Will the National Vaccine Injury Compensation Program Be Busy in 2021 (and Beyond)?

The recent withdrawal of emergency use authorization for hydroxychloroquine and chloroquine got us thinking about the implications of rushing Covid-19 remedies—and more specifically, vaccines. “Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, recently said that by the beginning of 2021 the United States hopes 100 million doses of a Covid-19 vaccine will be available.

Depending on when the coronavirus first appeared in humans, there will be a vaccine for it within 10-15 months as opposed to years. We all hope the heroic efforts of the public and private sectors working together to make that happen will result in a safe and effective vaccine. In the unfortunate event the vaccine does not prove to be safe, on some level, civil lawsuits would almost surely bankrupt companies involved in the manufacture of the vaccine(s). The U.S. has a system in place to attempt to keep that from happening, known as the National Vaccine Injury Compensation Program.

The VICP is a no-fault alternative to lawsuits that was created in the 1980s. Any individual who received a “covered vaccine” and believes he or she was injured can file a petition with the U.S. Court of Federal Claims. There is a review process that ultimately results in a decision by a court appointed special master as to whether the claimant will be compensated or not. Claimants who reject the decision may file a suit against the vaccine company and/or health care provider who administered the vaccine. It will be interesting to follow how the companies, insurance carriers and government respond to the risks associated with potential claims related to a Covid-19 vaccine.

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  1. Brian Dean Abramson

    I have actually been writing about this exact question quite a bit lately. In the short term, the NVICP will most likely be no busier than usual, as countermeasures to COVID-19 (including any vaccine developed for it) are covered by Secretary of HHS Alex Azar’s February 2020 invocation of the Public Readiness and Emergency Preparedness Act (PREP Act). Injuries attributed by covered countermeasures are covered exclusively under that act’s Countermeasures Injury Compensation Program (CICP), which has some important differences from the NVICP. Under the CICP, the statute of limitations to file is a year from the administration of the countermeasure (as opposed to the various longer terms provided by the NVICP, which instead run from the first symptom of injury appearing). The CICP only covers a nebulous class of “serious injuries” and has fewer categories of compensable damages. The period of the PREP Act invocation has been set through, I believe, October 2024, so there is no incentive in that period for HHS to add a COVID-19 vaccine to the list of NVICP-covered vaccines.

    As for the NVICP, the current epidemic has led to a drop in overall vaccination rates, as people are less at ease with going to doctor’s offices and pharmacies to receive vaccinations for themselves or their children. This may reverse course as concerns about the pandemic wane, but until it does, it is likely to effect a reduction in vaccination-attributed injuries.

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