Maine CDC Press Release

December 15, 2009

Voluntary Recall of Pediatric H1N1 Vaccine Announced - Vaccine Remains Safe, Testing Reveals Dose May Not Be Potent Enough

Dora Anne Mills, MD, MPH

AUGUSTA – A pharmaceutical company that produced vaccines for the H1N1 flu has issued a non-safety related, voluntary recall of 800,000 doses of the drug because tests suggest they may not meet potency standards.

“The vaccine is safe, and we do not believe that children need to be revaccinated. They should, however, still receive planned booster vaccinations for H1N1,” said Dr. Dora A. Mills, Director of the Maine Center for Disease Control. “The vaccines are being recalled because tests suggest that the antigen content no longer meets specifications.”

Sanofi Pasteur notified the federal Centers for Disease Control and Prevention about its concerns with four lots of pre-filled vaccine syringes for children ages six months to 35 months. The federal CDC began notifying health care providers today.

All vaccines are thoroughly tested prior to release and shipping to determine that they meet all manufacturer and Food and Drug Administration standards for purity, potency and safety. The affected vaccine met all specifications at the time of release. CDC and FDA have determined that there are no safety concerns for children who have received the vaccine and Sanofi Pasteur has discontinued distribution of this type of H1N1 pediatric vaccines.

The antigen content in the affected lots of vaccine is only slightly below the specification limit and the slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response, according to the US CDC.

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.

Health care providers may go to for complete details on the recall.

Like the remainder of the nation, the surge in H1N1 has declined in Maine, but the virus is expected to be circulating for months and years to come. Maine CDC announced on Monday that there is enough vaccine available to allow members of the general public to get vaccinated.

To find vaccine, call your health care provider; 211; or check for a list of public clinics.