Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric Vaccine in Pre-Filled Syringes Questions & Answers
December 15, 2009 

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.

Please visit the Centers for Disease Control and Prevention for more information regarding this topic.

When to Seek Medical Care for Your Child
October 21, 2009

Most children (and adults) with the flu who are generally in good health can be well taken care of at home and will not need to visit a health care provider. But if your child has any of the following symptoms, call your doctor right away or, if you can't, take your child to an urgent care center or emergency room:

• Fast breathing or having trouble breathing
• Bluish or gray skin color
• Flu symptoms get better, but then get worse again with fever and cough
• Severe or persistent vomiting
• Not drinking enough fluids
• Not waking up or not interacting

When caring for your child at home, be sure he or she gets as much rest as possible, drinks plenty of fluids and does not leave home. Be sure that your child doesn't return to school or day care until at least 24 hours after the fever is gone without the use of fever-reducing medicine like acetaminophen (Tylenol) or ibuprofen (Motrin).

10 Things You Should Know About H1N1
August 20, 2009

1. What is influenza? This is virus that every winter season causes fever and cough and so is called seasonal influenza.

2. What is different about 2009 H1N1 influenza? This virus is a new strain caused by mixing several influenza genes together (a mutation). Few persons, if anyone, have immunity from exposure in previous years. This means anyone exposed to the virus will likely become infected.

3. What kind of symptoms can 2009 H1N1 cause? All the symptoms are similar to the usual winter influenza so high fever, muscle aches, headache, sore throat and cough are most common.

4. Is this flu worse than usual flu? So far, this appears to be a mild version of influenza except in rare cases.

5. Should I get tested if I think I have H1N1? Probably not. Testing is recommended in patients with certain high risk underlying conditions like heart, lung disease, or immune problems since complications from influenza are more common in this group. It is also recommended in patients ill enough to be hospitalized.

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