Among the unexpected changes that came with 2020 and 2021 were the rapid development, testing, and administration of more than 300 million COVID-19 vaccines. Despite the effectiveness of the vaccine, the decision to be vaccinated remains a highly divisive topic. Notwithstanding the overwhelming data demonstrating the safety and effectiveness of the vaccines, there have been some adverse reactions creating doubt as to the safety of the vaccines.
Luckily, there is a little-known federal program specifically to help people that have an adverse reaction to a vaccine. That program is the National Vaccine Injury Compensation Program (NVICP), more commonly referred to as the Vaccine Program.
The government’s Vaccine Program was developed in 1986 in response to a noticeable rise in lawsuits brought against vaccine manufacturers. The basis for those lawsuits was that the vaccine manufacturer failed to warn about the potential side effects. The increasing number of lawsuits continued causing the price of vaccine production to soar, which forced some vaccine manufacturers to stop production. This began to create a vaccine shortage in the United States.
The shortage came at a time when the United States was beginning to see the eradication – because of vaccinations — of serious, highly contagious conditions such as polio and measles. Wanting to continue this positive trend and provide support for research and development of vaccines, Congress passed the National Childhood Vaccine Injury Act in 1986. Part of the Act established the Vaccine Program. Its sole purpose was to provide an avenue to compensate individuals who experience a rare adverse reaction to a covered vaccine.
Funding for the Vaccine Program comes from a $.75 excise tax taken from each administered vaccine in the United States. That small tax goes to a fund, which is used to pay damages to individuals who make a claim in the Vaccine Program. Since its implementation in 1988, 24,084 claims have been filed and $4.5 billion has been paid in damages.
To receive compensation from the Vaccine Program, a claim must be filed in the United States Court of Federal Claims. Among other requirements, an individual who wants to make a claim in the Vaccine Program must have received a covered vaccine and been injured thereafter. An attorney from the Department of Justice is responsible for responding to the claim and defending the fund. All the proceedings for the claim are heard and decided by a Special Master (functioning as a Judge).
To help remove barriers to entry and make the Vaccine Program accessible, attorney’s fees are paid by the fund regardless of the outcome, assuming the case is brought in good faith. Any attorney who has been admitted to practice in the U.S. Court of Federal Claims can bring a claim on behalf of an injured party. Even with all of these benefits, the Vaccine Program remains relatively unknown, even amongst physicians who treat patients with vaccine-related injuries.
While the Vaccine Program covers the most common vaccines administered in the United States, such as measles, seasonal flu, and whooping cough (DTaP or Tdap), the COVID-19 vaccines are not included because of their emergency approval status. Congress can add the COVID-19 vaccines as covered vaccines if and when they receive full approval from the FDA, which Pfizer and Moderna have applied to receive.
Although compensation for vaccine-injured individuals and liability protection for COVID-19 vaccine manufacturers exists while the vaccines have emergency approval status, it is more limited than the Vaccine Program. Full FDA approval would remove those protections, potentially causing consequences similar to those seen before the existence of the Vaccine Program. To protect individuals and manufacturers, Congress is likely to amend the list of covered vaccines to include the COVID-19 vaccines. This would be especially true if booster vaccinations are recommended for continued immunity against the COVID-19 variants.
The polarizing and political nature of the COVID-19 vaccines often distract from how extremely effective they have been in reducing the amount of serious complications and deaths arising from the virus. As virus variants remain an ever-present threat, the need for vaccination will continue. This underscores the importance of providing a means of compensation for rare adverse reactions that may come from any widely administered medicine, while also providing some protection to the vaccine manufacturers.
About the Author
Scharli Branch is a licensed Texas attorney, admitted to practice in the Court of Federal Claims. She spent two years at the United States Court of Federal Claims-Office of Special Masters analyzing and drafting decisions on hundreds of vaccine claims. She currently works as a healthcare litigation associate at Cantey Hanger, LLP in Fort Worth, Texas. Ms. Branch can be reached through her email address at sbranch@staging.poised-team.flywheelsites.com.