Pasadena Public Health Department

2009 Pandemic H1N1 Influenza Vaccine Recall: Recalled Doses Are Still Safe; No Need to be Re-Vaccinated



The Centers for Disease Control and Prevention (CDC) issued a Health Alert today announcing a
voluntary recall of four lots of H1N1 Pediatric Vaccine in Pre-Filled Syringes for children age 6 months
to 3 years old from one manufacturer, Sanofi Pasteur. This type of injectable vaccine does not constitute
a large percentage of H1N1 vaccine supply. The City of Pasadena Public Health Department has
assessed all pediatric vaccines distributed through its coordinated public H1N1 vaccine clinics and
found that none of the recalled vaccine supplies were used.

The Pasadena Public Health Department wants to emphasize that this recall is not related to
vaccine safety. Routine, ongoing testing of vaccine is done before and after it has been shipped to
providers. One manufacturer, Sanofi Pasteur, notified the CDC and Food and Drug Administration (FDA)
that the potency in four lots of pediatric syringes was found to have dropped after the vaccine was
distributed. The vaccine in these four lots is still expected to be effective in stimulating a protective
response despite this slight reduction in the concentration of antigen.

There is no need to re-vaccinate those who received vaccine from these lots. If a child age 6-35 months
received a first dose from one of these lots, only a second dose will be required, as would be the case for
all children this age. If a child age 6-35 months received a second dose from one of these lots, there is no
need to give a third dose. CDC’s recommendation is for all children less than 10 years old to get the
recommended two doses of H1N1 vaccine at least 21 days apart for the optimal immune response.

Pasadena Public Health Director and Health Officer, Dr. Takashi Wada said: “While we know of no
pediatric vaccines distributed in Pasadena from this recalled supply, parents who have already vaccinated
their children should feel confident they are protecting their children’s health. It remains true that for
children age 6 months through 9 years, a second dose is required to reach full immunity. All children in
that age group need their second dose to be fully protected.”

This voluntary recall does not change H1N1 vaccination recommendations. Of the vaccine affected by this
recall, California received approximately 47,800 doses affecting about 159 providers. The California State
Department of Public Health (CDPH) and the manufacturer, Sanofi Pasteur, will be contacting providers in
California who have received this vaccine with directions for returning any unused vaccine from these lots.
Sanofi Pasteur is investigating what caused the problem. The same vaccine packaged in other dosing forms,
such as pre-filled syringes for older children, adults, and multi-dose vials, continues to meet required
specifications. This recall does not affect H1N1 vaccine produced by other manufacturers.

For further updates, please visit the Pasadena Public Health Department’s website,


Posted: 12/16/2009 12:10:00 PM
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