Non-Safety-Related Voluntary Recall of Sanofi Pasteur H1N1 Vaccine
Q and A
Q-Why are some lots of pediatric H1N1 vaccine being recalled from the market?
A-Manufacturer Sanofi Pasteur noticed that the potency in some batches (called a “lot”) of pediatric syringes that had been distributed were later found to have dropped below a pre-specified limit.
Q-Are there any concerns about safety of vaccines from these lots?
A-No. There are no safety concerns with these lots of H1N1 vaccine.
Q-Should infants and children who received vaccines from these lots be revaccinated?
A-No. The vaccine potency is only slightly below the “specified” range. However, as is recommended for all 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.
Q-What action(s) should parents of children who have received vaccine from the recalled lots take?
A-Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed.
Q. How many shots will I need?
Will two doses of vaccine be required?
The CDC recommends that all children aged 6 months to 9 years and who have never received flu vaccine before receive 2 doses of vaccine for both for seasonal influenza vaccination and H1N1. The CDC further recommends that the two doses of H1N1 vaccine be separated by 4 weeks. However, if the second dose is separated from the first dose by at least 21 days, the second dose can be considered valid.
Q. Will there be enough vaccine for everyone?
A. Yes, the H1N1 vaccine will be available to everyone who wants to be vaccinated.
Q. How will I get the vaccine?
A. Once the vaccine is available, local health departments and health care systems will work together to share this information with the community. Wisconsin will follow the Center?s for Disease Control and Prevention?s (CDC) recommendations for administering the vaccine. This includes the use of target populations to assist public health prevent the spread of disease and protect those most vulnerable.
Q. What do I do if I get sick?
A. If you become ill with influenza-like symptoms, including fever, body aches, runny or stuffy nose, sore throat, nausea, or vomiting or diarrhea, you should stay home and avoid contact with other people. CDC recommends that you stay home for at least 24 hours after your fever is gone except to get medical care or for other necessities. Stay away from others as much as possible to keep from making others sick. This means avoiding normal activities, including work, school, sports, travel, shopping, social events, and public gatherings.
Q. Should I go to my doctor if I am sick?
A. It is expected that most people will recover without needing medical care. If you have severe illness or you are at high risk for flu complications, contact your health care provider or seek medical care.
In children, emergency warning signs that need urgent medical attention include:
- Fast breathing or trouble breathing
- Bluish or gray skin color
- Not drinking enough fluids
- Severe or persistent vomiting
- Not waking up or not interacting
- Flu-like symptoms improve but then return with fever and worse cough
In adults, emergency warning signs that need urgent medical attention include:
- Difficulty breathing or shortness of breath
- Pain or pressure in the chest or abdomen
- Sudden dizziness
- Confusion
- Severe or persistent vomiting
- Flu-like symptoms improve but then return with fever and worse cough
Q. Should I get a seasonal flu vaccine?
A. Yes, the seasonal flu vaccine protects against the three seasonal viruses that research suggests will be most common.
Q. Will the seasonal flu vaccine protect me from H1N1?
A. No, seasonal vaccine will not protect you against H1N1.
Source: Center for Disease Control and Prevention (CDC)
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