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IAC Express 2008 |
| Issue number 744: July 28, 2008 |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC and
FDA make updated information available about the safety of HPV vaccine
- CDC
reports on use of mass Tdap vaccination during a recent pertussis outbreak
in a high school in Cook County, IL
- Updated:
IAC revises several of its vaccine administration standing orders
protocols
- IAC
reviews and revises its resources on vaccinating healthcare personnel and
on vaccine handling and storage
- Mark your
calendar: August 28 is the date for CDC's webcast "Immunization Update
2008"
- HHS
announces the release of "Guidance on Pandemic Influenza Vaccine
Allocation"
- NFID sets
Clinical Vaccinology course for November 14-16 in Bethesda, MD
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| Abbreviations |
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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. |
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Issue 744: July 28, 2008 |
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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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