Immunizig Agents Active immunizing antigens Conjugating agents Suspending fluid Preservatives, stabilizers, antimicrobials.

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Presentation transcript:

Immunizig Agents Active immunizing antigens Conjugating agents Suspending fluid Preservatives, stabilizers, antimicrobials

Administration Site and route Pain management Scheduling Blood products & MMRV

Safety

Dr Sears messages Doctors do not understand vaccines Public Health Agencies and Pharma companies are not Trustworthy Vaccine Mandates or Optional Vaccine preventable diseases are not so bad Hide in the herd

Dr Sears messages Vaccination as a cause of chronic diseases Safety testing is insufficient

The problem Decision making Bad science vs good science VAERS reports overestimate adverse effects Risks from vaccine preventable diseases Thimerosal (Thompson et al NEJM 2007;357(13): Coincidence vs casuality

שיעור ל שעלת לפי קבוצות גיל,

What are Human Papillomaviruses? Group of viruses belonging to Papillomarividae family Double stranded DNA viruses –Non-enveloped capsid consisting of 72 pentavalent capsomeres Up to 200 different genotypes identified Classified according to: –Tropism: Cutaneous or Mucosal ≈ 30 – 40 anogenital mucosal HPV –Risk of neoplasia: Low risk or High risk ≈ 20 HPV cause cervical cancer Syrjänen and Syrjänen. Papillomavirus infections in human pathology. Wiley & Sons, Chichester; p.11–46

Clearly Defined Pathogenic Types and Related Diseases 1. Wieland et al. Papillomaviruses in human pathology: Epidemiology, pathogenesis and oncogenic role. In: Gross, Barasso Eds. Human papillomavirus infection: A clinical atlas. Ullstein-Mosby; p.1– Von Krogh. Eur J Dermatol. 2001; 11:598– Munoz et al. N Engl J Med. 2003;348:518–527 ClassificationExamples of TypesAssociated disease Cutaneous Low Risk1, 2, 3, 10, 27 Cutaneous warts (flat, common, plantar warts) High Risk5, 8Epidermodysplasia verruciformis Mucosal Low Risk6, 11, 42, 43, 44, 55Condylomata acuminata Laryngeal papillomatosis High Risk16, 18, 31, 33, 45Bowen's disease, bowenoïd papilosis Cervical dysplasia and cervical carcinoma Carcinoma of penis, vulva, vagina, anus

נוגדנים מנטרלים הכרחיים להגנה מפני הדבקה Neutralizing antibodies prevent HPV infection Nonneutralizing antibodies do not neutralize HPV No antibodies – viral infection Adapted from Chen XS et al. Molecular Cell. 2000;5:557–567. Cell surface receptors 5

Cervarix (GSK)GARDASIL (MSD) זני HPV בחיסון 20/2020/40/40/20 ריכוז למנה (μg) Insect cell substrate Yeast Proprietary assembly/reassembly process increasing stability טכנולוגיה בה מייצרים את חלקיקי הוירוס L1 AS04 Aluminum hydroxide + 3-deacetylated monophosphoryl lipid A (MPL, Corixa/GSK) AAHS Amorphous aluminum hydroxyphosphate sulfate (Merck and Co., Inc.) אדגובנט 500 μg/50 μg225 μg מינון אדג'ובנט אירופה, אוסטרליה, ניו-זילנד, דרום אמריקה, אסיה ארה"ב (FDA ), אירופה, קנדה, אוסטרליה, ניו-זילנד, דרום דרום אמריקה, אסיה אישורים בעולם חיסונים נגד HPV

HPV and Vaccines (Gardasil and Cervarix) Seroconversion: 100% neutralising antibody Antibody titers higher than natural antibody titers Duration at least 5 years, expected 10y+ Excellent efficacy and safety profile

גיל התנסות מינית ראשונה בארץ הראל י, קני ד, רהב ג. נוער בישראל. רווחה חברתית, בריאות והתנהגויות סיכון במבט בינלאומי. ג'וינט – מכון ברוקדייל, ירושלים, 1997

Age at Enrollment (Years) Per-protocol immunogenicity (PPI) population (ages 9–26)* Neutralizing anti-HPV 6 GMTs at month 7 *Inclusive of five study protocols; all GMTs measured using cLIA. cLIA = competitive Luminex ® immunoassay; CI = confidence interval Vaccination at a Younger Age Resulted in Higher Response for Neutralizing Antibodies 10

הדילמות בחיסון נגד HPV  בעיות אתיות  חיסון ילדות נגד מחלות המועברות במגע מיני (STI )  שיחה בנושא יחסי מין עם הורי הילדות  הסכמת ההורים לחסן את בנותיהן  בעיות תרבותיות  חיסון כנגד מחלות מין יגרום לירידה בערכים משפחתיים ועלול לעודד ירידה במוסר מיני  אמונות ודיעות לגבי חיסונים ויעילות חיסונים

הדילמות בחיסון נגד HPV (המשך)  תוכניות חיסון למתבגרות  מתן 3 מנות חיסון למתבגרות?  מחיר  מי צריך לשלם עבור החיסון?  השפעה אפשרית של חיסונים נגד HPV על בדיקות סקר למשטח צוואר הרחם והיענות לבדיקה  החיסון אינו תחליף לביצוע משטח צוואר הרחם (pap )  מי צריך לחסן?