• Why It’s Important to Monitor Vaccine Safety

      

  John Iskander, MD, MPH, acting director, Immunization Safety Office, and Robert T. Chen, MD, MA, blood safety specialist, Epidemiology Branch, NCHHSTP, wrote a chapter in the new book Infectious Disease Surveillance to explain why it is important to monitor vaccine safety.

    

  Rare Reactions. The most important reason is to detect rare reactions. Although vaccines are tested extensively before they are licensed for use in the United States, not enough people are included in the tests to detect reactions that happen only rarely. If serious reactions are found when the vaccine is in widespread use, the vaccine may be withdrawn.

     

  Higher Risk Groups. Vaccine safety monitoring also makes sure new vaccines are safe for groups such as the elderly, those with chronic medical conditions, and pregnant women. Vaccine trials may deliberately exclude members of these groups.

     

  Public Confidence in Vaccines. Monitoring vaccine safety also helps to maintain public confidence needed to keep enough people vaccinated to prevent disease outbreaks.

    

  How We Know If Vaccines Are Safe

     

  Vaccine safety cannot be measured directly. Instead, it is estimated by the number of "adverse events" reported. An adverse event is "... a medical incident that takes place after an immunization ... and is believed to be caused by the immunization."¹ Adverse events include—

    
   
  • True reactions to the vaccine.
   
  • Events that would have occurred even if the person had not been vaccinated (unrelated coincidences).
   
  • Reactions related to mistakes in vaccine preparation, handling, or administration.
   
  • Events that cannot be related directly to the vaccine; their cause is unknown.
   
     

  A formal scientific study usually is required to distinguish between coincidences and true reactions. It is rarely possible to say for sure whether a vaccine caused a specific adverse event.

     

  Almost all national immunization programs have a system for reporting adverse events. The United States Vaccine Adverse Event Reporting System (VAERS)² and the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)* are examples. People who report a vaccine reaction to VAERS or CAEFISS are asked if the reaction led to hospitalization, life-threatening illness, disability, or death. These events are classified as "serious," and are often subject to further study that yields important information.

     

  For example, reports to CAEFISS identified a common illness among people who received flu vaccines from one Canadian manufacturer in one season.³ Equally important, such systems have supported the safety of new vaccines such as the new meningococcal B and C vaccines in New Zealand and the United Kingdom.

    

  Other monitoring programs include the Vaccine Safety Datalink (VSD) project, the Clinical Immunization Safety Assessment (CISA) Network, and the Brighton Collaboration. The VSD project is a collaboration between CDC's Immunization Safety Office and eight large managed care organizations that allows for planned vaccine safety studies as well as quick investigation of possible issues. The CISA Network of six medical research centers conducts clinical research on vaccine-associated health risks, and the Brighton Collaboration develops standard case definitions for problems following immunization as well as guidelines for data collection, analysis, and presentation.

     

  Vaccine safety monitoring becomes more important with new vaccines, expanded vaccine recommendations, and new global immunization initiatives. Reporting systems like VAERS will continue to be used to monitor adverse events, so vaccines can continue to be held to very high standards of safety.

     

• <!-- content_ends_here //--> 

  Vaccine Safety Concerns      Most parents today have never seen a case of diphtheria, measles, or other once-common diseases now preventable by vaccines. As a result, some parents wonder why their children must receive shots for diseases that do not seem to exist. Myths and misinformation about vaccine safety abound and can confuse parents who are trying to make sound decisions about their children's healthcare.    Vaccination is a common, memorable event, and association of events in time often signals cause and effect. While some of the sickness or reactions that follow vaccination may be caused by the vaccine, many are unrelated events that occur by coincidence after vaccination. Therefore, the scientific research that attempts to distinguish true vaccine side effects from unrelated, chance occurrences is important.    Recent Health Concerns      Entertainment as a Source of Health Information   Questions About Vaccine Recalls   <!--li><a href="http://www.cdc.gov/syncope.htm">Fainting After Vaccination (Syncope)</a></li-->  Kawasaki Syndrome and RotaTeq Vaccine   Measles, Mumps, and Rubella (MMR) Vaccine and Autism   Guillain Barré Syndrome and Menactra® Meningococcal Vaccine fact sheet and frequently asked questions   Mercury and Vaccines (Thimerosal)   Frequently Asked Questions about Thimerosal   Frequently Asked Questions about Thimerosal-free Vaccines   Frequently Asked Questions about Mercury and Thimerosal   Timeline: Thimerosal in Vaccines (1999–2008)   Sudden Infant Death Syndrome      Archived Health Concerns      Acquired Immune Deficiency Syndrome (AIDS) (updated March 2004)   Cancer, Simian Virus 40, and the Polio Vaccine (updated April 2004) fact sheet and frequently asked questions   Chronic Diseases   Diabetes (updated May 2004)   Febrile Seizures After MMR and DTP Vaccinations   Hair Loss   Inflammatory Bowel Disease and the Measles Vaccine   Multiple Vaccinations and the Immune System (updated May 2004)   Multiple Sclerosis and the Hepatitis B Vaccine (updated September 2004)   Additives in Vaccines   Intussusception and Rotavirus Vaccine       Page last reviewed: February 29, 2008  Page last updated: February 29, 2008  Content source: Immunization Safety Office, Office of the Chief Science Officer

        <!--webbot bot="Include" U-Include="../00_includes/00_footer.htm" TAG="BODY" startspan -->  

• Recommendations and Guidelines:

   

  Guide to Contraindications to Vaccinations

    <!-- BEGIN TOC -->  <!-- END TOC -->  <!-- Insert Secondary Body Navigation Here -->  <!-- At a Glance --> 
   
   
  This guide is designed to help immunization providers determine what common symptoms
    and conditions should contraindicate vaccination and which ones should not. It supersedes the 2000 Guide to Contraindications to Childhood Vaccination and, unlike that and previous Guides, contains information on all licensed U.S. vaccines, not just pediatric vaccines:   
   
    Anthrax | BCG | DTaP | DT | Influenza (Flu) | Hepatitis A (HA) | Hepatitis B (HB)
    Japanese Encephalitis | MMR | Pneumococcal Conjugate (PCV) |
    Pneumococcal Polysaccharide (PPV) | Polio (IPV) | Rabies | Tb | Typhoid |
    Vaccinia (routine non-emergency use)* | Varicella | Yellow Fever (YF)
   
   
   
   

  Printer-friendly version of Contraindications and Vaccinations guide

    <!-- At a Glance END --> 

  Print version contains:

   
   
  • Checklist of Selected Conditions (for quick navigation)
   
  • Symptom or Condition chart
   
  • Appendix A: Summary of Contents of Vaccines Licensed in the U.S.
   
  • Appendix B: Suggested Intervals Between Administration of Antibody-Containing Products for Different Indications and Measles-Containing Vaccine and Varricella Vaccine
   
  • Feedback
   
   

  Related resources:

   
   
  • Recommended Childhood & Adolescent Immunization Schedule
   
  • Contraindications to Vaccines Chart
   
  • MMWR, General Recommendations on Immunizations
      (Feb. 8, 2002, Vol. 51, RR02, pages 1-35)

• <p align="center"><b><font face="Arial"><br/> GARDASIL AND HPV INFECTION — GET THE FACTS</font></b></p><br/> <p class="style11"><font color="#000080" face="Arial">NATIONAL VACCINE INFORMATION <br/> CENTER<br><br/> </font> <br/> </p><ul><br/> <li><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"> <br/> <strong>National <br/> Vaccine Information Center</strong></font><font size="2" face="Arial, Helvetica, sans-serif"> <br/> (Debold V, Downey C, Fisher B). (2007). NVIC <em>Analysis of Vaccine <br/> Adverse Events Reporting System Reports: Part III</em>, Human Papilloma <br/> Virus Vaccine Safety, Analysis of Vaccine Adverse Events Reporting System <br/> Reports: Part III (August 15, 2007 <o:p><strong><a rel="nofollow" target="_blank" href="http://www.nvic.org/Diseases/HPV/HPV_Vaccine_Safety_Report_-_Part_III_%28081507_revised%29%5B1%5D.pdf">http://www.nvic.org/Diseases/HPV/HPV_Vaccine_Safety_<br><br/> Report__Part_III_(081507_revised)[1].pdf</a> </strong></o:p></font></li><br/> <li><font face="Arial, Helvetica, sans-serif"><strong><font size="2"><o:p><span class="style1"><a rel="nofollow" href="http://www.909shot.com/../../PressReleases/PR081507HPV.htm"><span class="style12">NVIC <br/> Analysis Shows Greater Risk of GBS Reports When HPV<br><br/> Vaccine Is Given with Other Vaccines, August 15, 2007</span></a></span></o:p></font></strong><font size="2"><o:p><span class="style12">, <br/> <em>NVIC Press Release</em></span></o:p></font></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><span class="style1"><a rel="nofollow" href="http://www.909shot.com/D.Morse_in_PDF_2%5B1%5D.pdf"><span class="style12"><strong>NVIC <br/> Letter to ACIP Chairman regarding HPV VAERS reports</strong></span></a>, <br/> August 14, 2007</span></font></li><br/> <li><font face="Arial, Helvetica, sans-serif"><strong><font size="2"><a rel="nofollow" href="http://www.wusa9.com/video/player.aspx?aid=53002&amp;sid=65760&amp;bw="><span class="style1">Making <br/> An Informed Decision: WUSA-9</span></a></font></strong><font size="2">, <br/> Washington DC, November 28, 2007</font></font></li><br/> <li><font face="Arial, Helvetica, sans-serif"><strong><font size="2"><a rel="nofollow" href="http://one.revver.com/watch/197846"><span class="style1">Listen <br/> to Parents! Not Merck</span></a></font></strong><font size="2">, <span class="style1">March <br/> 8, 2007, Rally in Washington DC</span></font></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.909shot.com/../../Loe_Fisher/HPVDC.htm"><span class="style1"><strong>Statement <br/> at DC Rally by Barbara Loe Fisher</strong></span></a>, March 8, 2007</font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.909shot.com/pr022107HPV.htm"><font color="#000080"><strong>Vaccine <br/> Safety Group Releases GARDASIL Reaction Report,</strong></font></a><font color="#000080"><br><br/> February 21, 2007, <i>NVIC Press Release -FDA and CDC Should Warn&nbsp; <br/> Doctors</i></font></font></li><br/> <li><font face="Arial, Helvetica, sans-serif"><strong><font color="#000080" size="2">National <br/> Vaccine Information Center</font> </strong><font size="2">(Debold V, <br/> Fisher B). (2007). <em>Human Papilloma Virus Vaccine Safety, Analysis <br/> of Vaccine Adverse Events Reporting System Reports: Part II</em> (February <br/> 21, 2007). <a rel="nofollow" href="http://www.nvic.org/Diseases/HPV/HPVRPT2.htm"><strong>http://www.nvic.org/Diseases/HPV/HPVRPT2.htm</strong></a></font></font></li><br/> <li><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.909shot.com/HPVInfection.htm"><strong>HPV <br/> Infection Facts</strong></a></font><font face="Arial, Helvetica, sans-serif"><strong><font color="#000080" size="2">&nbsp;</font></strong></font></li><br/> <li><font color="#000000" face="Arial, Helvetica, sans-serif"><strong><font color="#000080" size="2">National <br/> Vaccine Information Center</font> </strong><font size="2">(Debold V, <br/> Fisher B). (2007).<em> Human Papilloma Virus Vaccine Safety, Analysis <br/> of Vaccine Adverse Events Reporting System Reports: Adverse Reactions, <br/> Concerns and Implications</em> (undated). <strong><a rel="nofollow" href="http://www.nvic.org/Diseases/HPV/HPVrpt.htm">http://www.nvic.org/Diseases/HPV/HPVrpt.htm</a></strong></font></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.909shot.com/../../PressReleases/pr020107HPV.htm"><font color="#000080"><strong>HPV <br/> Vaccine Mandates Risky and Expensive</strong>,</font></a> <font color="#000080">February <br/> 1, 2007, <i>NVIC Press Release<br><br/> and Citations</i></font></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.909shot.com/docsurvey.htm"><font color="#000080"><strong>Survey <br/> of GARDASIL Costs</strong></font></a>&nbsp;—<font color="#000080"><i> <br/> Private Pediatricians Offices,</i> January 2007</font></font></li><br/> <li><font face="Arial, Helvetica, sans-serif"><strong><font color="#000080" size="2"><a rel="nofollow" href="http://www.909shot.com/../../PressReleases/pr62706gardasil.htm">Merck's <br/> GARDASIL Not Proven Safe for Little Girls</a></font></strong><font color="#000080" size="2"><a rel="nofollow" href="http://www.909shot.com/../../PressReleases/pr62706gardasil.htm">,</a> <br/> </font></font> <font color="#000080" size="2" face="Arial, Helvetica, sans-serif">June <br/> 27, 2006, <i> <br><br/> NVIC Press Release on GARDASIL aluminum content and clinical trials <br/> with reference citations&nbsp;</i></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><b><a rel="nofollow" href="http://tinyurl.com/2kfkb4"><font color="#000080">TODAY <br/> SHOW</font></a><font color="#000080"> - FEBRUARY 13, 2007 - Should HPV <br/> Vaccine Be Mandatory?&nbsp;<br><br/> </font></b><font color="#000080">Barbara Loe Fisher, NVIC President <br/> and Co-founder, </font><a rel="nofollow" href="http://tinyurl.com/2kfkb4"> <font color="#000080">http://tinyurl.com/2kfkb4</font></a></font></li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.grinpro.com/Movies/HPVHiSpeed.wmv"><font color="#000080"><b>HPV <br/> Video</b></font></a><font color="#000080"> - 7 Minutes, Grindley Productions <br/> made for NVIC</font></font> </li><br/> <li><font size="2" face="Arial, Helvetica, sans-serif"><span style="font-size: 10pt; font-family: Arial; color: rgb(0, 0, 128);"><b><a rel="nofollow" href="http://www.wnyc.org/shows/bl/episodes/2007/02/22#segment74010"><font color="#000080">WNYC <br/> Radio (NPR)</font></a></b><br><br/> <br><br/> </span></font><font size="2" face="Arial, Helvetica, sans-serif"> </font> <br/> <font color="#000000" size="2" face="Arial"> <br/> <div><font size="2" face="Arial, Helvetica, sans-serif"><strong>The <br/> Brian Lehrer Show</strong></font></div><br/> <div> <font size="2" face="Arial, Helvetica, sans-serif"><strong>February <br/> 22, 2007</strong></font></div><br/> </font><font color="#000000" size="2" face="Arial, Helvetica, sans-serif"> <br/> <div><strong>Healthy &amp; Wise: "Strange Bedfellows"</strong></div><br/> </font> <br/> <blockquote><font color="#000000" size="2" face="Arial"> </font> <br/> <div> <br/> <p><font color="#000000" size="2" face="Arial">"At least 20 <br/> states are considering mandatory vaccination of young girls against <br/> the sexually transmitted virus that causes cervical cancer. But <br/> the backlash has been fast and furious--and has led to some unlikely <br/> alliances. <strong>Barbara Loe Fisher</strong>, co-founder and <br/> president of the<strong> <a rel="nofollow" target="_blank" title="http://www.909shot.com/Default.htm" href="http://www.909shot.com/Default.htm"> <br/> <span class="style1">National Vaccine Information Cente</span></a></strong><a rel="nofollow" target="_blank" title="http://www.909shot.com/Default.htm" href="http://www.909shot.com/Default.htm"><span class="style1">r</span></a><span class="style1">, <br/> and <strong>Moira Gaul</strong>, director of women's and reproductive <br/> health at the<strong> </strong></span> <strong><a rel="nofollow" target="_blank" title="http://www.frc.org/get.cfm?c=HOME" href="http://www.frc.org/get.cfm?c=HOME"> <br/> <span class="style1">Family Research Council</span></a><span class="style1">,</span></strong><span class="style1"> <br/> talk about their opposition to mandatory vaccination. <strong>Sheila <br/> Krumholz</strong>, executive director, </span> <a rel="nofollow" target="_blank" title="http://www.opensecrets.org/about/index.asp" href="http://www.opensecrets.org/about/index.asp"> <br/> <span class="style1"><strong>Center for Responsive Politics</strong></span></a><strong><span class="style1">, <br/> </span></strong><span class="style1">talks about the lobbying <br/> efforts and legislative influence of the pharmaceutical industry." <br/> </span></font></p><br/> <div align="center"><br><br/> </div><br/> <p><font color="#000080" size="2" face="Arial"><b>VAERS REPORTS <br/> — GARDASIL ADVERSE EVENT REPORTS</b></font> </p><br/> </div><br/> </blockquote><br/> </li><br/> </ul><br/> <p><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><b>VAERS <br/> REPORT — GARDASIL ADVERSE EVENTS REPORTS </b><br><br/> National Vaccine Information Center. VAERS reports related to HPV4 vaccine <br/> </font><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><a rel="nofollow" href="http://www.medalerts.org/vaersdb/findfield.php?PAGENO=1&amp;PERPAGE=10&amp;VAX=HPV4"><strong>http://www.medalerts.org/vaersdb/findfield.php?PAGENO=1&amp;PERPAGE=10&amp;VAX=HPV4</strong></a></font></p><br/> <p align="center"><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><b><br><br/> GARDASIL MANUFACTURER PRODUCT INSERT</b></font> </p><br/> <p align="center"><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><b>GARDASIL <br/> PRODUCT INSERT</b></font></p><br/> <p align="left"><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"> <br/> <strong>Merck &amp; Co.</strong> 2006. Quadrivalent Human Papillomavirus <br/> Types 6,11,16,18) Recombinant Vaccine <a rel="nofollow" href="http://www.fda.gov/cber/label/hpvmer060806LB.pdf"><strong>http://www.fda.gov/cber/label/hpvmer060806LB.pdf</strong></a></font></p><br/> <p class="style5" align="center"><font size="2" face="Arial, Helvetica, sans-serif"><strong>CENTERS <br/> FOR DISEASE CONTROL</strong></font></p><br/> <p class="style5"><font size="2" face="Arial, Helvetica, sans-serif"><strong> <br/> </strong><a rel="nofollow" href="http://0-www.cdc.gov.mill1.sjlibrary.org/mmwr/preview/mmwrhtml/rr5602a1.htm"><strong>Q<font color="#0b3d91"><span class="style1">uadrivalent <br/> Human Papillomavirus Vaccine</span></font></strong></a><font color="#0b3d91">, <br/> </font><span class="style1"> Recommendations of the Advisory<br><br/> Committee on Immunization Practices (ACIP), March 12, 2007</span></font></p><br/> <font color="#000080" size="2" face="Arial"> <br/> <p align="center"><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><b>CHECK <br/> PROPOSED HPV MANDATES IN YOUR STATE</b></font></p><br/> <p align="left"><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><b> <br/> </b></font><font color="#000080" size="2" face="Arial, Helvetica, sans-serif"><span style="font-size: 10pt; font-family: Arial;">To find out about legislation to mandate HPV vaccine <br/> for children in your state, go to the website of the National Conference <br/> of State Legislatures at&nbsp;<a rel="nofollow" href="http://www.ncsl.org/programs/health/HPVvaccine.htm"><strong>www.ncsl.org/programs/health/HPVvaccine.html</strong></a></span></font></p><br/> </font>

• PREVENT VACCINE REACTIONS
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• The Vaccine Page provides  access to up-to-the-minute news about vaccines and an annotated  database of vaccine resources on the Internet.
   
    A word of caution: The   news link above will take you to the latest published news items   about vaccines. The Vaccine Page does not control the content of   those news items, or of any commercial offerings you may   encounter on those pages. We encourage you to validate any   information you find there by contacting reputable,   science-based sources—such as the members of the  Allied Vaccine Group—for   trustworthy information about vaccines and immunization. -The   Editor

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• Females in the United States number 140 million people, comprising over half of the total population

• ancer screening. An estimated 662,870 women will be diagnosed with cancer in 2005, and cancer is projected to lead to death for 275,000 women. An estimated 211,240 women will be diagnosed with breast cancer and 10,370 with cervical cancer; 40,410 and 3,710 women are projected to die of breast and cervical cancer, respectively.⁴

    

  Mammograms and Pap tests are an effective means of reducing the incidence of late stage breast and cervical cancers, respectively, and mortality caused by these cancers.

    

• Treatment of heart attack. Each year, about half a million women die of heart disease⁵; it is the leading cause of death for both women and men.

    

1 more annotation...

• A Pap test is done to look for changes in the cells of the  cervix . During a Pap test, a small sample of cells  from the surface of the cervix is collected by your health professional. The  sample is then spread on a slide (Pap smear) or mixed in a liquid fixative  (liquid-based cytology) and sent to a lab for examination under a microscope.  The cells are examined for abnormalities that may indicate abnormal cell  changes, such as  dysplasia or  cervical cancer.

  It is important to have your first Pap test within 3 years of  having sex for the first time or by age 21. You may be able to stop having  regular Pap tests after you are 65 to 70 years of age, if you have had 3 normal  Pap tests in a row, you do not have a high risk of cervical cancer, and you  have not had any new sex partners over the last 3 years. If you do not have a  uterus, you don’t need a Pap test as long as cervical  dysplasia or cervical cancer was not the reason your uterus was removed. You  may need more frequent Pap tests if you have had an abnormal Pap test in the  past. Talk with your health professional about  how  often you should have Pap tests.

  A high-risk type of the  human papillomavirus (HPV) is the cause of most cases  of cervical cancer. In women older than 30, an HPV test may be done at the same  time as a Pap test. A vaccine (Gardasil) is available to prevent infection with  the types of HPV that are most likely to cause cervical cancer.

• How long does vaccine protection last? Will a booster shot be needed?

     

  The length of vaccine protection (immunity) is usually not known when a vaccine is first introduced. So far, studies have found that vaccinated persons are protected for five years. More research is being done to find out how long protection will last, and if a booster dose of vaccine will be needed.

   
• There are no federal laws requiring the immunization of children.

• How much will the HPV vaccine cost?

     

  The retail price of the vaccine is $120 per dose ($360 for full series).

   

1 more annotation...

• "Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer."
  
  The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer - it's only effective against two that cause about 70 percent of cervical cancers.
  
  For months, Harper said, she's been trying to convince major television and print media to listen to her and tell the facts about the usefulness and effectiveness of this vaccine.
  

  • Very good info

• 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.

    

• AHRP's stated rationale for objecting to a policy mandating Merck's HPV vaccine in 11 year old girls [Link] is validated by an internationally recognized expert in the field who tested the vaccine in clinical trials.
  
  Dr. Diane M. Harper, a lead researcher in the development of the human papilloma virus vaccine, who says giving the drug to 11-year-old girls "is a great big public health experiment."
  
  Dr. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire, said: "It is silly to mandate vaccination of 11- to 12-year-old girls There also is not enough evidence gathered on side effects to know that safety is not an issue."
  
  All of her trials have been with subjects ages 15 to 25. "This vaccine has not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer - they won't know for 25 years if they will get cervical cancer."
• She believes the ideal way of administering the new vaccine is to offer it to women ages 18 and up. At the time of their first inoculation, they should be tested for the presence of HPV in their system. If the test comes back negative, then schedule the follow-up series of the three-part shots.
• But if it comes back positive? "Then we don't know squat, because medically we don't know how to respond to that," Harper said.
  
• She said that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most - meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won't work at all if she was positive for the virus when she was inoculated in the first place.
  
  Merck knows this, Harper said. "To mandate now is simply to Merck's benefit, and only to Merck's benefit," she said.
  
• Merck's vaccine was approved last year by the Food and Drug Administration, and recommended in June for females ages 9 to 26 by the Centers for Disease Control's Advisory Committee on Immunization Practices (ACIP).
• "Also, the public needs to know that with vaccinated women and women who still get Pap smears (which test for abnormal cells that can lead to cancer), some of them will still get cervical cancer."
  
  The reason, she said, is because the vaccine does not protect against all HPV viruses that cause cancer - it's only effective against two that cause about 70 percent of cervical cancers.
  
• According to Harper, the facts about the HPV vaccine are:
  
  . It is not a cancer vaccine or cure. It is a prophylactic - preventative -vaccine for a virus that can cause cancer. "Merck has proven it has zero percent effectiveness for curing cancer," Harper said. "But it is a very, very good vaccine that prevents types of HPV responsible for half of the high-grade cervical lesions that cause about 70 percent of cervical cancers. For the U.S. what that means is the vaccine will prevent about half of high-grade precursors of cancer but half will still occur, so hundreds of thousands of women who are vaccinated with Gardasil and get yearly Pap testing will still get a high-grade dysplasia (cell abnormality)."
  
  . It is not 100 percent effective against all HPVs. It is 100 percent effective against two types that cause 70 percent of cervical cancers.
  
  . The vaccine only works if the woman/girl does not have a current vaccine type related infection (in other words, the vaccine only works when the woman/girl does not have HPV 6, 11, 16 or 18 - the viruses that Gardasil targets when she receives her first vaccine shot).
  
  . The vaccine doesn't care if the girl/woman has been sexually active, Harper said. "HPV is a skin-to-skin infection. Although the only way to get cervical dysplasia is through an HPV infection, and HPV is most often associated with sexual activity, HPV is not just spread through sex. We have multiple papers where that's documented. We know that 3-year-olds, 5-year-olds, 10-year-olds, and women who have never had sex have been found to be positive for the cancer-causing HPV types."
  
  . Therefore, for example, if a girl is positive for HPV 16 when she is inoculated with the vaccine at any age, she will not be protected against it later, Harper said. "That means it's a failure and those people are at risk for getting the HPV 16 and 18 cancers later."
  
  . The only way to test for the presence of HPV is through a vaginal swab -which is inappropriate for young girls, she said.
• So far more than 40 cases of Guillian-Barre syndrome - a dangerous immune disorder that causes tingling, numbness and even paralysis of the muscles have been reported in girls who have received the HPV vaccine in combination with the meningitis vaccine. Scientists already know that sometimes a vaccine can trigger the syndrome in a subject. "With the HPV vaccine, it is a small number but higher than is expected, and we don't know if it's the combination of the two, or the meningitis alone," Harper said.
  
  . In the end, inoculating young girls may backfire because it will give them a false sense of protection. And, for both young girls and women, because the vaccine's purpose has been so misinterpreted - and mis-marketed - Harper feels that too many girls and women who have had the vaccine will develop a false sense of security, believing they are immune to cancer when they are not, and failing to continue with their annual Pap exams, are crucial to diagnosing dysplasia before it can develop into cancer.
  
  Keep getting pap smears

6 more annotations...

• HPV does not lurk in the air, in swimming pools or on playground equipment. That makes the vaccine’s public health credentials dubious at best.

• For starters, it could cause harm. All vaccines carry the risk of injury or death. During trials, nine individuals developed arthritis after receiving the vaccine versus three for the placebo, out of approximately 21,000 individuals in that trial. Nine kids with arthritis after receiving the vaccine might not seem like a big deal in the grand scheme of things. After all, arthritis is better than cancer, right? That depends.

   

  Given the fact that cervical cancer is relatively rare, highly preventable and most often successfully treated early on, maybe the risk of arthritis — a painful and often debilitating disease — isn’t a worthwhile trade-off.

   

• In order to learn the truth about an unknown, honest science dictates that we have to compare it to a known. When most people think about a vaccine placebo, they are probably thinking about saline. But that’s not what was used during trials.

   

  The “placebo” in this case was an aluminium-containing shot. The vaccine itself also contains aluminium.

   

  Aluminium hydroxide is what’s known as an adjuvant — it stimulates immune response. Studies in both animals and humans have found that aluminium adjuvants can cause death of brain cells. Similar studies have also shown that aluminium adjuvants in vaccines can cross the blood-brain barrier, as well as cause injection-site inflammation leading to chronic joint and muscle pain and fatigue.

   

  Aluminium adjuvants have never been subjected to clinical trials for safety. Read that again: Although the metal has been used in vaccines for decades, it has never been rigorously studied for long-term safety.

   

  So perhaps the 1 case of lupus and 2 cases of arthritis out of 9,701 participants who received the “placebo” were not just statistical anomalies. Maybe it was the aluminium. Perhaps that would also explain the 1 case of juvenile arthritis, 2 cases of rheumatoid arthritis, 5 cases of arthritis and 1 case of reactive arthritis in 11,813 Gardasil recipients. We’ll never know. (Some of the trial participants did, in fact, receive straight saline but there’s no way to tell from the data released which cases are which.)

   

  More importantly, a reactive placebo artificially decreases the appearance of danger of an experimental vaccine in a clinical trial because the drug company only has to prove that adverse events weren’t statistically significant in the vaccine group versus the placebo group. So using aluminium-containing placebos falsely inflates the adverse-event data of the “placebo” group, making the vaccine look relatively safe by comparison.

   

  Gardasil contains 225 mcg of aluminium. Neither Merck nor the U.S. FDA would answer my questions as to how much aluminium was used in the placebo. (Sanofi Pasteur MSD is marketing the vaccine in Europe and is a joint venture of French company Sanofi Pasteur and U.S. pharmaceutical company Merck.)

   

  Clinical trial investigators dismissed most of the 102 serious adverse events including 17 deaths that occurred in the clinical trials as unrelated to the study. But given the reactivity profile of aluminium, can we really say that for sure?

• Those who received the vaccine reported even more serious adverse events such as gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.

   

  In a never before done study, scientists recently found a link between aluminium in vaccines and symptoms associated with Parkinson’s, amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and Alzheimer’s.

   

  “This is suspicious,” neuroscientist Chris Shaw told the Georgia Straight, Canada’s largest urban weekly. “Either this [link] is known by industry and it was never made public, or industry was never made to do these studies by Health Canada. I’m not sure which is scarier.”

   

  Shaw said there could be 10,000 studies showing aluminium hydroxide is safe to be injected, but that he hasn’t been able to find one study that looked beyond the first few weeks of injection. The reason this is significant, according to Shaw, is that neurological damage can take years to manifest.

   

• Sanofi Pasteur and Merck have an enormous amount at stake in the universal administration of the shots. A place on the childhood vaccination schedule means a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck’s most important pipeline contributor to top-line growth, with peak sales of at least $2 billion — revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that Gardasil will be required for school admittance.

   

  “It’s a stockholders dream,” said Barbara Loe Fisher, president of the NVIC, a U.S. non-profit organisation that promotes the right to informed consent on vaccine decisions. Fisher sat on the FDA’s committee that reviews vaccines in 2001, when the vaccine underwent early reviews.
• Fisher went on to explain that Merck did not reveal in public documents exactly how many 9- to 15-year-old girls were in the clinical trials and how many of them had serious adverse events after being injected with Gardasil or the aluminium-containing placebo. “For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.

4 more annotations...

• When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

   

  In addition, VAERS notes: “In some media reports and on some web sites on the Internet, VAERS reports are presented as verified cases of vaccine deaths and injuries. Statements such as these misrepresent the nature of the VAERS surveillance system.”

   

  Regarding the safety of Gardasil, the Wall Street Journal followed up on the JudicialWatch report and provided the following information regarding the adverse reports including the three deaths:

   

• WASHINGTON, DC, October 5, 2007 (LifeSiteNews.com) - Judicial Watch, the public interest group that investigates and prosecutes government corruption, yesterday released new documents obtained from the U.S. Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing a total of as many as eleven deaths related to Merck's HPV vaccine Gardasil.  Those deaths resulted between June 8, 2006 - when the vaccine received approval from the U.S. Food and Drug Administration (FDA) - and August 2007 when the latest data was available.
   
  The adverse reports coming from the HPV vaccine are increasing daily at an alarming rate.  A LifeSiteNews.com report which scanned a publicly available database of adverse affects coming from the HPV vaccine found 3,137 adverse effects reported on September 28, 2007.  Today the US Government's Vaccine Adverse Event Reporting System (VAERS) lists 3,779 adverse effects.  52 of the cases were deemed "life threatening" and 119 required hospitalization.
   
  In one case highlighted by Judicial Watch a 17 year old girl who was vaccinated in June 2007 died the very day she was vaccinated.  According to the report, she "was vaccinated with a first dose of Gardasil…During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful.  The patient subsequently died."
   
  Other serious reported side effects associated with Gardasil include paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures.  Says one report: "Initial and follow-up information has been received from a physician concerning an "otherwise healthy" 13 year old female who was vaccinated with her first and second doses of Gardasil.  Subsequently, the patient experienced…paralysis from the chest down, lesions of the optic nerve…At the time of the report, the patient had not recovered."
   
  "In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls," said Judicial Watch President Tom Fitton.  "These adverse reaction reports suggest the vaccine not only causes serious side effects, but might even be fatal."
   
  The toll from the HPV vaccine may be greater still.  Judicial Watch filed its request on August 20, 2007, and received the adverse event reports from the FDA on September, 13 2007, in what the agency described as a "partial response." On October 3, 2007, Judicial Watch filed a new lawsuit against the FDA for its failure to fully respond to Judicial Watch's FOIA request as required by law.

  • This is the good information on adverse effects