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Vaccines are powerful tools that protect individuals and families from serious illnesses and reduce the severity of disease. Because of widespread vaccination, diseases that were once deadly are now nearly eliminated.

The overwhelming benefits of vaccination outweigh the risks, as shown by thousands of peer-reviewed studies involving hundreds of thousands of people and continuous monitoring after approval. However, like any medical intervention, people can experience adverse effects from a vaccine.

The National Vaccine Injury Compensation Program (VICP) was established by the National Childhood Vaccine Injury Act of 1986 to provide fair and timely compensation to those who experience side effects from routinely recommended vaccines. Here’s what you need to know about VICP:

How does the VICP work?
The VICP allows people who claim they were injured by vaccines recommended for routine use by children or pregnant women to seek compensation. Compensation is paid without the need to prove that the manufacturer or health care practitioner did something wrong as would be required in a typical civil lawsuit. In many cases, the vaccine is actually presumed to cause certain injuries under the program, so that the only issue to resolve will be the amount of compensation to be paid.  

How does the VICP make it easier for individuals filing vaccine injury claims?
The VICP reduces the lengthy and costly legal burdens often experienced in traditional civil litigation. In many cases, claims are resolved through negotiations and settlements, so that no court proceedings are required. If someone who files a claim hires a lawyer, they will not owe anything for legal fees, because those are paid by the program. 

Does the VICP shield manufacturers from liability?
The VICP does not shield manufacturers.

The program exists to provide a streamlined process intended to resolve vaccine injury claims efficiently. People can still pursue civil lawsuits against a vaccine manufacturer if they are dissatisfied with the vaccine court’s decision.

Why was the VICP created?
The program was created after lawsuits against vaccine manufacturers threatened to disrupt vaccine production, diminishing the availability of vaccines.

In 1982, a misleading TV report claimed the whole-cell pertussis vaccine caused permanent brain damage, but later studies showed it was linked only to febrile seizures not brain damage - and took over a decade to dispel public fears. In 1984, only one manufacturer of diphtheria, tetanus and pertussis vaccines remained, leading to concerns about decreasing vaccine supply and future vaccination rates, risking the resurgence of vaccine-preventable diseases.

To address this, Congress took bipartisan action to establish a program that would provide compensation for those who experienced vaccine-related injury, while also stabilizing the vaccine market. The VICP relies upon an excise tax on each dose of vaccine administered that is deposited in a trust fund. 

Can the VICP be improved?
The VICP has been a vital part of the vaccine ecosystem for decades, but like any long-standing system, it could potentially benefit from targeted improvements. For example, the VICP relies on a Vaccine Court that is staffed by highly experienced special masters who serve as judicial officers. Increasing the number of those experienced experts to reduce case backlogs might help make the program more efficient and accessible. It is critical that any proposed changes are carefully evaluated and consider the long-term impacts of changing a system that has served public health so well.

The bottom line: The VICP has compensated thousands of injury claims while helping to safeguard the stability of our nation’s vaccine supply. A strong vaccine infrastructure protects Americans from infectious disease outbreaks, upholds U.S. leadership in innovation and strengthens national security. Weakening the VICP would jeopardize patient access to FDA-approved vaccines and leave communities more vulnerable to preventable diseases.

Andrew Powaleny

Andrew Powaleny is the Deputy Vice President of Public Affairs at PhRMA, where he leads communications on scientific, regulatory and intellectual property issues, highlighting the biopharmaceutical industry’s efforts in developing innovative medicines and vaccines while promoting an environment that encourages necessary risk-taking. For five years starting in 2019, he launched and led PhRMA’s grassroots initiative, Voters for Cures, bringing patients and caregivers together to advocate for access to medicine and biopharmaceutical innovation. He also co-founded and co-chaired PRIDE Umbrella, a resource group for LGBTQ+ individuals. Prior to joining PhRMA in 2015, Andrew worked as a communications consultant in Washington, D.C., and as Deputy Press Secretary for the U.S. House Committee on Energy and Commerce under Chairman Fred Upton. He holds a degree in public policy and government from Eastern Connecticut State University, with a minor in music. Outside of work, Andrew enjoys exercise, musical theater and mentoring college students through The Fund for American Studies alumni association.

Andrew Powaleny

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