WASHINGTON (Reuters Health) Sept 12 - Aventis Pasteur Inc., a US subsidiary of
French drugmaker Aventis SA, said on Thursday that it has received approval
from the US Food and Drug Administration (FDA) to market a preservative-free
formulation of its influenza vaccine Fluzone for infants ages 6 to 35 months.
According to the Swiftwater, Pennsylvania-based concern, this would be the
first preservative-free influenza vaccine approved for infant administration.
But due to the current manufacturing schedule, Aventis Pasteur said only a
limited quantity of pediatric vaccine will be available for the 2002-2003
season.
Aventis, which supplies about 50% of the nation's flu vaccine, said it
developed the pediatric formulation to boost public confidence in the
immunization of young children. Fears regarding the use of vaccines containing
preservatives in infants have grown in the US since the FDA revealed in 1999
that the amount of mercury intake for some babies in their first six months
might exceed limits set by the US Environmental Protection Agency (EPA).
Mercury is the main ingredient in the vaccine preservative thimerosal.
The firm has the capacity to produce greater quantities of the vaccine for
the 2003-2004 season and will proceed to make more if the US Centers for
Disease Control and Prevention's Advisory Committee on Immunization Practices
(ACIP) strengthens its current recommendations for the annual immunization of
healthy children, Aventis said.
The ACIP currently is considering a plan to strengthen its present
recommendations to include annual immunizations of healthy children aged 6 to
23 months.
For the 2002-2003 influenza season, Aventis said the infant vaccine will be
packaged in pre-filled syringes and launched in early to mid-November.
