If COVID jabs are added to the NVICP

Then what?

Thinking thru the scenarios of what will happen to the COVID-19 vaccines is mindboggling. Just too many different scenarios.

Will they be added to the National Vaccine Injury Compensation Program (NVICP)? Will it be just be the fully licensed, yet to be distributed, BLA versions? A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.

What about the EUA versions? An Emergency Use Authorization, or EUA, is just that — an authorization to distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services. Will the injuries incurred by the EUA see the light of day in the NVICP? What to do with the thousands of petitions submitted from EUA products if not permitted in the NVICP?

One scenario that will probably happen sometime next year or sooner is the BLA version will be added to the NVICP. After all, the CDC has now approved the COVID-19 vaccines for the childhood schedule.

The Sec’y of HHS has enlisted the National Academies of Science - NAS (formally known at the Institute of Medicine - IOM) to develop an injury table for the COVID-19 vaccines. The self-imposed deadline to report back to the Sec’ of HHS is by March 2024.

This report will set in motion how the tens of thousands of petitions will be adjudicated. There is some hope that for the first time, a table will be fair and flexible. But do not get your hopes up yet. The Sec’y of HHS could adopt a table that is similar to the what is being used today for all COVID-19 vaccine injuries in the CounterMeasures Injury Compensation Program (CICP).

The current table was adopted from the SmallPox Vaccine Injury Compensation Program established nearly 20 years ago. I previously wrote about the table here.

Myocarditis and related heart and cardiac conditions are listed on the table. But that leaves most of the petitions out there to fight for non-table or off-table related injuries.

There are two methods of achieving compensation in the NVICP. The injured person (petitioner) must establish a causal link between the vaccine and the injury. One way is to demonstrate the injured party received a licensed vaccine, developed an injury that is stated on the table for that specific vaccine and within a specific time period. If so, the table injury is “presumed” to have caused by the vaccination and the petitioner is entitled to compensation, unless it can be demonstrated that the injury was caused by some other factor not related to the vaccination.

For an example, a person receives the flu vaccine and develops Guillain-Barré syndrome (GBS) no earlier than 3 days and no later than 42 days. GBS is a known injury from the flu vaccine and the injury must manifest itself within a specific time period.

Lets not go down the rabbit hole of how the time periods are determined. I spent nearly 4 months a couple of years ago actively searching for the answers. The science behind it is horrible, stale and in need of actually being updated, some of it over 40 years old.

So a person who develops GBS 20 days after receiving the flu vaccine and has medical records to show the development of the medical condition, generally would be inclined to receive compensation based upon a review by Health Resources Service Administration (HRSA-a sub agency of HHS) medical staff and their analysis which shall lead to an entitlement decision.

The other method of achieving compensation in the NVICP is by proving your injury was caused by the vaccine. It is known as cause-in-fact.

This method, the petitioner must satisfy the “preponderance of evidence” standard. Under this standard, a petitioner must present evidence to support the three prongs of Althen. They are;

1) petitioner must show that it is more probable than not that the vaccination was the cause of the injury. They do not need to show the vaccine was the sole cause, but rather the vaccination was a significant factor.

2) petitioner must provide proof of a logical sequence of cause and effect showing the vaccination was the reason for the injury.

3) a showing of proximate temporal relationship between vaccination and the injury. Timing.

If the petition satisfies this burden, the three prongs of Althen, then the petitioner is entitled for compensation, unless the government shows by a preponderance of the evidence, the injury was caused by some other factor not related to the vaccination.

Seeking compensation via causation-in-fact is not easy. It is highly probable that the government represented by DOJ civil torts division attorneys will fight against most of the injuries from the COVID-19 vaccines. And the burden is very high for the petitioners. For the families who submitted claims from Gardasil or vaccines causing SIDS or autism, it was not a battle about science. It was about protecting policy, the vaccine program.

Yet this process is considerably more fair and equitable for the petitioner versus the current system in the CICP. The petitioner does have the affordability of obtaining an experienced vaccine injury attorney and the use of medical experts to testify on behalf of the petitioner. The fees and costs of the attorney and medical experts are paid from the Vaccine Injury Trust Fund.

What has been described above is the best case scenario for injuries from the COVID-19 vaccines.

There are several questions that need to be answered by the Sec’y of HHS and Congress.

1) How to address all the petitions for injury from the EUA vaccines.

2) How to address the three thousand plus petitions for injury from other countermeasures such as medical devices and anti-viral medicines.

3) If Sec’y of HHS moves COVID-19 vaccines into the NVICP, Congress will have to attach a tax or levy on those specific vaccines to help fund the Injury Trust Fund. What will the levy amount be?

4) All the petitioners from the COVID era that were dismissed because of the very short one year statute of limitations be allowed to prosecute their case in the NVICP?

Keep learning, keep challenging yourself and always, always question authority.

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Wayne Rohde, an author of two books on the National Vaccine Injury Compensation Program.

www.thevaccinecourt.com