How does the government monitor vaccines? Part 1 of 2

According to the Centers for Disease Control and Prevention (CDC) “Vaccines are developed with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict how individuals will react to a particular vaccine.”

In order to adequately track adverse events and reactions, The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA) and CDC established the Vaccine Adverse Events Reporting System (VAERS) in 1990.

VAERS is a key component of postlicensure vaccine safety surveillance. Its primary function is to detect early warning signals and generate hypotheses about possible new vaccine adverse events or changes in frequency of known ones. VAERS is a passive surveillance system that relies on physicians and others to voluntarily submit reports of illness after vaccination. Manufacturers are required to report all adverse events of which they become aware. There are a number of well-described limitations of such reporting systems.

VAERS demonstrated its public health importance by providing health scientists with signals about possible adverse events following immunization. In one instance, VAERS detected reports for intussusception over that what would be expected to occur by chance alone after the RotaShield rotavirus vaccine in 1999. Epidemiologic studies confirmed an increased risk, and these data contributed to the product’s removal from the US market. In another example, VAERS determined that there may be a potential for a small increase in risk for Guillain-Barre’ syndrome (GBS) after the meningococcal conjugate vaccine, Menactra. As a result of this finding, a history of GBS became a contraindication to the vaccine and further controlled studies are currently underway to research this issue.

VAERS data are monitored to detect new, unusual, or rare vaccine adverse events, to monitor increases in known adverse events, to identify potential patient risk factors for particular types of adverse events, to identify vaccine lots with increased numbers or types of reported adverse events, and to assess the safety of newly licensed vaccines.

Approximately 30,000 VAERS reports are filed annually, with 10-15% classified as serious. A serious event is associated with disability, hospitalization, life-threatening illness or even death, such serious adverse events include anaphylaxis and Guillain-Barré syndrome.

Pain, swelling, and redness at the injection site are common local reactions to vaccines. Systemic reactions, including fever, irritability, drowsiness, and rash, may also occur after some immunizations, these would all be classified as non serious events.

Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients or their parents or guardians. The VAERS form requests the type of vaccine received, the timing of the vaccination, the onset of the adverse event, current illnesses or medication, past history of adverse events following vaccination, and demographic information about the recipient.

VAERS forms can be completed online, or you can complete a paper form and mail or fax it to VAERS.

Additional information about VAERS is available at http://www.fda.gov/cber/vaers.html, and the VAERS form may be downloaded or printed from this website.

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