IAC Express 2009 |
Issue number 835: November 16, 2009 |
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as well as other FREE IAC periodicals. |
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Contents
of this Issue
Select a title to jump to the article. |
- FDA
approves expanded age indication for both of CSL's
inactivated influenza vaccines
- FDA
approves ID Biomedical's injectable H1N1 influenza
vaccine
- New: IAC
develops form for healthcare employees to sign if declining H1N1 influenza
vaccination
- New: AMA fact sheet has Q&As about using CPT codes for
providing and administering H1N1 vaccine
- FDA commissioner's letter to healthcare professionals
provides information on the safety of H1N1 vaccines
- MMWR Dispatch reports on 2009 mumps outbreak in New York,
New Jersey, and Quebec
- NCIRD director's letter to providers underscores the need
for PPSV vaccination for adults
- Update on recent U.S. influenza activity indicates 2009
H1N1 influenza virus is causing significant disease
- CDC updates its H1N1 web section with information on
pregnancy and H1N1 infection, importance of PPSV
vaccination, and more
- Two more hospitals added to IAC's Honor Roll for Patient
Safety; NEJM article discusses mandatory HCW vaccination
- IAC'S Video Of The Week highlights the impact of
rotavirus vaccine in the developing world
- CDC experts review and update three of IAC'S online "Ask
The Experts" Q&A sections
- Online, year-end sale! Get laminated child/teen and adult
U.S. immunization schedules for $1 each when you buy 11
or more!
- Laminated seasonal influenza vaccine pocket guides--FREE!--from the National Influenza Vaccine Summit
- CDC reports on the effectiveness of 2008-09 inactivated
influenza vaccine in protecting against 2009 H1N1
influenza
- National Influenza Vaccination Week set for December 6-12; be sure to submit your organization's event plans
- National Immunization Conference abstract deadline is
December 11; early-bird registration ends February 19
- Website of the Global Polio Eradication Initiative is
worth exploring
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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 835: November 16, 2009 |
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1. |
FDA approves expanded age indication for both of CSL's
inactivated influenza vaccines
On November 10, FDA approved the expansion of the
age
indication for both of CSL Limited's inactivated influenza
vaccines: the seasonal formulation (Afluria) and the 2009
H1N1 formulation. These two vaccines are now approved for
use in people age 6 months and older; previously, they were
licensed for use in people age 18 years and older.
In a related move, FDA posted a document, "Influenza A
(H1N1) 2009 Monovalent Vaccines Descriptions and
Ingredients," that contains (1) excerpts from the package
inserts of each of the licensed H1N1 influenza vaccines and
(2) links to the package insert for each vaccine. A link to
the documents is given at the end of this IAC Express
article.
To access the package insert for CSL's inactivated 2009-10
trivalent seasonal vaccine (Afluria), click
here.
To access the package insert for CSL's inactivated 2009 monovalent H1N1
influenza vaccine, click
here.
To access the FDA approval letter, click
here.
To access the FDA document "Influenza A (H1N1) 2009 Monovalent Vaccines
Descriptions and Ingredients," click
here.
To obtain package inserts for all licensed U.S. vaccines, go
to:
http://www.immunize.org/packageinserts
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2. |
FDA approves ID Biomedical's injectable H1N1 influenza
vaccine
On November 10, FDA approved the request of ID
Biomedical
Corporation of Quebec to supplement its biologics license
application for influenza virus vaccine to include the
influenza A (H1N1) 2009 monovalent vaccine. The vaccine is
licensed for use in adults age 18 years and older.
ID Biomedical is a wholly-owned subsidiary of
GlaxoSmithKline (GSK).
In a related move, FDA posted a document, "Influenza A
(H1N1) 2009 Monovalent Vaccines Descriptions and
Ingredients," that contains (1) excerpts from the package
inserts of each of the licensed H1N1 influenza vaccines and
(2) links to the package insert for each vaccine. A link to
the documents is given at the end of this IAC Express
article.
To access the FDA approval letter to ID Biomedical, click
here.
To access the package insert for ID Biomedical's injectable H1N1 vaccine,
click
here.
To access the FDA document "Influenza A (H1N1) 2009 Monovalent Vaccines
Descriptions and Ingredients," click
here.
To obtain package inserts for all licensed U.S. vaccines, go
to:
http://www.immunize.org/packageinserts
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3. |
New: IAC develops form for healthcare employees to sign
if declining H1N1 influenza vaccination
IAC recently developed a one-page form,
"Declination of H1N1
Influenza Vaccination." It is intended for use in healthcare
settings for employees who decline vaccination. Healthcare
employees are among the priority groups targeted to receive
H1N1 influenza vaccine.
The form succinctly states reasons for vaccinating
healthcare workers against H1N1 influenza and provides space
for the employee's signature if the employee declines
vaccination, allowing the employer to document employee
refusal.
To access "Declination of H1N1 Influenza Vaccination" go to:
http://www.immunize.org/catg.d/p4071.pdf
To access the declination form for seasonal influenza
vaccination, go to:
http://www.immunize.org/catg.d/p4068.pdf
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4. |
New: AMA fact sheet has Q&As about using CPT codes for
providing and administering H1N1 vaccine
The website of the American Medical Association
(AMA) now
includes a five-page document titled "AMA Fact Sheet on
Reporting for H1N1." It includes information on coding for
providing and administering H1N1 influenza vaccine and for
reporting National Drug Codes (NDC).
To access "AMA Fact Sheet on Reporting for H1N1," click
here.
To access a related IAC Express article published on October
12, go to:
http://www.immunize.org/express/issue827.asp#n5
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5. |
FDA commissioner's letter to healthcare professionals
provides information on the safety of H1N1 vaccines
On November 10, Dr. Margaret Hamburg,
Commissioner of Food
and Drugs, sent a letter to America's healthcare
professionals thanking them for their efforts during the
2009 H1N1 influenza outbreak and providing information on
the safety of the 2009 H1N1 vaccines.
"Some of your patients may be asking how the FDA, the
manufacturers, and the scientific community can have
confidence in vaccines that were available just six months
after the 2009 H1N1 virus emerged," Dr. Hamburg wrote.
"Understanding more about the manufacturing and approval
process for these vaccines should help you to answer their
questions."
To access the letter, go to:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm189691.htm
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6. |
MMWR Dispatch reports on 2009 mumps outbreak in New York,
New Jersey, and Quebec
On November 12, CDC published "Mumps
Outbreak--New York, New
Jersey, Quebec, 2009" as an MMWR Dispatch. The first
paragraph of the article and the last paragraph of the
Editorial Note are reprinted below.
[From the article text]
Mumps is a vaccine-preventable viral infection
characterized by fever and inflammation of the salivary
glands and whose complications include orchitis, deafness,
and meningo-encephalitis. In August 2009, CDC was notified
of the onset of an outbreak of mumps in a summer camp in
Sullivan County, New York. The outbreak has spread and
gradually increased in size and is now the largest U.S.
mumps outbreak since 2006, when the United States
experienced a resurgence of mumps with 6,584 reported cases.
On August 18, public health departments in Sullivan County,
New York state, and CDC began an investigation into the
mumps outbreak, later joined by departments in New York City
and other locales. As of October 30, a total of 179
confirmed or probable cases had been identified from
multiple locations in New York and New Jersey, and an
additional 15 cases had been reported from Canada. The
outbreak primarily has affected members of a tradition-observant religious community; median age of the patients is
14 years, and 83% are male. Three persons have been
hospitalized. Although little transmission has occurred
outside the Jewish community, mumps can spread rapidly in
congregate settings such as colleges and schools; therefore,
public health officials and clinicians should heighten
surveillance for mumps and ensure that children and adults
are appropriately vaccinated. . . .
[From the Editorial Note]
When possible, persons with suspected mumps should be
isolated for 5 days after onset of parotitis and, if they
visit a healthcare setting, droplet precautions should be
initiated immediately. Clinical specimens (both serum and
buccal swabs) should be collected from persons with
suspected mumps as soon as possible after symptom onset.
Adults and children should receive age-appropriate
vaccination. University students, healthcare personnel, and
persons with potential mumps outbreak exposure should have
documentation of 2 doses of mumps vaccine or other proof of
immunity to mumps. Although vaccination is not considered
effective postexposure prophylaxis for mumps, nonimmune
contacts should be vaccinated with measles, mumps, rubella
(MMR) vaccine to prevent risk from subsequent exposures. Any
suspected mumps case should be reported to the health
department in the area where the patient resides. Additional
information regarding mumps vaccination is available at
http://www.cdc.gov/vaccines/vpd-vac/mumps/default.htm#recs
To access the complete MMWR Dispatch in web-text (HTML)
format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm58d1112a1.htm
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7. |
NCIRD director's letter to providers underscores the need
for PPSV vaccination for adults
CDC recently posted a letter written by NCIRD's
director,
Dr. Anne Schuchat, to healthcare providers urging them to
vaccinate patients with existing indications for
pneumococcal polysaccharide vaccine (PPSV). The first
paragraph is reprinted below.
We're writing to urge you to make sure all your patients
with indications have received the pneumococcal vaccine.
Approximately 70 million persons with existing pneumococcal
polysaccharide vaccine (PPSV) indications are unvaccinated
(National Health Interview Survey, 2007). During the
influenza pandemics of the 20th century, secondary bacterial
pneumonia was a frequent cause of illness and death and
Streptococcus pneumoniae (pneumococcus) was reported as the
most common etiology. With the current 2009 H1N1 influenza
pandemic, and as with seasonal influenza, pneumococcal
infections are once again being found among fatal cases in
both children and adults. . . .
To read the full text of the letter, go to:
http://www.cdc.gov/h1n1flu/vaccination/provider/lettertoprovider.htm
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8. |
Update on recent U.S. influenza activity indicates 2009
H1N1 influenza virus is causing significant disease
CDC published "Update: Influenza Activity--United
States,
August 30-October 31, 2009" in the November 13 issue of
MMWR. The first paragraph is reprinted below.
The 2009 pandemic influenza A (H1N1) virus emerged in the
United States in April 2009 and has since spread worldwide.
Influenza activity resulting from this virus occurred
throughout the summer and, by late August, activity had
begun to increase in the southeastern United States. Since
August, activity has increased in all regions of the United
States. As of the week ending October 31, nearly all states
were reporting widespread disease. Since April 2009,
pandemic H1N1 has remained the dominant circulating
influenza strain. This report summarizes U.S.
influenza activity from August 30, 2009, defined as
the beginning of the 2009-10 influenza season, through
October 31, 2009. . . .
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a4.htm
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9. |
CDC updates its H1N1 web section with information on
pregnancy and H1N1 infection, importance of PPSV
vaccination, and more
CDC recently added or updated the following H1N1
influenza-related information for healthcare professionals and their
patients.
Interim Guidance: Considerations Regarding 2009 H1N1
Influenza in Intrapartum and Postpartum Hospital Settings
http://www.cdc.gov/h1n1flu/guidance/obstetric.htm
Information for Pregnant Women Working in Education, Child
Care, and Health Care Settings Concerning 2009 H1N1
Influenza Virus
http://www.cdc.gov/h1n1flu/guidance/pregnant-hcw-educators.htm
Letter to Providers Promoting PPSV for Adults
http://www.cdc.gov/h1n1flu/vaccination/provider/lettertoprovider.htm
CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations
and Deaths in the United States, April - October 17, 2009
http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm
U.S. Laboratory Confirmed Influenza-Associated
Hospitalizations and Deaths from August 30 to November 7,
2009
http://www.cdc.gov/h1n1flu/updates/us/#totalcases
Updated: Frequently asked questions on use of influenza
A(H1N1) 2009 monovalent vaccines (2009 H1N1 monovalent
influenza vaccines): Practical considerations for
immunization programs and providers
http://www.cdc.gov/H1N1flu/vaccination/top10_faq.htm
Updated: Disposable Respirators: General Donning
Instructions
English: http://www.cdc.gov/h1n1flu/eua/pdf/n95instructions.pdf
Spanish: http://www.cdc.gov/h1n1flu/eua/pdf/respirator-spanish.pdf
CDC's H1N1 Flu web section contains hundreds of documents
for healthcare professionals and the public. To access the
web section's home page, go to: http://www.cdc.gov/h1n1flu
To make it easy for you to keep up to date with
developments, IAC has gathered important information related
to H1N1 influenza into a single web section. To access this
resource, go to: http://www.immunize.org/h1n1
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10. |
Two more hospitals added to IAC's Honor Roll for Patient
Safety; NEJM article discusses mandatory HCW vaccination
Since November 2, when IAC Express last reported
on the
Honor Roll for Patient Safety, two more hospitals have
enrolled. The honor roll recognizes medical practices,
hospitals, professional organizations, and government
entities that have taken a stand for patient safety by
strengthening mandatory influenza vaccination policies for
healthcare workers (HCWs).
The two newly enrolled hospitals are Children's Hospital of
the King's Daughters Health System, Norfolk, VA, and
Children's Hospital of Orange County, CA. For specific
information on the mandates of these organizations and
previously enrolled organizations, as well as information
about the importance of HCW influenza vaccination, go to:
http://www.immunize.org/laws/influenzahcw.asp
IAC has updated the News and Articles portion of its Honor
Roll for Patient Safety web section with an article
published online by the New England Journal of Medicine
(NEJM) on November 4. Titled "Perspective: Mandatory
Vaccination of Health Care Workers," the article was written
by Alexandra M. Stewart, JD, George Washington University
Medical Center.
JOIN THE HONOR ROLL TODAY
To be included in the honor roll, your organization's
mandate must meet certain specifications. Please read the
section titled Criteria for Inclusion on the online
enrollment form, and then fill out the form to tell IAC
about influenza vaccination mandates in your healthcare
setting: http://www.immunize.org/laws/mandates.aspx
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11. |
IAC'S Video Of The Week highlights the impact of
rotavirus vaccine in the developing world
IAC encourages IAC Express readers to watch a
4-minute video
on the impact of rotavirus vaccine in Nicaragua produced by
the Bill & Melinda Gates Foundation.
Rotavirus kills 2 million children per year worldwide. The
disease hit Nicaraguan children hard. But in 2006, a
rotavirus vaccine came to the villages and the results were
remarkable.
The video will be available on the home page of IAC's
website through November 22. To access it, go to:
http://www.immunize.org and click on the image under the
words Video of the Week. It may take a few moments for the
video to begin playing; please be patient!
Remember to bookmark IAC's home page to view a new video
every Monday. To view an IAC Video of the Week from the
past, go to the video archive at http://www.immunize.org/votw
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12. |
CDC experts review and update three of IAC'S online "Ask
The Experts" Q&A sections
Vaccination experts at CDC recently reviewed and
updated
information on three of IAC's online "Ask the Experts" Q&A
sections: H1N1 influenza, measles-mumps-rubella (MMR), and
zoster. All of IAC's "Ask the Experts" Q&As are reviewed and
updated annually. The process is ongoing; IAC Express will
inform readers as sections are reviewed and revised.
To access the revised H1N1 influenza Q&As, go to:
http://www.immunize.org/askexperts/experts_h1n1.asp
To access the revised MMR Q&As, go to:
http://www.immunize.org/askexperts/experts_mmr.asp
To access the revised zoster Q&As, go to:
http://www.immunize.org/askexperts/experts_zos.asp
To access the index page of "Ask the Experts" Q&As for all
other vaccines, go to:
http://www.immunize.org/askexperts
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13. |
Online, year-end sale! Get laminated child/teen and adult
U.S. immunization schedules for $1 each when you buy 11
or more!
During our online, year-end sale, you'll save
significantly
when you order two or more of the laminated 2009 U.S.
Recommended Immunization Schedule for People Ages 0 Through
18 Years or the laminated 2009 U.S. Recommended Adult
Immunization Schedule. Both schedules are based on CDC's two
2009 immunization schedules.
Special pricing applies ONLY TO CREDIT-CARD ORDERS MADE
ONLINE (not to phone or fax orders). At these rock-bottom
prices, there's no reason not to order 11 schedules or more:
REGULAR PRICES
1-4 copies: $10.00 each
5-19 copies: $6.50 each
SALE PRICES
1 copy: $10.00
2 copies: $4.00 each
3-10 copies: $3.00 each
11+ copies: $1.00 each
This is a limited-time offer effective only while supplies
last. Don't be disappointed--order today!
PRODUCT AND ORDERING INFORMATION
Click on the following links to go to an image, description,
and ordering information for each schedule.
Child/teen schedule
http://www.immunize.org/shop/schedule_child.asp
Adult schedule
http://www.immunize.org/shop/schedule_adult.asp
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14. |
Laminated seasonal influenza vaccine pocket guides--FREE!--from the National Influenza Vaccine Summit
With vaccination against 2009 H1N1 influenza now
underway,
it is important to remember that seasonal influenza
vaccination efforts must continue. To aid in these efforts,
the Immunization Action Coalition is inviting IAC Express
readers to place orders now for the National Influenza
Vaccine Summit's laminated 2009-10 Seasonal Influenza
Vaccination Pocket Information Guides. They're free!
See an image of the laminated seasonal influenza vaccine
pocket guide at
http://www.preventinfluenza.org/fluguide/pocketguide_flu.pdf
For a description of the content of the pocket guides and
information on their background, go to:
http://www.immunize.org/express/issue833.asp#n16
The Summit is also pleased to be able to offer free
laminated pocket guides for the administration of
pneumococcal polysaccharide vaccine (PPSV). See an image of
the PPSV pocket guide at
http://www.immunize.org/ppvguide/pocketguide.pdf
HOW TO ORDER
Each order must be for a minimum of 100 pocket guides. Place
your order at http://www.preventinfluenza.org/pocketguides
There is no cost for the pocket guides, shipping, or
handling within the U.S. Quantities are limited, so to avoid
disappointment, place your order today!
If you have questions, email admininfo@immunize.org
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15. |
CDC reports on the effectiveness of 2008-09 inactivated
influenza vaccine in protecting against 2009 H1N1
influenza
CDC published "Effectiveness of 2008-09 Trivalent
Influenza
Vaccine Against 2009 Pandemic Influenza A (H1N1)--United
States, May-June 2009" in the November 13 issue of MMWR. A
summary made available to the press is reprinted below in
its entirety.
There was no evidence that the 2008-09 trivalent influenza
vaccine (i.e., the 2008-09 seasonal flu vaccine) provided
any protection against the 2009 influenza (H1N1) virus.
To complement the serologic studies and evaluate the
effectiveness of 2008-09 trivalent seasonal influenza
vaccine against laboratory-confirmed pandemic influenza A
(H1N1) illness, CDC used available data to conduct a case-cohort analysis. The analysis used surveillance reports from
eight states of persons aged =>18 years with confirmed
pandemic H1N1 illness during May-June 2009.
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5844a5.htm
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16. |
National Influenza Vaccination Week set for December 6-12; be sure to submit your organization's event plans
This year's National Influenza Vaccination Week (NIVW)
is
scheduled for December 6-12. If you are planning an activity
during National Influenza Vaccination Week--or beyond--to
encourage influenza vaccination, CDC would like to hear from
you.
To access the event submission form, go to:
http://www.cdc.gov/flu/NIVW/form.htm
To read the specific details about the myriad national,
state, territorial, and local events that took place during
last year's NIVW, go to:
http://www.cdc.gov/flu/NIVW/activities-original.htm
In the coming weeks, CDC will be updating its main webpage
for NIVW. IAC will notify readers as information is added.
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17. |
National Immunization Conference abstract deadline is
December 11; early-bird registration ends February 19
CDC's 2010 National Immunization Conference will
be held in
Atlanta on April 19-22. The deadline for abstract submission
is December 11. To submit an abstract, go to:
http://cdc.confex.com/cdc/nic2010/cfp.cgi
FEBRUARY 19 IS THE DEADLINE FOR EARLY-BIRD REGISTRATION
Take time now--before you start juggling work with a long
string of winter holiday celebrations--to register at the
early-bird rate. Remember, the earlier you register, the
more you save. The fee for early-bird registration is $225.
Wait until February 20, and it's $250 for standard
registration; wait until April 3, and it's $275 for onsite
registration. To register online, go to:
http://conferences.taskforce.org/nic10
For general information on the conference, go to:
http://www.cdc.gov/vaccines/events/nic
For additional information, contact the conference planning
team at (404) 639-8225 or nipnic@cdc.gov
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18. |
Website of the Global Polio Eradication Initiative is
worth exploring
If you have an interest in the progress being
made toward
polio eradication, you will want to explore the website of
the Global Polio Eradication Initiative and bookmark it. The
website includes the current global case count (updated
weekly), news about polio immunization activities that take
place in regions experiencing political insecurity, a
monthly situation report on worldwide polio eradication,
background and research information, and much more.
To access the initiative website, go to:
http://www.polioeradication.org
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