DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 02-6

(FDA Web site: www.fda.gov)

February 2002

Vaccines Provide Effective Protection

And FDA Makes Sure They Are Safe

Immunization saves lives—

millions of them. In the United

States, large-scale vaccination

programs have wiped out smallpox and polio and have reduced

measles, mumps, rubella, tetanus,

diphtheria, Haemophilus

influenzae meningitis, and whooping cough by 95 percent. Thanks

to immunization, flu and pneumonia are much less of a scourge of

the elderly and chronically ill. But

vaccines, which contain weakened

or killed disease-causing bacteria,

viruses, or their components, have

to be rigorously scrutinized for

their effectiveness and safety. This

vital task is an important part of

the public health mission of the

Food and Drug Administration.

Here are the principal protections of vaccine safety:

• The designs of studies for

testing new vaccines must be

approved by the FDA, which also

supervises the integrity of most of

the trials carried out in the United

States.

• The clinical trials that establish

the vaccines’ safety and effectiveness are frequently very large—for

example, the trial for Prevnar, a

vaccine against invasive pneumoproperly produce the vaccine

before it is licensed for marketing

by the agency.

• When the vaccine is in production, the FDA requires the firm to

test samples from each lot for

safety, potency and purity, and

carries out spot-testing of its own.

The FDA also cooperates with

the Centers for Disease Control

and Prevention (CDC) and other

institutions in research to develop

even safer vaccines. Since 1996,

for example, the agency has

licensed several whooping cough

vaccines that contain only part of

the disease-causing bacterium, and

are associated with fewer side

effects than the whole cell pertussis vaccines. In March 2001, the

FDA approved a newly formulated version of an acellular

pertussis vaccine that uses only a

trace amount of the mercurycontaining preservative thimerosal. In the United States, at

present, all routinely administered

pediatric vaccines are being

produced in either thimerosalreduced or thimerosal-free forms.”

For more information, call 301-

827-2000.

coccal diseases, included almost

40,000 infants.

• Following the completion of the

studies, FDA scientists review the

resulting data, the proposed

labeling, and the manufacturing

protocols, and conduct their own

tests of the product.

• FDA inspectors make certain

that the manufacturing facility can

Adverse Event Reporting System

The FDA and the CDC jointly

operate Vaccine Adverse Event

Reporting System (VAERS) that

receives 800 to 1,000 reports a

month—mostly from physicians—

of suspected adverse events

associated with the use of vaccines.

The FDA continuously reviews and

evaluates these reports and monitors overall reporting patterns, as

well as trends for individual

vaccine lots. The VAERS data make

an important contribution to

vaccine safety. For example,

following the licensure of

RotaShield, a vaccine against

rotavirus infection, VAERS began

receiving reports of bowel obstruction in infants who had received the

vaccine. The reports prompted a

CDC recommendation that the

RotaShield be further studied.

Following a consultation with the

FDA, the manufacturer withdrew

the product from use.