ALAMEDA COUNTY HEALTH CARE SERVICES AGENCY …

                           ALAMEDA COUNTY HEALTH CARE SERVICES AGENCY                    David J. Kears, Director
                           PUBLIC HEALTH DEPARTMENT                   Anthony B. Iton, MD, Director/Health Officer

                           Division of Communicable Disease Control and Prevention                                Muntu R. Davis, MD, MPH
                           1000 Broadway, 5th Floor                                                   Div. Director/Deputy Health Officer
                           Oakland, CA 94607
                           (510) 267-3200; Web: www.acphd.org




                                      PUBLIC HEALTH ALERT (UPDATED)
                Regarding Voluntary Recall of Haemophilus influenza type B (Hib) Vaccine by Merck & Co.

DATE:               December 14, 2007                                                                       DCDCP-FY0708-02
TO:                 Health Care Providers
FROM:               Muntu R. Davis, MD, MPH
                    Division Director/Deputy Health Officer, Alameda County Public Health Department
RE:                 Merck has announced a voluntary recall of specific lots of its Haemophilus influenza type B (Hib) vaccine

This Health Alert provides information about Merck's voluntary recall of certain lots of PedvaxHIB® and ComVax®, clinical information,
recommendations, reporting procedures, and information resources. This update and additional information on this voluntary recall is posted on
the Alameda County Public Health Department's website: www.acdph.org. See the News/Announcements section on the homepage.


ACTIONS REQUESTED OF ALL CLINICIANS:
      1.   Physicians are advised not to administer any vaccine from the recalled Merck PedvaxHIB® and ComVax® vaccine lots.
           (See recalled lot numbers below). No other lots of PedvaxHIB® or ComVax®and no other Merck products are affected by
           this recall.
      2.   Continue Hib vaccinations from non-implicated Merck lots or from Sanofi Pasteur's Hib vaccine (ActHIB®).
      3.   Follow Merck's instructions for returning recalled vaccine (both VFC and non-VFC vaccine).
      4.   Parents of children, especially those who are immunocompromised, recently vaccinated with recalled vaccine should be
           instructed to watch for any signs of localized (redness and swelling at the injection site) or disseminated infection, and
           contact their providers. These infections are most likely to occur within one week after vaccination.
      5.   Any potentially vaccine-related adverse events should be reported to the Vaccine Adverse Event Reporting System
           (VAERS) at 1-800-822-7967 (or at www.vaers.hhs.gov) and to Merck at 1-800-672-6372.


INCIDENT
Merck & Co. announced that it has initiated a voluntary recall in the United States of 11 lots of its Haemophilus influenza type B
vaccine, PedvaxHIB® and two (2) lots of its combination Haemophilus influenza type B/hepatitis B vaccine, ComVax®. The
affected lots of PedvaxHIB® and ComVax® were distributed starting April 2007. PedvaxHIB® is routinely used to vaccinate children
two to 71 months of age and ComVax® for infants six weeks to 15 months of age born to HBsAg-negative mothers.
This precautionary recall was issued because the company cannot assure the sterility for those specific vaccine lots. The potential
contamination of those lots was identified as part of Merck's standard quality assurance testing of its manufacturing equipment,
which identified the presence of the bacterium Bacillus cereus. Every vaccine lot is tested for bacterial contamination prior to
release and no contaminated vaccine has been identified. However, the potential for contamination of those lots exists.
The potential for contamination of any individual dose from the recalled vaccine lots is low and, if present, the level of
contamination would be low.
There have been no reports of any adverse reactions (abscesses or disseminated B cereus infection) among children who have
been previously vaccinated with the recalled vaccine. No potency concerns have been identified for those lots, therefore, any
vaccinations already administered to children should be considered effective and revaccination is not necessary.
The Vaccine Adverse Event Reporting System (VAERS) will continue to monitor adverse events following vaccination
nationally as they are reported.
                                                                   -more-

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Public Health Update: Regarding Voluntary Recall of Hib Vaccine by Merck & Co. - 2
The Merck Hib vaccine lots that are being recalled are:

Product Description          Lot #        Expiration Date                        ** No other lots of PedvaxHIB® or ComVax®
                                                                                 and no other Merck products are affected by this
                                                                                 recall.
PedvaxHIB®                   0677U        11 January 2010
             ®
PedvaxHIB                    0820U        12 January 2010
             ®
PedvaxHIB                    0995U        16 January 2010
             ®
PedvaxHIB                    1164U        18 January 2010
             ®
PedvaxHIB                    0259U        17 October 2009
             ®
PedvaxHIB                    0435U        18 October 2009
             ®
PedvaxHIB                    0436U        19 October 2009
             ®
PedvaxHIB                    0437U        19 October 2009
             ®
PedvaxHIB                    0819U        09 January 2010
             ®
PedvaxHIB                    1167U        10 January 2010
             ®