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Immunization Action Coalition
IAC Express 2008
Issue number 744: July 28, 2008
 
Contents of this Issue
Select a title to jump to the article.
  1. CDC and FDA make updated information available about the safety of HPV vaccine
  2. CDC reports on use of mass Tdap vaccination during a recent pertussis outbreak in a high school in Cook County, IL
  3. Updated: IAC revises several of its vaccine administration standing orders protocols
  4. IAC reviews and revises its resources on vaccinating healthcare personnel and on vaccine handling and storage
  5. Mark your calendar: August 28 is the date for CDC's webcast "Immunization Update 2008"
  6. HHS announces the release of "Guidance on Pandemic Influenza Vaccine Allocation"
  7. NFID sets Clinical Vaccinology course for November 14-16 in Bethesda, MD
 
Abbreviations
AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; AMA, American Medical Association; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD, National Center for Immunization and Respiratory Diseases; NIVS, National Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
  
Issue 744: July 28, 2008
1.  CDC and FDA make updated information available about the safety of HPV vaccine

 On July 22, CDC and FDA updated the information about the safety of the human papillomavirus (HPV) vaccine (Gardasil [Merck]) that is posted on their respective websites. The vaccine has recently received media attention because consumers, parents, and others have raised questions about its safety.

Portions of the updated information posted on CDC's Vaccine Safety web section are reprinted below. Links to updated information posted on the FDA website and on CDC's Features web section are given at the end of this IAC Express article, as are links to HPV resources.


GARDASIL BACKGROUND

FDA approved Gardasil vaccine on June 8, 2006, for use in girls and women 9 through 26 years of age. This vaccine prevents infection with the types of HPV that cause most cases of cervical cancer and genital warts. CDC's Advisory Committee on Immunization Practices (ACIP) recommended routine 3-dose vaccination of girls aged 11 and 12 years. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.

Gardasil was tested in over 11,000 women in the United States and around the world, and found to be safe and effective in preventing serious HPV-related diseases. These studies showed that in women who have never been infected by HPV types 6, 11, 16, or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina, and vulva, and in preventing genital warts often caused by these HPV types.

This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

MONITORING THE SAFETY OF GARDASIL

Vaccine Safety Overview
FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S. VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects). . . .

To date, the manufacturer, Merck and Co., has distributed over 16 million doses of Gardasil in the United States. Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in-depth medical review, are designed to detect serious events that occur at rates greater than expected, compared to what would be expected by chance alone. . . .

As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.

Non-Serious Reports (94% of total reports)
Since Gardasil was approved, the great majority (94%) of adverse events reported to VAERS after receiving this vaccine have not been serious. These reports include syncope (fainting), pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine's prescribing information was changed to include this information.

Serious Reports (6% of total reports)
Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of June 30, 2008, 20 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.

Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives, which are known to increase the risk of clotting. Thromboembolic disorders as well as other medical events are being studied through the Vaccine Safety Data Project in previously planned controlled studies. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine's safety.

SUMMARY

Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.

CDC has not changed its recommendations for use of Gardasil. FDA has not made any changes to the prescribing information for how the vaccine is used or to the vaccine's precautions. In addition, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV that cause the majority of cervical cancer, genital warts, and other HPV-related diseases.


Links to updated information from the CDC's Vaccine Safety web section, FDA's website, and CDC's Features web section follow:

To access the recently posted information from CDC's Vaccine Safety web section in its entirety, go to:
http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm

To access the recently posted information from the FDA website, go to: http://www.fda.gov/cber/safety/gardasil071408.htm

To access recently posted information from CDC's Features web section, go to: http://www.cdc.gov/Features/HPVvaccineSafety

Links to HPV resources from CDC and NCIRD follow:

To access CDC's fact sheet "HPV Vaccine: Questions and Answers for the Public," go to:
http://www.cdc.gov/vaccines/vpd-vac/hpv/hpv-vacsafe-effic.htm

To access NCIRD's HPV Vaccine web section, which includes links to information for the public, healthcare professionals, and the media, go to: http://www.cdc.gov/vaccines/vpd-vac/hpv

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2 CDC reports on use of mass Tdap vaccination during a recent pertussis outbreak in a high school in Cook County, IL

CDC published "Use of Mass Tdap Vaccination to Control an Outbreak of Pertussis in a High School--Cook County, Illinois, September 2006-January 2007" in the July 25 issue of MMWR. Portions of the article are reprinted below.


On September 6, 2006, the Cook County Department of Public Health (CCDPH) was notified that a local high school student aged 17 years had pertussis. During September 2006-January 2007, 36 pertussis cases directly linked to the high school were identified. Because Bordetella pertussis immunity from childhood vaccinations wanes over time, outbreaks of pertussis can periodically occur among students and staff at middle and high schools. School settings facilitate transmission of pertussis, disrupting school and community activities and putting vulnerable populations, such as unvaccinated infants, at risk. A pertussis booster vaccine suitable for adolescents and adults became available in the United States in 2005, when two new tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines were licensed for persons aged 10-18 years and 11-64 years, respectively. In 2006, the Advisory Committee on Immunization Practices (ACIP) recommended that all adolescents and adults receive a one-time Tdap booster vaccination. This report summarizes strategies used to control the pertussis outbreak in Cook County, Illinois, including efforts to increase Tdap vaccination coverage. Despite multiple communications recommending Tdap vaccination and implementation of a cough exclusion policy during the pertussis outbreak, student vaccination rates did not increase substantially until a school-based Tdap vaccination clinic was implemented. Because persons at risk for pertussis might not seek vaccination from their usual healthcare provider, even during an outbreak, local health departments might consider early implementation of a cough exclusion policy and on-site Tdap vaccination clinic as control measures. . . .

Editorial Note:
Because a pertussis vaccine suitable for adolescents and adults was not available until 2005, pertussis outbreak control measures historically relied on rapid identification of cases for treatment and chemoprophylaxis of close contacts. In the Cook County outbreak, pertussis spread quickly to all grades within the high school, making this control strategy difficult to implement; only seven (19.4%) of the 36 cases had a clear epidemiologic link to another case.

Strict enforcement of exclusion for cough illness was likely an important factor in controlling the outbreak. This measure limited exposure to persons with respiratory illness within the school, encouraged timely medical evaluation and treatment of cases, and promoted prompt administration of chemoprophylactics to close contacts. The time between cough onset and diagnosis for cases was reduced significantly after implementation of the policy. The exclusion measure began on November 6, after 10 cases had been reported. Additional study is needed to evaluate the point when application of more aggressive control measures, such as exclusion for cough illness or mass Tdap vaccination clinics, might be warranted to control an outbreak.

Public health messages alone, particularly regarding the need for vaccination during the outbreak, had some effect on student vaccination rates. During the first 13 weeks after the first notices to parents and area physicians from CCDPH, Tdap vaccination coverage increased 5.8%. Before the on-site clinic at the school, Tdap vaccination coverage of students overall did not exceed 50%, even after the strict cough exclusion policy was adopted. After the on-site vaccination clinic, coverage increased another 30.8%. Which barriers prevented an earlier, more substantial increase in Tdap vaccination rates is unclear; however, the convenience of an on-site school clinic versus scheduling an appointment in a private physician's office might have played a role. Another barrier was the limited supply of Tdap vaccine for adults. . . .

Although the effect of the Tdap vaccination clinic in shortening the duration of the outbreak is unclear, this experience shows that school-based Tdap vaccination clinics can quickly achieve high coverage during a pertussis outbreak. More experience with large Tdap vaccination clinics as part of the response to school pertussis outbreaks is needed to develop new recommendations for outbreak control. Preventing outbreaks of pertussis by increasing routine Tdap vaccination rates remains an important public health goal. As an initial step to prevent pertussis outbreaks, healthcare providers, public health officials, and schools should promote routine Tdap vaccination before outbreaks occur.


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5729a2.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5729.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP recommendations), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html

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3 Updated: IAC revises several of its vaccine administration standing orders protocols

IAC recently revised several of its standing orders protocols for vaccinating infants, children, teens, and/or adults with the following vaccines: Haemophilus influenzae type b (Hib), hepatitis A, human papillomavirus (HPV), and varicella. Details follow.

CHILD AND TEEN STANDING ORDERS PROTOCOLS
Hib vaccine: The information on needle length and minimum intervals between doses was changed.

To access the revised standing orders protocol for administering Hib vaccine to children, go to:
http://www.immunize.org/catg.d/p3083.pdf

Hepatitis A vaccine: Information on vaccinating children with recent possible exposure to hepatitis A virus was added; other minor changes were made.

To access the revised standing orders protocol for administering hepatitis A vaccine to children and teens, go to:
http://www.immunize.org/catg.d/p3077a.pdf

HPV vaccine: The minimum interval between administering the first and third doses was changed to 24 weeks.

To access the revised standing orders protocol for administering HPV vaccine to children and teens, go to:
http://www.immunize.org/catg.d/p3090.pdf

Varicella vaccine: Extensive revisions were made, particularly about vaccinating HIV-infected children and teens and about contraindications to vaccination.

To access the revised standing orders protocol for administering varicella vaccine to children and teens, go to:
http://www.immunize.org/catg.d/p3080a.pdf

ADULT STANDING ORDERS PROTOCOLS
Hepatitis A vaccine: Information on vaccinating adults who have had recent possible exposure to hepatitis A virus (HAV) was added; other minor changes were made.

To access the revised standing orders protocol for administering hepatitis A vaccine to adults, go to:
http://www.immunize.org/catg.d/p3077.pdf

HPV vaccine: The minimum interval between administering the first and third doses was changed to 24 weeks.

To access the revised standing orders protocol for administering HPV vaccine to adults, go to:
http://www.immunize.org/catg.d/p3091.pdf

Varicella vaccine: Extensive revisions were made, particularly about vaccinating HIV-infected adults and about contraindications to vaccination.

To access the revised standing orders protocol for administering varicella vaccine to adults, go to:
http://www.immunize.org/catg.d/p3080.pdf

To access a table with links to all IAC's standing orders protocols for vaccine administration and medical management of vaccine reactions, as well as standing orders for newborn-nursery hepatitis B vaccination, go to: http://www.immunize.org/standingorders

IAC's Print Materials web section has more than 175 FREE, ready-to-print English-language resources for healthcare professionals and the public--as well as many in translation. To access all of IAC's print resources, go to: http://www.immunize.org/printmaterials

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4 IAC reviews and revises its resources on vaccinating healthcare personnel and on vaccine handling and storage

IAC recently reviewed and updated two of its print resources for healthcare professionals. Details follow.

Information on meningococcal vaccination was revised on the print resource titled "Healthcare Personnel Vaccination Recommendations." To access this revised resource, go to:
http://www.immunize.org/catg.d/p2017.pdf

Information on the preferred refrigerators for storing vaccine was changed on the print resource titled "Checklist for Safe Vaccine Handling and Storage." To access this revised resource, go to: http://www.immunize.org/catg.d/p3035.pdf

IAC's Print Materials web section has more than 175 FREE, ready-to-print English-language resources for healthcare professionals and the public--as well as many in translation. To access all of IAC's print resources, go to: http://www.immunize.org/printmaterials

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5 Mark your calendar: August 28 is the date for CDC's webcast "Immunization Update 2008"

Scheduled from noon to 2PM ET on August 28, the webcast "Immunization Update 2008" will provide up-to-date information on the rapidly changing field of immunization. Anticipated topics include influenza and zoster vaccines, recently approved vaccines, and updates on vaccine supplies and vaccine safety.

Faculty. The course instructors include William L. Atkinson, MD, MPH; Donna L. Weaver, MN, RN; Andrew T. Kroger, MD, MPH, and guest experts. All are with the CDC's National Center for Immunization and Respiratory Diseases.

To access the webcast, go to: http://www2a.cdc.gov/PHTN/webcast/immupdate2008 A replay of this program will be available through the URL above shortly after the August 28 webcast.

Note: There will NOT be a satellite broadcast of this program, as there was in previous years.

Registration. Registration is not required. HOWEVER, ONLINE REGISTRATION IS REQUIRED TO RECEIVE CONTINUING EDUCATION CREDITS. To register, go to: http://www2a.cdc.gov/TCEOnline

Continuing Education for this activity will open on August 28 and expire on September 29. For full accreditation statements, including information about pharmacy credit, go to the program website after August 7.

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6 HHS announces the release of "Guidance on Pandemic Influenza Vaccine Allocation"

On July 23, the Department of Health and Human Services (HHS) issued a press release, "HHS and DHS Announce Guidance on Pandemic Vaccination Allocation." Portions of the press release are reprinted below. Also on July 23, the federal government's Pandemic Flu website posted a document titled "Guidance on Pandemic Vaccine Allocation"; a link to the document is given at the end of this IAC Express article.


The U.S. Departments of Health and Human Services (HHS) and Homeland Security (DHS) released today guidance on allocating and targeting pandemic influenza vaccine. The guidance provides a planning framework to help state, tribal, local and community leaders ensure that vaccine allocation and use will reduce the impact of a pandemic on public health and minimize disruption to society and the economy. . . .

The ultimate goal of the pandemic vaccination program is to vaccinate every person in the United States who wants to be vaccinated. Because pandemic vaccine cannot be made fast enough for everyone to be vaccinated at once, federal, state, local and tribal governments, communities, and the private sector can use the guidance to decide who should be vaccinated during this early stage to best protect people and communities. . . .


To access the complete press release, go to:
http://www.hhs.gov/news/press/2008pres/07/20080723a.html

To access "Guidance on Pandemic Vaccine Allocation," go to:
http://www.pandemicflu.gov/vaccine/allocationguidance.pdf

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7 NFID sets Clinical Vaccinology course for November 14-16 in Bethesda, MD

The National Foundation for Infectious Diseases (NFID) recently announced that its Clinical Vaccinology course will be held November 14-16 in Bethesda, MD. It is intended for primary care physicians, nurses, nurse practitioners, physician assistants, public health specialists, infectious disease specialists, and other healthcare professionals involved with clinical aspects of vaccinology. Continuing education credit is available.

To access the course brochure, go to:
http://www.nfid.org/pdf/conferences/idcourse08.pdf

To register online, go to:
https://secure.bnt.com/webresponse/nfid/idcourse08

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Immunization Action Coalition  •  Saint Paul, MN
tel 651-647-9009  •  fax 651-647-9131
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.