Immunization Action Coalition and the Hepatitis B Coalition

IAC EXPRESS

Previous issues index

Home page

Issue Number 454            April 5, 2004

CONTENTS OF THIS ISSUE

  1. CDC notifies readers about a manufacturer's recall of IMOVAX human rabies vaccine
  2. Update: IAC revises two resources on childhood and teen vaccination
  3. Going, going, gone: The photo notebook and slide set are being discontinued--get yours now!
  4. Reminder: April 16 is the nomination deadline for AIM's award recognizing an outstanding Immunization Program Manager

----------------------------------------------------------

Back to Top

---------------------------------------------------------------

ABBREVIATIONS: AAFP, American Academy of Family Physicians; AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NIP, National Immunization Program; VIS, Vaccine Information Statement; VPD, vaccine-preventable disease; WHO, World Health Organization.
---------------------------------------------------------------

(1 of 4)
April 5, 2004
CDC NOTIFIES READERS ABOUT A MANUFACTURER'S RECALL OF IMOVAX HUMAN RABIES VACCINE

On April 2, CDC published "Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine--April 2, 2004" in the "MMWR Dispatch." The article is reprinted below in its entirety.

**********************

CDC and the Food and Drug Administration (FDA) have been notified that a recent quality-assurance test of IMOVAX Rabies Vaccine (Aventis Pasteur, Swiftwater, Pennsylvania) identified the presence of noninactivated Pitman-Moore virus (the attenuated vaccine strain) in a single product lot. IMOVAX is an inactivated viral vaccine and should not contain live virus. The vaccine lot containing noninactivated virus was not distributed.

As a precautionary measure, Aventis Pasteur initiated a voluntary recall of lot numbers X0667-2, X0667-3, W1419-2, and W1419-3, which were produced during the same period as the lot that contained noninactivated Pitman-Moore virus. These four lots, which were distributed in the United States from September 23, 2003, through April 2, 2004, passed all FDA-approved release tests, including testing to confirm the absence of live virus. These test results suggest that any potential risk to those vaccinated with recalled vaccine is likely to be low. No unusual adverse events associated with the recalled vaccine have been reported.

The manufacturer has indicated that additional lots of recalled vaccine were distributed internationally. These lots also passed all release tests, including testing to confirm the absence of live virus. The manufacturer is working with regulatory authorities to determine lot numbers of vaccine and countries that might have received recalled lots. More information about these internationally distributed lots will be provided as it becomes available.

Aventis Pasteur is providing additional detailed information to all distributors and providers. Health care providers should contact persons who received recalled vaccine to implement the recommendations outlined in this notice (see Recommendations for Persons Who Received Recalled Vaccine). In addition, persons who know they received rabies vaccine between September 23, 2003, and April 2, 2004, should contact their health care providers to determine whether they received vaccine from one of the four lots being recalled and, if so, whether they should be treated as outlined below. Vaccine distributors and health care providers who have any remaining doses of the recalled lots should not use them and should contact Aventis Pasteur regarding their disposition. Information about this recall is available from the Aventis Pasteur Medical Information Services Department, telephone (800) 835-3587, or at http://www.vaccineshoppe.com

All persons who have begun a rabies vaccination series (whether for pre- or postexposure prophylaxis) must complete that vaccination series on time, using nonrecalled vaccine. Information about human rabies prevention based on current recommendations of the Advisory Committee on Immunization Practices (ACIP) is available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00056176.htm

RECOMMENDATIONS FOR PERSONS WHO RECEIVED RECALLED RABIES VACCINE
Most persons receiving rabies vaccine do so because of exposure to a rabid animal, and treatment is needed to prevent fatal illness. Thus, persons who are receiving postexposure prophylaxis (PEP) must not omit or delay receiving any remaining injections; injections needed to complete the series should use nonrecalled vaccine. Recalled vaccine is considered fully immunogenic, and previously administered doses can be considered a dose in a PEP regimen.

Although unlikely, a theoretical possibility exists that persons who received vaccine from a recalled lot could have been exposed to the noninactivated Pitman-Moore vaccine strain of rabies virus. Even in the event of such an exposure, the timely administration of treatment, as described here, will help to ensure negligible risk to persons who have received vaccine from a recalled lot. Persons who received recalled vaccine should receive treatment equivalent to PEP, similar to published guidelines, as follows:

Persons who were vaccinated with recalled vaccine as part of a course of PEP for a possible rabies exposure.

  • Not previously immune (i.e., persons who had not received at least 3 doses of vaccine at some time before the possible rabies exposure). Persons without prior immunity who have a possible rabies exposure routinely receive a 5-dose postexposure immunization series. If this postexposure series has not already been completed, such persons should complete the full postexposure series, using nonrecalled vaccine to complete the series. Doses that have been administered already as part of the 5-dose series need not be repeated, even if recalled vaccine was used. In addition, if rabies immune globulin (RIG)** was not administered with the first dose of vaccine and it has been <7 days since the first dose of vaccine, RIG should be administered at this time. Once PEP is completed, persons are considered fully vaccinated against both the original rabies exposure and any possible exposure to noninactivated virus in the recalled vaccine.
     
  • Previously immune (i.e., persons who had received at least 3 doses of vaccine at some time before the possible rabies exposure). Persons with preexisting immunity (i.e., who have completed a full preexposure or postexposure vaccination series) who then have a possible rabies exposure routinely receive 2 booster doses of rabies vaccine. If one or both doses already were administered using recalled vaccine, such persons should receive 2 more doses, using nonrecalled vaccine. RIG is not recommended.

Persons who were vaccinated with recalled vaccine for reasons other than a possible rabies exposure.

  • Not previously immune (i.e., persons who had not received at least 3 doses of vaccine at some previous time). Persons without prior immunity who received recalled vaccine as part of a 3-dose preexposure vaccination series should receive additional doses using nonrecalled vaccine for a total of 5 doses (dosing intervals should follow the PEP schedule as closely as possible). RIG** is recommended if <7 days have elapsed since administration of the first dose of vaccine.
     
  • Previously immune (i.e., persons who had received at least 3 doses of vaccine at some previous time). Persons with preexisting immunity (i.e., who have completed a full preexposure or postexposure vaccination series before they received recalled vaccine) who received recalled vaccine as a routine booster dose should receive 2 additional doses of nonrecalled vaccine. RIG is not recommended.

All clinically significant adverse events following receipt of rabies vaccine should be reported to (1) Aventis Pasteur, telephone (800) 835-3587 and (2) the Vaccine Adverse Event Reporting System (VAERS) at http://www.vaers.org or telephone (800) 822-7967. Additional information about rabies and its prevention is available from CDC, telephone (404) 639-1050, or at http://www.cdc.gov/ncidod/dvrd/rabies

** Where available (including the United States), Human Rabies Immune Globulin (HRIG) is preferred and is administered in a dose of 20 IU/kg. Where HRIG is not available, Equine Rabies Immune Globulin may be used in a dose of 40 IU/kg. These dosages are applicable for all age groups, including children. For persons receiving RIG after having received recalled vaccine administered as part of PEP, as much of the dose as is anatomically feasible should be infiltrated at the site of the original rabies exposure (e.g., a wound), and as much of the remaining dose as is anatomically feasible should be infiltrated at the site(s) where the recalled vaccine was injected. If any RIG remains, it should be administered intramuscularly at an anatomically distant site. Persons receiving RIG for recalled vaccine administered as part of a preexposure vaccination series should have as much of the dose as is anatomically feasible infiltrated at the site(s) where recalled vaccine was administered, and the rest should be administered intramuscularly at an anatomically distant site. RIG should never be administered in the same syringe as vaccine, or into the same anatomical site used for concomitant vaccination. Because RIG might partially suppress active production of antibody, no more than the recommended dose should be administered.

**********************

To access a web-based (HTML) version of this article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm53d402a1.htm

To access a ready-to-copy (PDF) version of it, go to:
http://www.cdc.gov/mmwr/pdf/wk/mm53d402.pdf
---------------------------------------------------------------

Back to Top

(2 of 4)
April 5, 2004
UPDATE: IAC REVISES TWO RESOURCES ON CHILDHOOD AND TEEN VACCINATION

IAC recently modified information on two of its resources on childhood and teen vaccination: The "Summary of Rules for Childhood and Adolescent Immunization" and "When Do Children and Teens Need Vaccinations?"

On the "Summary of Rules for Childhood and Adolescent Immunization," we have made several changes, including revisions to the sections on hepatitis A, hepatitis B, and influenza vaccination.

To access a ready-to-copy (PDF) version, go to:
http://www.immunize.org/catg.d/rules1.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/nslt.d/n17/rules1.htm

We have reformatted and updated "When Do Children and Teens Need Vaccinations?"

To access a ready-to-copy (PDF) version, go to:
http://www.immunize.org/catg.d/when1.pdf

To access a web-text (HTML) version, go to:
http://www.immunize.org/nslt.d/n17/when1.htm
---------------------------------------------------------------

Back to Top

(3 of 4)
April 5, 2004
GOING, GOING, GONE: THE PHOTO NOTEBOOK AND SLIDE SET ARE BEING DISCONTINUED--GET YOURS NOW!

Two of IAC's most popular items--the "Photo Notebook of Vaccine-Preventable Diseases" and the "Slide Set of Vaccine-Preventable Diseases"--are being discontinued. Developed by IAC, the Photo Notebook and Slide Set are intended for community outreach workers and health professionals who conduct immunization presentations. We have fewer than 20 Photo Notebooks on hand and a limited supply of Slide Sets; if you are interested in owning either, please order immediately. When they're gone, they're gone!

The Photo Notebook and Slide Set include color images of children and adults with vaccine-preventable diseases. When you show your patients a picture of an infant with severe varicella disease or other infections, they will begin to understand the seriousness of the diseases that vaccines can prevent. Whether viewed as photos on a tabletop or as slides on a screen, each riveting image is easily worth more than a thousand words in conveying the gravity of VPDs to parents and patients.

THE PHOTO NOTEBOOK OF VACCINE-PREVENTABLE DISEASES holds 20 plastic-protected, 8" x 10" color photographs and comes in a three-ring binder. Each picture is accompanied by simple text that explains the disease portrayed. ($75 per set; discounts for orders of more than five sets--please call (651) 647-9009.)

To view an image of the Photo Notebook, go to:
http://www.immunize.org/images/r2053.jpg

THE SLIDE SET OF VACCINE-PREVENTABLE DISEASES contains eight more disease images than the Photo Notebook. To assist you with slide presentations, an English-language script is included. A Spanish-language script, translated by the Puerto Rico Immunization Program, is available upon request. ($25 per set; discounts for orders of more than five sets--please call (651) 647-9009.)

To obtain the English-language script, go to:
http://www.immunize.org/catg.d/3010slid.pdf

To obtain the Spanish-language script, go to:
http://www.immunize.org/catg.d/3010-01.pdf

BOTH CAN BE ORDERED ONLINE. To order a Photo Notebook, go to:
https://www.immunize.org/photobook

To order a Slide Set, go to:
https://www.immunize.org/slideset

TO ORDER BY MAIL OR FAX, print and fill out an IAC order form, available at http://www.immunize.org/catalog or http://www.immunize.org/nslt.d/n29/catalog.pdf

MAIL YOUR ORDER FORM with payment information (credit card information, purchase order number, or check [made out to Immunization Action Coalition]) to Immunization Action Coalition, 1573 Selby Ave., Ste. 234, St. Paul, MN 55104. Please include your complete mailing information and daytime phone number.

FAX YOUR ORDER FORM with payment information (credit card information or purchase order number) to IAC at (651) 647-9131.

SHIPPING IS FREE by fourth-class mail in the United States. Please allow 3-4 weeks for delivery of your order.

TO PLACE AN ORDER FROM OUTSIDE THE UNITED STATES, please call IAC at (651) 647-9009 for shipping cost information, or email us at admin@immunize.org (no phone orders, please).
---------------------------------------------------------------

Back to Top

(4 of 4)
April 5, 2004
REMINDER: APRIL 16 IS THE NOMINATION DEADLINE FOR AIM'S AWARD RECOGNIZING AN OUTSTANDING IMMUNIZATION PROGRAM MANAGER

April 16 is the deadline for nominations for the "Natalie J. Smith, MD, Award." In establishing the award in memory of Dr. Smith, the Association of Immunization Managers (AIM) seeks to recognize the contributions a city, state, or territory Immunization Program Manager has made in achieving vaccine-preventable disease goals and/or advancing the mission of AIM. The award will be presented at the National Immunization Conference in May.

To access detailed information about the award, including the nomination criteria and a 2004 nomination form, go to: http://www.immunize.org/news.d/smithaward.pdf

For additional information, contact Claire Hannan, AIM executive director, by email at channan@astho.org, by phone at (202) 715-1676, or by fax at (202) 371-9797.

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-9131

This page was updated on April 5, 2004