2020 has been a difficult year for all. With the approval of the Pfizer and Moderna COVID-19 vaccinations, there is a mix of hope and fear across the country. Four out of ten people have stated that they will not get the vaccine, based on concerns over the safety of the COVID-19 vaccines. Most of the concerns stem from the fact that these mRNA vaccines were created and approved in less than one year, when it typically takes years to develop the vaccine, and test its safety, as reactions may occur months or years down the road. In fact, prior to the 2019 Novel Coronavirus (“COVID-19” or “2019-nCoV”) vaccine, the quickest turnaround for a vaccine was four-years for the mumps vaccine. With such a quick turnaround, (only eight months) there are concerns about adverse reactions, allergic reactions, and the long-term effects of the vaccines. Moreover, with mRNA vaccines being a new “vaccinology”, little is known about the long-term impact of these vaccines on our health.
As the Supreme Court of the United States recognized, vaccines are “unavoidably unsafe”, so many are curious to know, if you are injured, is there any recourse? The short answer is yes, but not against the vaccine manufacturers, administrators, or the FDA directly.
Vaccine manufacturers have been protected from liability for decades, dating back to 1986. Another layer of protection was added in 2005, when the Bush Administration signed into law the Public Readiness and Emergency Preparedness Act, which authorizes the Secretary of the Department of Health and Human Services (“HHS”) to declare that a vaccine manufacturer, along with others involved with the creation and distribution of the vaccine, are immune from liability for claims of loss or injury caused by the administration of the vaccine. This immunity is active for four years, but can be extended. The only exception to this immunity is if there is “willful misconduct” by the company. HHS Secretary Alex Azar invoked the PREP Act in February 2020 to protect COVID-19 manufacturers, distributors, developers, and administrators.