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.
The Countermeasures Injury Compensation Program (CICP) was established under the PREP Act as a narrow route to recover for vaccine injuries. It is a tough route but, if successful, the payoff is substantial – up to $50,000 annually for life. A division of the HHS – the Health Resources and Services Administration (“HRSA”) – manages the CICP. The U.S. Department of Treasury maintains a fund to pay awards to vaccine victims who succeed in a case under the CICP.
In order to be compensated under the CICP, you must submit a “Request Package” to the CICP within one year from the date that you were administered the COVID vaccine – a strict, short statute of repose period. There is no allowance for a discovery period, meaning that your time to file a claim is not delayed until after you experience symptoms. The CICP medical panel will review the submission to determine if your injury is covered pursuant to the CICP table, which restricts recovery to only specific symptoms that occurred within a specific time frame. For example, if you were injured by the H1N1 vaccine, your injury is covered if you experienced symptoms of Guillain Barré Syndrome between 3 and 42 days. If you experienced symptoms of GBS within 48 hours after the vaccine, then you would not be covered. Or, if you experience anaphylaxis within four hours of receiving the vaccine, you also are not covered. A table has not been created for the COVID-19 vaccine yet, but according to the HRSA “requesters who demonstrate that their injury occurred as the direct result of the administration or use of a covered countermeasure based on compelling reliable, valid, medical, and scientific evidence, may be eligible for compensation.” What this means is yet to be interpreted.
In the 10 years of its existence, 499 claims have been submitted to the CICP but only 29, or 5.8%, have been compensated, totaling over $6 million in compensation. Unlike the VICP, which pays for your attorney’s fees, attorney’s fees are not paid by the CICP fund.
The vaccines and other countermeasures covered under the CICP are more rare countermeasures, including COVID-19, Marburg, Ebola, Nerve Agents and Insecticides, Zika, Pandemic Influenza, Anthrax, Acute Radiation Syndrome, Botulinum Toxin, and Smallpox.
If COVID-19 becomes a more routine vaccination, it may be moved from the CICP to the National Vaccine Injury Compensation Program (“VICP”), which covers more routine childhood and adult vaccinations, like the MMR, DTP/DTaP/Tdap, Polio, seasonal flu, and Hepatitis vaccines. Claims under the VICP are filed through the U.S. Court of Federal Claims, commonly referred to as the “Vaccine Court”. For now, the CICP is the only option for the over 550,000 Americans who have received the COVID-19 vaccine in the first week.
The Food and Drug Administration (FDA) is protected by sovereign immunity, so you cannot sue the FDA for approving the vaccine. Questions have also been raised as to whether your employer can require you to receive the COVID-19 vaccination, which is a controversial topic. In short, in the event that an employer requires vaccination, they make be held liable but it would be treated as a workers compensation injury.
Given the short limitations period implemented by the CICP, if you are experiencing any symptoms or adverse reactions since receiving your COVID-19 vaccination, or any other vaccinations, please contact our office for a free evaluation immediately. We handle cases on a contingency fee basis, so we don’t get paid until you do!