Vaccine Recall Dear Doctor Letter

Voluntary Recall of Certain Lots of
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein
Conjugate)] and COMVAX® [Haemophilus b Conjugate (Meningococcal Protein
Conjugate) and Hepatitis B (Recombinant) Vaccine] / NDC 0006-4897-00 and
0006-4898-00

Dear Customer, Doctor, Healthcare Provider:
Merck & Co., Inc. (“Merck”) has initiated a voluntary recall in the United States for ten lots of
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and two
lots of COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis
B (Recombinant) Vaccine]. This letter is being written to inform you of this recall, and to advise
you not to administer any vaccine from the vaccine lots being recalled. The lots that are being
recalled are:
PRODUCT DESCRIPTION LOT # EXP. DATE
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
COMVAX® 0376U 05 January 2010
COMVAX® 0377U 08 January 2010
The affected doses were distributed st PDF Converter Assistant.lnk arting in April 2007. No other
lots of PedvaxHIB® or COMVAX® and no other Merck products are affected by this recall.
The company is taking this voluntary action due to the fact that we cannot assure sterility for
these specific vaccine lots. The potential contamination in these specific lots was identified as
part of our standard evaluation of our manufacturing processes. In routine testing of the vaccine
manufacturing equipment used to produce PedvaxHIB® and COMVAX®, Merck identified an
issue that creates the potential for microorganisms to survive the sterilization process.
Specifically, during this evaluation, Merck identified the presence of Bacillus cereus. Sterility
tests of the vaccine lots themselves have not found any contamination. The potential for
contamination of any individual vaccine is low, and, if present, the level of contamination would
be low. However, because we cannot guarantee the sterility of these specific lots of vaccine,
we are conducting this recall.
Based on this information, Merck recommends that you immediately discontinue use of any of
the affected lots. If an individual was vaccinated with a vial of PedvaxHIB® or COMVAX® that
contained B. cereus or other microorganisms, there is a risk that they could develop localized or
disseminated infections. By analogy to other B. cereus infections, immunocompromised
individuals may be at the greatest risk for these infections.
No potency concerns have been identified for these vaccine lots. Individuals who received
vaccine from these lots should complete their immunization series with a Haemophilus b
conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to
replace a dose they received from a recalled lot.
Merck is working closely with the Food and Drug Administration and the Centers for Disease
Control and Prevention to inform affected customers of this recall action. If you have purchased
any of these affected lots directly from Merck, please return the vaccine to us according to the
procedure described below; if you did not purchase directly from Merck, please return the
vaccine to your distributor. In addition, if you have further distributed these lots of PedvaxHIB®
and COMVAX® to other health care providers or offices, please contact them to ensure that all
affected product is returned.
In order to ensure an effective recall and return process, it is important that you do the following
for product purchased directly from Merck:
1. Please complete the enclosed Business Reply Card and the Packing Slip labeled
“Non-VFC Vaccine” including entry of number of vials returned.
2. Mail the postage paid Business Reply Card even if you do not have any of the
product identified above to ensure accountability.
3. Return all of the product identified above and the Packing Slip using the prepaid
Shipping Labels to:
Stericycle, Attn: Merck Returns
2670 Executive Drive, Suite A
Indianapolis, IN 46241
Credit for product will be issued at the price in effect for purchase directly from Merck at the time
of purchase.
For any Vaccines for Children (VFC) vaccine from the affected lots, please do the following:

1. Please complete the Business Reply Card and the Packing Slip labeled “VFC
   Vaccine” including entry of number of vials returned.
2. Mail the postage paid Business Reply Card even if you do not have any of the
   product identified above to ensure accountability.
3. Return all of the product identified above and the Packing Slip using the prepaid Shipping Labels to:

Stericycle, Attn: Merck Returns
2670 Executive Drive, Suite A
Indianapolis, IN 46241
If you have both non-VFC and VFC vaccine to return, you may ship them together in the
same shipping container as long as you have accounted for the vials separately using the
appropriate forms outlined above.
Please report any potentially vaccine-related adverse experiences 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. If you have any questions concerning medical or other issues, please
contact the Merck National Service Center at 1-800-672-6372. The Prescribing Information for
PedvaxHIB and COMVAX is available from the Merck National Service Center or at
www.merckvaccines.com.
We appreciate your immediate attention to this recall and sincerely regret any difficulty caused
by this action. Merck is committed to resolving this issue as quickly as possible and to ensure
that our full line of vaccines is available to our customers as soon as possible.
Sincerely,
Mark Feinberg, MD, PhD, FACP
Vice President
Medical Affairs and Policy
Merck Vaccines and Infectious Diseases
Merck & Co., Inc.