Vaccine Safety >
Issues of Interest > Thimerosal
Availability
of Thimerosal-free Vaccines
-
Which
childhood vaccines do not contain
thimerosal?
Today,
with the exception of some influenza
vaccine, none of the vaccines used
to protect preschool children against
12 infectious diseases contain thimerosal
as a preservative. (Those with a concentration
of less than 0.0002% contain what is
considered “trace,” or insignificant,
amounts.) Certain Influenza (flu) vaccines
and tetanus-diphtheria vaccines (Td)
given to children age 7 and older contain
thimerosal as a preservative. For more
information on thimerosal content in
some currently manufactured U.S. licensed
vaccines, go to http://www.fda.gov/cber/vaccine/thimerosal.htm
Top
|
-
Why
does some flu vaccine contain thimerosal
when the preservative has been removed
from other pediatric vaccines?
Influenza
(flu) vaccine is a new addition to
the recommended childhood immunization
schedule. In 2004, the CDC added
the vaccine to the childhood immunization
schedule, recommending that children
6-23 months of age be vaccinated
against flu each year. Inactivated
influenza vaccine for children 6-23
months of age is currently available
both with thimerosal as a preservative
and preservative-free. For the 2004-05
influenza season, it is likely that
6-8 million doses of inactivated
influenza vaccine without thimerosal
as a preservative will be available.
This represents a substantial increase
in the available amount of inactivated
influenza vaccine without thimerosal
as a preservative, compared with
about 3.2 million doses that were
available during the 2003-04 influenza
season.
The
removal of thimerosal as a preservative
from influenza vaccine is a complicated
process. The total amount of flu
vaccine without thimerosal as a preservative
will be increased as vaccine manufacturing
capabilities are expanded. In the
meantime, it is important to keep
in mind that the benefits of influenza
vaccination outweigh the theoretical
risk, if any, for exposure to thimerosal.
Each year, an average of about 36,000
people in the United States die from
influenza, and 114,000 have to be
admitted to the hospital as a result
of influenza. People age 65 years
and older, people of any age with
chronic medical conditions, and very
young children are more likely to
get complications from influenza.
Top
|
-
Why
weren’t thimerosal-containing vaccines
taken off the market?
Scientific
data have not established that vaccines
containing thimerosal, used as a preservative,
create an imminent or substantial hazard
to public health or are in violation
of FDA laws or regulations, and therefore
do not justify such a recall. A mandatory
recall requires that the product present
“an imminent or substantial hazard
to the public health.”
The
U.S. Food and Drug Administration (FDA)
is responsible for voluntary and mandatory
recalls of drug and vaccine products.
The FDA continuously monitors the safety
of these products.
Top
|
-
Should
immunization providers stop using
licensed pediatric vaccines that
contain thimerosal?
No.
Immunization providers should use
the vaccines available in their stock.
The use of vaccines should continue
according to the currently recommended
schedule. The risks of not vaccinating
children on time are significant, whereas
the risks of thimerosal- containing
vaccines have not been proven scientifically.
Furthermore, availability of any vaccine
containing thimerosal preservative
is rare.
Top
|
-
With
the exception of some influenza vaccines
and tetanus-diphtheria (Td) vaccines
(given to children age 7 and older),
the last lots of recommended childhood
vaccines which contained thimerosal
as a preservative expired by early
2003. If providers have such expired
vaccines in their stocks, they should
discard them.
Top
|
-
What
is the availability of the preservative-free
hepatitis B vaccine?
All
hepatitis B vaccines intended for use
in infants and children are free of
thimerosal as a preservative, and an
adequate supply of these vaccines is
available for all infant and childhood
vaccinations. This vaccine should be
administered to all newborn infants
and is a major cornerstone in the prevention
of a potentially fatal disease in children
and adults.
Top
|
|