Vaccine
Safety
Use of Human Cell Cultures
in Vaccine Manufacturing
CDC's responsibility is to ensure that the U.S. population is adequately vaccinated
with safe and effective vaccines to prevent sickness, disability and death. The CDC
does not manufacture vaccines. The Food and Drug Administration licenses vaccines
for use in the United States.
CDC is aware that some, but not all, vaccines are made from human cell-line cultures,
and some of these cell lines originated from aborted fetal tissue, obtained from legal
abortions in the 1960's. No new fetal tissue is needed to produce cell lines to make
these vaccines, now or in the future. Fetal tissue is not used to produce vaccines;
cell lines generated from a single fetal tissue source are used--vaccine manufacturers
obtain human cell lines from FDA-certified cell banks.
Vaccines work in preventing disease, disability and death, but only when children and
adults in a community are adequately vaccinated. In the United States, disease
incidence, disability and death from vaccine-preventable diseases have declined
dramatically since the development and widespread use of vaccines. For example, in
1964, there were an estimated 20,000 babies born with congenital rubella syndrome (CRS) in
the United States. When women contract rubella during early pregnancy, this often
causes neurological damage to the unborn child, resulting in the child suffering
blindness, deafness and retardation. In 1993, the number of CRS cases was seven,
reflecting a 99.9% reduction in this preventable disease since 1964.
In January 1996, CDC, the American Academy of Pediatrics and the American Academy of
Family Physicians jointly recommended routine use of varicella vaccine to protect children
from chicken pox. In March 1995, this vaccine was licensed for use in the United
States by the FDA and was shown to be safe and effective. Widespread use of
varicella vaccine--which took more than 20 years for the development, testing, and
licensing--can help prevent thousands of children from being hospitalized each year
because of complications from chicken pox. Complications include secondary
infections such as group A streptococcal infections that can lead to necrotizing
fasciitis, multiple organ failure, shock and death. Approximately 100
people in
the United States each year die from complications associated with their chicken pox
illness.
A community's optimum opportunity to prevent disease, disability, and death through
vaccination is obtained only with the widest participation of community members. No
vaccine offers immunity to everyone vaccinated. Some people who may elect to be
vaccinated will not obtain immunity from the vaccine and will remain susceptible to
viruses. However, as more and more members of a population are vaccinated, the odds
of the nonimmune person being exposed to the disease goes down. A community needs
nearly everyone's participation in the disease prevention effort to protect those people
who maybe unable to protect themselves even through vaccination. Health care
providers cannot predict which people will not become immune after vaccination. In
addition, some children, for medical reasons, cannot be vaccinated and these children must
rely on their community members to help protect them from disease exposure by being
vaccinated. When vaccination levels go down, disease incidence and deaths go up such
as during the U.S. measles epidemic which killed 130 between 1989-91.
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