Issue
Number 454
April 5, 2004
CONTENTS OF THIS ISSUE
- CDC notifies readers about a manufacturer's recall of IMOVAX
human rabies vaccine
- Update: IAC revises two resources on childhood and teen
vaccination
- Going, going, gone: The photo notebook and slide set are being
discontinued--get yours now!
- Reminder: April 16 is the nomination deadline for AIM's award
recognizing an outstanding Immunization Program Manager
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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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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.
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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.
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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
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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
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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).
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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. |
