Under the PREP Act program, vaccine producers seem to have very little to no liability for any injuries or deaths arising from a COVID-19 vaccine. It is unclear what benefits the program will provide to individuals. (Credit: Dejan Dundjerski/stock.adobe.com)
The COVID vaccine has brought on some positive health care developments, but, as with most vaccines and drugs on the market, it can also cause side effects ranging from pain, redness and swelling and fatigue to life-threatening blood clots. The possibility of such a severe reaction as blood clots brings forth the question of liability.
Since mid-December, when the first COVID-19 vaccines were administered in the United States, there has been a mad dash to get as many Americans vaccinated as soon as possible with hopes of achieving a level of herd immunity so we may resume our daily lives. The Federal Drug Administration authorized the first vaccine for emergency use on December 11, 2020, and since then, millions have received the vaccine. At the time of this writing, the U.S. is administering around 3,384,387 vaccines per day.
Under the Public Readiness and Emergency Preparedness Act (the PREP Act) countermeasures injury compensation program, health care providers, including manufacturers, have immunity from tort liability. The PREP Act was developed in December 2005 to amend the Public Health Service Act with the goal of addressing liability immunity for organizations that make products that are used in an emergency and authorizes a compensation program through a fund in the United States Treasury to eligible individuals who have sustained serious physical injury or death directly caused by vaccines, drugs, medical devices, or any other measure covered by the declaration of the PREP Act.
According to the Public Health Emergency website, the PREP Act "authorizes the Secretary of the Department of Human Services to issue a PREP Act declaration, providing immunity from liability (with the exception of willful misconduct) for claims:
- of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions;
- determined by the Secretary to constitute a present or credible risk of a future public health emergency;
- determined by the secretary to constitute a present or credible risk of a future public health emergency, and
- to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasure."
One PREP Act declaration and seven amendments have been issued in response to the COVID-19 pandemic over the last year. The Act became effective on February 4, 2020, when then-Secretary of Health and Human Services Alex Azar declared COVID-19 a public health emergency.
Under the PREP Act program, vaccine producers seem to have very little to no liability for any injuries or deaths arising from a COVID-19 vaccine. It is unclear what benefits the program will provide to individuals who have sustained serious physical injury due to the vaccine or the families of those who died after getting the vaccine. Claims are filed with the U.S. Department of Health and Human Services.
PREP Act takes center stage
A discussion of the PREP Act becomes more relevant now as the Johnson and Johnson (J&J) vaccine has been pulled from clinics across the country. The Centers for Disease Control and the Federal Drug Administration released a joint statement recently, stating that there have been six reported U.S. cases of a "rare and severe" type of blood clot in individuals who received the J&J Vaccine, out of more than 6.8 million to whom it had been administered as of April 12.
A seventh possible case, in a 28-year-old woman, was identified on April 14. The cases occurred in women between the ages of 14 to 48 with symptoms appearing a week or two of taking the shot. The women began experiencing headaches, some also experienced muscle aches, chills, fever, back pain and labored breathing, some of which are typical J&J vaccine side effects, but the increasing severity and clotting in their brain's sinus veins and drainage systems were not typical. Of the six confirmed cases, one woman has died, and three remain hospitalized with two in intensive care.
The agencies announced that they were pausing the vaccine out of an "abundance of caution" until review processes of the vaccine were complete.
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