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Issue Number 604            June 12, 2006

CONTENTS OF THIS ISSUE

  1. FDA approves Gardasil, a vaccine to protect females ages 9–26 years from cervical cancer and other HPV-related diseases
  2. MMWR includes ACIP's updated recommendations for control and elimination of mumps
  3. ACHA and CDC issue joint letter to provide guidance for residential colleges regarding the current mumps outbreak
  4. HAN issues CDC Health Update on revised interim guidance for testing persons with suspected avian influenza infection
  5. New: 2006 Red Book available in print format at the end of June; preorders being accepted now
  6. Free: Order two pads of the Vaccine Education Center's rotavirus information sheets at no charge

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ABBREVIATIONS: AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NIP, National Immunization Program; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
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June 12, 2006
FDA APPROVES GARDASIL, A VACCINE TO PROTECT FEMALES AGES 9–26 YEARS FROM CERVICAL CANCER AND OTHER HPV-RELATED DISEASES

On June 8, the Food and Drug Administration (FDA) approved Merck's Gardasil, a quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine. The vaccine is intended to be administered in three doses to girls and women ages 9–26 years to prevent cervical cancer and other diseases caused by human papillomavirus (HPV).

Also on June 8, FDA issued a press release announcing the approval. It is reprinted below in its entirety.

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For immediate release
June 8, 2006

FDA LICENSES NEW VACCINE FOR PREVENTION OF CERVICAL CANCER AND OTHER DISEASES IN FEMALES CAUSED BY HUMAN PAPILLOMAVIRUS: Rapid Approval Marks Major Advancement in Public Health

The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions, and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine is approved for use in females 9–26 years of age. Gardasil was evaluated and approved in six months under FDA's priority review process—a process for products with potential to provide significant health benefits.

"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, deputy secretary, U.S. Department of Health and Human Services (HHS). "HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans."

HPV is the most common sexually-transmitted infection in the United States. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with genital HPV each year and that over half of all sexually active men and women become infected at some time in their lives. On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year. Worldwide, cervical cancer is the second most common cancer in women; and is estimated to cause over 470,000 new cases and 233,000 deaths each year.

For most women, the body's own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later can turn into cancer. Other HPV types can cause genital warts. The vaccine is effective against HPV types 16 and 18, which cause approximately 70 percent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 percent of genital warts.

"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," said Andrew C. von Eschenbach, MD, acting commissioner of food and drugs. "The development of this vaccine is a product of extraordinary work by scientists as well as by FDA's review teams to help facilitate the development of very novel vaccines to address unmet medical needs. This work has resulted in the approval of a number of new products recently, including Gardasil, which address significant public health needs."

Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period. Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine. However, females are not protected if they have been infected with that HPV type(s) prior to vaccination, indicating the importance of immunization before potential exposure to the virus. Also, Gardasil does not protect against less common HPV types not included in the vaccine, thus routine and regular pap screening remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.

"This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research.

Four studies, one in the United States and three multinational, were conducted in 21,000 women to show how well Gardasil worked in women between the ages of 16 and 26 by giving them either the vaccine or placebo. The results showed that in women who had not already been infected, Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed. While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.

The studies also evaluated whether the vaccine can protect women already infected with some HPV types included in the vaccine from developing diseases related to those viruses. The results show that the vaccine is only effective when given prior to infection.

Two studies were also performed to measure the immune response to the vaccine among younger females aged 9-15 years. Their immune response was as good as that found in 16-26 year olds, indicating that the vaccine should have similar effectiveness when used in the 9–15 year age group.

The safety of the vaccine was evaluated in approximately 11,000 individuals. Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the site of injection.

The manufacturer has agreed to conduct several studies following licensure, including additional studies to further evaluate general safety and long-term effectiveness. The manufacturer will also monitor the pregnancy outcomes of women who receive Gardasil while unknowingly pregnant. Also, the manufacturer has an ongoing study to evaluate the safety and effectiveness of Gardasil in males.

Gardasil is manufactured by Merck & Co., Inc., of Whitehouse Station, NJ.

For more information, see
http://www.fda.gov/cber/products/hpvmer060806.htm
http://www.fda.gov/womens/getthefacts/hpv.html

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To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html

To read questions and answers about the disease and the vaccine, go to: http://www.fda.gov/cber/products/hpvmer060806qa.htm

To read the package insert, go to:
http://www.fda.gov/cber/label/hpvmer060806LB.pdf

To read the FDA approval information, go to:
http://www.fda.gov/cber/products/hpvmer060806.htm
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June 12, 2006
MMWR INCLUDES ACIP'S UPDATED RECOMMENDATIONS FOR CONTROL AND ELIMINATION OF MUMPS

CDC published "Notice to readers: Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) for the control and elimination of mumps" in the June 9 MMWR. Previously, the article was available in electronic format as an MMWR Early Release.

To access a web-text (HTML) version of the MMWR article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5522a4.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5522.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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June 12, 2006
ACHA AND CDC ISSUE JOINT LETTER TO PROVIDE GUIDANCE FOR RESIDENTIAL COLLEGES REGARDING THE CURRENT MUMPS OUTBREAK

The American College Health Association (ACHA) and CDC recently released a letter to all U.S. residential colleges and universities. The letter presents a strategy to protect college students from mumps. A portion of the letter is reprinted below.

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The most effective strategy to protect college students from mumps is to ensure that all students have received two doses of the measles-mumps-rubella vaccine (MMR) or have other evidence of immunity (i.e., documentation of physician-diagnosed mumps, laboratory evidence of immunity, or birth before 1957). This statement reflects the vaccine policy recommendations of the Advisory Committee on Immunization Practices (ACIP), which were made in 1998 (two doses of MMR for all college students), and a recent change in ACIP recommendations made on May 17, 2006, requiring that presumptive evidence of mumps immunity through vaccination for college students be two doses, rather than one dose, of live mumps virus vaccine. Summer vacation and the return to classes in the fall represent an important opportunity to uniformly implement this vital strategy. . . .

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To access the complete letter, go to:
http://www.acha.org/achamumpssignedfinal.pdf
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June 12, 2006
HAN ISSUES CDC HEALTH UPDATE ON REVISED INTERIM GUIDANCE FOR TESTING PERSONS WITH SUSPECTED AVIAN INFLUENZA INFECTION

On June 7, the Health Alert Network (HAN) issued an official CDC Health Update about revised interim guidance for testing persons with suspected avian influenza infection. The opening paragraph of the Health Update is reprinted below.

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THIS IS AN OFFICIAL CDC HEALTH UPDATE
Distributed via Health Alert Network
June 7, 2006 19:50 EDT (7:50 PM EDT)

UPDATED INTERIM GUIDANCE FOR LABORATORY TESTING OF PERSONS WITH SUSPECTED INFECTION WITH AVIAN INFLUENZA A (H5N1) VIRUS IN THE UNITED STATES

CDC Health Update
This update provides revised interim guidance for testing of suspected human cases of avian influenza A (H5N1) in the United States and is based on the current state of knowledge regarding human infection with H5N1 viruses. The epidemiology of H5N1 human infections has not changed significantly since February 2004. Therefore, CDC recommends that H5N1 surveillance in the United States remain at the enhanced level first established at that time. However, this revised interim guidance provides an updated case definition of a suspected H5N1 human case for the purpose of determining when testing should be undertaken and also provides more detailed information on laboratory testing. Effective surveillance will continue to rely on healthcare providers obtaining information regarding international travel and other exposure risks from persons with specified respiratory symptoms as detailed in the recommendations below. This guidance will be updated as the epidemiology of H5N1 changes. Note: CDC is revising its interim guidance for infection control precautions for avian influenza A (H5N1). These will be issued as soon as they are available. . . .

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To access the Health Advisory, go to:
http://www.phppo.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00246
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June 12, 2006
NEW: 2006 RED BOOK AVAILABLE IN PRINT FORMAT AT THE END OF JUNE; PREORDERS BEING ACCEPTED NOW

The American Academy of Pediatrics' "Red Book: 2006 Report of the Committee on Infectious Diseases" will be available in print format on June 26.

The 2006 publication, the book's 27th edition, offers readers the latest clinically tested guidelines on the manifestations, etiology, epidemiology, diagnosis, and treatment of 200 childhood infectious diseases. It was developed jointly by AAP, CDC, FDA, and other leading institutions, with contributions from hundreds of physicians nationwide.

To access comprehensive information on the 2006 edition's major changes, go to:
http://aapredbook.aappublications.org/home/2006Summary.pdf

The 2006 edition is available in five formats:

1. Red Book softbound; for information/online ordering, go to:
http://www.aap.org/bst/showdetl.cfm?&DID=15&Product_ID=4143&CatID=132

2. Red Book hardbound; for information/ online ordering, go to:
http://www.aap.org/bst/showdetl.cfm?&DID=15&Product_ID=4144&CatID=132

3. Red Book Plus (print and electronic); for information/online ordering, go to:
http://www.aap.org/bst/showdetl.cfm?&DID=15&Product_ID=4145&CatID=132

4. Redbook for PDA; for information/online ordering, go to:
http://www.aap.org/bst/showdetl.cfm?&DID=15&Product_ID=4146&CatID=132

5. Redbook online; for information/online ordering, go to:
http://aapredbook.aappublications.org/subscriptions

For additional information or to place an order by phone, call (888) 227-1770.
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June 12, 2006
FREE: ORDER TWO PADS OF THE VACCINE EDUCATION CENTER'S ROTAVIRUS INFORMATION SHEETS AT NO CHARGE

The Vaccine Education Center at the Children's Hospital of Philadelphia recently announced that it has published a two-page information sheet, "Rotavirus: What you should know." Intended for patients and providers, the sheet answers the most frequently asked questions about rotavirus disease and vaccine. English- and Spanish-language versions are available.

Health professionals can order two 50-sheet pads in each language at no charge. Additional pads are available for $3, plus shipping.

To access a ready-to-copy (PDF) version of the sheet in English, click here.

To access a ready-to-copy (PDF) version of the sheet in Spanish, click here.

To order online, go to:
http://www.chop.edu/vaccine/vec/vecprof_order.cfm

Order by email at vaccines@email.chop.edu or by phone at (215) 590-9990.

For additional ordering information, go to:
http://www.chop.edu/consumer/jsp/division/generic.jsp?id=75982

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-9131

This page was updated on June 12, 2006