From: Rodewald, Lance (CDC/CCID/NCIRD)\
Sent: Monday, October 20, 2008 4:42 PM\
To: NCIRD Immunization Grantee Mailbox (CDC)\
Cc: Santoli, Jeanne (CDC/CCID/NCIRD)\
Subject: Hib vaccine supply update talking points

To Immunization Program Managers - Attached (below) are talking points
about the Hib vaccine shortage.  One item that is new since Laurel
Wood\'s update on Friday is that sanofi pasteur says they are confident
that they will be able to supply Hib-containing vaccine in sufficient
amounts to maintain the 3-dose primary series through mid-2009, which is
when Merck now projects returning to the market.  They will maintain the
Hib supply with a combination of Pentacel and ActHIB.  This
information is reflected in the talking points.

 

Thanks,

Lance

Hib Vaccine Shortage Talking Points

October 20, 2008

In December of 2007, Merck announced a recall of Hib vaccine and
temporarily stopped selling the vaccine in the U.S. market as they
changed manufacturing processes.

-   On December 13, 2007, Merck & Co., Inc. announced a voluntary recall
    of certain lots of two Haemophilus influenzae type b (Hib) conjugate
    vaccines, PedvaxHIB^®^ (monovalent Hib vaccine) and Comvax^®^
    (Hib/hepatitis B vaccine).

-   In the U.S., there are two licensed manufacturers of Hib vaccine --
    Merck, who produces PedvaxHIB and Comvax, and sanofi pasteur, who
    produces Hib vaccine in combination with DTP and IPV vaccines
    (Pentacel: DTP/IPV/Hib and TriHiBit: DTaP/Hib).

At that time, the recommended vaccination schedule for all available
Hib-containing vaccines consisted of a primary series administered
beginning at age 2 months and a booster dose at age 12\--15 months.

In response to the decrease in vaccine supply resulting from Merck's
inability to supply Hib vaccine to the US market, CDC changed the
recommendation for Hib vaccination to defer the booster dose given at 12
to 15 months because it was unlikely that there would be there would
adequate supplies of vaccine to fully vaccinate all children with Hib
vaccine. Further recommendations included:

-   Provider should continue regular vaccination for infants under 12
    months.

-   Providers temporarily defer the routine Hib vaccine booster dose
    given at 12-15 months of age except for specific high-risk groups,
    who should continue to receive the full vaccination series and the
    booster dose.

-   Children at increased risk for Hib include: children with sickle
    cell disease, leukemia and malignant neoplasms, HIV and certain
    other immunocompromising conditions, asplenia, as well as American
    Indian and Alaska Native children. Vaccinating these children with
    the full schedule including a booster dose is a high priority.

-   Providers should register and track children in whom the booster
    dose is deferred to facilitate recalling them for vaccination when
    supply improves.

On October 17, 2008, Merck released a public statement that they will
not return to the Hib vaccine market until mid-2009.

-   Merck was anticipating returning to the U.S. Hib vaccine market
    during the fourth quarter of 2008.

-   Additional manufacturing changes at Merck will require a regulatory
    filing with FDA.

-   Merck now projects a return to the U.S. market during mid-2009 in
    the U.S.

At this time, CDC is not changing Hib vaccine recommendations, but CDC
will closely monitor the Hib vaccine supply situation and will make
appropriate recommendations if the need arises.

CDC will continue to work closely with sanofi pasteur as they review
their current Hib vaccine supply and their capacity to serve the U.S.
market of the next 6-8 months. At this time, sanofi pasteur is confident
that they have sufficient hib doses (ActHIB and Pentacel) to cover the 3
dose series through mid 2009.

American Indian and Alaska Native children living in American Indian or
Alaska Native communities will continue to be provided with PedvaxHIB
from CDC's stockpile.

CDC will closely monitor the Hib vaccine supply situation and will make
appropriate recommendations if the need arises.

Thus far, we have not yet seen an increase in disease because of
deferral of the booster dose at 12 to 15 months.

-   The incidence of invasive Hib disease has declined dramatically in
    the U. S., resulting from high Hib conjugate vaccine coverage
    levels.

-   Currently, the incidence of invasive Hib disease in children less
    than 5 years of age is 0.21 per 100,000 representing a greater than
    99% reduction in disease compared to the pre-vaccine incidence.

-   Children have a cushion of protection against Hib infection because
    population or community immunity afforded high immunization coverage
    rates made possible by success of Hib vaccination program.

-   We are not certain how long this indirect protection will last. It
    is very important to directly protect infants by timely vaccination
    with the three-dose primary series at 2, 4, and 6 months of age.

This document can be found on the CDC website at:

<http://www.cdc.gov/vaccines/programs/vmbip/downloads/agm/hib-vac-su-508.doc>