FAQs About Recalled Vaccines
October 30, 2002
Why would a vaccine or batch of vaccine be withdrawn
Many types of products, including cars, toys, and food products, are
sometimes recalled temporarily or withdrawn permanently from the market
because they are found to not work properly or because a safety concern
was identified after the product was used widely. Similarly, vaccines or
vaccine lots can also be withdrawn or recalled. The vaccine manufacturer
may volunteer to recall or withdraw a vaccine or vaccine lot on its own,
or the Food and Drug Administration (FDA) can ask the manufacturer to do
Have vaccine lots been recalled because of
no drugs, including vaccines, are 100%
effective or safe there have only been
a few vaccine recalls or withdrawals,
most of which were due to concerns regarding
the effectiveness of the vaccine and
not because of safety. When the strength
of a vaccine lot has been reduced, those
vaccines may not produce an immune response
that is strong enough to protect against
disease. Even though vaccine lots may
not be effective, they are still safe.
Vaccines are carefully tested and continuously
monitored before and after they are
licensed for use. If a vaccine lot were
found to be unsafe, the FDA would immediately
recall it from the market. Also consult
of recalled vaccines or vaccine lots.
any vaccines been permanently withdrawn from the US market
due to a safety concern?
Yes. In 1999, the Advisory Committee on Immunization Practices
(ACIP) decided that RotaShield®, the only U.S.-licensed
rotavirus vaccine, should no longer be recommended for infants
in the United States (Centers for Disease Control and Prevention
1999). This decision was based on the results of a review
of scientific studies that indicated a strong association
between RotaShield® and intussusception (a rare, potentially
life-threatening form of intestinal obstruction) among some
infants during the first 1-2 weeks following vaccination.
RotaShield® was voluntarily withdrawn by the manufacturer
before the ACIP withdrew its recommendation, but after the
CDC recommended suspending use of the vaccine. See http://www.cdc.gov/nip/issues/rota/
for more information about RotaShield®.
early 1976, the CDC detected the circulation of a flu virus,
known as swine flu, which was similar to the Spanish flu
virus that killed many people in 1918. The government, out
of fear of a devastating flu epidemic like the one in 1918,
began a mass swine flu vaccination campaign. However, in
December of 1976 the campaign was stopped because of reports
of Guillain-Barré syndrome or GBS (a rare disorder
that causes weakness and oftentimes temporary paralysis,
usually in the arms, legs or face) in some people who received
the swine flu vaccine (Schonberger et al. 1979). The swine
flu vaccination campaign did not continue and the swine
flu vaccine is no longer used. A study that looked at the
1992-1993 and 1993-1994 flu vaccines found a possible very
slight increase in the risk of GBS (Lasky et al. 1998).
However, no flu vaccine has been associated with a similar
increased risk of GBS as the swine flu vaccine.
What was the "Cutter incident"?
“Cutter incident” is named after the manufacturer
of polio vaccine lots that accidentally created a serious
safety problem. This incident involved a safety-related recall
by the US Public Health Service (PHS). At the very beginning
of the polio vaccine program, some people developed polio
soon after receiving the polio vaccine. After the PHS recalled
the vaccine, an investigation showed that some vaccinated
people got polio because the poliovirus in the vaccine was
still active (or live), when it should have been killed. New
manufacturing and safety testing procedures were introduced,
and the vaccination program resumed without any further safety
problems (Nathanson and Langmuir 1963).
do I know and what do I do if a vaccine lot is recalled?
Your doctor should notify you if a vaccine given
to you or your child is recalled. Most vaccine recalls are
due to low vaccine potency or strength. When the strength
of a vaccine lot is lower than it should be, vaccines from
the lot might not produce an immune response that is strong
enough to protect against disease. Therefore, in order to
make sure that the people vaccinated with a recalled vaccine
are protected against the vaccine-preventable disease it may
be necessary for them to get revaccinated. For information
about which vaccines (and other products) have been recalled
see the FDA’s recall and withdrawal website
- What is
being done to monitor the safety of vaccines?
assure the safety of vaccines, the Centers for Disease Control
and Prevention (CDC), the Food and Drug Administration (FDA),
the National Institutes of Health (NIH), and other Federal
agencies routinely monitor vaccine safety and conduct research
to examine any new evidence that would suggest possible problems
with the safety of vaccines. The Vaccine Adverse Event Reporting
System, or VAERS, was designed to give health care workers
and others a place to report possible problems following vaccination.
VAERS helps the FDA and CDC to continuously monitor vaccine
safety. The FDA reviews reports weekly and closely monitors
reporting trends for individual vaccine lots. To request a
VAERS form or to get more information about VAERS, please
call 1-800-822-7967 or go to the VAERS website at http://www.vaers.org.
more information about vaccines and immunizations:
Contact the CDC Information Contact Center
for Disease Control and Prevention. Notice to Readers: Recall
of TripediaTM Vaccine. MMWR 1999; 48(07):146-8.
for Disease Control and Prevention. Withdrawal of rotavirus
vaccine recommendation. MMWR 1999; 48(43):1007.
JK, Miller ER, Pless RP, Chen RT. Vaccine safety post-marketing
surveillance: The Vaccine Adverse Event Reporting System. Centers
for Disease Control and Prevention continuing education activity,
T, Terracciano GJ, Madger L, Koski CL, Ballesteros M, Nash D,
Clark S, Haber P, Stolley PD, Schonberger LB, Chen RT. Guillain-Barré
syndrome and the 1992-93 & 1993-94 influenza vaccines. New
England Journal of Medicine 1998; 339(25): 1797-1802.
N, Langmuir AD. The Cutter Incident: Poliomyelitis following
formaldehyde-inactivated poliovirus vaccination in the United
States during the spring of 1955. American Journal of Hygiene
1963; 78: 16-81
MT, Salive ME, Ellenberg SS. Post-marketing surveillance for
adverse events after vaccination: the national Vaccine Adverse
Event Reporting System (VAERS). MEDWATCH Continuing Education
Article, November 1998.
LB, Bregman DJ, Sullivan-Bolyai JZ, Keenlyside RA, Ziegler DW,
Retailliau HF, Eddins DL, and Bryan JA. Guillan-Barré
syndrome following vaccination in the National Influenza Immunization
Program, United States, 1976-1977. American Journal of Epidemiology
1979; 110(2): 105-23.