FAQs about Recalled Vaccines
Vaccines go through rigorous testing before and after they are approved for use, but sometimes a vaccine or particular lot (batch) of vaccine may need to be withdrawn or recalled from the market (for example, from doctor's offices and clinics). It is important to recognize, however, that almost all vaccine recalls happen because the vaccine is not as strong (potent) or effective as it should be and not because the vaccine or vaccine lot is unsafe. For information about which vaccines have been recalled--see the FDA's recall and withdrawal website.
Why would a vaccine be withdrawn or recalled?
Many types of products, including cars, toys, and food products, are sometimes recalled temporarily or withdrawn permanently from the market because they are found to not work properly or because a safety concern was identified after the product was used widely. Similarly, vaccines or vaccine lots can also be withdrawn or recalled.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 so.
While no drugs, including vaccines, are 100% effective or safe, vaccines that are licensed for use in the United States undergo extensive testing prior to licensure and are monitored for safety after licensure as well. There have been vaccine recalls in the past. However, most 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 these vaccine lots may not be effective, they are still safe. If a vaccine lot were found to be unsafe, the FDA would immediately recall it from the market.
Have any vaccines been permanently withdrawn from the US market due to a safety concern?
Yes. As an example, in 1999 the Advisory Committee on Immunization Practices (ACIP) decided that RotaShield®, the only U.S.-licensed rotavirus vaccine at that time, 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 safety data 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 more information about RotaShield®.
In 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 concern about a potentially devastating flu pandemic like the one in 1918, began a mass swine flu vaccination campaign. In December of 1976 the campaign was stopped because of an unusually high number 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). A study that looked at the 1992-1993 and 1993-1994 seasonal flu vaccines found a small increase in the risk of GBS following vaccination (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"?
The 1955 “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).
How do I know and what do I do if a vaccine lot is recalled?
Your doctor may 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?
To assure the safety of vaccines, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continuously monitor vaccine safety in surveillance systems and conduct studies to identify and investigate possible vaccine safety problems. The Vaccine Adverse Event Reporting System, or VAERS, was designed to give healthcare workers and others a place to report possible adverse events following vaccination. To request a VAERS form or to get more information about VAERS, please call 1-800-822-7967 or go to the VAERS website.
For more information about vaccines and immunizations:
- Contact the CDC Information Contact Center
- 1-800-CDC-INFO (1-800-232-4636)
- TTY: 1-888-232-6348
Centers for Disease Control and Prevention. Notice to Readers: Recall of TripediaTM Vaccine. MMWR 1999; 48(07):146-8.
Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendation. MMWR 1999; 48(43):1007.
Iskander 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, 2002.
Lasky 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.
Nathanson 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
Niu 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.
Schonberger 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.
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Content last reviewed on March 5, 2012
Content Source: National Center for Immunization and Respiratory Diseases