IAC Express 2009
Issue number 835: November 16, 2009
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Contents of this Issue
Select a title to jump to the article.
  1. FDA approves expanded age indication for both of CSL's inactivated influenza vaccines
  2. FDA approves ID Biomedical's injectable H1N1 influenza vaccine
  3. New: IAC develops form for healthcare employees to sign if declining H1N1 influenza vaccination
  4. New: AMA fact sheet has Q&As about using CPT codes for providing and administering H1N1 vaccine
  5. FDA commissioner's letter to healthcare professionals provides information on the safety of H1N1 vaccines
  6. MMWR Dispatch reports on 2009 mumps outbreak in New York, New Jersey, and Quebec
  7. NCIRD director's letter to providers underscores the need for PPSV vaccination for adults
  8. Update on recent U.S. influenza activity indicates 2009 H1N1 influenza virus is causing significant disease
  9. CDC updates its H1N1 web section with information on pregnancy and H1N1 infection, importance of PPSV vaccination, and more
  10. Two more hospitals added to IAC's Honor Roll for Patient Safety; NEJM article discusses mandatory HCW vaccination
  11. IAC'S Video Of The Week highlights the impact of rotavirus vaccine in the developing world
  12. CDC experts review and update three of IAC'S online "Ask The Experts" Q&A sections
  13. Online, year-end sale! Get laminated child/teen and adult U.S. immunization schedules for $1 each when you buy 11 or more!
  14. Laminated seasonal influenza vaccine pocket guides--FREE!--from the National Influenza Vaccine Summit
  15. CDC reports on the effectiveness of 2008-09 inactivated influenza vaccine in protecting against 2009 H1N1 influenza
  16. National Influenza Vaccination Week set for December 6-12; be sure to submit your organization's event plans
  17. National Immunization Conference abstract deadline is December 11; early-bird registration ends February 19
  18. Website of the Global Polio Eradication Initiative is worth exploring
 
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 835: November 16, 2009
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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About IZ Express

IZ Express is supported in part by Grant No. 1NH23IP922654 from CDC’s National Center for Immunization and Respiratory Diseases. Its contents are solely the responsibility of Immunize.org and do not necessarily represent the official views of CDC.

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Editorial Information

  • Editor-in-Chief
    Kelly L. Moore, MD, MPH
  • Managing Editor
    John D. Grabenstein, RPh, PhD
  • Associate Editor
    Sharon G. Humiston, MD, MPH
  • Writer/Publication Coordinator
    Taryn Chapman, MS
    Courtnay Londo, MA
  • Style and Copy Editor
    Marian Deegan, JD
  • Web Edition Managers
    Arkady Shakhnovich
    Jermaine Royes
  • Contributing Writer
    Laurel H. Wood, MPA
  • Technical Reviewer
    Kayla Ohlde

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