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Shots In The Dark by Barbara Loe Fisher   The worldwide acceptance of mass vaccination to suppress infectious childhood diseases once fiercely resisted is one of the most successful public relations stories in the history of medicine. As a result, epidemics of smallpox, which once swept through 18th- and 19th-century port cities such as Halifax, New York, and Boston without warning and cut down entire families, are now dry facts relegated to medical books. Images of children struggling through whooping cough, walking down the street coughing spasmodically, and stopping at curbs to spit up sticky mucus are only fading memories for grandparents alive to talk about what their parents told them.  Baby boomers and their parents still remember lining up in school in 1955 for polio vaccinations, with the hope that this magic bullet would keep them out of the dreaded iron lung.  Mass vaccination has dramatically suppressed childhood diseases. In Canada, recorded diphtheria cases dropped from 9,000 in 1924 to two to five by 1994.  When measles vaccination began in the United States between 1963 and 1965, doctors reported more than 400,000 cases annually; by 1995, that number had dwindled to 309. Cases of tetanus are almost unheard of in North America and Europe.   Yet the universal use of vaccines as a worthy goal that prevents needless suffering and that benefits all mankind has begun to be challenged.   The voices of critics are heard in the living rooms of families whose children have been injured or have died from reactions to routine childhood vaccinations, and in courtrooms, where parents are suing vaccine makers and challenging mandatory vaccination laws. In the U.S. Congress, legislators who have heard them have set up a vaccine injury compensation program. At scientific conferences and in the pages of prestigious medical journals, researchers and physicians are risking their careers by discussing vaccine side effects.

Today, vaccinations are big business. In 1995, an international high-technology research firm, Frost & Sullivan, projected that the worldwide human vaccine market will increase from $2.9 billion to more than $7 billion by the year 2001.   Public health officials in every country assist the industry�s growth, often by force of laws that ensure citizens use about a dozen different viral and bacterial vaccines, including ones to suppress even generally mild childhood diseases such as chicken pox. Traditional public health measures, improving sanitation, nutrition, living conditions, health education, and access to affordable medical care, especially in underprivileged populations often take a backseat to achieving a 100 per cent vaccination rate.   Most medical doctors consider vaccines their single most important tool in protecting public health. Few would question the profound importance of vaccines to public health, wrote Richard B. Johnston, Jr., MD, medical director of the March of Dimes and chairman of the Institute of Medicine Vaccine Safety Committee, in a 1994 National Academy of Sciences report, 

Adverse Events Associated with Vaccines Not only have deaths from the most common childhood infections been almost eliminated, but also so have the devastating morbidities of diseases like measles, paralytic polio, and congenital rubella. This revolution has . . . led to major savings in medical costs and gains in work productivity, as well as to reductions in deaths and suffering.   An ancient philosophical dispute goes modern   The whole idea of man versus nature can be traced back to the origins of western medicine more than 2,000 years ago. In a four-volume book series Divided Legacy: A History of Schism in Medical Thought by medical historian Harris L. Coulter, PhD, the centuries-old war between empiricism and rationalism in medicine is revealed as a contest between two competing health philosophies. Is each individual governed by a vital force that, through unique reactions to external stimuli, is capable of participating in the healing process, as empiricists, including Hippocrates, have maintained?  Or are all human organisms simply a series of complex chemical reactions governed by the laws of physics, chemistry, and mechanics, as rationalists, including Louis Pasteur, have maintained?   Empiricists accept the existence of viruses and bacteria as part of nature and illness as part of the life process. They consider fevers, diarrhea, and runny noses good, not bad, and do not suppress them with chemically based drugs that might interfere with the body�s natural ability to harness the immune system to participate in the healing process. They stress that each individual is unique and that individualized therapeutic techniques can stimulate the body to restore health. Empiricists dislike the one-size-fits-all mass vaccination approach. 

Methods 277 young women (mean age 20·2 years [SD 1·7]) were randomly assigned to quadrivalent HPV (20 É g type 6, 40 É g type 11, 40 É g type 16, and 20 É g type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20·0 years [1·7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0·0001) in those assigned vaccine compared with those assigned placebo. Interpretation A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types. AUTHOR DISCUSSION We have shown that a multivalent vaccine is efficacious against HPV types that cause cancer and genital warts. Over 35 months’ follow-up, incidence of persistent infection associated with HPV 6, 11, 16, or 18 decreased by 89% in women allocated active vaccine who had at least one dose (ie, the modified intention-to-treat population) compared with those allocated placebo. Vaccine efficacy was 90% in the per-protocol efficacy population, suggesting that the vaccine was protective even during the vaccination period. For example, during the course of vaccination (day 1 through month 7), three women assigned active vaccine and five women assigned placebo were detected with HPV 18 DNA. Of these, only one was verifiable persistent infection (in the placebo group). Thus, one woman allocated placebo and no women allocated active vaccine developed persistent HPV 18 infection during the vaccination period. Furthermore, efficacy with regard to clinical disease associated with HPV 6, 11, 16, or 18 was 100%.

Methods Study design A phase II randomised, multicentre, double-blind placebo-controlled study of a quadrivalent HPV (type 6, 11, 16, and 18) L1 VLP vaccine was done in two parts. Part A was a sequential dose-escalation safety assessment, in which participants, investigators, and staff were blinded as to assignment of vaccine or placebo, but not to assignment of doses in the active-treatment group. Part B was a fully blinded dose-ranging assessment of immunogenicity and efficacy. Study procedures for individuals in part A and part B were identical. The results presented in this article are from part B. 1158 women aged 16-23 years were recruited in Brazil, Europe, and the USA. The study enrolled healthy women, who were not pregnant, had no previous abnormal Pap smears, and reported a lifetime history of four or fewer male sex partners. Enrolment of virgins was restricted to women who were 18 years or older and who were seeking contraception. This study did not exclude women with previous HPV infection. Participants were required to use effective contraception during the trial. The active quadrivalent vaccine was a mixture of four recombinant HPV type-specific VLPs (Merck Research Laboratories, West Point, PA, USA) consisting of the L1 major capsid proteins of HPV 6, 11, 16, and 18 synthesised in Saccharomyces cerevisiae.10,14,16 The four VLP types were purified and adsorbed onto amorphous aluminium hydroxyphosphate sulfate adjuvant. The placebo consisted of the same adjuvant and was visually indistinguishable from vaccine. Three preparations of a quadrivalent HPV types 6, 11, 16, and 18 L1 VLP were used. The three preparations were : 20 É g type 6, 40 É g type 11, 40 É g type 16, and 20 É g type 18, with 225 É g aluminium adjuvant ; 40 É g type 6, 40 É g type 11, 40 É g type 16, and 40 É g type 18, with 225 É g aluminium adjuvant ; and 80 É g type 6, 80 É g type 11, 40 É g type 16, and 80 É g type 18, with 395 É g aluminium adjuvant. The study had two placebo groups with adjuvant doses of 225 É g or 450 É g for appropriate safety comparisons. 0·5 mL vaccine or placebo was given by intramuscular injection at day 1, month 2, and month 6. After vaccination, participants were observed for 30 min. Temperatures were also recorded orally every day in the evening for 5 days after vaccination, and the participant noted adverse events by standard diary card for 14 days after vaccination. Gynaecological examination was done at day 1 and at months 7, 12, 24, and 36. A ThinPrep™ Pap test (Cytyc, Boxborough, MA, USA) and external genital, lateral vaginal, and cervical swabs for PCR analysis of HPV were obtained from all participants at day 1 and at months 7, 12, 18, 24, 30, and 36. Biopsy samples of external genital lesions identified during the study were taken, and serum samples were obtained at day 1 and months 2, 3, 6, 7, 12, 18, 24, 30, and 36. This study was done in accordance with national or local requirements for ethics-committee review, informed consent, and other statutes or regulations regarding the protection of the rights and welfare of those participating in biomedical research. All individuals, or their parents or legal guardians, gave written informed consent after review of the protocol procedures. The aim of the study was to assess a quadrivalent HPV L1 VLP vaccine in terms of the composite primary endpoint of persistent infection associated with HPV 6, 11, 16, or 18, or cervical or external genital disease compared with placebo. Women with persistent infection were defined as those who had the same vaccine-HPV-type DNA in cervicovaginal samples obtained 7 months after vaccination as those obtained from two or more consecutive visits (required to be 4 months or longer apart unless at least one tissue sample was diagnosed as cervical disease by a panel of pathologists), or as those who had vaccine-HPV-type DNA detected in a sample recorded during the last visit before being lost to follow-up. HPV-associated disease was defined as a tissue sample diagnosed as CIN by a panel of pathologists 7 months after vaccination ; vulval intraepithelial neoplasia ; vaginal intraepithelial neoplasia ; external genital warts ; or cervical, vulval, or vaginal cancer with vaccine-HPV-type DNA detected in tissue from, or in a swab of, the same lesion and in cervicovaginal samples obtained at the visit before the biopsy visit.

RA638 .I4665 2003eb Immunization safety review [electronic resource] : SV40 contamination of polio vaccine and cancer / Immunization Safety Review Committee, Board on Health Promotion and Disease Prevention ; Kathleen Stratton, Donna A. Alamario [i.e. Almario], and Marie C. c2003. [  3  ] RA638 .I4667 2004eb Immunization safety review [electronic resource] : influenza vaccines and neurological complications / Immunization Safety Review Committee, Board on Health Promotion and Disease Prevention ; Kathleen Stratton ... [et al.], editors, Institute of Medicine c2004.

RA638 .L565 2005 Vaccine controversy : the history, use, and safety of vaccinations / Kurt Link. Link, Kurt, 1937- c2005. [  7  ] RA638 .R5 Shots without guns; the story of vaccination. Riedman, Sarah Regal, 1902- [c1960]

RA638 .V33 1997*(ONLINE) Vaccine safety forum [computer file] : summaries of two workshops / Vaccine Safety Forum, Board on Health Promotion and Disease Prevention, Institute of Medicine. 1997.