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Introduction to Vaccines. MedCh 401 Spring 2006 Kirsten L. Vadheim, Ph.D. Why study vaccines?. Patient education Pharmacists are often the most accessible medical professional too many choices! Flu: yes or no? live or inactivated? Pneumococcal? Meningococcal? TD booster?.
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Introduction to Vaccines • MedCh 401 Spring 2006 • Kirsten L. Vadheim, Ph.D. KL Vadheim Lecture 1
Why study vaccines? • Patient education • Pharmacists are often the most accessible medical professional • too many choices! • Flu: yes or no? • live or inactivated? • Pneumococcal? • Meningococcal? • TD booster? KL Vadheim Lecture 1
Why study vaccines? II • Misinformation • Only children get pertussis - no • MMR vaccination causes autism - no • HepB vaccination is linked to development of autoimmune disorders - no • Childhood vaccinations increase the risk of SIDS - no • SV40-contaminated polio vaccine caused cancer - inadequate data KL Vadheim Lecture 1
More reasons to study vaccines • Vaccine administration • you may have to give them! • New vaccines, changing recommendations • Rotavirus • Lyme disease • OPV to IPV • Pertussis • Public health KL Vadheim Lecture 1
History • Variolation • c. 16th centure China • 1721 - Lady Mary Montagu brought it to England • 1774 - cattle breeder Benjamin Jesty inoculated his wife and children with cowpox to protect them from a smallpox epidemic KL Vadheim Lecture 1
History II • Edward Jenner • 1798 Variolae Vaccinae • demonstrated that cowpox could be passed directly from one infected person to another, providing large-scale, effective inoculation against smallpox • 1840: variolation made a felony in England KL Vadheim Lecture 1
History III • Louis Pasteur • 1880: attenuation of Pasteurella multocida to protect against chicken cholera • 1881: developed animal vaccine for anthrax, demonstrating that one could create standardized, reproducible vaccines at will • 1885: successful vaccination of first human (Joseph Meister, rabies) KL Vadheim Lecture 1
History III • Killed vaccines • Salmon and Smith, 1886; killed hog cholera virus vaccine (actually a bacterial vaccine against salmonellosis) • 1896-7: Human typhoid, cholera, plague vaccines KL Vadheim Lecture 1
History IV • Paul Ehrlich • 1897: receptor theory of immunity explained toxin-antitoxin interactions • active and passive immunity • ‘magic bullets’ • Emil von Behring • 1890: Development of diphtheria antitoxin as protection during diphtheria epidemics KL Vadheim Lecture 1
History V • Early 1900s • 23 U.S. children died from diphtheria antitoxin derived from horse infected with tetanus • post-WWII progress on viral vaccines • virus propagation in stationary cell culture • CPE KL Vadheim Lecture 1
History VI • Polio • Salk et al.: formalin-inactivated vaccine • Sabin: live attenuated vaccine • Cutter incident • inadequately inactivated vaccine • 204 cases of type I polio KL Vadheim Lecture 1
Immune Globulins • Immediate transfer of passive immunity • Homologous pooled human antibody • Homologous human hyperimmune globulines • Heterologous hyperimmune serum (antitoxin) • Tetanus, Rabies • Polyclonal (RSV-IGIV) • Monoclonal (Palivizumab) KL Vadheim Lecture 1
Comparison of Maximum and Current Morbidity KL Vadheim Lecture 1
Licensed Vaccines I • FDA/CBER • BLA • IND • Clinical trials • Extensive agency review • Inspection • Approval KL Vadheim Lecture 1
Licensed Vaccines II • Post-approval • Lot release • Biennial inspections • Annual reports • Pharmacovigilence • 21CFR601.12 KL Vadheim Lecture 1
Anthrax BCG DTaP Haemophilus influenzae b Meningococcal Plague Pneumococcal Typhoid - Ty21a and Vi Licensed Bacterial Vaccines KL Vadheim Lecture 1
Hep A Hep B Flu JEV Measles Mumps Polio Rabies Rotavirus Rubella Rotavirus Smallpox Varicella Yellow Fever Licensed Viral Vaccines KL Vadheim Lecture 1
Types of Vaccines I • Prophylactic • Therapeutic KL Vadheim Lecture 1
Types of Vaccines II KL Vadheim Lecture 1
Types of Vaccines III KL Vadheim Lecture 1
The Perfect Vaccine • 100% effective • Oral dosage form • No adverse effects • Highly immunogenic • life-long immunity • no boosters required • Cheap • Stable at room temperature • no cold chain required KL Vadheim Lecture 1
Combination vaccines • DT • DTaP • DTaP-HepB-IPV • HepA-HepB • MM • MMR • MMRV KL Vadheim Lecture 1