800,000 doses of kids' swine flu vaccine recalled - Spokane, North Idaho News & Weather KHQ.com

800,000 doses of kids' swine flu vaccine recalled

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ATLANTA, Ga. - Health officials are recalling hundreds of thousands of doses of swine flu vaccine after tests indicated they may not be potent enough to protect against the virus.
     
The Centers for Disease Control and Prevention notified doctors about the recall Tuesday. The recall involves about 800,000 doses made by Sanofi Pasteur. The doses are pre-filled syringes intended for young children, ages 6 months to almost three years.
     
Health officials recommend children those ages get two doses, spaced about a month apart.
     
Health officials say it's not clear how many doses have already been given, but they don't think children need to be re-vaccinated.

The lots passed potency tests when they were first shipped, but tests indicate the potency waned after.

From the CDC:
Why are some lots of pediatric H1N1 vaccine manufactured by Sanofi Pasteur in pre-filled syringes being recalled from the market?

As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a "lot") of pediatric syringes that had been distributed 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, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. This means that doses from these four vaccine lots no longer meet the manufacturer's specifications for potency. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.

What does potency mean for the H1N1 vaccine?

Potency (or strength) is determined by the measurement of the concentration of the active ingredient (also called antigen) in the H1N1 vaccine.

Are there any concerns about safety of vaccines from these lots?

No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.

Should infants and children who received vaccines from these lots be revaccinated?

No. The vaccine potency is only slightly below the "specified" range. The vaccine in these 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-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.


The Spokane Regional Health District does not have any further public vaccination clinics planned. The H1N1 vaccine is currently available at local doctor's offices in both the nasal mist and injectable form.  Many pharmacies now have the vaccine. Policies vary by pharmacy, especially when it comes to vaccinating children. Pharmacies are permitted to charge a small fee.

Those who are uninsured can get the vaccine free of charge at the following sites:

  • SRHD Public Health Clinic – all ages, appointment needed (324-1648)
  • Safeway pharmacies – over 8 years of age for injectable; 5 yrs and older for nasal spray
  • US Health Works Urgent Care – all ages, walk-in for Valley and South; 4 yrs + for North side
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