H1N1 Recall Information
The Washington Township Health
Department did not distribute any of the recalled
H1N1 Vaccine at any of their vaccination clinics. The recall
is not a safety recall, but rather a recall because the vaccine
was determined to be not as effective as governmental standards
required.
If a member of your family
received a vaccination from a pre-filled syringe pediatric
(0.25 mL.) vaccine at a clinic run by another municipality,
please contact that Health Department for information.
The small manila colored vaccination
record documents you received at the clinic contains the lot
number of the vaccination you or your family member received.
Again, none
of the recalled vaccine was distributed at ANY Washington Township H1N1 clinic.
From the Health Alert Network (12/16/2009)
Non-Safety Related Voluntary Recall of H1N1 Vaccine in Pre-Filled
Syringes
Summary:
As part of its quality assurance
program, Sanofi Pasteur, Inc., performs additional routine,
ongoing testing of influenza vaccines after the vaccine has
been distributed to health care providers to ensure that vaccines
continue to meet required specifications.In recent testing
of the amount of antigen in its influenza A (H1N1) monovalent
vaccine, Sanofi Pasteur found four distributed lots of single-dose,
pre-filled syringe pediatric (0.25 mL.) vaccine with antigen
content lower than required potency levels. The manufacturer
is conducting a non-safety related voluntary recall of these
affected lots of vaccine.
Background
After performing these tests, Sanofi Pasteur
notified the Centers for Disease Control and Prevention
(CDC) and the Food and Drug Administration (FDA) that the
antigen content in one lot of pediatric syringes that had
been distributed to providers was later found to have dropped
below a pre-specified limit. As a result of this finding,
Sanofi Pasteur tested additional lots and found that three
other lots that had been distributed also had an antigen
content that had fallen below pre-specified limits. This
means that doses from these four vaccine lots no longer
meet the specifications for antigen content.
Recommendations
While the antigen content of these lots is
now below the specification limit for the product, CDC and
FDA are in agreement that the small decrease in antigen content
is unlikely to result in a clinically significant reduction
in immune response among persons who have received the
vaccine. For this reason, there is no need to revaccinate
persons who have received vaccine from these lots. |
