Faceless corporations and complicated medical jargon often fuel concerns about vaccine safety. After all, vaccines are a product, and someone is making money when they are sold. So, it’s easy to see why some people conclude that profit motives drive the vaccine industry and wonder if it is at the expense of vaccine safety.

However, people should be assured by the fact that vaccines, unlike medications, are given to large numbers of healthy people. This means that not only would it be easier to detect a dangerous side effect, but it also means vaccines are held to the highest standards of safety.

That said, the Vaccine Education Center (VEC) gets questions related to pharmaceutical companies and their role in vaccine development and manufacturing. Here are some common questions and concerns.

The government compensates vaccine-injured people. Doesn’t this prove that vaccines cause injuries?

Congress passed the National Childhood Vaccine Injury Act of 1986, which included the creation of the Vaccine Injury Compensation Program (VICP). The Act followed a deluge of personal injury lawsuits resulting from a perceived safety issue with the DTP (diphtheria, tetanus, and whole cell pertussis) vaccine in the early 1980s. The Act was created for two reasons. First, to ensure that individuals harmed by a vaccine are provided fair and efficient compensation; and second, to ensure a stable vaccine supply.

Like medicines, vaccines have mild side effects, such as pain, tenderness or redness at the injection site. Some vaccines can cause rare but more serious side effects, such as an allergic reaction. However, the risks associated with vaccines are miniscule compared with the risks of suffering the diseases they prevent.

Thousands of peer-reviewed, high-quality studies involving hundreds of thousands of people and decades of experience giving vaccines to millions of people have shown that for the overwhelming majority of people, vaccines are safe.

Why are vaccine manufacturers shielded from liability?

A 1982 TV news report entitled Vaccine Roulette suggested that the whole-cell pertussis vaccine was the cause of permanent brain injury. Subsequent studies indicated that while the whole-cell vaccine was associated with febrile seizures, it was not associated with long-term brain damage. However, those studies took at least 10 years to exonerate the vaccine.

In the meantime, as vaccine manufacturers were flooded with lawsuits, some decided to stop making vaccines rather than face continued legal pressures. Consequently, production dropped, leading to concerns about vaccine supply and subsequent vaccination rates.

By shielding vaccine manufacturers from liability, Congress assured that future generations would be protected from devastating diseases. A common misconception is that this process completely shields vaccine makers. However, a plaintiff may file a civil court claim against vaccine companies after filing a claim in the VICP if they reject the vaccine court's decision.

If I suspect my child had a side effect from a vaccine or is vaccine-injured, what can I do?

You should first contact your child’s doctor to discuss your child’s situation, particularly if the symptoms are changing or worsening. You can also talk to the doctor about filing a report with the Vaccine Adverse Effects Reporting System, or VAERS. Anyone can submit a report to VAERS — healthcare professionals, vaccine manufacturers, vaccine recipients, and parents or family members of vaccine recipients. VAERS is a national early-warning system to detect possible vaccine safety problems in U.S.-licensed vaccines.

Reports of an adverse event or possible side effect after vaccination do not necessarily mean that the vaccine caused the specified problem. Rather, VAERS reports help alert scientists to possible cause-and-effect relationships that require further investigation. The law requires doctors to report all adverse events occurring within 30 days of vaccination to VAERS.

A VAERS report is separate from a petition to the Vaccine Court described below.

How does the court decide who is compensated?

Any individual of any age who received a recommended vaccine and believes that they are a victim of vaccine injury can file a petition. Parents, legal guardians and legal representatives can file on behalf of children, disabled adults and the deceased. That process is as follows:

1. A petition is filed in the U.S. Court of Federal Claims.
2. The U.S. Department of Health and Human Services (HHS) reviews the petition. If medical criteria are met, HHS makes a preliminary recommendation for compensation.
3. The Department of Justice (DOJ) develops legal and medical reports and submits them to the court.
4. That DOJ report is presented to a court-appointed special master who makes the final decision whether or not to award compensation and determines the amount. This usually occurs after a hearing in which both parties present evidence.

Compensation is usually awarded for injuries that scientific studies found could be attributed to vaccines that occur according to a widely accepted timeline and symptom pattern. One example is an extreme allergic reaction. Injuries that are compensated can be found on the vaccine injury table.

One important aspect to remember about compensation for vaccine injury is the burden of proof. In order to be compensated, a reasonable burden of proof must be met. Much of the dismay toward the VICP among anti-vaccine activists stems from autism not being included on the vaccine injury compensation table. However, scientific studies have clearly shown that vaccines do not cause autism; therefore, autism is not a compensable injury.

I have heard that all of the safety studies on vaccines were completed by the vaccine manufacturers. Is that true?

While pharmaceutical companies invariably perform studies prior to licensure (usually in tens of thousands of people), many systems are in place after licensure (when the vaccine is given to millions of people) to make sure that the vaccine is safe. In fact, many people, not just those who manufacture vaccines, study vaccine safety. The Food and Drug Administration (FDA) reviews all data associated with studies completed by vaccine manufacturers as well as visiting manufacturing sites and continuing to monitor the vaccine as long as it is being made. Additionally, the CDC has systems in place to monitor vaccine safety, of which vaccine manufacturers are not a part:

• Vaccine Adverse Effects Reporting System (VAERS): As described above, VAERS is continuously monitored for trends in data that would indicate a vaccine safety issue.
• Vaccine Safety DataLink (VSD): A collaboration among eight large healthcare organizations from various parts of the United States. Health records are monitored for vaccine receipt and illnesses to study vaccine safety in an ongoing and controlled manner.
• Clinical Immunization Safety Assessment Project (CISA): A national group of vaccine experts from the CDC, seven medical research centers, and other experts who conduct research around specific vaccine safety concerns, provide consultations for individual healthcare providers on specific patients and review adverse event data.

In addition, the National Academy of Medicine, previously called the Institute of Medicine, periodically conducts comprehensive reviews of the literature to monitor vaccine safety. They completed a review related to adverse effects of vaccines in 2012.

Resources for additional information

• Making Vaccines: Process of Vaccine Development
• Making Vaccines: Licensure, Recommendations and Requirements