1773
- A serologic follow-up of the 1942 epidemic of post-vaccination hepatitis in the United States Army.N Engl J Med. 1987; 316: 965-970
- The cutter incident, poliomyelitis following formaldehyde- inactivated poliovirus vaccination in the United States during the spring of 1955. I. Background.Am J Hygiene. 1963; 78: 16-28
- The cutter incident, poliomyelitis following formaldehyde- inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to cutter vaccine.Am J Hygiene. 1963; 78: 29-60
- The Cutter incident, 50 years later.N Engl J Med. 2005; 352: 1411-1412
- The hazards of immunization.Athlone P, London1967: 324
- Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977.Am J Epidemiol. 1979; 110: 105-123
- Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) – United States, 1991–2001.MMWR Surveill Summ. 2003; 52: 1-24
- Monitoring system for adverse events following immunization.Vaccine. 1987; 5: 169-174
- Adverse-drug-reaction monitoring.N Engl J Med. 1986; 314: 1589-1592
- Data mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination.Vaccine. 2001; 19: 4627-4634
- The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI).Vaccine. 2002; 21: 298-302
- Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team.Pediatrics. 1997; 99: 765-773
- Risky business: challenges in vaccine risk communication.Pediatrics. 1998; 101: 453-458
- National Immunization Information Hotline: Calls concerning adverse events, 1998–2000.J Health Commun. 2004; 9: 387-394
- Howson C.P. Howe C.J. Fineberg H.V. Adverse Effects of Pertussis and Rubella Vaccines: A Report of the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. National Academy Press, Washington (DC)1991
- Stratton K.R. Howe C.J. Johnston R.B. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. National Academy Press, Washington (DC)1994
- Immunization Safety Review 2001–2004: National Academy Press (US).2004 ([updated 7/24/2013; cited 2015 August 11]. Available from: http://www.iom.edu/activities/publichealth/immunizationsafety.aspx)
- Stratton K. Ford A. Rusch E. Clayton E.W. Adverse Effects of Vaccines: Evidence and Causality. National Academy Press, Washington (DC)2011
- A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines.Lancet. 1995; 345: 567-569
- Post licensure epidemiology of childhood vaccination: the Danish experience.Expert Rev Vaccines. 2006; 5: 641-649
- Improving vaccine safety through a better understanding of vaccine adverse events.Clin Infect Dis. 2015;
- Outbreak of aseptic meningitis associated with mass vaccination with a urabe-containing measles-mumps-rubella vaccine: implications for immunization programs.Am J Epidemiol. 2000; 151: 524-530
- Investigation of an outbreak of hypersensitivity-type reactions during the 2004 national measles-mumps-rubella vaccination campaign in Brazil.Vaccine. 2013; 31: 950-954
- Adverse events following immunization during mass vaccination campaigns at first introduction of a meningococcal A conjugate vaccine in Burkina Faso, 2010.Vaccine. 2012; 30: B46-B51
- Injection safety: a global challenge.Bull World Health Organ. 1999; 77: 787-788
- The use of a computerized database to monitor vaccine safety in Viet Nam.Bull World Health Organ. 2005; 83: 604-610
- Prevalence of anti-gelatin IgE antibodies in people with anaphylaxis after measles-mumps rubella vaccine in the United States.Pediatrics. 2002; 110: e71
- Does influenza vaccination exacerbate asthma? Analysis of a large cohort of children with asthma. Vaccine Safety Datalink Team.Arch Fam Med. 2000; 9: 617-623
- HLA type and immune response to Borrelia burgdorferi outer surface protein a in people in whom arthritis developed after Lyme disease vaccination.Arthritis Rheum. 2009; 60: 1179-1186
- A genomics-based approach to assessment of vaccine safety and immunogenicity in children.Vaccine. 2012; 30: 1865-1874
- HLA antigens in Guillain-Barre syndrome.Neurology. 1984; 34: 240-242