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Notice to Readers: Manufacturer's Recall of Human Rabies
Vaccine --- April 2, 2004
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.
Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of
Health and Human Services.References to non-CDC sites on the Internet are
provided as a service to MMWR readers and do not constitute or imply
endorsement of these organizations or their programs by CDC or the U.S.
Department of Health and Human Services. CDC is not responsible for the content
of pages found at these sites. URL addresses listed in MMWR were current as of
the date of publication.
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