Issue Number 485            October 18, 2004

CONTENTS OF THIS ISSUE

EDITOR'S NOTE: This issue of "IAC EXPRESS" is devoted exclusively to articles about the current influenza vaccine supply shortage. Later this week, we will issue another "IAC EXPRESS" that will cover other news of interest to the immunization community, as well as any late-breaking information about the vaccine shortage.

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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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October 18, 2004
ATTENTION: CDC POSTS SLIDES FROM THE OCTOBER 14 INFLUENZA IMMUNIZATION NET CONFERENCE ON THE NIP WEBSITE

Broadcast on October 14, the "Current Issues in Immunization" net conference focused on influenza immunization and influenza vaccine supply. CDC has posted the two PowerPoint slide sets from the conference on the NIP website; this makes the slide sets available to those who have PowerPoint installed on their computers. CDC has also made the re-cast available in Windows Media and RealPlayer formats.

Given by Raymond Strikas, MD, the first set of slides is titled Influenza Vaccine 2004-2005: Supply and Recommendations. To access it, go to:
http://www.cdc.gov/nip/ed/ciinc/powerpoint/October/FluSupply_Strikas.ppt

Given by William Atkinson, MD, the second set of slides is titled Influenza Vaccine 2004-2005: Practical Issues. To access it, go to:
http://www.cdc.gov/nip/ed/ciinc/powerpoint/October/FluPractical_Atkinson.ppt

To sign in for the re-cast, go to:
http://www.cdc.gov/nip/ed/ciinc/default.htm You will be taken to a page of format options for viewing the re-cast.
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October 18, 2004
NEW: IAC'S ONLINE "2004-05 INFLUENZA VACCINATION POCKET INFORMATION GUIDE" IS A USEFUL, UP-TO-DATE RESOURCE

In August, the National Influenza Summit, in collaboration with IAC, developed the "2004-05 Influenza Vaccination Pocket Information Guide." Many professional associations, specialty societies, public health departments, Indian Health Service Area Offices, and vaccine manufacturers distributed the pocket guide to their members and constituents in September.

WHAT IS THE POCKET GUIDE?

Laminated and sized to fit in the pocket of a shirt or lab coat, the pocket guide is intended to be a provider's partner throughout the current influenza season. It gives front-line health care personnel useful information about the use of both inactivated (injectable) and live (intranasal) influenza vaccines. It lists the groups targeted to receive the vaccine, vaccine contraindications, dosing information, administration methods, and side effects. It also supplies providers with talking points useful in convincing patients about the importance of being vaccinated.

WITH THE CURRENT VACCINE SHORTAGE, IS THE POCKET GUIDE USEFUL?

If you have received a laminated guide, DO NOT THROW IT AWAY! It is still useful. IAC recently posted a revised version of the pocket guide on its website. The revised guide incorporates material from the interim influenza vaccine recommendations, which CDC published on October 5 in response to Chiron Corporation's announcement that its trivalent inactivated influenza vaccine will not be available in the United States for the 2004-05 influenza season.

HOW TO MODIFY YOUR LAMINATED POCKET GUIDE

Modify the guide to conform to the interim ACIP recommendations by using the revised version on IAC's website at http://www.immunize.org/influenza/pocketguide.htm Follow the directions under the subhead titled "Important Notice."

HOW TO CREATE YOUR OWN UPDATED POCKET GUIDE

If you don't have a laminated guide, you can create a copy by clicking on the link above and following the directions under the subhead titled "How Do I Get One?"
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October 18, 2004
CDC AND AVENTIS PASTEUR ANNOUNCE TIV ALLOCATION PLAN TO ADDRESS INFLUENZA VACCINE SHORTAGE

On October 12, CDC issued a press release announcing the allocation plan it and Aventis Pasteur developed to address the current shortage of trivalent inactivated influenza vaccine (TIV). It is reprinted below in its entirety.

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October 12, 2004
For immediate release

CDC, AVENTIS PASTEUR ANNOUNCE ALLOCATION PLAN TO ADDRESS INFLUENZA VACCINE SHORTAGES

The Centers for Disease Control and Prevention (CDC) and Aventis Pasteur announced today the first phase of the plan to allocate influenza vaccine in response to the recently announced loss of half of the nation's expected flu vaccine supply for the 2004-2005 season. The plan, announced by CDC Director Dr. Julie Gerberding and Aventis Pasteur US President Damian Braga, calls for CDC to work closely with Aventis to distribute in phases 22.4 million doses of unshipped vaccine to identified areas of need throughout the country.

Beginning immediately, about 14.2 million doses of vaccine will be allocated over the next 6-8 weeks through Aventis Pasteur contracts directly to high-priority vaccine providers, including hospitals, long-term care facilities, nursing homes, and private providers who care for young children.

"This plan will help ensure that vaccine gets to those people who need it most," said CDC Director Dr. Julie Gerberding. "This is a troubling, frustrating situation for all of us and we need for all Americans to pull together in the weeks to come to meet this challenge head on. This plan is the result of unprecedented collaboration between CDC, Aventis Pasteur, and state and local health departments across the country. And we must not forget the other public health heroes on the front lines in grocery stores, pharmacies, and health clinics working to prioritize vaccine."

CDC will continue to work with Aventis Pasteur and state and local health departments to identify people, by region, on the vaccination priority list. The approximately 8.2 million doses remaining after the first phase is completed will be shipped to other high-need areas.

"Since Dr. Gerberding contacted us last week, we at Aventis Pasteur have worked with the CDC around the clock to tackle the complex task of getting millions of doses of influenza vaccine to thousands of health care providers around the country. Our goal has been to direct remaining doses as quickly as possible to those areas where large numbers of at-risk individuals are in need," said Damian Braga, president, Aventis Pasteur US. "It is a huge logistical feat and we are proud to have contributed our knowledge and expertise to this plan."

Last week CDC announced priority groups for vaccination with inactivated influenza vaccine for the 2004-2005 influenza season:

• all children aged 6-23 months,
• adults aged 65 years and older,
• persons aged 2-64 years with underlying chronic medical conditions,
• all women who will be pregnant during influenza season,
• residents of nursing homes and long-term care facilities,
• children 6 months-18 years of age on chronic aspirin therapy,
• health-care workers with direct patient care, and
• out-of-home caregivers and household contacts of children aged <6 months.

Influenza season typically peaks in the United States between December and March. Because each season is unpredictable, it's not known how severe the 2004-2005 season might be.

Although vaccination is the best protection against influenza, everyone can take practical steps to help prevent spread of flu, such as avoiding close contact with people who are sick and keeping your distance from others if you're sick; when possible, staying home from work, school, and errands when you are sick; covering your mouth and nose when coughing or sneezing, and cleaning your hands often.

For more information about the flu and this year's recommendations, visit the CDC Website: www.cdc.gov/flu

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To access the press release directly, go to:
http://www.cdc.gov/od/oc/media/pressrel/r041012.htm

To access a transcript of a press briefing on influenza vaccine supply given by the director of CDC, Dr. Julie Gerberding, and the president of Aventis Pasteur US, Damian Braga, on October 12, 2004, go to: http://www.cdc.gov/od/oc/media/transcripts/t041012.htm
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October 18, 2004
AVENTIS PASTEUR SHIPS MORE THAN 2 MILLION DOSES OF INFLUENZA VACCINE TO PROVIDERS WHO SERVE HIGH-PRIORITY GROUPS

On October 15, CDC issued a press release announcing that it and Aventis Pasteur collaborated to ship more than 2 million doses of influenza vaccine to providers who serve high-priority groups. The press release is reprinted below in its entirety.

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For Immediate Release
October 15, 2004

CDC/AVENTIS PASTEUR COLLABORATE TO SHIP MORE THAN 2 MILLION DOSES OF INFLUENZA VACCINE TO PROVIDERS WHO SERVE HIGH-PRIORITY GROUPS

More than 2 million doses of influenza vaccine were shipped this week by Aventis Pasteur to health care providers throughout the country who serve the high-priority groups recommended by the Centers for Disease Control and Prevention to receive influenza vaccine during the 2004-2005 season.

After pairing CDC information on geographic locations of high-priority risk groups and Aventis Pasteur US information on providers scheduled to receive vaccine for the high-risk populations, this round of influenza vaccine went to:

• Veterans Administration
• Long-term care facilities/acute care hospitals
• State public health officials
• Vaccines for Children program
• Private providers who care for young children

"More doses of vaccine will be going out over the next 6-7 weeks so there will be more opportunity for those who need the vaccine to get it in time for this year's influenza season," said CDC Director Dr. Julie Gerberding. "This shortage is frightening to people and they're rushing out and standing in long lines thinking they need the vaccine right now before it's all gone. We want them to know that more is coming, so as hard as it may be, please try and be patient and check with your provider ahead of time for availability of vaccine in your area."

To ensure that providers who ordered vaccine from Chiron this year also get some of the vaccine they need for priority populations, CDC and Aventis are taking these actions:

• filling remaining Vaccines For Children (VFC) orders to Aventis Pasteur,
• contacting states that ordered vaccine from Chiron distributors to begin re-directing their orders to Aventis Pasteur,
• collaborating with Chiron distributors to identify providers to high-priority populations including long-term care facilities, hospitals, and primary care and specialty physicians, [and]
• working with the Visiting Nurses Association of America to ensure high-priority populations it serves are immunized as recommended.

For the 2004-2005 influenza season, Aventis Pasteur produced 55.4 million doses of vaccine. Before the Chiron announcement on October 5, 2004, approximately 33 million doses had already been shipped to pediatricians, primary care and other office-based physicians, as well as to public health providers.

On October 5, 2004, CDC announced priority groups for vaccination with inactivated influenza vaccine for the 2004-2005 influenza season:

• all children aged 6-23 months,
• adults aged 65 years and older,
• persons aged 2-64 years with underlying chronic medical conditions,
• all women who will be pregnant during influenza season,
• residents of nursing homes and long-term care facilities,
• children 6 months-18 years of age on chronic aspirin therapy,
• health care workers with direct patient care, and
• out-of-home caregivers and household contacts of children aged <6 months.

Influenza season typically peaks in the United States between December and March. Because each season is unpredictable, it's not known how severe the 2004-2005 season might be.

Although vaccination is the best protection against influenza, everyone can take practical steps to help prevent spread of flu, such as avoiding close contact with people who are sick and keeping your distance from others if you're sick; when possible, staying home from work, school, and errands when you are sick; covering your mouth and nose when coughing or sneezing, and cleaning your hands often.

For more information about the flu and this year's recommendations, visit the CDC website: http://www.cdc.gov/flu

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To access the press release, go to:
http://www.cdc.gov/od/oc/media/pressrel/r041015.htm
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October 18, 2004
DHHS ISSUES A PRESS RELEASE ABOUT INFLUENZA VACCINE PRICE GOUGING

On October 14, the Department of Health and Human Services (DHHS) issued a press release containing the text of a letter the secretary of the department wrote to state attorneys general regarding influenza vaccine price gouging. The text of the press release is reprinted below in its entirety.

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For immediate release
October 14, 2004

HHS SECRETARY URGES STATES TO AGGRESSIVELY PROSECUTE FLU VACCINE PRICE GOUGING

HHS Secretary Tommy G. Thompson sent a letter to the Attorney General of each state today urging them to thoroughly investigate reports of price gouging involving the flu vaccine and to prosecute those found to be taking advantage of the vaccine shortage.

"It is extremely disturbing to learn of reports of price gouging by immoral individuals looking to make a quick buck off of a public health challenge," Secretary Thompson wrote in the letter. "I am encouraging the attorney general of each state to thoroughly investigate reports of price gouging and prosecute those engaging in this immoral and illegal activity to the full extent of the law."

Secretary Thompson said it will take the good faith and cooperation of all Americans--the public, doctors, nurses, and public health professionals--to ensure that the flu vaccine goes to those who truly need it most this flu season. Information on who is recommended to get the flu vaccine is available from the Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/flu/protect/whoshouldget.htm

In the letter, Secretary Thompson said the CDC is collecting reports on price gouging and sharing the information with the National Association of Attorneys General and state prosecutors.

The full text of the letter is as follows:

October 14, 2004

Dear Attorney General:

The disappointing loss of half of our nation's flu vaccine due to manufacturing issues in England poses a serious challenge to our vaccine supply for the upcoming flu season. Chiron was to produce between 46-48 million doses for America, and we are calling on all Americans to work together to ensure the vaccine gets to those who need it most.

A vast majority of Americans are working to meet this test, but it is extremely disturbing to learn of reports of price gouging by immoral individuals looking to make a quick buck off of a public health challenge.

I am encouraging the attorney general of each state to thoroughly investigate reports of price gouging and prosecute those engaging in this immoral and illegal activity to the full extent of the law. The Department of Health and Human Services' Centers for Disease Control and Prevention is collecting reports on price gouging and sharing it with the National Association of Attorneys General and state prosecutors.

We have faced vaccine shortages in the past, most recently in 2000-2001. We have worked through them successfully. And we need to come together to work through this challenge as well. Let's all work together to make sure those who really need the vaccine get it this flu season.

Sincerely,

Tommy G. Thompson

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To access the press release, go to:
http://www.hhs.gov/news/press/2004pres/20041014b.html
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October 18, 2004
NEW: CDC POSTS PROVIDER- AND PATIENT-EDUCATION INFORMATION ON INFLUENZA VACCINE SHORTAGE ON ITS "INFLUENZA" WEB SECTION

The week of October 11, CDC posted seven newly developed or updated resources related to the influenza vaccine shortage on its "Influenza" web section. Following are links to the seven:

FOR HEALTH PROFESSIONALS

(1) "2004-05 Flu Vaccine Shortage: Who Should Get Vaccinated" is a fact sheet about the shortage and who should get vaccinated this season; updated 10/14. To access a ready-to-print (PDF) version, go to: http://www.cdc.gov/flu/protect/pdf/0405shortage.pdf

To access a web-text (HTML) version, go to:
http://www.cdc.gov/flu/protect/0405shortage.htm

(2) "Questions & Answers: 2004-05 Flu Season" answers common questions about vaccine supply, vaccination, prevention, and flu season characteristics; updated through 10/15. To access a web-text (HTML) version, go to: http://www.cdc.gov/flu/about/qa/0405season.htm

(3) "Interim Estimate of Populations Targeted for Influenza Vaccination" displays information from 2002 National Health Interview Survey Data and presents estimates for 2004, based on influenza-vaccine-shortage priority groups; posted 10/11. To access a ready-to-copy (PDF) version, go to: http://www.cdc.gov/flu/professionals/vaccination/pdf/targetpopchart.pdf

(4) "Flu Related Public Health Legal Preparedness Materials" is intended for persons researching the 2004-05 influenza vaccine shortage in the United States; posted 10/13. To access a web-text (HTML) version, go to: http://www.phppo.cdc.gov/od/phlp/Influenza.asp


FOR PATIENTS (materials for waiting rooms, classrooms, lunchrooms, and other public places)

(5) "Preventing the Flu" presents numerous resources for patients, parents, school nurses, workplace nurses, and public health professionals; includes links to fact sheets, flyers, brochures, toolkits, and posters on topics such as health habits that prevent the spread of germs, antiviral drugs, and the current vaccine shortage. Posted through 10/15. To access this web section, go to: http://www.cdc.gov/flu/protect/preventing.htm

(6) "Vaccination is not the only way to help prevent the flu" lists actions people can take to stop the spread of germs and protect themselves from sickness; updated through 10/18. With photos. To access a ready-to-copy (PDF) version, go to: http://www.cdc.gov/flu/professionals/flugallery/images04_05/notonlyway2.pdf

(7) "Influenza Information in Other Languages" has updated information (through 10/14) related to the vaccine shortage in the following languages: Spanish, Chinese, Vietnamese, and Tagalog. To access this web section, go to: http://www.cdc.gov/flu/languages.htm

The professional and patient information above is listed on the following web page, along with other materials. Check this page frequently for new postings: http://www.cdc.gov/flu/protect/vaccineshortage.htm
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October 18, 2004
OCTOBER ISSUE OF CDC'S "IMMUNIZATION WORKS" ELECTRONIC NEWSLETTER FOCUSES ON CURRENT INFLUENZA VACCINE SHORTAGE

The October issue of "Immunization Works," a monthly email newsletter published by CDC, presents a broad range of information about the current influenza vaccine shortage. The newsletter offers members of the immunization community non-proprietary information. CDC encourages its wide dissemination.

Following is the text of the section on the vaccine shortage. Information on other topics covered in the October issue has already appeared in previous issues of "IAC EXPRESS"; consequently, it is not reprinted here.

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2004-05 FLU VACCINE SHORTAGE

On October 5, 2004, CDC was notified by Chiron Corporation that none of its influenza vaccine (Fluvirin) would be available for distribution in the United States for the 2004–05 influenza season. Chiron was to make 46-48 million doses of the vaccine for the United States. This action reduced the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004–05 influenza season by approximately one half.

The remaining supply of influenza vaccine expected to be available in the United States this season is nearly 54 million doses of Fluzone (inactivated flu shot) manufactured by Aventis Pasteur, Inc. Of these doses, approximately 33 million doses already have been distributed by the manufacturer. In addition, approximately 2 million doses of live attenuated influenza vaccine (LAIV/FluMist) manufactured by MedImmune will be available this season.

INTERIM RECOMMENDATIONS: Because of this urgent situation, CDC, in coordination with its Advisory Committee for Immunization Practices (ACIP), issued interim recommendations for influenza vaccination during the 2004–05 season. These interim recommendations were formally recommended by ACIP on October 5, 2004, and take precedence over earlier recommendations.

PRIORITY GROUPS FOR INFLUENZA VACCINATION: The following priority groups for vaccination with inactivated influenza vaccine this season are considered to be of equal importance and are:

• All children aged 6-23 months
• Adults aged 65 years and older
• Persons aged 2-64 years with underlying chronic medical conditions
• All women who will be pregnant during influenza season
• Residents of nursing homes and long-term care facilities
• Children aged 6 months-18 years on chronic aspirin therapy
• Health care workers involved in direct patient care
• Out-of-home caregivers and household contacts of children aged <6 months

OTHER VACCINATION RECOMMENDATIONS:

• Persons in priority groups identified above should be encouraged to search locally for vaccine if their regular health care provider does not have vaccine available.
• Intranasally administered, live, attenuated influenza vaccine, if available, should be encouraged for health care workers (except those who care for severely immunocompromised patients in special care units) and persons caring for children aged <6 months.
• Certain children aged <9 years require 2 doses of vaccine if they have not previously been vaccinated. All children at high risk for complications from influenza, including those aged 6-23 months, who are brought for vaccination, should be vaccinated with a first or second dose, depending on vaccination status. However, doses should not be held in reserve to ensure that 2 doses will be available. Instead, available vaccine should be used to vaccinate persons in priority groups on a first-come, first-serve basis.

VACCINATIONS OF PERSONS IN NON-PRIORITY GROUPS: Persons who are not included in one of the priority groups described above should be informed about the urgent vaccine supply situation and are asked to forego or defer vaccination.

NATION ALLOCATION PLAN

On October 12, CDC and Aventis Pasteur announced the first phase of the plan to allocate influenza vaccine. The plan calls for CDC to work closely with Aventis to distribute in phases 22.4 million doses of unshipped vaccine to identified areas of need throughout the country.

Beginning immediately, about 14 million doses of vaccine will be allocated over the next 6-8 weeks through Aventis Pasteur contracts directly to high-priority vaccine providers, including hospitals, long-term care facilities, nursing homes, and private providers who care for young children.

CDC will continue to work with Aventis Pasteur and state and local health departments to identify people, by region, on the vaccination priority list. The approximately 8 million doses remaining after the first phase is completed will be shipped to other high-need areas.

REDISTRIBUTION AT THE STATE AND LOCAL LEVELS

Public health departments and health care providers and institutions involved in reallocating influenza vaccine this year should be aware of the following information from the FDA. Anticipated shortages of influenza vaccine this flu season constitute emergency medical reasons, within the meaning of Section 503(c)(3)(B)(iv) of the Food, Drug, and Cosmetic Act (FDC Act), as determined by FDA. It is therefore permissible under the FDC Act for a hospital or health care entity to redistribute influenza vaccine to alleviate shortages this flu season. When redistribution occurs, the hospital or health care entity that is redistributing the influenza vaccine should document and maintain the following information:

• vaccine brand name
• manufacturer and distributor
• lot number
• number of doses transferred
• recipient's name and address

Health departments throughout the United States are trying to make sure that as many high-risk people as possible will eventually be able to go to either their regular vaccine provider or a flu shot clinic to get the vaccine.

More information on the flu vaccine shortage in your state is available through State Health Department immunization programs at http://www.cdc.gov/other.htm#states

Although vaccination is the best protection against influenza, everyone can take practical steps to help prevent spread of flu, such as avoiding close contact with people who are sick and keeping your distance from others if you're sick; when possible, stay[ing] home from work, school, and errands when you are sick; covering your mouth and nose when coughing or sneezing, and cleaning your hands often.

Additional information is available at http://www.cdc.gov/flu or through the CDC public response hotline: 888-246-2675 (English), 888-246-2857 (Espanol), or 866-874-2646 (TTY).

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To access the complete October issue from the NIP website, go to: http://www.cdc.gov/nip/news/newsltrs/imwrks/2004/200410.htm