Understanding Vaccines What They Are How They Work - VIOLIN

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Follow-Up Surveillance Once a vaccine is on the market, FDA continues to monitor its safety. FDA periodically inspects the manufacturing facility, and it tests samples of the vaccine for potency, safety, and purity for as long as the vaccine is made. The manufacturer must also safety test each batch, or lot, of the vaccine. In addition, most licensed vaccines continue to be evaluated with very large studies that look at tens of thousands of people who have received the vaccine. These Phase IV studies try to pick up rare or delayed adverse reactions that might not have been apparent in the smaller studies that led to licensure. Finally, FDA and CDC gather information on licensed vaccines through the Vaccine Adverse Events Reporting System (VAERS). Anyone—health care providers, patients, parents— can report adverse vaccine reactions to VAERS. FDA reviews weekly VAERS reports for each lot of vaccine in use, searching for anything unusual. Volunteering for a Clinical Study Clinical trials rely entirely on volunteers—people who contribute their time and energy for the advancement of science and improved health care for all. Tens of thousands of volunteers of all ages and walks of life have participated in these trials. Typically, a volunteer in a vaccine study agrees to be given the vaccine (or a lookalike placebo), visits a clinic frequently for evaluation, undergoes medical tests, and provides blood samples that researchers will use to assess the vaccine. Because no one knows yet how well the vaccine works, participants should not expect the experimental vaccine to protect them against disease. Volunteers are fully informed about how the study will be conducted, its potential risks and benefits, and measures taken to ensure their safety and privacy. To find out more about government clinical studies, visit www.clinicaltrials.gov. UNDERSTANDING VACCINES 41
Vaccine Concerns, Myths, and Safety Issues on the Web Now that vaccines have virtually eliminated many once-feared diseases, the possibility of vaccine side effects or adverse reactions loom larger in some people’s minds than the diseases that vaccines prevent. Most parents today have never seen a case of diphtheria or measles, and some wonder why their children must receive so many shots. Rumors and misinformation about vaccine safety abound. For example, many parents are concerned that multiple vaccines may weaken or overwhelm an infant’s immune system or that certain vaccines may cause autism, multiple sclerosis, or diabetes. For information about vaccine concerns, myths, and safety issues, try the following sources. AIDSinfo A service of the U.S. Department of Health and Human Services aidsinfo.nih.gov 800–448–0440 Centers for Disease Control and Prevention National Immunization Program www.cdc.gov/nip 800–232–2522 Immunization Safety Review Committee of the Institute of Medicine www.iom.edu/imsafety 202–334–1342 42 Institute for Vaccine Safety Johns Hopkins Bloomberg School of Public Health www.vaccinesafety.edu National Network for Immunization Information www.immunizationinfo.org 409–772–0199 National Partnership for Immunization www.partnersforimmunization.org 703–836–6110 Vaccine Education Center at The Children’s Hospital of Philadelphia www.vaccine.chop.edu 215–590–9990
Page 1 and 2: Understanding nderstanding VACCINES
Page 3 and 4: Contents 1 2 4 6 11 21 36 38 43 47
Page 5 and 6: What Is aVaccine? 2 Chances are you
Page 7 and 8: Vaccine Benefits 4 You and Your Com
Page 9 and 10: Harmful Microbes 6 Vaccines protect
Page 11 and 12: 8 • The toxic bacterium Bordetell
Page 13 and 14: 10 What Do Cows Have to Do with Vac
Page 15 and 16: 12 A mosquito bite transmits the ye
Page 17 and 18: 14 T Cells T cells function either
Page 19 and 20: T cell B cell 16 Virus B cell Antib
Page 21 and 22: 18 fever antibody if needed. Memory
Page 23 and 24: 20 How Viruses Work Viruses such as
Page 25 and 26: 22 Live, Attenuated Vaccines Some s
Page 27 and 28: 24 Inactivated Vaccines An inactiva
Page 29 and 30: 26 They also could manufacture the
Page 31 and 32: 28 When making a conjugate vaccine,
Page 33 and 34: 30 So-called naked DNA vaccines con
Page 35 and 36: 32 An infant’s immune system cont
Page 37 and 38: Some Vaccine Types and Diseases The
Page 39 and 40: Vaccines of the Future 36 Aside fro
Page 41 and 42: Making Safe Vaccines 38 No vaccine
Page 43: 40 Because Phase III trials are com
Page 47 and 48: 44 testing sites are based at unive
Page 49 and 50: 46 system’s response to HIV infec
Page 51 and 52: Glossary 48 adjuvant—a substance
Page 53 and 54: 50 DNA vaccine or naked DNA vaccine
Page 55 and 56: 52 lymph node—a small bean-shaped
Page 57 and 58: 54 recombinant subunit vaccine—a
Page 59: U.S. DEPARTMENT OF HEALTH AND HUMAN

Understanding Vaccines What They Are How They Work - VIOLIN

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