WASHINGTON-Vaccine maker Sanofi-Aventis SA.PA> is recalling four lots of its pediatric H1N1 swine flu vaccine because it is not as potent as it should be, U.S. officials said on Tuesday.
There is no safety concern and children vaccinated from the lots already will not need to be re-vaccinated, the U.S. Centers for Disease Control and Prevention said.
The affected vaccines are pre-filled syringes for children under age 3, the CDC said in a message to state and local health officers, public information officers and doctors' groups. A CDC spokesman said about 800,000 doses of vaccine from the lots had been distributed to providers.
The CDC said the four lots were discovered as part of a quality assurance testing program and that the company had also notified the U.S. Food and Drug Administration....