Vaccine adverse event

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Vaccine adverse event
Other namesVaccine injury
Specialty Emergency medicine

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. [1] The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI). [2]

Contents

AEFIs can be related to the vaccine itself (product or quality defects), to the vaccination process (administration error or stress related reactions) or can occur independently from vaccination (coincidental). [3]

Most vaccine adverse events are mild. Serious injuries and deaths caused by vaccines are very rare, [4] [5] and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO. [6] Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who attribute their children's autism to vaccine injury, [7] despite the fact that vaccines do not cause autism. [8] [9]

Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th century. Some families have won substantial awards from sympathetic juries, even though many public health officials have said that the claims of injuries are unfounded. [10] In response, several vaccine makers stopped production, threatening public health, resulting in laws being passed at several points to shield makers from liabilities stemming from vaccine injury claims. [10]

Adverse events

According to the U.S. Centers for Disease Control and Prevention, while "any vaccine can cause side effects", [11] most side effects are minor, primarily including sore arms or a mild fever. [11] Unlike most medical interventions vaccines are given to healthy people, where the risk of side effects is not as easily outweighed by the benefit of treating existing disease. As such, the safety of immunization interventions is taken very seriously by the scientific community, with constant monitoring of a number of data sources looking for patterns of adverse events. [12]

As the success of immunization programs increases and the incidence of disease decreases, public attention shifts away from the risks of disease to the risk of vaccination. [13] Concerns about immunization safety often follow a pattern. [13] First, some investigators suggest that a medical condition of increasing prevalence or unknown cause is due to an adverse effect of vaccination. The initial study, and subsequent studies by the same investigators, have inadequate methodology, typically a poorly controlled or uncontrolled case series. [13] A premature announcement is made of the alleged adverse effect, which resonates with individuals who have the condition and which underestimates the potential harm of not being vaccinated. The initial study is not reproduced by other investigators. [13] Finally, it takes several years before the public regains confidence in the vaccine. [13]

Controversies in this area revolve around the question of whether the risks of adverse events following immunization outweigh the benefits of preventing infectious disease. In rare cases immunizations can cause serious adverse effects, such as gelatin measles-mumps-rubella vaccine (MMR) causing anaphylaxis, a severe allergic reaction. [13] Allegations particularly focus on disorders claimed to be caused by the MMR vaccine and thiomersal, a preservative used in vaccines routinely given to U.S. infants prior to 2001. Current scientific evidence does not support claims of vaccines causing various disorders. [14] [15]

The debate is complicated by misconceptions around the recording and reporting of adverse events by anti-vaccination activists. [16] According to authorities, anti-vaccination websites greatly exaggerate the risk of serious adverse effects from vaccines and falsely describe conditions such as autism and shaken baby syndrome as vaccine injuries, [17] [18] [19] leading to misconceptions about the safety and effectiveness of vaccines. [20] [21] This has had the result of stigmatizing autistic people and the parents who had them immunized. [22]

Many countries, including Canada, Germany, Japan, and the United States have specific requirements for reporting vaccine-related adverse effects, while other countries including Australia, France, and the United Kingdom include vaccines under their general requirements for reporting injuries associated with medical treatments. [23] : 8–11  A number of countries have programs for the compensation of injuries alleged to have been caused by a vaccination. [23] : 9–44 

United States

Vaccine Injury Compensation Program

In 1988, the National Vaccine Injury Compensation Program (VICP) went into effect to compensate individuals and families of individuals who have been injured by specified childhood vaccines. [24] The VICP was adopted in response to an earlier scare over the pertussis portion of the DPT vaccine. These claims were later generally discredited, but some U.S. lawsuits against vaccine makers won substantial awards; most makers ceased production, and the last remaining major manufacturer threatened to do so. [25] As of October 2019, $4.2 billion in compensation (not including attorneys fees and costs) has been awarded. [26]

VICP uses a streamlined system for litigating vaccine injury claims under which the claimant must show that the vaccine caused the injury, but just as in litigation for injury by any other product, they are not required to establish it was anyone's fault (i.e. negligence need not be proven) [27] Claims that are denied can be pursued through civil lawsuits, though this is rare, and the statute creating the VICP also imposes substantial limitations on the ability to pursue such lawsuits. The VICP covers all vaccines listed on the Vaccine Injury Table [28] which is maintained by the Secretary of Health and Human Services. To win an award, a claimant is required to show a causal connection between an injury and one of the vaccines listed in the Vaccine Injury Table. Compensation is payable for "table" injuries, those listed in the Vaccine Injury Table, as well as, "non-table" injuries, injuries not listed in the table. [29]

In addition, an award may only be given if the claimant's injury lasted for more than 6 months after the vaccine was given, resulted in a hospital stay and surgery or resulted in death. Awards are based on medical expenses, lost earnings and pain and suffering (capped at $250,000). [30]

From 1988 until March 3, 2011, 5,636 claims relating to autism, and 8,119 non-autism claims, were made to the VICP. 2,620 of these claims, one autism-related, were compensated, with 4,463 non-autism and 814 autism claims dismissed; awards (including attorney's fees) totaled over $2 billion. The VICP also applies to claims for injuries sustained before 1988; there were 4,264 of these claims of which 1,189 were compensated with awards totaling $903 million. [28] As of October 2019, $4.2 billion in compensation (not including attorneys fees and costs) has been awarded over the life of the program. [26]

As part of NVICP, a table has been created which lists various vaccines, side effects that might plausibly be caused by them, and the time within which the symptoms must present in order to be eligible to apply for compensation. [31] [32] For example, for vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or TT), anaphylaxis within four hours or brachial neuritis between two and twenty-eight days after administration, may be compensated. [33]

Countermeasures Injury Compensation Program

Established by PREP Act, [34] in the case of pandemic, epidemic, or other major security threat requiring a medical countermeasures, such as vaccines and medications, the CICP provides compensation to eligible individuals for serious physical injuries or death. [35] Covid-19 vaccines are covered under the program. [36] [37]

Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). [38]

VAERS is intended to track adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events that occur after the administration of US licensed vaccines. VAERS has several limitations, including underreporting, [39] unverified reports, inconsistent data quality, and inadequate data about the number of people vaccinated. [40] 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. [40] [41] [42]

The Vaccine Safety Datalink (VSD), funded by the Centers for Disease Control, is composed of databases from several organizations containing information regarding health outcomes for millions of US citizens and to enhance assessment of vaccine injuries. It was designed to allow for such things as comparisons between vaccinated and non-vaccinated populations, and for the identification of possible groups at risk for adverse events.[ citation needed ]

United Kingdom

The Vaccine Damage Payment Act 1979 governs AEFIs in the UK, and sets up the Vaccine Damage Payment Scheme (VDPS).

Vaccine Damage Payment Scheme

Under the VDPS, it is thought that thousands of unsuccessful claims have been made. The maximum payment per claim is currently £120,000. The 'disability threshold' before payments are granted is 60%. The scheme covers vaccinations for illnesses such as tetanus, measles, tuberculosis, and meningitis C. As of 2005, the British government had paid out £3.5 million to vaccine injury patients since 1997. [43]

Until the advent of COVID-19, disabled vaccine injury patients were allowed to file a claim up to the age of 21.[ citation needed ] On the 2 December 2020, government agreed under regulation secondary to the 1979 Act the statutory £120,000 blanket payout for any person provably damaged by the vaccine, and by the same addition of COVID-19 to the list, government-approved Covax manufacturers were exempted from legal pursuit. Individuals who provide the vaccine (and thus are permitted by government to do so) are also protected. [44]

Canada

Quebec has a legal process to compensate certain forms of vaccination injuries; the program was set up by statute in 1985, [45] and its first awards were made in 1988. [46]

On 10 December 2020, the nations was made aware via an op-ed published in the Globe and Mail that "Canada needs to prepare for rare but serious health problems resulting from [Covid-19] vaccination" by, inter alia, the Honourable Dr Jane Philpott, former cabinet member and Dean of the Faculty of Health Sciences of Queen's University. The authors observed that, outside of Quebec, "People suffering severe AEFIs are left to assume the costs of legal fees, lost wages, uninsured medical services and rehabilitation supports", and plumped for a no-fault system, in which "compensation is needs-based and not punitive." [45] They go on to write:

In the context of the COVID-19 pandemic, we are concerned that, given the anticipated scale of the COVID-19 immunization campaign and new vaccine technologies employed, mass immunization may result in a small number of Canadians experiencing serious AEFIs, despite adherence to best practices. While AEFIs are possible with routine immunizations, pandemic situations are unique with respect to the speed and scale with which vaccine technologies are developed and distributed. Rare serious AEFIs may not be captured during phases of clinical trials because it may require very large numbers of the population to be immunized for AEFIs to manifest. The anticipated incidence of serious AEFIs can be estimated at 1 in one million immunizations... the potential health consequences of adverse events following immunization borne by the few will be for our collective benefit in stopping the deadly spread of the virus. Operating under this estimate, we anticipate 25 Canadians may suffer a serious health outcome following COVID-19 vaccination, or 0.1 per 100,000 doses.

The authors conclude that an "equitable and fair compensation system with a transparent accountability process for monitoring potential AEFIs associated with COVID-19 immunization could increase public confidence in vaccines and promote uptake." [45]

Germany

Germany has established a treatment and research centre for VAEs at Marburg University Hospital (UKGM). [47] [48] [49]

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</span> Pathogen-derived preparation that provides acquired immunity to an infectious disease

A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and recognize further and destroy any of the microorganisms associated with that agent that it may encounter in the future.

<span class="mw-page-title-main">MMR vaccine</span> Combined vaccine against measles, mumps, and rubella

The MMR vaccine is a vaccine against measles, mumps, and rubella, abbreviated as MMR. The first dose is generally given to children around 9 months to 15 months of age, with a second dose at 15 months to 6 years of age, with at least four weeks between the doses. After two doses, 97% of people are protected against measles, 88% against mumps, and at least 97% against rubella. The vaccine is also recommended for those who do not have evidence of immunity, those with well-controlled HIV/AIDS, and within 72 hours of exposure to measles among those who are incompletely immunized. It is given by injection.

<span class="mw-page-title-main">Thiomersal</span> Organomercury antiseptic and antifungal agent

Thiomersal (INN), or thimerosal, also sold under the name merthiolate is an organomercury compound. It is a well-established antiseptic and antifungal agent.

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. 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. Although adverse effects associated with vaccines are occasionally observed, 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 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). VAERS is a postmarketing surveillance program, collecting information about adverse events that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.

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.

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.

Concerns about thiomersal and vaccines are commonly expressed by anti-vaccine activists. Claims relating to the safety of thiomersal, a mercury-based preservative used in vaccines, are refuted, but still subject to fearmongering, notably claims it could cause neurological disorders such as autism, leading to its removal from most vaccines in the US childhood schedule. This had no effect on the rates of diagnosis of pervasive developmental defects, including autism. Extensive scientific research shows no credible evidence linking thiomersal to such conditions.

<span class="mw-page-title-main">National Vaccine Injury Compensation Program</span> U.S. no-fault system for litigating vaccine injury claims

The Office of Special Masters of the U.S. Court of Federal Claims, popularly known as "vaccine court", administers a no-fault system for litigating vaccine injury claims. These claims against vaccine manufacturers cannot normally be filed in state or federal civil courts, but instead must be heard in the U.S. Court of Federal Claims, sitting without a jury.

Claims of a link between the MMR vaccine and autism have been extensively investigated and found to be false. The link was first suggested in the early 1990s and came to public notice largely as a result of the 1998 Lancet MMR autism fraud, characterised as "perhaps the most damaging medical hoax of the last 100 years". The fraudulent research paper, authored by Andrew Wakefield and published in The Lancet, falsely claimed the vaccine was linked to colitis and autism spectrum disorders. The paper was retracted in 2010 but is still cited by anti-vaccine activists.

<span class="mw-page-title-main">2009 swine flu pandemic vaccine</span> Protection against the H1N1/09 virus

The 2009 swine flu pandemic vaccines were influenza vaccines developed to protect against the pandemic H1N1/09 virus. These vaccines either contained inactivated (killed) influenza virus, or weakened live virus that could not cause influenza. The killed virus was injected, while the live virus was given as a nasal spray. Both these types of vaccine were produced by growing the virus in chicken eggs. Around three billion doses were produced, with delivery in November 2009.

A Vaccine Information Statement (VIS) is a document designed by the Centers for Disease Control and Prevention (CDC) to provide information to a patient receiving a vaccine in the United States. The National Childhood Vaccine Injury Act requires that medical professionals provide a VIS to patients before receiving certain vaccinations. The VIS includes information about the vaccine's benefits and risks, a description of the vaccine, indications and contraindications, instructions for patients experiencing an adverse reaction, and additional resources.

<i>Cedillo v. Secretary of Health and Human Services</i> Legal case in US Court of Federal Claims, decided in 2009

Michelle Cedillo v. Secretary of Health and Human Services, also known as Cedillo, was a court case involving the family of Michelle Cedillo, an autistic girl whose parents sued the United States government because they believed that her autism was caused by her receipt of both the measles-mumps-and-rubella vaccine and thimerosal-containing vaccines. The case was a part of the Omnibus Autism Proceeding, where petitioners were required to present three test cases for each proposed mechanism by which vaccines had, according to them, caused their children's autism; Cedillo was the first such case for the MMR-and-thimerosal hypothesis.

Extensive investigation into vaccines and autism spectrum disorder has shown that there is no relationship between the two, causal or otherwise, and that vaccine ingredients do not cause autism. The American scientist Peter Hotez researched the growth of the false claim and concluded that its spread originated with Andrew Wakefield's fraudulent 1998 paper, and that no prior paper supports a link.

Shoulder injury related to vaccine administration (SIRVA) is "shoulder pain and limited range of motion occurring after the administration of a vaccine intended for intramuscular administration in the upper arm... thought to occur as a result of unintended injection of vaccine antigen or trauma from the needle into and around the underlying bursa of the shoulder".

<span class="mw-page-title-main">Vaccination policy of the United States</span> Overview of the vaccination policy in the United States of America

Vaccination policy of the United States is the subset of U.S. federal health policy that deals with immunization against infectious disease. It is decided at various levels of the government, including the individual states. This policy has been developed over the approximately two centuries since the invention of vaccination with the purpose of eradicating disease from the U.S. population, or creating a herd immunity. Policies intended to encourage vaccination impact numerous areas of law, including regulation of vaccine safety, funding of vaccination programs, vaccine mandates, adverse event reporting requirements, and compensation for injuries asserted to be associated with vaccination.

Misinformation related to immunization and the use of vaccines circulates in mass media and social media in spite of the fact that there is no serious hesitancy or debate within mainstream medical and scientific circles about the benefits of vaccination. Unsubstantiated safety concerns related to vaccines are often presented on the internet as being scientific information. A large proportion of internet sources on the topic are mostly inaccurate which can lead people searching for information to form misconceptions relating to vaccines.

References

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