Issue
Number 604
June 12, 2006
CONTENTS OF THIS ISSUE
- FDA approves Gardasil, a vaccine to protect females ages
9–26 years from cervical cancer and other HPV-related diseases
- MMWR includes ACIP's updated recommendations for control
and elimination of mumps
- ACHA and CDC issue joint letter to provide guidance for
residential colleges regarding the current mumps outbreak
- HAN issues CDC Health Update on revised interim guidance
for testing persons with suspected avian influenza infection
- New: 2006 Red Book available in print format at the end
of June; preorders being accepted now
- Free: Order two pads of the Vaccine Education Center's
rotavirus information sheets at no charge
----------------------------------------------------------
Back to Top
---------------------------------------------------------------
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.
---------------------------------------------------------------
(1 of 6)
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.
*********************
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
*********************
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
---------------------------------------------------------------
Back to Top
(2 of 6)
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
---------------------------------------------------------------
Back to Top
(3 of 6)
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.
***********************
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. . . .
***********************
To access the complete letter, go to:
http://www.acha.org/achamumpssignedfinal.pdf
---------------------------------------------------------------
Back to Top
(4 of 6)
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.
**********************
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. . . .
**********************
To access the Health Advisory, go to:
http://www.phppo.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00246
---------------------------------------------------------------
Back to Top
(5 of 6)
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.
---------------------------------------------------------------
Back to Top
(6 of 6)
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 |
