Vaccine Adverse Event Reporting System

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The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1] VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.

Contents

VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety [2] to fulfill their duty as regulatory agencies charged with protecting the public.

As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. [3] Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformation regarding the safety of vaccines; it is generally not possible to find out from VAERS data if a vaccine caused an adverse event, or how common the event might be. [4]

Origins

The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report:

VAERS was established in 1990 and is managed jointly by the FDA and the CDC. [5] It is meant to act as a sort of "early warning system" [6] —a way for physicians and researchers to identify possible unforeseen reactions or side effects of vaccination for further study. [7]

Operation

Higher-priority uses of the data include reports of death and other serious adverse events, recognizing and detecting adverse effects, and finding unexpected adverse events involving new vaccines. The VAERS data are also used to monitor known reactions to vaccines and for vaccine lot surveillance. Data mining techniques such as empirical Bayes methods can be used to improve the quality of data analysis. [5] The system was used in 1999 to identify a rotavirus vaccine that had an increased risk of a bowel obstruction condition, and confirmatory research led to the vaccine's use being suspended. [8] [9] [10]

Use in research and litigation

Many medical researchers make use of VAERS to study the effects of vaccination. VAERS warns researchers using its database that the data should not be used in isolation to draw conclusions about cause and effect. [11] Nonetheless, raw data from VAERS has been used in vaccine litigation to support the claim that vaccines cause autism.

Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in Pediatrics found that most VAERS reports related to thimerosal, and many related to autism, were filed in connection with litigation, leading the authors to caution that inappropriate reliance on VAERS data may be a source of bias. [12] The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research." [13] Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia, wrote:

Public health officials were disappointed to learn that reports of autism to VAERS weren't coming from parents, doctors, nurses, or nurse practitioners; they were coming from personal-injury lawyers ... For the lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy. [13]

Limitations and abuse

Like other spontaneous reporting systems, VAERS has several limitations, including underreporting, unverified reports, inconsistent data quality, and inadequate data about the number of people vaccinated. [14] Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data is often used in false claims regarding vaccine safety. [14] [15] [16] The Centers for Disease Control and Prevention (CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse event. [17]

For instance, noted anesthesiologist Jim Laidler once reported to VAERS that a vaccine had turned him into The Incredible Hulk. The report was accepted and entered into the database, but the dubious nature of the report prompted a VAERS representative to contact Laidler, who then gave his consent to delete it from the database. [18] [19]

During the COVID-19 pandemic, raw VAERS data has often been disseminated by anti-vaccine groups in order to justify inaccurate safety claims related to COVID-19 vaccines, including adverse reactions and alleged fatalities claimed to have been caused by vaccines. [17] [19] Websites such as Medalerts (published by the anti-vaccine group National Vaccine Information Center) and OpenVAERS (which published a tally of vaccine adverse events and fatalities allegedly linked to COVID-19 vaccines based on VAERS data), have been linked to this misinformation. [19] [20] Comparative studies of VAERS, which look at relative reporting rates, have found that the data does not support these claims. [21] [22]

See also

Related Research Articles

<span class="mw-page-title-main">Vaccination</span> Administration of a vaccine to protect against disease

Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating the body's adaptive immunity, they help prevent sickness from an infectious disease. When a sufficiently large percentage of a population has been vaccinated, herd immunity results. Herd immunity protects those who may be immunocompromised and cannot get a vaccine because even a weakened version would harm them. The effectiveness of vaccination has been widely studied and verified. Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the elimination of diseases such as polio and tetanus from much of the world. However, some diseases, such as measles outbreaks in America, have seen rising cases due to relatively low vaccination rates in the 2010s – attributed, in part, to vaccine hesitancy. According to the World Health Organization, vaccination prevents 3.5–5 million deaths per year.

<span class="mw-page-title-main">Vaccine trial</span> Clinical trial

A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.

An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Adverse effects can also be caused by placebo treatments . Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen. Adverse effects of medical treatment resulted in 142,000 deaths in 2013 up from 94,000 deaths in 1990 globally.

<span class="mw-page-title-main">Vaccine hesitancy</span> Reluctance or refusal to be vaccinated or have ones children vaccinated

Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain about their use, or using certain vaccines but not others. The scientific consensus that vaccines are generally safe and effective is overwhelming. Vaccine hesitancy often results in disease outbreaks and deaths from vaccine-preventable diseases. Therefore, the World Health Organization characterizes vaccine hesitancy as one of the top ten global health threats.

The National Vaccine Information Center (NVIC), founded under the name Dissatisfied Parents Together (DPT) in 1982, is an American 501(c)(3) organization that has been widely criticized as a leading source of fearmongering and misinformation about vaccines. While NVIC describes itself as the "oldest and largest consumer-led organization advocating for the institution of vaccine safety and informed consent protections", it promotes false and misleading information including the discredited claim that vaccines cause autism, and its campaigns portray vaccination as risky, encouraging people to consider "alternatives." In April 2020, the organization was identified as one of the greatest disseminators of COVID-19 misinformation on Facebook.

<span class="mw-page-title-main">National Childhood Vaccine Injury Act</span> US law

The National Childhood Vaccine Injury Act (NCVIA) of 1986 was signed into law by United States President Ronald Reagan as part of a larger health bill on November 14, 1986. NCVIA's purpose was to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims. Under the NCVIA, the National Vaccine Injury Compensation Program (NVICP) was created to provide a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters.

<span class="mw-page-title-main">Childhood immunizations in the United States</span>

The schedule for childhood immunizations in the United States is published by the Centers for Disease Control and Prevention (CDC). The vaccination schedule is broken down by age: birth to six years of age, seven to eighteen, and adults nineteen and older. Childhood immunizations are key in preventing diseases with epidemic potential.

The Vaccine Safety Datalink Project (VSD) was established in 1990 by the United States Centers for Disease Control and Prevention (CDC) to study the adverse effects of vaccines.

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Joseph Michael Mercola is an American alternative medicine proponent, osteopathic physician, and Internet business personality. He markets largely unproven dietary supplements and medical devices. On his website, Mercola and colleagues advocate unproven and pseudoscientific alternative health notions including homeopathy and opposition to vaccination. These positions have received persistent criticism. Mercola is a member of several alternative medicine organizations as well as the political advocacy group Association of American Physicians and Surgeons, which promotes scientifically discredited views about medicine and disease. He is the author of two books.

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event caused by vaccination. The World Health Organization (WHO) knows VAEs as Adverse Events Following Immunization (AEFI).

<span class="mw-page-title-main">Paul Offit</span> American pediatric immunologist

Paul Allan Offit is an American pediatrician specializing in infectious diseases, vaccines, immunology, and virology. He is the co-inventor of a rotavirus vaccine. Offit is the Maurice R. Hilleman Professor of Vaccinology, professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania, former chief of the Division of Infectious Diseases (1992–2014), and the director of the Vaccine Education Center at the Children's Hospital of Philadelphia.

The rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe diarrhea among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of the risk of death among young children due to severe diarrhea. Immunizing babies decreases rates of disease among older people and those who have not been immunized.

The FDA Adverse Event Reporting System is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery. The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012.

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OpenVAERS is an American anti-vaccine website created in 2021 by Liz Willner. The website misrepresents data from the Vaccine Adverse Event Reporting System (VAERS) to promote misinformation about COVID-19 vaccines.

Anti-vaccine activism is organized activity designed to increase vaccine hesitancy, often by disseminating misinformation or disinformation. Although myths, conspiracy theories, misinformation and disinformation spread by the anti-vaccination movement and fringe doctors leads to vaccine hesitancy and public debates around the medical, ethical, and legal issues related to vaccines, there is no serious hesitancy or debate within mainstream medical and scientific circles about the benefits of vaccination.

References

  1. ↑ Bol, Hayley. "Understanding COVID-19 vaccine side effect data". kfyrtv.com. Retrieved October 19, 2021.
  2. ↑ Centers for Disease Control and Prevention, Vaccine Safety Monitoring at CDC , retrieved March 11, 2015.
  3. ↑ Shimabukuro, TT; Nguyen, M; Martin, D; DeStefano, F (August 2015). "Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)". Vaccine. 33 (36): 4398–4405. doi:10.1016/j.vaccine.2015.07.035. PMC   4632204 . PMID   26209838.
  4. ↑ "Vaccine Adverse Event Reporting System (VAERS)". www.cdc.gov. February 27, 2019. Retrieved December 6, 2019.
  5. 1 2 Woo EJ, Ball R, Burwen DR, Braun MM (2008). "Effects of stratification on data mining in the US Vaccine Adverse Event Reporting System (VAERS)". Drug Saf. 31 (8): 667–74. doi: 10.2165/00002018-200831080-00003 . PMID   18636785. S2CID   40587832.
  6. ↑ "How the Vaccine Adverse Event Reporting System (VAERS) works". newswest9.com. September 23, 2021. Retrieved October 19, 2021.
  7. ↑ "The Pfizer-BioNTech vaccine explained: What's in it and how does it work". KELOLAND.com. October 13, 2021. Retrieved October 19, 2021.
  8. ↑ "Intussusception Among Recipients of Rotavirus Vaccine -- United States, 1998-1999". www.cdc.gov. Retrieved November 12, 2020.
  9. ↑ "Vaccines: VPD-VAC/Rotavirus/Rotashield and Intussusception Historical info". www.cdc.gov. April 15, 2019. Retrieved November 12, 2020.
  10. ↑ Murphy, Trudy V.; Gargiullo, Paul M.; Massoudi, Mehran S.; Nelson, David B.; Jumaan, Aisha O.; Okoro, Catherine A.; Zanardi, Lynn R.; Setia, Sabeena; Fair, Elizabeth; LeBaron, Charles W.; Schwartz, Benjamin (February 22, 2001). "Intussusception among Infants Given an Oral Rotavirus Vaccine". New England Journal of Medicine. 344 (8): 564–572. doi: 10.1056/NEJM200102223440804 . ISSN   0028-4793. PMID   11207352.
  11. ↑ "VAERS Data". VAERS.
  12. ↑ Goodman MJ, Nordin J (2006). "Vaccine adverse event reporting system reporting source: a possible source of bias in longitudinal studies". Pediatrics. 117 (2): 387–90. doi:10.1542/peds.2004-2687. PMID   16452357. S2CID   36547618.
  13. 1 2 Offit, Paul A. (2008). Autism's False Prophets: Bad Science, Risky Medicine, and the Search for a Cure. New York: Columbia University Press. ISBN   978-0-231-14636-4.
  14. 1 2 Rizk JG, Barr CE, Rizk Y, Lewin JC. The next frontier in vaccine safety and VAERS: Lessons from COVID-19 and ten recommendations for action. Vaccine. 2021;39(41):6017-6018. doi:10.1016/j.vaccine.2021.08.006
  15. ↑ "Vaccine injury database VAERS considered unreliable, 'subject to biases'". mlive. October 13, 2021. Retrieved October 19, 2021.
  16. ↑ Lyons, Silas. "Setting the record straight: Ad repeated lies about safety of COVID-19 vaccine". Redding Record Searchlight. Retrieved October 19, 2021.
  17. 1 2 Gabrielle Settles (May 3, 2021). "Federal VAERS database is a critical tool for researchers, but a breeding ground for misinformation". PolitiFact.
  18. ↑ Hall, Harriet (2018). "Diving into the VAERS Dumpster: Fake News about Vaccine Injuries". Skeptical Inquirer. 42 (6): 28–31.
  19. 1 2 3 Goldin, Melissa; Gregory, John; McDonald, Kendrick (May 25, 2021). "How a well-meaning U.S. government database fuels dangerous vaccine misinformation". Newsweek. Archived from the original on August 12, 2021. Retrieved August 6, 2021.
  20. ↑ Khandelwal, Devika; Backovic, Nick; Miller, Edie (August 12, 2021). "California Woman Behind Anti-Vax Site Outperforming Government Database". Logically . Archived from the original on August 12, 2021. Retrieved January 11, 2023.
  21. ↑ Csefalvay, Chris von (June 13, 2021). "Early evidence for the safety of certain COVID-19 vaccines using empirical Bayesian modeling from VAERS". medRxiv   10.1101/2021.06.10.21258589v1 .
  22. ↑ Gee, Julianne; Marquez, Paige; Su, John; Calvert, Geoffrey M.; Liu, Ruiling; Myers, Tanya; Nair, Narayan; Martin, Stacey; Clark, Thomas; Markowitz, Lauri; Lindsey, Nicole (February 26, 2021). "First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021". Morbidity and Mortality Weekly Report. 70 (8): 283–288. doi:10.15585/mmwr.mm7008e3. ISSN   0149-2195. PMC   8344985 . PMID   33630816.
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