BACTERIAL MENINGITIS VACCINE
FDA expands age range of bacterial
23 October, 2007
The United States Food and Drug
Administration (FDA) has approved
vaccination of children for bacterial
The FDA expanded the age range for the
vaccine Menactra, made by French
pharmaceutical company Sanofi-Aventis,
to start from two years of age.
Previously, the age range was 11 to 55
years of age.
Bacterial meningitis, an inflammation
of the lining surrounding the brain
and spinal cord, is a potentially
deadly inflammatory infection.
The vaccine Menactra, licensed in the
United States for the prevention of
meningococcal disease, treats a rare,
serious bacterial infection that often
causes meningitis or sepsis, a
statement from Sanofi-Aventis said.
The vaccine had first received the
FDA’s license in 2005 for immunization
of adolescents and adults aged 11 to
55. The FDA’s new decision to license
Menactra vaccine for children in the
age range of 2 to 10 was based on data
from two clinical studies.
Dr Jesse Goodman, director of FDA’s
Center for Biologics said that
“approving Menactra for younger
children offers another option for
health-care providers and parents. Now
there are two vaccines available for
children between 2 and 10 years of age
who may be at increased risk of
Sanofi-Aventis makes the other
meningitis vaccine as well.
According to the FDA, around 2,600
people fall ill in the United States
annually from bacterial meningitis,
with 10% dying from it.
The United States Centers for Disease
Control and Prevention recommends
vaccination for travelers to countries
where the infection is a problem,
those with damaged spleens, college
students living in dorms, and military
The infection can cause seizures,
brain damage, memory loss and death in
otherwise healthy people in less than
48 hours, with a 15% fatality rate if
treated with antibiotics.
Bacterial meningitis – a relatively
rare disease – is marked by fever,
headache, and stiff neck and is more
serious than viral meningitis.
The vaccine Menactra has been linked
with a few cases of a neurological
disorder called Guillain-Barre
syndrome among some teens.
The Centers for Disease Control and
Prevention said it was investigating
whether the vaccine caused the
reaction, which has been associated
with other vaccines, too.
Sanofi-Aventis said that, in the
studies, immediate reactions were
uncommon and consisted primarily of
local redness at or near the injection
The vaccine Menactra is manufactured
by Sanofi Pasteur, which is the
vaccines unit of Sanofi-Aventis.